Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of MFPP

NCT04746352 | Completed

• 1 other identifier: Zhongda Hospital
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Myofascial pelvic pain (MFPP) caused by myofascial trigger points (MTrPs) is a major contributor of female chronic pelvic pain. However, the effect of the patient's self-myofascial release (SMFR) is not clear. Current study is to investigate the effect of SMFR combined with biofeedback and electrical stimulation (BES) therapy compared with BES alone in patients with MFPP.

Conditions

Myofascial Pelvic Pain

Outcome Measures

Primary Outcomes (1)

• The change of pain intensity

  Pain intensity was calculated by using the visual numeric rating scale (NRS), which is a 11-point rating scale ranging from "0" (no pain) to "10" (worst pain imaginable) . For each patient, the NRS referred to pain elicited while palpating bilaterally each PFM groups and was averaged pain across all the muscles. Upon palpation, the patient was asked to place in a resting, semi-recumbent position with legs supported by pillow to prevent excessive tension in the PFMs.

  Up to 12 weeks

Secondary Outcomes (3)

• The degree in activation of MTrPs

  Up to 12 weeks

• Surface electromyography (sEMG) levels of the PFMs

  Up to 12 weeks

• The score of Patient Global Impression of Improvement (PGI-I)

  Up to 12 weeks

Study Arms (2)

BES-SMFR group

EXPERIMENTAL

Using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. Three standardized programs were used in our study: (1) Tens electricity (first program): 5 min of 50-280 Hz frequency and a pulse duration of 50 µs. (b) Endorphin electricity (second program): 5 min of 1-10 Hz frequency and a pulse duration of 200 µs. (c) Spasmolysis electricity (third program): 5 min of 1-2 Hz frequency and a pulse duration of 300 µs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive.

Procedure: BES-SMFR

BES group

ACTIVE COMPARATOR

1. A standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. 2. Patients were required to participate in intensive training regarding myofascial release techniques. (I) Pressing: press directly on a specific MTrP with gentle, slow pressures (2kg/cm2) using a flat palpation, the pressure was sustained until the participant perceived the pain decreased and taut band released, and then gradually increased to previous level of MTrPs tension and maintained until a reduction of pain again. The process was usually 3 to 5 repetitions for 90 sec. (II) Stretching: stretch in parallel to the direction of the myofascial to facilitate elongation of a contracted muscle. (III) Strumming: stroking and strumming the affected muscles region with the fingertips to aid in MTrPs tension release, the initial pressure was small and increased gradually until the patients adapted.

Procedure: BES

Interventions

BES-SMFR PROCEDURE

For the BES intervention, it was performed using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. BES was performed once every 2 days for 4 weeks.

BES-SMFR group

BES PROCEDURE

First, a standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. Second, patients were required to participate in intensive training regarding myofascial release techniques. Following the training, SMFR was regularly performed by at home for 5 minutes daily for 4 weeks. SMFR was confirmed with patients at all their follow up visits.

BES group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 70 years;
• presence of persistent chronic pelvic pain ≥ 4 points on a 10 points numeric rating scale for at least 3 months;
• at least one active MTrP in one of muscle group including obturator internus, levator ani, piriformis, coccygeus on pelvic examination.

You may not qualify if:

• diseases of the urinary, genital, colorectal systems;
• prolapse of the pelvic organ;
• a history of pelvic rehabilitation within the 3 months prior to study;
• psychiatric disorders;
• pregnancy;
• breastfeeding.

Sponsors & Collaborators

• Zhongda Hospital: lead

Study Sites (1)

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Interventions

BES

Study Officials

• Yang Shen, MD,PhD

  Zhongda Hospital

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 9, 2021
• Study Start: September 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)