Photobiomodulation for Myofascial Pelvic Pain

NCT05926752 | Unknown DMC FDA Device

• 1 other identifier: 1591638
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Levator Ani Syndrome; Spastic Pelvic Floor Syndrome; Chronic Pelvic Pain Syndrome; Myalgia of Pelvic Floor

Keywords

photobiomodulation; pelvic floor physical therapy; chronic pelvic pain; spastic pelvic floor syndrome; levator ani syndrome; myalgia of pelvic floor

Outcome Measures

Primary Outcomes (1)

• Pelvic Pain Intensity

  Change pelvic pain intensity using a 0-10cm visual analog scale. High score means a worse outcome.

  3 months post treatment

Secondary Outcomes (3)

• Intensity of Dyspareunia

  3 months post treatment

• Intensity of pain with sitting

  3 months post treatment

• Pain interference

  3 months post treatment

Study Arms (2)

Photobiomodulation

ACTIVE COMPARATOR

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

Pelvic Floor Physical therapy

ACTIVE COMPARATOR

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

Interventions

SoLá therapy DEVICE

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

Photobiomodulation

Pelvic floor physical therapy OTHER

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

Pelvic Floor Physical therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orlando VA Medical Center: lead

Study Sites (1)

Orlando VA Medical Center

Orlando, Florida, 32827, United States

RECRUITING

Related Publications (8)

• Bonder JH, Chi M, Rispoli L. Myofascial Pelvic Pain and Related Disorders. Phys Med Rehabil Clin N Am. 2017 Aug;28(3):501-515. doi: 10.1016/j.pmr.2017.03.005.

  PMID: 28676361 BACKGROUND

• Lamvu G, Carrillo J, Witzeman K, Alappattu M. Musculoskeletal Considerations in Female Patients with Chronic Pelvic Pain. Semin Reprod Med. 2018 Mar;36(2):107-115. doi: 10.1055/s-0038-1676085. Epub 2018 Dec 19.

  PMID: 30566976 BACKGROUND

• Cichowski SB, Rogers RG, Komesu Y, Murata E, Qualls C, Murata A, Murata G. A 10-yr Analysis of Chronic Pelvic Pain and Chronic Opioid Therapy in the Women Veteran Population. Mil Med. 2018 Nov 1;183(11-12):e635-e640. doi: 10.1093/milmed/usy114.

  PMID: 29788455 BACKGROUND

• Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019 Dec;35(12):1131-1138. doi: 10.1080/09593985.2018.1472687. Epub 2018 May 14.

  PMID: 29757068 BACKGROUND

• FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012 Jun;187(6):2113-8. doi: 10.1016/j.juro.2012.01.123. Epub 2012 Apr 12.

  PMID: 22503015 BACKGROUND

• Chow RT, Johnson MI, Lopes-Martins RA, Bjordal JM. Efficacy of low-level laser therapy in the management of neck pain: a systematic review and meta-analysis of randomised placebo or active-treatment controlled trials. Lancet. 2009 Dec 5;374(9705):1897-908. doi: 10.1016/S0140-6736(09)61522-1. Epub 2009 Nov 13.

  PMID: 19913903 BACKGROUND

• Glazov G, Yelland M, Emery J. Low-level laser therapy for chronic non-specific low back pain: a meta-analysis of randomised controlled trials. Acupunct Med. 2016 Oct;34(5):328-341. doi: 10.1136/acupmed-2015-011036. Epub 2016 May 20.

  PMID: 27207675 BACKGROUND

• Lev-Sagie A, Kopitman A, Brzezinski A. Low-Level Laser Therapy for the Treatment of Provoked Vestibulodynia-A Randomized, Placebo-Controlled Pilot Trial. J Sex Med. 2017 Nov;14(11):1403-1411. doi: 10.1016/j.jsxm.2017.09.004. Epub 2017 Sep 29.

  PMID: 28970071 BACKGROUND

MeSH Terms

Conditions

Pelvic Pain; Levator syndrome; Vaginismus

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Chensi Ouyang, MD

CONTACT

4076314010; chensi.ouyang@va.gov

Mario Castellanos, MD

CONTACT

4076314010; mario.castellanos@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: July 3, 2023
• Study Start: October 27, 2021
• Primary Completion: February 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)