Injuries, Injury, Ankle, Injury Arm, Injury Finger, Injury Foot, Injury, Hand, Injury, Knee, Injury Leg, Injury;Sports, Injury Wrist
Conditions
Keywords
pain, disability, injury, orthopedics, rehabilitation, mind-body
Brief summary
The goal of this study is to pilot test a skills-based virtual reality (VR) for acute orthopedic injury. It will measure the feasibility, signals of improvement, exploratory pain mechanisms, and user experience of an established skills-based program (RelieveVRx) for acute orthopedic injury.
Detailed description
This study will use mixed-methods to investigate the feasibility of skills-based virtual reality (VR) for acute orthopedic injury in an open pilot with individual exit interviews (target N=10). Participants will be patients with acute orthopedic musculoskeletal injuries who are at risk for chronic pain and disability (PCS ≥ 20 and PASS-20 ≥ 40) and meet inclusionary/exclusionary criteria. Participants will be recruited through the MGH Orthopedics Department, flyers, and the Rally research platform. Participants will self-administer a skills-based virtual reality (VR) program at home over an 8-week period. Participants will attend two in-person study assessments to complete study assessments (surveys and an fNIRS imaging session). The primary outcome for the pilot will be a-priori Go/No-Go feasibility markers (feasibility, acceptability, fidelity, credibility, expectancy, satisfaction) of the VR program and data collection procedures to increase the success of subsequent trials. Exploratory measures include: multi-modal assessment of pain intensity, pain-specific coping (catastrophizing, self-efficacy, acceptance), disability, physical function, and emotional function (depression, anxiety, stress). The VR headset will collect usage data and daily smartphone surveys will track changes in pain during the 8-week intervention. Completers will have the opportunity to attend 30 min individual exit interviews to understand patients' perception of the VR and their experience with the study procedures to increase the success of larger trials.
Interventions
DEVICERelieveVRx
Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education.
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Outpatient adults in the Level 1 Trauma Center 2. Age 18 or older 3. Able to meaningfully participate meaningfully (English fluency and literacy) and stable living situation 4. Acute musculoskeletal injury (e.g., fracture, dislocation, rupture) 1-2 months earlier (acute phase). 5. Pain Catastrophizing Scale ≥20 or Pain Anxiety Symptom Scale-20 ≥40 6. Has access to internet (Wi-Fi or wireless) 7. Willing to participate and comply with the requirements of the study protocol, including virtual reality program and questionnaire completion No psychotropics or stable for \>6 weeks 8. Free of concurrent psychotropic medication for at least 2 weeks prior to initiation of treatment, OR stable on current psychotropic medication for a minimum of 6 weeks and willing to maintain a stable dose (i.e., no psychotropics or stable for \>6 weeks) 9. Cleared by orthopedic surgeon for study participation
Exclusion criteria
1. Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological diseases that are contraindicated for VR 2. Medical condition predisposing to nausea or dizziness. 3. Hypersensitivity to flashing light or motion. 4. Vision or severe hearing impairment. 5. Injury to eyes, face, or neck that impedes comfortable use of virtual reality 6. Diagnosed with a medical illness expected to worsen in the next 3 months (e.g., malignancy) 7. Other serious injuries that occurred with the orthopedic injury or surgical complications (e.g., infection, need for repeat surgery) 8. Current or prior untreated mental illness, substance use disorder, or suicidal ideation 9. Self-reported pregnancy 10. Currently in litigation or under Workman's Comp 11. Practice of cognitive-behavioral therapy, yoga/meditation, or other mind body techniques once per week for 45 minutes or more within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale | Pre-intervention (week 0) only | Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent). |
| Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale | Pre-intervention (week 0) only | Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent). |
| Client Satisfaction Questionnaire | Post-intervention (week 8) only | Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent). |
| System Usability Scale | Post-intervention (week 8) only | Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Pain Surveys | Pre-intervention (week 0), Post-intervention (week 8) | Adherence to Pain Surveys was determined by the percentage of participants who responded to at least 5/7 days for at least 6/8 weeks during the intervention period (≥70% good, ≥80% excellent). |
| Patient's Global Impression of Change | Post-intervention (week 8) only | The number of participants that improved much or very much or minimally on the Patient's Global Impression of Change Scores for pain, emotional, and physical function during the VR program. |
| Feasibility of Outcome Assessments | Pre-intervention (week 0), Post-intervention (week 8) | The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent). |
| Motion Sickness and Nausea | Post-intervention (week 8) only | Assess adverse experiences with VR, determined by the percentage of participants with responses (range = 0 never to 3 always) below the scale's midpoint (≥70% good, ≥ 80% excellent). |
| Feasibility of Enrollment | Throughout the study completion, approximately 1 year | We will report the number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent). |
| Acceptability of Treatment | Pre-intervention (week 0), Post-intervention (week 8) | Acceptability of treatment was determined by the percentage of participants who completed at least 6 of 8 weeks of VR modules (≥70%, good; ≥ 80% excellent). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiologic Study of Depression (CESD) Scale | Pre-intervention (week 0), Post-intervention (week 8) | The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report that assesses how often participants' experience symptoms of depression in the last week. CES-D items are scored on a 0 (rarely or none of the time, less than 1 day) to 3 (most or all of the time, 5-7 days) scale. Higher scores (range = 0-60) indicate greater depressive symptoms. |
| Cognitive and Affective Mindfulness Scale (CAMS) | Pre-intervention (week 0), Post-intervention (week 8) | The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self-report that measures mindfulness principles: attention regulation, present focus, awareness, and non-judgmental awareness. CAMS-R items are scored on a 1 (rarely/not at all) to 4 (almost always) scale. Higher total scores (range = 12-48) indicate greater use of mindfulness. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Activity Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. |
| Non-narcotic Pain Medications | Pre-intervention (week 0), Post-intervention (week 8) | Number of days that non-narcotic pain medications were taken in the last week. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Mood Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Stress Subscale) reported and scored is scored on 0 (does not interfere) to 10 (completely interferes) scale. |
| Measure of Current Status (MOCS) | Pre-intervention (week 0), Post-intervention (week 8) | The Measure of Current Status (MOCS) is a 13-item self-report of the ability to use various skills to cope with daily stressors. MOCS items are scored on a 0 (I cannot do this at all) to 4 (I can do this extremely well) scale. Higher total scores (range = 0-52) indicate greater ability and confidence to utilize coping skills. |
| Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. | The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Sleep Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance | Pre-intervention (week 0), Post-intervention (week 8) | The PROMIS Sleep Disturbance is an 8-item self-report of challenges affecting sleep and overall sleep quality and satisfaction over the past seven days. PROMIS Sleep Disturbance items are scored between 1 and 5: not at all (1) to very much (5), never (1) to always (5), and very poor (1) to very good (5). Total raw scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating worse outcome (greater sleep disturbance or worse sleep quality). |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | Pre-intervention (week 0), Post-intervention (week 8) | The PROMIS Physical Function is an 8-item self-report to assess participants' general ability to complete daily living activities. PROMIS Physical Function items are scored on a 1 (unable to do) to 5 (without any difficulty) or 1 (cannot do) to 5 (not at all) point scale. Total scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating greater better outcome (higher physical function). |
| Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index | Pre-intervention (week 0), Post-intervention (week 8) | The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Dysfunction Intex contains 34 items that assess musculoskeletal function. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calcuted by summing items 1-34 for the Dysfunction Index. Total scores are standardized \[(Actual raw score - lowest possible raw score/possible raw score range) \*100\], with high scores indicating poor function (standardized subscale range, min = 0, max = 100). |
| Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index | Pre-intervention (week 0), Post-intervention (week 8) | The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Bother Index has 12 items that assess symptom burden. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calculated by summing items 35-46 for the Bothersome Index. Total scores are standardized \[(Actual raw score - lowest possible raw score/possible raw score range) \*100\], with high scores indicating poor function (standardized subscale range, min = 0, max = 100). |
| Numerical Rating Scale (NRS) - Pain at Rest | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. | The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity at rest during the past week. One of two NRS items (pain at rest) is reported and scored on a 0 (no pain) to 10 (worst ever) scale. |
| Numerical Rating Scale (NRS) - Pain With Activity | Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported. | The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity with activity during the past week. One of two NRS items (pain with activity) reported and scored on a 0 (no pain) to 10 (worst ever) scale. |
| Pain Catastrophizing Scale (PCS) | Pre-intervention (week 0), Post-intervention (week 8) | The Pain Catastrophizing Scale (PCS) is a 13-item self-report of catastrophic thoughts and emotions related to pain. The PCS-13 is scored on 0 (not at all) to 4 (all the time) scale. Higher scores (range = 0-52) indicate greater pain catastrophizing. |
| Pain Anxiety Scale (PASS) | Pre-intervention (week 0), Post-intervention (week 8) | The Pain Anxiety Symptoms Scale (PASS) is a 20-item self-report of fear and anxiety related to pain. The PASS-20 is scored on 0 (never) to 5 (always) scale. Higher scores (range= 0-100) indicate greater pain anxiety. |
| Pain Self-Efficacy Questionnaire (PSEQ) | Pre-intervention (week 0), Post-intervention (week 8) | The Pain Self-Efficacy Questionnaire is a 10-item self-report that measures participants' confidence in completing daily tasks and leisure activities despite experiencing pain. PSEQ items are scored on a 0 (not at all confident) to 6 (completely confident) scale. Higher total sum scores (total range = 0-60) indicate greater better outcome (pain self-efficacy). |
Countries
United States
Participant flow
Pre-assignment details
No enrolled participants were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Skills-Based VR Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education.
RelieveVRx: Participants will complete daily skills-based Virtual Reality (VR) sessions for 8 weeks (an average of 6 minutes per day) to determine the feasibility of at-home VR technology to aid the recovery of acute orthopedic musculoskeletal injuries. The VR device software is equipped with pain-specific treatment modules (e.g., Pain Education, Relaxation/Interoception, Mindful Escapes, and Pain Distraction Games) derived from evidence-based principles of cognitive behavioral therapy (CBT), mindfulness, and pain neuroscience education. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Skills-Based VR |
|---|---|
| Age, Continuous | 46.8 years STANDARD_DEVIATION 11.86 |
| Education Completed college (16 years) | 3 Participants |
| Education Graduate/professional degree (>16 years) | 6 Participants |
| Education Some college/Associates degree (<16 years) | 1 Participants |
| Employment Employed full-time | 8 Participants |
| Employment Employed part-time | 1 Participants |
| Employment Unemployed | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Income $15,000 to less than $20,000 | 1 Participants |
| Income $50,000 to less than $75,000 | 3 Participants |
| Income $75,000 or more | 6 Participants |
| Marital Status Married | 3 Participants |
| Marital Status Separated or Divorced | 1 Participants |
| Marital Status Single, never married | 5 Participants |
| Marital Status Widowed | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Client Satisfaction Questionnaire
Participants' treatment satisfaction, determined by the percentage of participants with scores (range = 3-12) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Post-intervention (week 8) only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Client Satisfaction Questionnaire | 9 Participants |
Primary
Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale
Participants' perceived credibility, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Pre-intervention (week 0) only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Credibility and Expectancy Questionnaire (CEQ)- Credibility Subscale | 8 Participants |
Primary
Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale
Participants' treatment expectancy, determined by the percentage of participants with scores (range = 3-27, higher scores mean better outcomes) over the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Pre-intervention (week 0) only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Credibility and Expectancy Questionnaire (CEQ)- Expectancy Subscale | 9 Participants |
Primary
System Usability Scale
Assess global user experience of the VR device, with higher percentile rankings (range = 0-100) indicating greater usability. Usability was determined by the number of participants with System Usability Scale scores 68 and above (≥70% good, ≥ 80% excellent).
Time frame: Post-intervention (week 8) only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | System Usability Scale | 8 Participants |
Secondary
Acceptability of Treatment
Acceptability of treatment was determined by the percentage of participants who completed at least 6 of 8 weeks of VR modules (≥70%, good; ≥ 80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Acceptability of Treatment | 10 Participants |
Secondary
Adherence to Pain Surveys
Adherence to Pain Surveys was determined by the percentage of participants who responded to at least 5/7 days for at least 6/8 weeks during the intervention period (≥70% good, ≥80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Adherence to Pain Surveys | 8 Participants |
Secondary
Feasibility of Enrollment
We will report the number of participants who agree to participate out of those eligible, evaluated at the end of study for all participants (≥70% good, ≥ 80% excellent).
Time frame: Throughout the study completion, approximately 1 year
Population: This benchmark indicates the number of participants enrolled out of total eligible. More participants were deemed eligible than the number that enrolled, ultimately making the overall number of participants greater than the number stated in the participant flow.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Feasibility of Enrollment | 10 Participants |
Secondary
Feasibility of Outcome Assessments
The feasibility of data collection was determined by the percentage of participants with no missing outcomes data (≥70% good, ≥80% excellent).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Feasibility of Outcome Assessments | 10 Participants |
Secondary
Motion Sickness and Nausea
Assess adverse experiences with VR, determined by the percentage of participants with responses (range = 0 never to 3 always) below the scale's midpoint (≥70% good, ≥ 80% excellent).
Time frame: Post-intervention (week 8) only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Motion Sickness and Nausea | 10 Participants |
Secondary
Patient's Global Impression of Change
The number of participants that improved much or very much or minimally on the Patient's Global Impression of Change Scores for pain, emotional, and physical function during the VR program.
Time frame: Post-intervention (week 8) only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Skills-Based VR | Patient's Global Impression of Change | 10 Participants |
Other Pre-specified
Center for Epidemiologic Study of Depression (CESD) Scale
The Center for Epidemiological Studies Depression Scale (CES-D) is a 20-item self-report that assesses how often participants' experience symptoms of depression in the last week. CES-D items are scored on a 0 (rarely or none of the time, less than 1 day) to 3 (most or all of the time, 5-7 days) scale. Higher scores (range = 0-60) indicate greater depressive symptoms.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Center for Epidemiologic Study of Depression (CESD) Scale | Pre-intervention | 20.00 score on a scale | Standard Deviation 8.63 |
| Skills-Based VR | Center for Epidemiologic Study of Depression (CESD) Scale | Post-intervention | 10.90 score on a scale | Standard Deviation 6.61 |
Other Pre-specified
Cognitive and Affective Mindfulness Scale (CAMS)
The Cognitive and Affective Mindfulness Scale - Revised (CAMS-R) is a 12-item self-report that measures mindfulness principles: attention regulation, present focus, awareness, and non-judgmental awareness. CAMS-R items are scored on a 1 (rarely/not at all) to 4 (almost always) scale. Higher total scores (range = 12-48) indicate greater use of mindfulness.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Cognitive and Affective Mindfulness Scale (CAMS) | Pre-intervention | 31.20 score on a scale | Standard Deviation 3.88 |
| Skills-Based VR | Cognitive and Affective Mindfulness Scale (CAMS) | Post-intervention | 35.90 score on a scale | Standard Deviation 5.92 |
Other Pre-specified
Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Activity Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale | Pre-intervention | 6.90 score on a scale | Standard Deviation 2.56 |
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Activity Subscale | Post-intervention | 2.00 score on a scale | Standard Deviation 2.05 |
Other Pre-specified
Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Mood Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale | Pre-intervention | 6.00 score on a scale | Standard Deviation 1.83 |
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Mood Subscale | Post-intervention | 2.10 score on a scale | Standard Deviation 1.79 |
Other Pre-specified
Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Sleep Subscale) reported and scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale | Pre-intervention | 5.90 score on a scale | Standard Deviation 3.41 |
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Sleep Subscale | Post-intervention | 1.80 score on a scale | Standard Deviation 2.74 |
Other Pre-specified
Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale
The Defense and Veterans Pain Rating Scale (DVPRS) is a 4-item self-report that measures the extent to which pain interferes with usual activity, sleep, mood, and stress. One of four DVPRS (Stress Subscale) reported and scored is scored on 0 (does not interfere) to 10 (completely interferes) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale | Pre-intervention | 6.40 score on a scale | Standard Deviation 1.51 |
| Skills-Based VR | Defense and Veterans Pain Rating Scale (DVPRS) - Stress Subscale | Post-intervention | 2.20 score on a scale | Standard Deviation 2.1 |
Other Pre-specified
Measure of Current Status (MOCS)
The Measure of Current Status (MOCS) is a 13-item self-report of the ability to use various skills to cope with daily stressors. MOCS items are scored on a 0 (I cannot do this at all) to 4 (I can do this extremely well) scale. Higher total scores (range = 0-52) indicate greater ability and confidence to utilize coping skills.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Measure of Current Status (MOCS) | Pre-intervention | 2.19 score on a scale | Standard Deviation 0.53 |
| Skills-Based VR | Measure of Current Status (MOCS) | Post-intervention | 2.78 score on a scale | Standard Deviation 0.64 |
Other Pre-specified
Non-narcotic Pain Medications
Number of days that non-narcotic pain medications were taken in the last week.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
Population: Out of 10 total participants, only 6 were included in the analysis for the Outcome Measure as they were taking non-narcotic medications during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Non-narcotic Pain Medications | Pre-intervention | 1.9 days per week | Standard Deviation 2.23 |
| Skills-Based VR | Non-narcotic Pain Medications | Post-intervention | 0.6 days per week | Standard Deviation 0.97 |
Other Pre-specified
Numerical Rating Scale (NRS) - Pain at Rest
The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity at rest during the past week. One of two NRS items (pain at rest) is reported and scored on a 0 (no pain) to 10 (worst ever) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Numerical Rating Scale (NRS) - Pain at Rest | Pre-intervention | 3.50 score on a scale | Standard Deviation 1.27 |
| Skills-Based VR | Numerical Rating Scale (NRS) - Pain at Rest | Post-intervention | 1.00 score on a scale | Standard Deviation 0.94 |
Other Pre-specified
Numerical Rating Scale (NRS) - Pain With Activity
The Numerical Rating Scale (NRS) is a 2-item self-report that assesses participants' pain intensity with activity during the past week. One of two NRS items (pain with activity) reported and scored on a 0 (no pain) to 10 (worst ever) scale.
Time frame: Assessed Pre-intervention (week 0), Bi-weekly, Post-intervention (week 8). Pre-intervention (week 0) and Post-intervention (week 8) reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Numerical Rating Scale (NRS) - Pain With Activity | Pre-intervention | 6.30 score on a scale | Standard Deviation 1.64 |
| Skills-Based VR | Numerical Rating Scale (NRS) - Pain With Activity | Post-intervention | 2.90 score on a scale | Standard Deviation 1.79 |
Other Pre-specified
Pain Anxiety Scale (PASS)
The Pain Anxiety Symptoms Scale (PASS) is a 20-item self-report of fear and anxiety related to pain. The PASS-20 is scored on 0 (never) to 5 (always) scale. Higher scores (range= 0-100) indicate greater pain anxiety.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Pain Anxiety Scale (PASS) | Pre-intervention | 51.10 score on a scale | Standard Deviation 17.4 |
| Skills-Based VR | Pain Anxiety Scale (PASS) | Post-intervention | 18.40 score on a scale | Standard Deviation 12.8 |
Other Pre-specified
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) is a 13-item self-report of catastrophic thoughts and emotions related to pain. The PCS-13 is scored on 0 (not at all) to 4 (all the time) scale. Higher scores (range = 0-52) indicate greater pain catastrophizing.
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Pain Catastrophizing Scale (PCS) | Pre-intervention | 23.90 score on a scale | Standard Deviation 9.62 |
| Skills-Based VR | Pain Catastrophizing Scale (PCS) | Post-intervention | 7.50 score on a scale | Standard Deviation 5.08 |
Other Pre-specified
Pain Self-Efficacy Questionnaire (PSEQ)
The Pain Self-Efficacy Questionnaire is a 10-item self-report that measures participants' confidence in completing daily tasks and leisure activities despite experiencing pain. PSEQ items are scored on a 0 (not at all confident) to 6 (completely confident) scale. Higher total sum scores (total range = 0-60) indicate greater better outcome (pain self-efficacy).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Pain Self-Efficacy Questionnaire (PSEQ) | Pre-intervention | 35.50 score on a scale | Standard Deviation 12.67 |
| Skills-Based VR | Pain Self-Efficacy Questionnaire (PSEQ) | Post-intervention | 50.90 score on a scale | Standard Deviation 6.95 |
Other Pre-specified
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
The PROMIS Physical Function is an 8-item self-report to assess participants' general ability to complete daily living activities. PROMIS Physical Function items are scored on a 1 (unable to do) to 5 (without any difficulty) or 1 (cannot do) to 5 (not at all) point scale. Total scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating greater better outcome (higher physical function).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | Pre-intervention | 35.32 T-score | Standard Deviation 6.86 |
| Skills-Based VR | Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function | Post-intervention | 43.26 T-score | Standard Deviation 7.13 |
Other Pre-specified
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance
The PROMIS Sleep Disturbance is an 8-item self-report of challenges affecting sleep and overall sleep quality and satisfaction over the past seven days. PROMIS Sleep Disturbance items are scored between 1 and 5: not at all (1) to very much (5), never (1) to always (5), and very poor (1) to very good (5). Total raw scores are converted to T-scores, with higher T-score values (e.g., 50 indicates the population mean with a standard deviation of 10) indicating worse outcome (greater sleep disturbance or worse sleep quality).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance | Pre-intervention | 57.86 T-score | Standard Deviation 7.94 |
| Skills-Based VR | Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance | Post-intervention | 47.27 T-score | Standard Deviation 9.55 |
Other Pre-specified
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index
The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Bother Index has 12 items that assess symptom burden. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calculated by summing items 35-46 for the Bothersome Index. Total scores are standardized \[(Actual raw score - lowest possible raw score/possible raw score range) \*100\], with high scores indicating poor function (standardized subscale range, min = 0, max = 100).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index | Pre-intervention | 60.76 Standardized subscale score | Standard Deviation 10.61 |
| Skills-Based VR | Short Musculoskeletal Functional Assessment (SMFA) Questionnaire - Bother Index | Post-intervention | 38.17 Standardized subscale score | Standard Deviation 11.18 |
Other Pre-specified
Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index
The Short Musculoskeletal Function Assessment (SMFA) is a 46-item self-report to assess the extent to which one's injury interferes with their ability to complete daily living activities. The SMFA Dysfunction Intex contains 34 items that assess musculoskeletal function. SMFA items are scored on a 1 (no problems/difficulty) to 5 (unable to do) scale. Total scores are calcuted by summing items 1-34 for the Dysfunction Index. Total scores are standardized \[(Actual raw score - lowest possible raw score/possible raw score range) \*100\], with high scores indicating poor function (standardized subscale range, min = 0, max = 100).
Time frame: Pre-intervention (week 0), Post-intervention (week 8)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Skills-Based VR | Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index | Pre-intervention | 51.93 Standardized subscale score | Standard Deviation 8.45 |
| Skills-Based VR | Short Musculoskeletal Functional Assessment (SMFA) Questionnaire- Dysfunction Index | Post-intervention | 35.46 Standardized subscale score | Standard Deviation 7.59 |