Clinical trial NCT02867774: Impact of Physical Activity for Chronic Pelvic Pain
Official title: Impact of Physical Activity for Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Pain
Keywords: chronic pelvic pain
central pain amplification
exercise
physical activity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical Function
timeFrame: 8 weeks
measure: Fatigue
timeFrame: 8 weeks
measure: Sexual Function
timeFrame: 8 weeks
measure: Sleep
timeFrame: 8 weeks
measure: Anxiety
timeFrame: 8 weeks
measure: Depression
timeFrame: 8 weeks
measure: Catastrophization
timeFrame: 8 weeks
measure: Overall symptom improvement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sawsan As-Sanie, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Sara R Till, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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