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Photobiomodulation for Myofascial Pelvic Pain (PMPP)

Primary Purpose

Pelvic Pain, Levator Ani Syndrome, Spastic Pelvic Floor Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SoLá therapy
Pelvic floor physical therapy
Sponsored by
Orlando VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Pain focused on measuring photobiomodulation, pelvic floor physical therapy, chronic pelvic pain, spastic pelvic floor syndrome, levator ani syndrome, myalgia of pelvic floor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Orlando VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Photobiomodulation

Pelvic Floor Physical therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intensity of Dyspareunia
Change in dyspareunia intensity using a 0-10cm visual analog scale. High score means a worse outcome.
Intensity of pain with sitting
Change in intensity of pain with sitting using a 0-10cm visual analog scale. High score means a worse outcome.
Pain interference
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.

Full Information

First Posted
June 9, 2023
Last Updated
June 21, 2023
Sponsor
Orlando VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05926752
Brief Title
Photobiomodulation for Myofascial Pelvic Pain
Acronym
PMPP
Official Title
Photobiomodulation Therapy for Myofascial Pelvic Pain: A Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando VA Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photobiomodulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pelvic Floor Physical therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SoLá therapy
Intervention Description
SoLá therapy is a photobiomodulation device that works by stimulating mitochondria, soothing tense muscles, and promotes healing.
Intervention Type
Other
Intervention Name(s)
Pelvic floor physical therapy
Intervention Description
Physical therapy is manual myofascial release, muscles stretches, and exercises designed to help myofascial pelvic pain
Primary Outcome Measure Information:
Title
Pelvic Pain Intensity
Description
Change pelvic pain intensity using a 0-10cm visual analog scale. High score means a worse outcome.
Time Frame
3 months post treatment
Secondary Outcome Measure Information:
Title
Intensity of Dyspareunia
Description
Change in dyspareunia intensity using a 0-10cm visual analog scale. High score means a worse outcome.
Time Frame
3 months post treatment
Title
Intensity of pain with sitting
Description
Change in intensity of pain with sitting using a 0-10cm visual analog scale. High score means a worse outcome.
Time Frame
3 months post treatment
Title
Pain interference
Description
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.
Time Frame
3 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chensi Ouyang, MD
Phone
4076314010
Email
chensi.ouyang@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Castellanos, MD
Phone
4076314010
Email
mario.castellanos@va.gov
Facility Information:
Facility Name
Orlando VA Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chensi Ouyang, MD
Phone
407-631-4010
Email
chensi.ouyang@va.gov
First Name & Middle Initial & Last Name & Degree
mario castellanos, MD
Phone
4076314010
Email
mario.castellanos@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Final data sets underlying publications resulting from the proposed research will not be shared outside VA, except as required under the Freedom of Information Act (FOIA).
Citations:
PubMed Identifier
28676361
Citation
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Results Reference
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PubMed Identifier
30566976
Citation
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.
Results Reference
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PubMed Identifier
29788455
Citation
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.
Results Reference
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PubMed Identifier
29757068
Citation
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.
Results Reference
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PubMed Identifier
22503015
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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. Erratum In: Lancet. 2010 Mar 13;375(9718):894.
Results Reference
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PubMed Identifier
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Citation
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Citation
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Results Reference
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Photobiomodulation for Myofascial Pelvic Pain

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