Clinical Trial: Impact of Physical Activity for Chronic Pelvic Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Impact of Physical Activity for Chronic Pelvic Pain

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 Summary: 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.
Sponsor: University of Michigan

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Physical Function [ Time Frame: 8 weeks ]
    Change in reported physical function, measured by the PROMIS Physical Function Scale
  • Fatigue [ Time Frame: 8 weeks ]
    Change in reported fatigue, measured by the PROMIS Fatigue Scale
  • Sexual Function [ Time Frame: 8 weeks ]
    Change in reported sexual function, measured by the Female Sexual Function Index
  • Sleep [ Time Frame: 8 weeks ]
    Change in reported sleep, measured by the PROMIS Sleep Disturbance Scale
  • Anxiety [ Time Frame: 8 weeks ]
    Change in reported anxiety, measured by the PROMIS Anxiety Scale
  • Depression [ Time Frame: 8 weeks ]
    Change in reported depression, measured by the PROMIS Depression Scale
  • Catastrophization [ Time Frame: 8 weeks ]
    Change in reported catastrophization, measured by the Pain Catastrophization Scale
  • Overall symptom improvement [ Time Frame: 8 weeks ]
    Change in overall symptoms, measured by the Patient Global Impression of Change Scale


Original Secondary Outcome: Same as current

Information By: University of Michigan

Dates:
Date Received: August 12, 2016
Date Started: August 2016
Date Completion:
Last Updated: August 12, 2016
Last Verified: August 2016