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Impact of Physical Activity for Chronic Pelvic Pain

Not Applicable
Completed
Conditions
Pelvic Pain
Interventions
Behavioral: Physical Activity
Registration Number
NCT02867774
Lead Sponsor
University of Michigan
Brief Summary

The purpose of this pilot study is to evaluate the impact of an intervention to increase physical activity on pain, function and quality of life in women with chronic pelvic pain.

Detailed Description

The primary aim of this pilot study is to evaluate the impact of moderate-intensity physical activity on pelvic pain in women with chronic pelvic pain. We will develop a moderate-intensity physical activity program for patients with chronic pelvic pain in conjunction with exercise physiologists and physical medicine and rehabilitation (PM\&R) physicians. Based on prior research in fibromyalgia and other centralized pain disorders, we hypothesize that eight weeks of moderate-intensity physical activity will reduce pain intensity and pain interference in women with chronic pelvic pain. We will also evaluate the impact of moderate-intensity physical activity on physical function, fatigue, sexual function, sleep, anxiety, depression, catastrophization and patient global impression of change in women with chronic pelvic pain. We hypothesize that eight weeks of moderate-intensity physical activity will result in improvements in these measures of function and quality of life.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
22
Inclusion Criteria
  • Female
  • 18-65 years old
  • ≥ 6 months of noncyclic pelvic pain
  • Pain that is severe enough to cause functional limitations, defined here as an average self-reported daily pain score of 4 on a 10 point scale
  • Willing to attend activity session in Ann Arbor, MI at least 3 times per week
  • English speaking
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Exclusion Criteria
  • Pelvic surgery within the previous 3 months or plan for pelvic surgery within the following 3 months
  • Participation in pelvic floor physical therapy during the 12 week study period
  • Medical co-morbidities that prohibit participation in an exercise program, such as significant cardiovascular, pulmonary or orthopedic disease
  • Pregnancy
  • Documented history of significant dementia
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
InterventionPhysical ActivityThis pilot study will enroll 25 women age 18-65 with greater than six months of noncyclic pelvic pain. Subjects will participate in an 8-week physical activity program specifically designed for patients with chronic pain and supervised by personal trainers and exercise physiologists in a rehab-focused, medically-based fitness center. Subjects will complete web-based assessment tools at the start of the program, immediately after completion of the 8-week program and four weeks after the conclusion of the program (at the 12-week time point).
Primary Outcome Measures
NameTimeMethod
Pain8 weeks

Change in reported pain after physical activity intervention, measured using VAS and Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale

Secondary Outcome Measures
NameTimeMethod
Physical Function8 weeks

Change in reported physical function, measured by the PROMIS Physical Function Scale

Fatigue8 weeks

Change in reported fatigue, measured by the PROMIS Fatigue Scale

Sexual Function8 weeks

Change in reported sexual function, measured by the Female Sexual Function Index

Sleep8 weeks

Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale

Anxiety8 weeks

Change in reported anxiety, measured by the PROMIS Anxiety Scale

Depression8 weeks

Change in reported depression, measured by the PROMIS Depression Scale

Catastrophization8 weeks

Change in reported catastrophization, measured by the Pain Catastrophization Scale

Overall symptom improvement8 weeks

Change in overall symptoms, measured by the Patient Global Impression of Change Scale

Trial Locations

Locations (1)

University of Michigan

🇺🇸

Ann Arbor, Michigan, United States

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