Health TrialsbyHealthPanel

Empowered Relief for Chronic Pelvic Pain

ConditionChronic Pelvic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity of Chicago

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients scheduled for surgery within the study period or within 1 month post-op

Gross cognitive impairment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empowered Relief (ER) Therapy

    Behavioral

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Usual care.No intervention 0 interventions
Group B: Usual care with enrollment in an ER virtual class within four weeks of being approached with studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
12 weeks

Secondary outcomes

1

Pain Catastrophization Scale (PCS)

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.

Time frame
12 weeks
2

Numeric Rating Scale (NRS)

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)

Time frame
12 weeks
3

36-Item Short Form Health Survey (SF-36)

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.

Time frame
12 weeks
4

Patient Health Questionnaire-8 (PHQ-8)

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Chicago

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: