PMPP: Photobiomodulation for Myofascial Pelvic Pain

Sponsor

Orlando VA Medical Center (U.S. Fed)

Overall Status

Recruiting

CT.gov ID

NCT05926752

Collaborator

(none)

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of photobiomodulation of the pelvic floor muscles in female Veterans with chronic pelvic pain. The main questions it aims to answer are:

Is there a difference in reduction in overall pelvic pain between women who undergo photobiomodulation compared to women who received pelvic floor physical therapy?
Is there a difference in compliance with therapy between the two groups? Participants will be randomized to treatment with either 9 treatments of photobiomodulation (two treatments per week) or 8 weeks of pelvic floor physical therapy (one treatment a week). Researchers will compare both groups to see if there is a difference in overall pelvic pain reduction.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Pain Levator Ani Syndrome Spastic Pelvic Floor Syndrome Chronic Pelvic Pain Syndrome Myalgia of Pelvic Floor	Device: SoLá therapy Other: Pelvic floor physical therapy	N/A

Detailed Description

Background:

Myofascial pelvic pain (MFPP) is defined as pain in the pelvic floor muscles, the pelvic floor connective tissue, and the surrounding fascia. Standard treatment options of MFPP include pharmacotherapy and pelvic floor physical therapy (PT). In severe cases (approximately 25%) who are not responsive to therapy, pudendal blocks and trigger point injections (TPs) may be used to temporarily alleviate pain and improve function. However, these are more invasive and may require anesthesia. Photobiomodulation therapy (PBMT) delivered by a low-level laser emitter has recently emerged as a treatment option for musculoskeletal disorders such as neck and low back pain. In patients with vaginal musculoskeletal pain, PBMT is also thought to be effective with minimal side-effects. SoLá is low-level pelvic laser emitter / photobiomodulation device that has FDA approval for intravaginal use to specifically treat myofascial pelvic pain and chronic pelvic pain. Although it is FDA approved and thought to be effective and less invasive, photobiomodulation using SoLá has not been rigorously studied in randomized controlled trials (RCTs).

Study Aims:

The primary aim is to evaluate the efficacy of SoLá pelvic therapy by comparing reduction in overall pelvic pain between women who undergo 9 treatments of photobiomodulation with SoLá (approximately 1 treatment twice a week), compared to women who receive standard pelvic floor PT once a week for 8 weeks. The secondary aim is to compare dyspareunia, pain with sitting, and compliance with therapy between the two groups.

Study Design and Methods:

The investigators will conduct a RCT comparing overall pelvic pain (primary outcome), dyspareunia, and pain with sitting in women who receive PBMT with SoLá (group 1) vs. women who receive pelvic floor PT (group 2). Twenty-eight total participants will be randomized to either study group after providing informed consent. After enrollment, participants will be treated with 8 weekly treatments of pelvic PT or 9 treatments of SoLá (administered twice weekly). Patient outcomes will be evaluated at baseline (before treatment 1), midway through their treatment (before treatment 5 of SoLá and treatment 5 of PT), and at the end of their treatment (1-2 weeks after treatment 8 of PT/treatment 9 of SoLá and 3 months after treatment 8 of PT/treatment 9 of SoLá). Pain levels will be assessed using the Short Form McGill Pain Questionnaire (SF-MPQ) which assesses sensory and affective components of pain, Pain Interference Short Form which evaluates the effect of pain on quality of life, and pain severity on a 1-10cm Visual Analog Scale (VAS).

Anticipated Results:

The investigators hypothesize that women who undergo PBMT will demonstrate greater improvements in all pain outcomes when compared to pelvic floor PT.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Photobiomodulation Therapy for Myofascial Pelvic Pain: A Randomized Clinical Study

Actual Study Start Date :

Oct 27, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Photobiomodulation The participant will be treated with intravaginal SoLá photobiomodulation therapy for a total of nine treatments (two treatments a week). Each treatment lasting 5 minutes.	Device: SoLá therapy SoLá therapy is a photobiomodulation device that works by stimulating mitochondria, soothing tense muscles, and promotes healing.
Active Comparator: Pelvic Floor Physical therapy The participant will be treated with pelvic floor physical therapy once a week for 8 weeks. Physical therapy involves standard approach of manual therapy including trigger point release, soft tissue mobilization, stretching, biofeedback, breathing techniques, relaxation yoga, and therapeutic exercises.	Other: Pelvic floor physical therapy Physical therapy is manual myofascial release, muscles stretches, and exercises designed to help myofascial pelvic pain

Arm

Intervention/Treatment

Active Comparator: Photobiomodulation

The participant will be treated with intravaginal SoLá photobiomodulation therapy for a total of nine treatments (two treatments a week). Each treatment lasting 5 minutes.

Device: SoLá therapy

SoLá therapy is a photobiomodulation device that works by stimulating mitochondria, soothing tense muscles, and promotes healing.

Active Comparator: Pelvic Floor Physical therapy

The participant will be treated with pelvic floor physical therapy once a week for 8 weeks. Physical therapy involves standard approach of manual therapy including trigger point release, soft tissue mobilization, stretching, biofeedback, breathing techniques, relaxation yoga, and therapeutic exercises.

Other: Pelvic floor physical therapy

Physical therapy is manual myofascial release, muscles stretches, and exercises designed to help myofascial pelvic pain

Outcome Measures

Primary Outcome Measures

Pelvic Pain Intensity [3 months post treatment]
Change pelvic pain intensity using a 0-10cm visual analog scale. High score means a worse outcome.

Secondary Outcome Measures

Intensity of Dyspareunia [3 months post treatment]
Change in dyspareunia intensity using a 0-10cm visual analog scale. High score means a worse outcome.
Intensity of pain with sitting [3 months post treatment]
Change in intensity of pain with sitting using a 0-10cm visual analog scale. High score means a worse outcome.
Pain interference [3 months post treatment]
change in the score from the Pain Interference Short Form 8A PROMIS® (Patient-Reported Outcomes Measurement Information System) Health Organizations questionnaire. High score is associated with worse outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Clinically diagnosed MFPP
Age ≥ 18
Able to provide informed consent
English speaking
Agree not to participate in any other form of treatment of myofascial pelvic pain for 3 months after end of trial

Exclusion Criteria:

Prior pelvic floor physical therapy or SoLá therapy for pelvic pain
Pregnancy documented by urine or blood
Taking drugs that have heat- or light- sensitive contraindications
Reporting decreased sensation in the vagina or rectum or if they are found to have abnormalities on the external neurosensory exam of the vagina
Have a known history of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected to have neoplasia or pre-cancerous lesions
Have an active infection of the bladder, vagina, vulva, or urethra
Have active vaginal bleeding or blood in the vaginal canal
Have evidence of active vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown
Cannot tolerate vaginal examination either due to discomfort, pain or history or traumatic experience