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Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Primary Purpose

Chronic Interstitial Cystitis, Bladder Pain Syndrome, Cystitis, Interstitial

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial Treatment
Attention Control
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Interstitial Cystitis focused on measuring interstitial cystitis, bladder pain syndrome, clinical trial, psychosocial intervention, pelvic pain, therapy, urological chronic pelvic pain syndrome, chronic prostatitis, self-management, cognitive behavioral therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Psychosocial Treatment

Attention Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).
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.
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.
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.
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.

Full Information

First Posted
February 11, 2020
Last Updated
July 23, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04275297
Brief Title
Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Official Title
Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2020 (Actual)
Primary Completion Date
June 16, 2022 (Actual)
Study Completion Date
June 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychosocial Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial Treatment
Intervention Description
The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
The Attention Control will reflect a similar visit pattern and duration as intervention sessions.
Primary Outcome Measure Information:
Title
Change in the Genitourinary Pain Index (GUPI) 2 Months
Description
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
Title
Change in the Genitourinary Pain Index (GUPI) 5 Months
Description
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
Secondary Outcome Measure Information:
Title
Change in Depressive Symptoms Measured by the Patient Health Questionnaire (PHQ-8)
Description
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
Title
The Widespread Pain Index (Derived From CHOIR Bodymap)
Description
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
Title
Fibromyalgia Symptom Scale (FSS)
Description
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
Title
Change in Posttraumatic Stress Symptoms Measured by PTSD Checklist for DSM-5 (PCL-5) With Criterion A
Description
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
Title
Change in Anxiety Symptoms Measured by the Generalized Anxiety Disorder (GAD-7) Questionnaire
Description
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
Title
Difference in Response to Treatment/Perceived Improvement and Quality of Life Between Groups as Measured by the Patient Global Impression of Change Scale (PGIC)
Description
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
Title
Quantitative Sensory Testing (Optional) - Threshold Average
Description
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
Title
Quantitative Sensory Testing (Optional) - Tolerance Average
Description
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
Title
Quantitative Sensory Testing - Temporal Summation (Slope)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey McKernan, PhD MPH
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study is occurring via a career development award mechanism through the NIDDK. The PI will establish an IPD sharing plan following consultation with study team mentors at a bi-annual mentorship team meeting in April. The information will be updated in the system accordingly.
Citations:
PubMed Identifier
21497847
Citation
Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
Results Reference
background
PubMed Identifier
20303099
Citation
Berry SH, Bogart LM, Pham C, Liu K, Nyberg L, Stoto M, Suttorp M, Clemens JQ. Development, validation and testing of an epidemiological case definition of interstitial cystitis/painful bladder syndrome. J Urol. 2010 May;183(5):1848-52. doi: 10.1016/j.juro.2009.12.103. Epub 2010 Mar 29.
Results Reference
background
PubMed Identifier
26835782
Citation
Brummett CM, Bakshi RR, Goesling J, Leung D, Moser SE, Zollars JW, Williams DA, Clauw DJ, Hassett AL. Preliminary validation of the Michigan Body Map. Pain. 2016 Jun;157(6):1205-1212. doi: 10.1097/j.pain.0000000000000506.
Results Reference
background
PubMed Identifier
21285161
Citation
Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.
Results Reference
background
PubMed Identifier
25746197
Citation
Kratz AL, Schilling SG, Goesling J, Williams DA. Development and initial validation of a brief self-report measure of cognitive dysfunction in fibromyalgia. J Pain. 2015 Jun;16(6):527-36. doi: 10.1016/j.jpain.2015.02.008. Epub 2015 Mar 4.
Results Reference
background
PubMed Identifier
10782451
Citation
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
Results Reference
background
PubMed Identifier
9187685
Citation
Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30. doi: 10.1016/s0090-4295(97)00238-0.
Results Reference
background
PubMed Identifier
19542801
Citation
Desrochers G, Bergeron S, Khalife S, Dupuis MJ, Jodoin M. Fear avoidance and self-efficacy in relation to pain and sexual impairment in women with provoked vestibulodynia. Clin J Pain. 2009 Jul-Aug;25(6):520-7. doi: 10.1097/AJP.0b013e31819976e3.
Results Reference
background
PubMed Identifier
20554116
Citation
Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
Results Reference
background
PubMed Identifier
17443116
Citation
Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
Results Reference
background
PubMed Identifier
18752852
Citation
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
Results Reference
background
PubMed Identifier
16717171
Citation
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Results Reference
background
PubMed Identifier
26606250
Citation
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
Results Reference
background
PubMed Identifier
26535150
Citation
Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015. Erratum In: RMD Open. 2015;1(1):e000146corr1.
Results Reference
background
PubMed Identifier
25967582
Citation
Sherman AL, Morris MC, Bruehl S, Westbrook TD, Walker LS. Heightened Temporal Summation of Pain in Patients with Functional Gastrointestinal Disorders and History of Trauma. Ann Behav Med. 2015 Dec;49(6):785-92. doi: 10.1007/s12160-015-9712-5.
Results Reference
background
PubMed Identifier
26856520
Citation
Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.
Results Reference
background
PubMed Identifier
9928779
Citation
Li J, Simone DA, Larson AA. Windup leads to characteristics of central sensitization. Pain. 1999 Jan;79(1):75-82. doi: 10.1016/S0304-3959(98)00154-7.
Results Reference
background
PubMed Identifier
12654951
Citation
Shy ME, Frohman EM, So YT, Arezzo JC, Cornblath DR, Giuliani MJ, Kincaid JC, Ochoa JL, Parry GJ, Weimer LH; Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology. 2003 Mar 25;60(6):898-904. doi: 10.1212/01.wnl.0000058546.16985.11.
Results Reference
background
PubMed Identifier
25581383
Citation
Ezenwa MO, Molokie RE, Wang ZJ, Yao Y, Suarez ML, Pullum C, Schlaeger JM, Fillingim RB, Wilkie DJ. Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain? Pain Pract. 2016 Mar;16(3):282-93. doi: 10.1111/papr.12279. Epub 2015 Jan 12.
Results Reference
background

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Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome

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