Chronic Pelvic Pain
Conditions
Keywords
chronic pelvic pain, empowered relief therapy, pain interference, cognitive behavior therapy, Gynecology
Brief summary
Primary Aim To determine if the addition of empowered relief therapy to standard treatment is superior to standard treatment alone in patients with chronic pelvic pain as measured by pain interference in patients with chronic pelvic pain. The investigators hypothesize that patients will show improved pain interference at two-weeks post-baseline. In addition, the investigators hypothesize that patients receiving ER (Empowered Relief) will show a better trajectory of pain interference over time, relative to the control group. Secondary Aims 1. To compare pain intensity scores (as measured by NRS-The Numerical Rating Scale pain) with the addition of empowered relief therapy to standard treatment in patients with chronic pelvic pain. a. The investigators hypothesize that patients with the addition of ER to standard treatment will show greater improvement in pain intensity scores. 2. To compare health related quality of life scores with the addition of empowered relief therapy to standard treatment in patients with chronic pelvic pain. 1. The investigators hypothesize that patients with addition of ER to standard treatment will show greater improvement in quality of life (QOL).
Detailed description
This will be a pilot single site, randomized controlled clinical trial comparing the addition of empowered relief therapy to standard treatment alone in 100 women with chronic pelvic pain. Patients randomized to standard treatment alone will be offered to attend an empowered relief session after 12 weeks if they are not satisfied with their symptom control. Patients presenting to the Gynecology Clinics at the UChicago Medicine will be approached for inclusion if they desire treatment for chronic pelvic pain and meet inclusion criteria. Consenting participants will be randomized to referral to Empowered Relief session within 4 weeks in addition to their standard treatment or standard treatment alone. Both groups will receive standard treatment for chronic pelvic pain which may include medications (hormonal, muscle relaxants, neuromodulators, anti-depressants), pelvic floor physical therapy and/or trigger point/nerve block injections for pain relief. Specifics of standard treatment will be documented for both treatment groups. Both groups will complete baseline questionnaires assessing pain interference, catastrophizing, pain intensity, and quality of life as well as follow up questionnaires at 2 weeks and 12 weeks after ER class or initiating standard therapy (See Schedule of Measures).
Interventions
BEHAVIORALEmpowered Relief (ER) Therapy
The Empowered Relief classes will be offered virtually via the Zoom platform every 2 weeks. Approved study personnel will contact patients to remind them of the upcoming ER group and to troubleshoot technological challenges. The certified ER leader uses a prepared, standardized PowerPoint presentation and lecture notes. Class involves didactic material about pain and strategies to manage it as well as experiential exercises including relaxation, reframing, and developing a pain coping toolbox. Participants are welcome to ask questions, but because time is limited, they will also be encouraged to pose questions in the chat box, stay after class, or contact the leader directly. The class is about 120 mins long and there are brief breaks at approximately 45 mins, 75 mins, and 105 mins. Nancy Beckman, PhD, is a clinical psychologist who specializes in chronic pain conditions and already runs ER sessions twice a month. She along with her trainees who are specializing in chronic pain and h
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
This will be a pilot single site, randomized controlled clinical trial comparing the addition of empowered relief therapy to standard treatment alone in 100 women with chronic pelvic pain. Patients randomized to standard treatment alone will be offered to attend an empowered relief session after 12 weeks. if they are not satisfied with their symptom control
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to provide written informed consent. * Has pelvic pain of at least 6 months in duration and at least 7 days per month; defined as pain in the abdomen below the level of the umbilicus, bladder pain, and/or vaginal pain. * Female sex at birth * Clinic pain intensity score of at least 4 (range, 0-10, with 10 indicating worst pain imaginable) * English fluency * Adults aged 18 to 70 years
Exclusion criteria
* Patients scheduled for surgery within the study period or within 1 month post-op * Gross cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determining if the addition of empowered relief therapy in addition to standard treatment is superior to standard treatment alone in patients with chronic pelvic pain as measured by pain interference in patients with chronic pelvic pain | 12 weeks | 1\. PROMIS pain interference scale score (an 8-item questionnaire which measures the extent to which pain hinders engagement with various life activities, including physical, cognitive, emotional, recreational, and social activities, as well as sleep and enjoyment of life). One represents never or normal functioning, and the higher number means always or more interference. The minimum raw score is 8 and the maximum raw score is 40. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophization Scale (PCS) | 12 weeks | Pain Catastrophization Scale (PCS) scor, a 13-item self-report questionnaire that measures the extent to which people experience catastrophic thoughts and feelings when experiencing pain. 13 statements rated on a 5-point Likert scale from 0 ("not at all") to 4 ("all the time") where higher scores reflect higher levels of catastrophic thinking. |
| Numeric Rating Scale (NRS) | 12 weeks | Numeric Rating Scale (NRS) pain scale score (a pain assessment tool that uses a 0-to-10 scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable," to allow patients to self-report their pain intensity) |
| 36-Item Short Form Health Survey (SF-36) | 12 weeks | 36-Item Short Form Health Survey (SF-36) QOL scale score (a 36-item, patient-reported survey used to measure health-related quality of life (HRQOL) across eight domains, providing summary scores for physical and mental health components). The higher scores indicate a better outcome or more favorable health state. |
| Patient Health Questionnaire-8 (PHQ-8) | 12 weeks | Patient Health Questionnaire-8 (PHQ-8) Depression index score (an 8-item self-reported measure used to assess depressive symptoms). Each item is rated from 0 to 3. The higher score means greater severity of depressive symptoms. |
| Generalized Anxiety Disorder-7 (GAD-7) | 12 weeks | Generalized Anxiety Disorder-7 (GAD-7) Anxiety index score (a brief, 7-item self-report questionnaire used to screen for and assess the severity of generalized anxiety disorder). Each of the seven items is scored from 0 to 3, with the total score ranging from 0 to 21. The higher score means increased severity of anxiety. |
Countries
United States
Contacts
CONTACTInsiyyah Patanwala, MD
CONTACTSumeyra Agambayev, MS
STUDY_CHAIRKimberly Kenton, MD
University of Chicago, Urogynecology and Reconstructive Pelvic Surgery
Outcome results
None listed