Anxiety Disorders, Complex Regional Pain Syndrome Type II, Depressive Disorders, Post-Traumatic Stress Disorder, Substance Abuse
Conditions
Keywords
Anesthesia, Regional, Causalgia, Trauma, Complex Regional Pain Syndrome Type II, Neuropathic Pain, PTSD, Combat Stress Disorders, Afghan War, 2001-, Iraq War, 2003-
Brief summary
The purpose of this study is to examine the short and long-term benefits of implementing early regional anesthesia techniques for pain control after a major traumatic injury to one or more extremities during combat in the Iraqi/Afghanistan war, including the effects on acute and chronic pain, quality of life, and mental health.
Detailed description
BACKGROUND: Adequate pain management for combat casualties balances the need for emergent, life-saving care with the urgency to remove soldiers from harm's way. Control of pain in traumatic battlefield situations may be impossible until safe evacuation to a surgical facility is achieved and a wounded soldier can receive general anesthesia. Recent evidence suggests that neural plasticity in the central nervous system coupled with hyperstimulation of central neuronal pathways lead to neuropathological remodeling. This neural rewiring may result in chronic pain for patients who have experienced severe, unrelieved acute pain. In addition, the stress of combat along with the suffering of prolonged uncontrolled pain may contribute to psychological disorders, such as post-traumatic stress disorder, depression, and substance abuse. OBJECTIVE: The purpose of this study is to evaluate the effect of early and aggressive advanced regional anesthesia on the chronic neuropathic pain, health related quality of life, and mental health of Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) Veterans who have suffered a major limb injury in combat. An additional aim of this study is to quantify and characterize the short-term and long-term effects of traumatic combat limb injuries on post-injury acute pain, chronic pain, health related quality of life, functional status, social reintegration, psychological adjustment, and substance abuse behaviors in a population of injured military personnel. METHOD: This study employs a cohort repeated measures study design involving prospective data collection at scheduled intervals. Interviews with participants provide data on pain outcomes, psychiatric morbidities, and quality of life. Follow up evaluations conclude at the two year anniversary of the start of combat injury rehabilitation. Medical records information collected retrospectively from armed services treatment facilities provide data on the use of pain management therapies as well as individual responses to regional anesthesia. IMPLICATIONS FOR RESULTS: The findings of this study may impact the clinical field by providing information on the effectiveness and benefits of early advanced regional anesthesia for chronic pain control. This study may also provide data to determine whether regional anesthesia pain treatments prevent or reduce the development of psychological maladjustment disorders such as post-traumatic stress disorder, depression, and substance abuse in a population of military personnel with combat limb injuries.
Interventions
PROCEDURERegional Anesthesia
Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.
PROCEDUREStandard Pain Management Protocol
Intermittent dosing of analgesics and anxiolytics instituted prior to continuous intravenously dosing which was individually titrated to patient care goals.
Sponsors
Walter Reed National Military Medical Center
Brooke Army Medical Center
University of Pennsylvania
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Major injury in one or more extremities requiring hospitalization and inpatient rehabilitation.
Exclusion criteria
* Major head trauma * Cognitive deficits * Inability to concentrate * Poor judgment and impulse control * Substantial hearing loss * Bilateral upper extremity amputation with no alternate means to complete the survey forms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropathic Pain Scale - Pain Intensity | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense pain imaginable. |
| Neuropathic Pain Scale - Overall Pain Quality | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch. |
| Neuropathic Pain Scale - Total Score | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The NPS total score is an average of all ten items. |
| Brief Pain Inventory - Worst Pain | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine. |
| Brief Pain Inventory - Average Pain | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine. |
| Brief Pain Inventory - Pain Interference | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where 0 is pain from combat limb injury does not interfere and 10 is pain from combat limb injury completely interferes with this aspect of daily life. |
| Brief Pain Inventory - Treatment Relief | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief. |
| SF-36 Physical Component Summary | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996 |
| SF-36 Mental Component Summary | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996 |
| Post Traumatic Stress Disorder (PTSD) Total Severity | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms. |
| Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. |
| Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied. |
| Treatment Outcomes in Pain Survey (TOPS):Life Control | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. |
| Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. |
| Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied. |
| Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. |
| Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. |
Countries
United States
Participant flow
Recruitment details
Six hundred eighty-seven (687) combat-injured military service members hospitalized with at least one major limb injury were assessed for eligibility as an inpatient at one of two military treatment facilities. Three hundred one (301) of these patients did not meet criteria for study enrollment.
Pre-assignment details
Three hundred eighty-six (386) participants provided study data. Twenty-Eight (28) of these participants were excluded from group observation due to completion of less than two study visits.
Participants by arm
| Arm | Count |
|---|---|
| RA Within 7 Days From Injury During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | 126 |
| RA 8 - 14 Days From Injury During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | 42 |
| RA > 14 Days From Injury During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. | 20 |
| No Regional Anesthesia (RA) During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia. | 170 |
| Total | 358 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | completion of less than two study visits | 6 | 3 | 4 | 14 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Total | No Regional Anesthesia (RA) | RA > 14 Days From Injury | RA 8 - 14 Days From Injury | RA Within 7 Days From Injury |
|---|---|---|---|---|---|
| Age, Continuous | 28.04 years STANDARD_DEVIATION 7.1 | 28.15 years STANDARD_DEVIATION 7.87 | 29.08 years STANDARD_DEVIATION 8.97 | 26.68 years STANDARD_DEVIATION 4.8 | 28.20 years STANDARD_DEVIATION 6.3 |
| Education Bachelor's Degree or Higher | 65 participants | 24 participants | 3 participants | 6 participants | 32 participants |
| Education High School/GED | 147 participants | 74 participants | 8 participants | 18 participants | 47 participants |
| Education Some College | 146 participants | 72 participants | 9 participants | 18 participants | 47 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 19 Participants | 4 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 313 Participants | 151 Participants | 16 Participants | 34 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Injury Severity Score (ISS) | 18.37 units on a scale STANDARD_DEVIATION 10.79 | 18.07 units on a scale STANDARD_DEVIATION 11.57 | 24.65 units on a scale STANDARD_DEVIATION 12.59 | 19.74 units on a scale STANDARD_DEVIATION 11.88 | 17.31 units on a scale STANDARD_DEVIATION 8.56 |
| Length of Initial Hospital Stay | 36.69 months STANDARD_DEVIATION 33.35 | 27.95 months STANDARD_DEVIATION 30.72 | 59.90 months STANDARD_DEVIATION 47.64 | 47.45 months STANDARD_DEVIATION 33.74 | 41.14 months STANDARD_DEVIATION 30.54 |
| Marital Status Married or Living w/Partner | 172 participants | 67 participants | 13 participants | 22 participants | 70 participants |
| Marital Status Never Married | 166 participants | 89 participants | 7 participants | 19 participants | 51 participants |
| Marital Status Separated/Divorced | 20 participants | 14 participants | 0 participants | 1 participants | 5 participants |
| Number of Deployments, Continuous | 1.97 deployments STANDARD_DEVIATION 1.25 | 1.85 deployments STANDARD_DEVIATION 1.05 | 2.40 deployments STANDARD_DEVIATION 2.54 | 1.80 deployments STANDARD_DEVIATION 0.9 | 2.13 deployments STANDARD_DEVIATION 1.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 6 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 6 Participants | 0 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 12 Participants | 2 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 36 Participants | 17 Participants | 1 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 278 Participants | 129 Participants | 17 Participants | 31 Participants | 101 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 355 Participants | 168 Participants | 20 Participants | 41 Participants | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 0 / 42 | 0 / 20 | 0 / 170 |
| serious Total, serious adverse events | 0 / 126 | 0 / 42 | 0 / 20 | 0 / 170 |
Outcome results
Primary
Brief Pain Inventory - Average Pain
The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Brief Pain Inventory - Average Pain | 2.18 units on the Brief Pain Inventory Scale | Standard Error 0.13 |
| RA 8 - 14 Days From Injury | Brief Pain Inventory - Average Pain | 2.45 units on the Brief Pain Inventory Scale | Standard Error 0.23 |
| RA > 14 Days From Injury | Brief Pain Inventory - Average Pain | 3.21 units on the Brief Pain Inventory Scale | Standard Error 0.42 |
| No RA | Brief Pain Inventory - Average Pain | 2.45 units on the Brief Pain Inventory Scale | Standard Error 0.13 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.03702, -0.0185]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.2752Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.109495% CI: [-0.6851, 0.06941]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.878695% CI: [-0.5079, 0.5935]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.084795% CI: [-0.09297, 1.4448]Mixed Models Analysis
Primary
Brief Pain Inventory - Pain Interference
The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where 0 is pain from combat limb injury does not interfere and 10 is pain from combat limb injury completely interferes with this aspect of daily life.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Brief Pain Inventory - Pain Interference | 1.91 units on the Brief Pain Inventory Scale | Standard Error 0.15 |
| RA 8 - 14 Days From Injury | Brief Pain Inventory - Pain Interference | 2.03 units on the Brief Pain Inventory Scale | Standard Error 0.25 |
| RA > 14 Days From Injury | Brief Pain Inventory - Pain Interference | 2.57 units on the Brief Pain Inventory Scale | Standard Error 0.46 |
| No RA | Brief Pain Inventory - Pain Interference | 1.88 units on the Brief Pain Inventory Scale | Standard Error 0.14 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.04808, -0.02481]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.3677Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.792695% CI: [-0.4929, 0.3766]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.595395% CI: [-0.461, 0.8026]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.126195% CI: [-0.1943, 1.5689]Mixed Models Analysis
Primary
Brief Pain Inventory - Treatment Relief
The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Brief Pain Inventory - Treatment Relief | 67.53 percentage of pain relief | Standard Error 2.39 |
| RA 8 - 14 Days From Injury | Brief Pain Inventory - Treatment Relief | 66.80 percentage of pain relief | Standard Error 3.04 |
| RA > 14 Days From Injury | Brief Pain Inventory - Treatment Relief | 58.58 percentage of pain relief | Standard Error 4.88 |
| No RA | Brief Pain Inventory - Treatment Relief | 66.77 percentage of pain relief | Standard Error 1.86 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.000295% CI: [-0.7286, -0.2377]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.3617Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.253295% CI: [-2.2715, 8.5863]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.75895% CI: [-6.5833, 9.0286]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.183795% CI: [-17.7484, 3.4187]Mixed Models Analysis
Primary
Brief Pain Inventory - Worst Pain
The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where 0 is no pain, and 10 is pain as bad as you can imagine.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Brief Pain Inventory - Worst Pain | 4.54 units on the Brief Pain Inventory Scale | Standard Error 0.18 |
| RA 8 - 14 Days From Injury | Brief Pain Inventory - Worst Pain | 4.95 units on the Brief Pain Inventory Scale | Standard Error 0.36 |
| RA > 14 Days From Injury | Brief Pain Inventory - Worst Pain | 5.83 units on the Brief Pain Inventory Scale | Standard Error 0.44 |
| No RA | Brief Pain Inventory - Worst Pain | 4.62 units on the Brief Pain Inventory Scale | Standard Error 0.19 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: <0.000195% CI: [-0.5446, -0.02613]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.3631Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.714895% CI: [-0.6404, 0.4396]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.374195% CI: [-0.4318, 1.1453]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.021395% CI: [0.1938, 2.4]Mixed Models Analysis
Primary
Neuropathic Pain Scale - Overall Pain Quality
The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Neuropathic Pain Scale - Overall Pain Quality | 1.90 units on the Neuropathic Pain Scale | Standard Error 0.11 |
| RA 8 - 14 Days From Injury | Neuropathic Pain Scale - Overall Pain Quality | 2.04 units on the Neuropathic Pain Scale | Standard Error 0.2 |
| RA > 14 Days From Injury | Neuropathic Pain Scale - Overall Pain Quality | 2.13 units on the Neuropathic Pain Scale | Standard Error 0.27 |
| No RA | Neuropathic Pain Scale - Overall Pain Quality | 1.82 units on the Neuropathic Pain Scale | Standard Error 0.1 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.03076, -0.01589]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.4772Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.607795% CI: [-0.2184, 0.3729]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.361695% CI: [-0.2311, 0.6319]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.315595% CI: [-0.2948, 0.9112]Mixed Models Analysis
Primary
Neuropathic Pain Scale - Pain Intensity
The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where 0 is no pain and 10 is the most intense pain imaginable.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Neuropathic Pain Scale - Pain Intensity | 3 units on the Neuropathic Pain Scale | Standard Error 0.16 |
| RA 8 - 14 Days From Injury | Neuropathic Pain Scale - Pain Intensity | 3.44 units on the Neuropathic Pain Scale | Standard Error 0.3 |
| RA > 14 Days From Injury | Neuropathic Pain Scale - Pain Intensity | 3.92 units on the Neuropathic Pain Scale | Standard Error 0.45 |
| No RA | Neuropathic Pain Scale - Pain Intensity | 3.04 units on the Neuropathic Pain Scale | Standard Error 0.15 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.0448, -0.02013]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.4492Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.6495% CI: [-0.5621, 0.3461]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.328695% CI: [-0.3334, 0.9932]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.069495% CI: [-0.06841, 1.7866]Mixed Models Analysis
Primary
Neuropathic Pain Scale - Total Score
The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where 0 is no pain and 10 is the most intense sensation imaginable. The NPS total score is an average of all ten items.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Neuropathic Pain Scale - Total Score | 2.35 units on the Neuropathic Pain Scale | Standard Error 0.12 |
| RA 8 - 14 Days From Injury | Neuropathic Pain Scale - Total Score | 2.60 units on the Neuropathic Pain Scale | Standard Error 0.22 |
| RA > 14 Days From Injury | Neuropathic Pain Scale - Total Score | 2.80 units on the Neuropathic Pain Scale | Standard Error 0.31 |
| No RA | Neuropathic Pain Scale - Total Score | 2.29 units on the Neuropathic Pain Scale | Standard Error 0.11 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.03573, -0.01919]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.3345Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.822395% CI: [-0.2993, 0.3765]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.244895% CI: [-0.2009, 0.7848]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.201495% CI: [-0.2405, 1.1369]Mixed Models Analysis
Primary
Post Traumatic Stress Disorder (PTSD) Total Severity
Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Post Traumatic Stress Disorder (PTSD) Total Severity | 27.99 units on the PCL scale | Standard Error 1.1 |
| RA 8 - 14 Days From Injury | Post Traumatic Stress Disorder (PTSD) Total Severity | 30.23 units on the PCL scale | Standard Error 1.98 |
| RA > 14 Days From Injury | Post Traumatic Stress Disorder (PTSD) Total Severity | 25.62 units on the PCL scale | Standard Error 2 |
| No RA | Post Traumatic Stress Disorder (PTSD) Total Severity | 27.63 units on the PCL scale | Standard Error 0.87 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.193895% CI: [-0.02369, 0.1165]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.4884Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.659395% CI: [-2.1348, 3.3696]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.088995% CI: [-0.528, 7.4431]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.872795% CI: [-5.9692, 5.0694]Mixed Models Analysis
Primary
SF-36 Mental Component Summary
The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | SF-36 Mental Component Summary | 52.47 t-score | Standard Error 1.11 |
| RA 8 - 14 Days From Injury | SF-36 Mental Component Summary | 52.12 t-score | Standard Error 1.84 |
| RA > 14 Days From Injury | SF-36 Mental Component Summary | 49.90 t-score | Standard Error 2.94 |
| No RA | SF-36 Mental Component Summary | 51.30 t-score | Standard Error 0.82 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.2987, -0.1352]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.095Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.587895% CI: [-1.9056, 3.3547]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.905395% CI: [-4.3231, 3.8299]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.468295% CI: [-8.7034, 4.012]Mixed Models Analysis
Primary
SF-36 Physical Component Summary
The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | SF-36 Physical Component Summary | 40.30 t-score | Standard Error 0.96 |
| RA 8 - 14 Days From Injury | SF-36 Physical Component Summary | 37.00 t-score | Standard Error 1.72 |
| RA > 14 Days From Injury | SF-36 Physical Component Summary | 31.51 t-score | Standard Error 2.05 |
| No RA | SF-36 Physical Component Summary | 41.94 t-score | Standard Error 0.92 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [0.3971, 0.5511]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.6075Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.455895% CI: [-3.4675, 1.5607]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.091495% CI: [-7.2442, 0.5432]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.00795% CI: [-14.4589, -2.281]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance | 41.85 units on TOPS scale | Standard Error 2.07 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance | 43.57 units on TOPS scale | Standard Error 3.65 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance | 51.27 units on TOPS scale | Standard Error 6.29 |
| No RA | Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance | 40.62 units on TOPS scale | Standard Error 1.91 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: <0.000195% CI: [-0.6973, -0.3486]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.18Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.415195% CI: [-3.253, 7.857]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.315795% CI: [-4.1592, 12.8344]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.091195% CI: [-1.904, 25.5541]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction | 61.01 units on TOPS scale | Standard Error 1.8 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction | 56.29 units on TOPS scale | Standard Error 3.54 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction | 47.68 units on TOPS scale | Standard Error 4.67 |
| No RA | Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction | 58.77 units on TOPS scale | Standard Error 1.68 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.001695% CI: [-0.4675, -0.11]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.0966Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.219595% CI: [-1.7938, 7.7697]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.510595% CI: [-9.8289, 4.9018]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.090395% CI: [-22.4174, 1.6433]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS):Life Control
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS):Life Control | 75.82 units on TOPS scale | Standard Error 1.92 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS):Life Control | 68.02 units on TOPS scale | Standard Error 4.15 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS):Life Control | 58.52 units on TOPS scale | Standard Error 5.76 |
| No RA | Treatment Outcomes in Pain Survey (TOPS):Life Control | 73.76 units on TOPS scale | Standard Error 1.7 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.660295% CI: [-0.2252, 0.1429]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.6764Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.345895% CI: [-2.7036, 7.684]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.196995% CI: [-13.2466, 2.743]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.04895% CI: [-25.8429, -0.1162]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability | 48.29 units on TOPS scale | Standard Error 2.37 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability | 51.04 units on TOPS scale | Standard Error 4.05 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability | 57.51 units on TOPS scale | Standard Error 4.33 |
| No RA | Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability | 47.87 units on TOPS scale | Standard Error 1.75 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.019995% CI: [-0.4323, -0.03745]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.4577Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.741795% CI: [-6.624, 4.7236]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.777895% CI: [-7.5129, 10.0289]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.241195% CI: [-5.7608, 22.8073]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms | 35.97 units on TOPS scale | Standard Error 1.92 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms | 41.22 units on TOPS scale | Standard Error 3.86 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms | 48.82 units on TOPS scale | Standard Error 5.91 |
| No RA | Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms | 36.80 units on TOPS scale | Standard Error 1.77 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.00195% CI: [-0.4465, -0.1493]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.4361Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.729795% CI: [-6.0247, 4.2246]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.286895% CI: [-3.625, 12.2043]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.151695% CI: [-3.327, 21.3505]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes | 66.72 units on TOPS scale | Standard Error 1.75 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes | 61.46 units on TOPS scale | Standard Error 3.56 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes | 53.06 units on TOPS scale | Standard Error 5 |
| No RA | Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes | 66.24 units on TOPS scale | Standard Error 1.67 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.p-value: 0.050495% CI: [-0.00029, 0.3261]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.6942Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.529795% CI: [-3.2469, 6.2951]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.315595% CI: [-11.1478, 3.612]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.110595% CI: [-21.7515, 2.2399]Mixed Models Analysis
Primary
Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses
Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Time frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA Within 7 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses | 48.29 units on TOPS scale | Standard Error 2.37 |
| RA 8 - 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses | 51.07 units on TOPS scale | Standard Error 5.18 |
| RA > 14 Days From Injury | Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses | 71.65 units on TOPS scale | Standard Error 6.85 |
| No RA | Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses | 48.02 units on TOPS scale | Standard Error 2.57 |
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. Tp-value: <0.000195% CI: [-1.2584, -0.6967]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.p-value: 0.8548Chi-squared
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.388295% CI: [-4.3026, 11.0296]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.932295% CI: [-12.1376, 11.1317]Mixed Models Analysis
Comparison: A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.p-value: 0.023395% CI: [2.8992, 39.3341]Mixed Models Analysis