Health TrialsbyHealthPanel

Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment

ConditionsChronic Interstitial CystitisBladder Pain SyndromePainful Bladder SyndromeCystitis, InterstitialCystitis, Chronic InterstitialInterstitial CystitisInterstitial Cystitis, ChronicInterstitial Cystitis (Chronic) With HematuriaInterstitial Cystitis (Chronic) Without HematuriaChronic ProstatitisChronic Prostatitis With Chronic Pelvic Pain Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center

About this trial

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. Individuals with IC/BPS have distinct subgroups, or "phenotypes," largely characterized by the distribution of pain throughout the body. Supported by our preliminary evidence, the overall goal of this project is to assess how IC/BPS phenotype may affect response to two different therapies often given without regard to patient phenotype, pelvic floor physical therapy (PT) and cognitive-behavioral therapy (CBT) for IC/BPS.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years of age or older;

Diagnosis of IC/BPS as indicated by structured assessments;

Capable of giving written informed consent;

Able to enroll for the duration of the study period;

Disqualifiers

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, active suicidal ideation, homicidal ideation, substance abuse dependency) reported within the past six months;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychosocial Treatment

    Behavioral

    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 and tested in a prior study. Treatment modules are individualized and include topics such as pain coping strategies, relaxation training, education on IC/BPS, and communication strategies.

  • Pelvic Floor Physical Therapy

    Other intervention

    The pelvic floor physical therapy condition consists of 10 weekly 45-minute individual visits with an assigned trained physical therapist. In IC/BPS, pelvic floor physical therapy (PT) uses manual manipulation to release localized muscle tension, trigger points, and correct other scars and restrictions to reduce pain and urgency symptoms. Specific techniques will include external connective tissue manipulation to the abdominal wall, back, buttocks and thighs, myofascial trigger point release, and internal transvaginal/transrectal treatment of the soft tissues of the pelvic floor with connective tissue and myofascial manipulation to pelvic floor musculature

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Psychosocial TreatmentExperimental treatment 1 intervention
Group B: Pelvic Floor Physical TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Differences in response to treatment by phenotype measured by the Global Response Assessment (GRA) scale.

GRA provides a global index used to rate the response of a condition to an intervention. The GRA is a 7-point centered scale that assesses patient impression of change in IC/BPS symptoms since entering the study ranging from 7= "very much worse" to 1= "very much improved." This scale will be administered at post-treatment and at follow-up. Global improvement is a core domain recommended for conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain according to Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT). We will examine the mean differences in GRA scores by phenotype in each treatment condition, and we will then calculate the percentage of patients classified as treatment responders (GRA\<3) within each treatment and phenotype.

Time frame
Post-treatment (either Week 8 or 10)

Secondary outcomes

1

Chronic Overlapping Pain Condition-Screener (COPCS)

The COPCS is designed to identify up to 10 chronic overlapping pain conditions that often occur together in the same individual. The first part of the survey presents a body map, inquiring about pain locations. Based on participant responses to the body map, additional questions about symptoms are asked to determine the type of pain conditions that are experienced. Endorsed pain locations are collapsed into "regions" to reflect the number of zones in the body with pain (1-7 pain regions). Participants will be categorized into "peripheral" or "centralized" pain types based on the number of pain regions endorsed. This information will be used to examine the role of pain type in treatment response, and to assess how treatment outcomes may differ within pain phenotypes.

Time frame
Baseline (Week 0)
2

Quantitative Sensory Testing - Tolerance Average (QST-TOL)

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 10 = "Worst Possible Pain", with higher scores indicating a higher pain tolerance. This information will inform both how pain tolerance may predict treatment response, and change in response to treatment.

Time frame
Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
3

Quantitative Sensory Testing - Threshold Average (QST-THR)

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 10 = "Worst Possible Pain", with higher scores indicating a higher pain threshold. This information will inform both how pain threshold may predict treatment response, and change in response to treatment.

Time frame
Baseline (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)
4

Quantitative Sensory Testing - Temporal Summation (QST-TS)

Psychophysical testing methods will replicate existing protocols used at VUMC and include an evaluation of temporal summation (as a biomarker for central sensitization). Temporal summation includes a series of 10 sequential heat pulses applied to the forearm. In each sequence, after each heat pulse, subjects provide a verbal numeric pain intensity rating on a 0-10 scale (0 = "No Pain or Warmth" and 10 = "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. Two slopes will be calculated from two sequences. These slopes reflect the relationship between pain and pulse, representing average pain increase for each unit increase in pulse. This information will inform both how temporal summation may predict treatment response, and change in response to treatment.

Time frame
Baseline, (Week 0), Post-treatment (either Week 8 or 10), Follow-up (Week 24)

Other outcomes

Sponsors and contacts

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Vanderbilt University Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
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