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Clinical Trials/NCT02867774
NCT02867774
Completed
Not Applicable

Impact of Physical Activity for Chronic Pelvic Pain

University of Michigan1 site in 1 country22 target enrollmentAugust 2016
ConditionsPelvic Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Pain
Sponsor
University of Michigan
Enrollment
22
Locations
1
Primary Endpoint
Pain
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 28, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara Till, MD, MPH

Minimally Invasive Gynecologic Surgery Fellow

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • 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

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

Outcomes

Primary Outcomes

Pain

Time Frame: 8 weeks

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

Secondary Outcomes

  • Physical Function(8 weeks)
  • Fatigue(8 weeks)
  • Sexual Function(8 weeks)
  • Sleep(8 weeks)
  • Anxiety(8 weeks)
  • Depression(8 weeks)
  • Catastrophization(8 weeks)
  • Overall symptom improvement(8 weeks)

Study Sites (1)

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