Physical Therapy for Endometriosis

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Opioids

Disqualifiers: Non-English, Mobility device, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a home pelvic floor physical therapy program can improve recovery and quality of life for individuals who have undergone surgery to remove endometriosis. The trial compares this therapy to the usual post-surgery care. Suitable participants should be premenopausal, speak English, have experienced chronic pelvic pain for at least six months, and be preparing for endometriosis surgery without a hysterectomy at Legacy Health. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance post-surgery recovery options.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this physical therapy program is safe for endometriosis patients?

Research has shown that pelvic floor physical therapy is generally safe and beneficial. Studies have found that exercise and physical activity can enhance quality of life and reduce pain for those with pelvic floor issues. This therapy also supports mental health. In one study on a digital pelvic health program, participants experienced reduced pelvic pain, anxiety, and depression over 4 to 12 weeks.

These studies do not specifically mention serious side effects, suggesting that this therapy is well-tolerated. However, individual experiences may vary. Always consult a healthcare provider to determine the best course of action. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how pelvic floor physical therapy can aid recovery for endometriosis patients post-surgery. While current treatments often focus on medication or surgery alone, this approach incorporates active recovery, emphasizing core and pelvic floor exercises to address urinary and bowel symptoms. This could enhance recovery by empowering patients to actively participate in their healing process, potentially reducing symptoms more effectively than standard postoperative care.

What evidence suggests that pelvic floor physical therapy is effective for endometriosis?

Research has shown that pelvic floor physical therapy can benefit people with endometriosis. One study found that an eight-week exercise program greatly reduced pain and improved posture for those with endometriosis. Another study showed that guided exercises and pelvic floor muscle training lessened pelvic and genital pain in just one month. Additionally, a review of studies highlighted the positive effects of physical activity and exercise on endometriosis symptoms. In this trial, participants in the "Active Recovery" arm will follow a protocol that includes pelvic floor exercises, which might enhance recovery and quality of life for endometriosis patients after surgery. ^{2 5 6 7 8}

Who Is on the Research Team?

Jacqueline Wong

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone endometriosis excision surgery without hysterectomy and are looking to compare the effectiveness of home pelvic floor physical therapy with routine post-operative care.

Inclusion Criteria

I have not gone through menopause.

English speaking

I have reliable email and phone access for study updates.

Exclusion Criteria

Non-English speaking

I am unable to give consent by myself.

I cannot do moderate activities for 30 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Postoperative Care

Participants undergo endometriosis excisional surgery and receive immediate postoperative care

Immediate

1 visit (in-person)

Active Recovery or Standard Postoperative Care

Participants follow either a home physical therapy program or standard postoperative instructions for 12 weeks

12 weeks

2 visits (in-person) at 6 and 12 weeks

Follow-up

Participants are monitored for quality of life, pain, and endometriosis symptoms

12 weeks

2 visits (in-person) at 6 and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic Floor Physical Therapy

Trial Overview The study tests whether a home-based pelvic floor physical therapy program can improve quality of life and reduce symptoms better than standard post-surgery instructions after endometriosis excision.

How Is the Trial Designed?

Group I: Active Recovery Experimental Treatment 1 Intervention

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.

Group II: Standard Postoperative Instructions Active Control 1 Intervention

Participants will receive standard postoperative recovery instructions

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5890212/

Efficacy of exercise on pelvic pain and posture associated ... It was proven that eight weeks of an exercise program is very effective in decreasing pain and postural abnormalities associated with endometriosis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1836955325001092

Supervised exercise and pelvic floor muscle training eases ... The primary outcomes were: change in worst pelvic and genital pain severity over the course of 1 month; and change in conditional pelvic and genital pain, ...

3. academic.oup.com academic.oup.com/painmedicine/advance-article/doi/10.1093/pm/pnaf083/8211830

Physiotherapy for endometriosis-associated pelvic pain The study showed that exercise was effective in reducing pelvic pain (MD −1.13, 95% CI −3.94 to 1.68) compared to the control group. However, ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0317820

The effectiveness and safety of physical activity and exercise ... The present review indicates that physical activity and exercise have beneficial effects on the treatment of symptoms associated with endometriosis, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06795243

Efficacy of Physical Therapy Treatment in Endometriosis ... This project aims to examine the relationship between the efficacy of physical therapy treatment in patients diagnosed with endometriosis.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39946383/

The effectiveness and safety of physical activity and ... The results indicated that physical activity and exercise have a beneficial impact on quality of life, pain intensity, mental health, pelvic floor dysfunction, ...

7. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03475-4

Clinical outcomes of a digital musculoskeletal women's pelvic ... This longitudinal, observational study of a digital women's pelvic health program examined pelvic pain, anxiety, and depression at 4 and 12 weeks.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525003598

Changes in fatigue, health-related fitness, sleep quality ... A 9-week supervised multimodal therapeutic exercise program is effective in ameliorating a broad range of endometriosis-related impairments.