Chronic Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Interstitial, Painful Bladder Syndrome, Cystitis, Chronic Interstitial, Interstitial Cystitis, Interstitial Cystitis, Chronic, Interstitial Cystitis (Chronic) With Hematuria, Interstitial Cystitis (Chronic) Without Hematuria, Chronic Prostatitis, Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Conditions
Keywords
interstitial cystitis, bladder pain syndrome, clinical trial, psychosocial intervention, pelvic pain, therapy, urological chronic pelvic pain syndrome, chronic prostatitis, self-management, cognitive behavioral therapy
Brief summary
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. By creating and testing a psychosocial intervention specific to IC/BPS, we will learn if this intervention improves patient wellness, who the intervention works best for, and how the body's pain processing influences outcomes.
Detailed description
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a debilitating, incurable, and costly pain condition affecting approximately 3-8 million individuals in the United States and is extremely challenging to treat. Evidence suggests psychosocial factors accompany and intensify the illness. Unaddressed psychosocial co-morbidities are associated with reduced functionality and poorer outcomes, which suggests that psychosocial symptoms and bladder-specific symptoms reinforce each other. While psychosocial self-management interventions have demonstrated efficacy for other pain conditions, the IC/BPS field lacks the gold standard - randomized controlled trials - studying these interventions. At the same time, the chronic pain field is adopting a new approach driven by mechanisms of illness and treatment. Growing evidence suggests that subgroups (called phenotypes) of patients with IC/BPS respond differently to medical intervention. Presence of central sensitization (CS) largely defines patient subgroups and may be a biological factor affecting response to medical treatment. The overall goal of this project is to fully develop, optimize, and evaluate a patient-centered CBT self-management intervention specific to IC/BPS. To achieve this goal, we will develop (Aim 1) and test (Aim 2) an empirically-based psychosocial treatment for IC/BPS compared to attention control, while examining pain mechanisms and subgroup characteristics that may alter treatment response (Aim 3). We hypothesize that a) inclusion of a self-management intervention will be more effective than a control treatment for IC/BPS, and that b) treatment effects will be moderated by degree of psychological co-morbidity, presence of chronic overlapping pain conditions, and elevated central sensitization. Successful completion of these aims will determine whether the addition of a tailored self-management intervention for IC/BPS will improve outcomes compared to control, whether particular subgroups are more responsive to this intervention, and whether a biological mechanism (CS) influences treatment responsiveness.
Interventions
BEHAVIORALPsychosocial Treatment
The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
BEHAVIORALAttention Control
The Attention Control will reflect a similar visit pattern and duration as intervention sessions.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study involves a two group parallel design, with one group receiving individual psychosocial intervention online/in person and another individual symptom monitoring and discussion via telephone.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Diagnosis of IC/BPS as given by providers or indicated by assessments
Exclusion criteria
* Comorbid neurological conditions including spinal cord injury or systematic neurologic illnesses, or central nervous system diseases such as brain tumor or stroke * Current or history of diagnosis of primary psychotic or major thought disorder within the past five years * Hospitalization for psychiatric reasons other than suicidal ideation, homicidal ideation, and/or PTSD (within the past 5 years) * Psychiatric or behavioral conditions in which symptoms are unstable or severe (e.g. current delirium, mania, psychosis, suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months * Non-English speaking * Presenting symptoms at time of screening that would interfere with participation, specifically active suicidal ideation with intent to harm oneself or active delusional or psychotic thinking * Difficulties or limitations communicating over the telephone * Any planned life events that would interfere with participating in the key elements of the study * Any major active medical issues that could preclude participation * Currently being treated for cancer * Cancer-related pain * Currently engaged in individual counseling/psychotherapy or unwilling to pause this treatment for the trial duration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Genitourinary Pain Index (GUPI) 2 Months | baseline to 2 months | The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest. |
| Change in the Genitourinary Pain Index (GUPI) 5 Months | baseline to 5 months | The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fibromyalgia Symptom Scale (FSS) | baseline, 2 months (after treatment is complete), 5 months | 7-item questionnaire assessing modified 2010 American College of Rheumatology diagnostic criteria for fibromyalgia and includes a) an index of widespread pain and b) an index of symptom severity via patient self-report. The FSS is the index of symptom severity and can range from 0-12. Higher scores indicate higher symptom severity, a worse outcome. When combined with the WPI score above, a total score on this scale (WPI + FSS) ranges from 0-31, with scores ≥ 13 indicating a high likelihood of fibromyalgia. |
| Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A | baseline, 2 months (after treatment is complete), 5 months | The PTSD Checklist for the DSM-5 measures post-traumatic stress. It utilizes the symptom checklist for PTSD in the DSM-5 and inquires about trauma-induced thoughts and behaviors in the past month. The total score ranges from 0-80, with 31-33 and above indicating probable diagnosis of PTSD. |
| Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire | baseline, 2 months (after treatment is complete), 5 months | The Generalized Anxiety Disorder (GAD-7) questionnaire is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD to identify probable cases of GAD along with measuring anxiety symptom severity. Questions are on a 4-point Likert scale, with 0 being not at all sure and 3 being nearly every day. Cumulative scoring is tiered from minimal anxiety (0-4) to mild anxiety (5 to 9) to moderate anxiety (10-14) to severe anxiety (15-21). |
| Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) | baseline, 2 months (after treatment is complete), 5 months | The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. It consists of 8 questions where participants indicate on a Likert scale the extent to which they have experienced symptoms of depression within the past two weeks, with 0 being not at all and 3 being nearly every day. Cumulative scores range from 0-24, with cutoff points for none, mild, moderate, moderately severe, and severe marked at 5, 10, 15, and 20. |
| Quantitative Sensory Testing (Optional) - Threshold Average | baseline | Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and threshold is reported here. Scores range from 0 = No Pain or Warmth to 100 = Worst Possible Pain, with higher scores indicating a higher pain threshold. |
| Quantitative Sensory Testing (Optional) - Tolerance Average | baseline | Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and tolerance is reported here. Scores range from 0 = No Pain or Warmth to 100 = Worst Possible Pain, with higher scores indicating a higher pain tolerance. |
| Quantitative Sensory Testing - Temporal Summation (Slope) | Baseline | Psychophysical testing methods will replicate existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Regarding temporal summation: in each sequence, immediately after each heat pulse, subjects provide a verbal numeric pain intensity rating on a 0-100 scale (0 = No Pain or Warmth and 100 = Worst Possible Pain). The standardized slope of the line fitted to the series of 10 pulses at each temperature indexes temporal summation and serves as a quantitative marker of central sensitization. These slopes reflected the relationship between pain and pulse, representing average pain increase for each unit increase in pulse. |
| Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) | 2 months (after treatment is complete), 5 months | Patient Global Impression of Improvement measures the response of a condition to an intervention. Patients rate their impression of change on a Likert scale ranging from 1-7 with 1 being No change/condition has gotten worse to 7 being a great deal better and a considerable improvement that has made all the difference. This scale was administered at post-treatment and follow-up only. |
| The Widespread Pain Index (Derived From CHOIR Bodymap) | baseline, 2 months (after treatment is complete), 5 months | The Widespread Pain Index measures the location(s) of chronic pain complaints and widespread body pain. Widespread pain was assessed using the Collaborative Health Outcomes Information Registry (CHOIR) bodymap, condensed into a Widespread Pain Index (WPI) score assessing 19 potential body pain areas. Scores on the WPI range from 0-19, with one point given for each potential body pain area endorsed; higher scores indicate higher widespread pain. The WPI was coupled with the Fibromyalgia Symptom Scale (FSS) below, a 7-item questionnaire, to calculate the American College of Rheumatology classification criteria for fibromyalgia, and assess fibromyalgia symptom severity (higher scores indicate higher symptom severity). The WPI total (0-19) can be combined with the FSS (0-12) in a sum total score (0-31) to assess the degree of a person's widespread pain and fibromyalgia symptom severity, with higher scores indicating a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Psychosocial Treatment The psychosocial self-management intervention consists of 8 weekly 50-minute individual visits with an assigned trained therapist. Sessions follow a structured protocol that has been developed with the patient population. Treatment modules are individualized and include topics such as pain coping strategies, relaxation training, education on IC/BPS, and communication strategies.
Psychosocial Treatment: The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist. | 52 |
| Attention Control The attention control condition consists of 8 weekly telephone calls with a study interventionist. Sessions will occur via scheduled telephone calls and follow a structured procedure. Telephone calls are designed to monitor symptoms and overall wellness. Each week, participants will be asked about current symptoms, flare patterns, and physical and emotional wellbeing.
Attention Control: The Attention Control will reflect a similar visit pattern and duration as intervention sessions. | 26 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Psychosocial Treatment | Total | Attention Control |
|---|---|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 16.5 | 44.4 years STANDARD_DEVIATION 16.3 | 43.1 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 76 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 49 Participants | 70 Participants | 21 Participants |
| Region of Enrollment United States | 52 participants | 78 participants | 26 participants |
| Sex: Female, Male Female | 48 Participants | 71 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 26 |
| other Total, other adverse events | 1 / 52 | 0 / 26 |
| serious Total, serious adverse events | 0 / 52 | 0 / 26 |
Outcome results
Primary
Change in the Genitourinary Pain Index (GUPI) 2 Months
The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest.
Time frame: baseline to 2 months
Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total genitourinary pain index (GUPI) score between both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment | Change in the Genitourinary Pain Index (GUPI) 2 Months | 6.6 score on a scale | Standard Deviation 6.9 |
| Attention Control | Change in the Genitourinary Pain Index (GUPI) 2 Months | 4.8 score on a scale | Standard Deviation 9 |
Primary
Change in the Genitourinary Pain Index (GUPI) 5 Months
The Genitourinary Pain Index measures genitourinary symptom severity in both men and women. It is comprised of three subscales: pain, urinary symptoms, and impact on quality of life. The total score ranges from 0-35, with 0 being the lowest severity of symptoms and 35 being the highest.
Time frame: baseline to 5 months
Population: We analyzed a total of N=77 individuals from baseline to follow-up. Below is the change in the total genitourinary pain index (GUPI) score between both timepoints.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment | Change in the Genitourinary Pain Index (GUPI) 5 Months | 8.1 score on a scale | Standard Deviation 9.9 |
| Attention Control | Change in the Genitourinary Pain Index (GUPI) 5 Months | 6.6 score on a scale | Standard Deviation 7.3 |
Secondary
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire
The Generalized Anxiety Disorder (GAD-7) questionnaire is a self-administered 7 item instrument that uses some of the DSM-V criteria for GAD to identify probable cases of GAD along with measuring anxiety symptom severity. Questions are on a 4-point Likert scale, with 0 being not at all sure and 3 being nearly every day. Cumulative scoring is tiered from minimal anxiety (0-4) to mild anxiety (5 to 9) to moderate anxiety (10-14) to severe anxiety (15-21).
Time frame: baseline, 2 months (after treatment is complete), 5 months
Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total GAD-7 score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychosocial Treatment | Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire | Baseline to post-treatment (2 months) | 0.5 score on a scale | Standard Deviation 4 |
| Psychosocial Treatment | Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire | Baseline to follow-up (5 months) | 0.1 score on a scale | Standard Deviation 4.5 |
| Attention Control | Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire | Baseline to post-treatment (2 months) | 0.6 score on a scale | Standard Deviation 4 |
| Attention Control | Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire | Baseline to follow-up (5 months) | -0.1 score on a scale | Standard Deviation 3.5 |
Secondary
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)
The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. It consists of 8 questions where participants indicate on a Likert scale the extent to which they have experienced symptoms of depression within the past two weeks, with 0 being not at all and 3 being nearly every day. Cumulative scores range from 0-24, with cutoff points for none, mild, moderate, moderately severe, and severe marked at 5, 10, 15, and 20.
Time frame: baseline, 2 months (after treatment is complete), 5 months
Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total PHQ score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychosocial Treatment | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) | Baseline to post-treatment (2 months) | 0.9 score on a scale | Standard Deviation 4.6 |
| Psychosocial Treatment | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) | Baseline to follow-up (5 months) | 0.8 score on a scale | Standard Deviation 5.2 |
| Attention Control | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) | Baseline to follow-up (5 months) | 0.0 score on a scale | Standard Deviation 3.4 |
| Attention Control | Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8) | Baseline to post-treatment (2 months) | 1.0 score on a scale | Standard Deviation 4.3 |
Secondary
Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A
The PTSD Checklist for the DSM-5 measures post-traumatic stress. It utilizes the symptom checklist for PTSD in the DSM-5 and inquires about trauma-induced thoughts and behaviors in the past month. The total score ranges from 0-80, with 31-33 and above indicating probable diagnosis of PTSD.
Time frame: baseline, 2 months (after treatment is complete), 5 months
Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total PCL-5 score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychosocial Treatment | Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A | Baseline to post-treatment (2 months) | -2.8 score on a scale | Standard Deviation 9.9 |
| Psychosocial Treatment | Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A | Baseline to follow-up (5 months) | 0.1 score on a scale | Standard Deviation 13.8 |
| Attention Control | Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A | Baseline to post-treatment (2 months) | -1.3 score on a scale | Standard Deviation 11.6 |
| Attention Control | Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A | Baseline to follow-up (5 months) | -3.5 score on a scale | Standard Deviation 12.1 |
Secondary
Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC)
Patient Global Impression of Improvement measures the response of a condition to an intervention. Patients rate their impression of change on a Likert scale ranging from 1-7 with 1 being No change/condition has gotten worse to 7 being a great deal better and a considerable improvement that has made all the difference. This scale was administered at post-treatment and follow-up only.
Time frame: 2 months (after treatment is complete), 5 months
Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total PGIC score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychosocial Treatment | Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) | Baseline to post-treatment (2 months) | 4.7 score on a scale | Standard Deviation 1.6 |
| Psychosocial Treatment | Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) | Baseline to follow-up (5 months) | 4.4 score on a scale | Standard Deviation 1.5 |
| Attention Control | Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) | Baseline to post-treatment (2 months) | 2.8 score on a scale | Standard Deviation 1.6 |
| Attention Control | Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC) | Baseline to follow-up (5 months) | 3.1 score on a scale | Standard Deviation 1.6 |
Secondary
Fibromyalgia Symptom Scale (FSS)
7-item questionnaire assessing modified 2010 American College of Rheumatology diagnostic criteria for fibromyalgia and includes a) an index of widespread pain and b) an index of symptom severity via patient self-report. The FSS is the index of symptom severity and can range from 0-12. Higher scores indicate higher symptom severity, a worse outcome. When combined with the WPI score above, a total score on this scale (WPI + FSS) ranges from 0-31, with scores ≥ 13 indicating a high likelihood of fibromyalgia.
Time frame: baseline, 2 months (after treatment is complete), 5 months
Population: We analyzed a total of N=77 individuals from baseline to post-treatment. Below is the change in the total FSS score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up. Change in WPI is reported separately above.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychosocial Treatment | Fibromyalgia Symptom Scale (FSS) | Baseline to follow-up (5 months) | 0.8 score on a scale | Standard Deviation 1.8 |
| Psychosocial Treatment | Fibromyalgia Symptom Scale (FSS) | Baseline to post treatment (2 months) | 0.4 score on a scale | Standard Deviation 1.9 |
| Attention Control | Fibromyalgia Symptom Scale (FSS) | Baseline to post treatment (2 months) | 0.7 score on a scale | Standard Deviation 1.4 |
| Attention Control | Fibromyalgia Symptom Scale (FSS) | Baseline to follow-up (5 months) | 0.2 score on a scale | Standard Deviation 1.3 |
Secondary
Quantitative Sensory Testing (Optional) - Threshold Average
Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and threshold is reported here. Scores range from 0 = No Pain or Warmth to 100 = Worst Possible Pain, with higher scores indicating a higher pain threshold.
Time frame: baseline
Population: We analyzed a total of 40 participants who completed Quantitative Sensory Testing at baseline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment | Quantitative Sensory Testing (Optional) - Threshold Average | 44.65 score on a scale | Standard Deviation 3.41 |
| Attention Control | Quantitative Sensory Testing (Optional) - Threshold Average | 40.76 score on a scale | Standard Deviation 2.96 |
Secondary
Quantitative Sensory Testing (Optional) - Tolerance Average
Psychophysical testing methods replicated existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Thermal measures involved four pain threshold trials, followed by four pain tolerance trials, with the probe applied to slightly different target sites for each trial to avoid local sensitization. Means for the four threshold and tolerance trials are separately derived, and tolerance is reported here. Scores range from 0 = No Pain or Warmth to 100 = Worst Possible Pain, with higher scores indicating a higher pain tolerance.
Time frame: baseline
Population: We analyzed a total of 40 participants who completed Quantitative Sensory Testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment | Quantitative Sensory Testing (Optional) - Tolerance Average | 47.89 units on a scale | Standard Deviation 1.09 |
| Attention Control | Quantitative Sensory Testing (Optional) - Tolerance Average | 47.29 units on a scale | Standard Deviation 1.79 |
Secondary
Quantitative Sensory Testing - Temporal Summation (Slope)
Psychophysical testing methods will replicate existing protocols used at VUMC and include the following elements: 1) an evaluation of temporal summation (as a biomarker for central sensitization), 2) thermal pain threshold and tolerance. Regarding temporal summation: in each sequence, immediately after each heat pulse, subjects provide a verbal numeric pain intensity rating on a 0-100 scale (0 = No Pain or Warmth and 100 = Worst Possible Pain). The standardized slope of the line fitted to the series of 10 pulses at each temperature indexes temporal summation and serves as a quantitative marker of central sensitization. These slopes reflected the relationship between pain and pulse, representing average pain increase for each unit increase in pulse.
Time frame: Baseline
Population: A total of 40 participants completed (optional) quantitative sensory testing at baseline allowing us to calculate temporal summation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Psychosocial Treatment | Quantitative Sensory Testing - Temporal Summation (Slope) | -.23 units on a scale/pulse | Standard Deviation 2.18 |
| Attention Control | Quantitative Sensory Testing - Temporal Summation (Slope) | -.21 units on a scale/pulse | Standard Deviation 2.7 |
Secondary
The Widespread Pain Index (Derived From CHOIR Bodymap)
The Widespread Pain Index measures the location(s) of chronic pain complaints and widespread body pain. Widespread pain was assessed using the Collaborative Health Outcomes Information Registry (CHOIR) bodymap, condensed into a Widespread Pain Index (WPI) score assessing 19 potential body pain areas. Scores on the WPI range from 0-19, with one point given for each potential body pain area endorsed; higher scores indicate higher widespread pain. The WPI was coupled with the Fibromyalgia Symptom Scale (FSS) below, a 7-item questionnaire, to calculate the American College of Rheumatology classification criteria for fibromyalgia, and assess fibromyalgia symptom severity (higher scores indicate higher symptom severity). The WPI total (0-19) can be combined with the FSS (0-12) in a sum total score (0-31) to assess the degree of a person's widespread pain and fibromyalgia symptom severity, with higher scores indicating a worse outcome.
Time frame: baseline, 2 months (after treatment is complete), 5 months
Population: We analyzed a total of N=77 individuals from baseline to follow-up. Below is the change in the total WPI score between both timepoints both from pre-post treatment and then from pre-treatment to follow-up. Change in total FSS score is not included here, but is reported separately.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Psychosocial Treatment | The Widespread Pain Index (Derived From CHOIR Bodymap) | Baseline to post treatment (2 months) | 0.6 score on a scale | Standard Deviation 2.9 |
| Psychosocial Treatment | The Widespread Pain Index (Derived From CHOIR Bodymap) | Baseline to follow up (5 months) | 0.9 score on a scale | Standard Deviation 3.5 |
| Attention Control | The Widespread Pain Index (Derived From CHOIR Bodymap) | Baseline to post treatment (2 months) | 0.1 score on a scale | Standard Deviation 2.7 |
| Attention Control | The Widespread Pain Index (Derived From CHOIR Bodymap) | Baseline to follow up (5 months) | 0.4 score on a scale | Standard Deviation 3.6 |