- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07127783
- Original Trial
Physical Therapy After Endometriosis Excision
The Role of a Postoperative Home Physical Therapy Program for the Treatment of Pelvic Pain in Patients Undergoing Endometriosis Excision
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled pilot study conducted at a single institution comparing a home pelvic floor physical therapy program to routine post-operative care for patients undergoing endometriosis excisional surgery without hysterectomy. Patients will be recruited from a referral gynecological surgery group specializing in the diagnosis and treatment of pelvic pain and endometriosis. The goal is to assess the role of the active recovery program on quality of life and on pain and endometriosis symptoms.
Subjects will be randomized to routine post-operative care or to a home physical therapy program, in which they will receive written instruct ions and videos of exercises to complete immediately after surgery. The home exercise program was developed by the Department of Urogynecology in conjunction with pelvic floor physical therapists, and includes videos created by the education communications division. Quality of life, pain score, and endometriosis symptoms will be assessed at their pre-operative appointment, and at 6 and 12 weeks postoperatively.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Women's Health Research Unit Department of OB/Gyn
- Phone Number: 503-494-3666
- Email: whru@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Women's Health Research Unit
- Phone Number: 503-494-3666
- Email: whru@ohsu.edu
-
Principal Investigator:
- Jacqueline Wong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Premenopausal
- English speaking
- Undergoing endometriosis excision surgery without hysterectomy at Legacy Health with subspecialty-trained surgeons specializing in endometriosis care
- History of chronic pelvic pain (defined as >= 6 months of pain in the anatomic pelvis)
- Diagnosis of high tone pelvic floor dysfunction on examiniation
- Have access to reliable email and phone for study-related communication
Exclusion Criteria:
- Non-English speaking
- Unable to consent
- Unable to sustain 30 minutes of moderate activity at baseline
- Uses a mobility assistive device at baseline
- Chronic opioid use
- No histologic diagnosis of endometriosis on surgical pathology
- Need for additional pelvic rest (>2 weeks) postoperatively
- Pregnancy or planning to pursue pregnancy or undergo fertility treatments within 12 weeks postoperatively
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Postoperative Instructions
Participants will receive standard postoperative recovery instructions
|
Standard of care postoperative instructions covering incision care, pain control, dietary instructions, and emergency precautions.
Also includes guidelines regarding pelvic rest and lifting restrictions.
|
|
Experimental: Active Recovery
Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms.
Exercises are to be completed twice per day for the 12 weeks following surgery.
|
Participants will receive postoperative instructions to follow an active recovery protocol focused on increasing activity level, core strength exercises, and pelvic floor exercises focused on urinary and bowel symptoms.
Exercises are to be completed twice per day for the 12 weeks following surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form Survey (SF-36)
Time Frame: Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery
|
The Short Form Survey (SF-36) is a 36-item survey regarding general health and pain and its impact on quality of life including physical activities, work, social activities, and emotional well-being over the last four weeks.
Scores range from 0 to 100 with a higher score representing a more favorable health state.
|
Collected immediately following surgery, 6 weeks following surgery, and 12 weeks following surgery
|
|
Pelvic Floor Impact Questionnaire (PFIQ)
Time Frame: Collected immediately following surgery and 12 weeks following surgery
|
The Pelvic Floor Impact Questionnaire (PFIQ) asks about how bladder, bowel, and pelvic symptoms affect the ability to do physical activities as well as their impact on emotional well-being over the last 3 months.
Scores range from 0 to 300 with a lower score representing a lesser impact on quality of life.
|
Collected immediately following surgery and 12 weeks following surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Scores
Time Frame: Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.
|
Pain measured using a Visual Analog Scale (VAS).
This scale asks patients to rate their pelvic pain and dyspareunia over the last 4 weeks.
Responses are on a scale from 0 to 10, with 10 being the worst pain.
|
Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.
|
|
Endometriosis Health Profile (EHP-5)
Time Frame: Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.
|
The Endometriosis Health Profile (EHP-5) is a 5-item questionnaire asking about the perception of endometriosis symptoms on physical ability, emotional well-being, mood, social isolation, and appearance over the last four weeks.
Scores range from 0 to 100 where 0 indicates the best health status.
|
Collected at baseline, 6 weeks following surgery, and 12 weeks following surgery.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacqueline Wong, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00028168
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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