Impact of Physical Activity for Chronic Pelvic Pain (IPA-CPP)

University of Michigan

Status: Completed

Conditions: Pelvic Pain

Treatments: Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT02867774

HUM00112656

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Intervention

Experimental group

Description:

This 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).

Treatment:

Behavioral: Physical Activity