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

Not Applicable

Completed

• Conditions: Myofascial Pelvic Pain

• Registration Number: NCT04746352
• Lead Sponsor: Zhongda Hospital

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.

Detailed Description

68 patients was enrolled and randomly allocated into two groups: BES-SMFR group (n=34) and BES group (n=34). Every patient received 4 weeks treatment, and was evaluated at baseline (T0), 4-week post-intervention (T4) and 12-week follow-up (T12). The primary outcome was pain intensity. The secondary outcomes were degree in activation of MTrPs, surface electromyography (sEMG) levels, and Patient Global Impression of Improvement (PGI-I).

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-05
• Study First Posted: 2021-02-09
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The change of pain intensity	Up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
The degree in activation of MTrPs	Up to 12 weeks	MTrPs were considered as active when the following criteria was met: (1) Presence of a palpable taut band in the muscle; (2) Presence of a hypersensitive spot in the taut band; (3) Local twitch response elicited by snapping palpation; (4) Reproduction of the typical referred pain pattern in response to the compression of tender spots; and (5) Spontaneous presence of the typical referred pain pattern. Active MTrPs localized mainly in the bilateral obturator internus, levator ani, piriformis and coccygeus were assessed respectively by pelvic floor manual palpation. Using the inclusion criterion of having active MTrPs at least one in the bilateral muscles as a cutoff point.
The score of Patient Global Impression of Improvement (PGI-I)	Up to 12 weeks	PGI-I is a patient self-reporting evaluation that assesses overall perception of response to treatment according to a 7-point scale, including very much worse, much worse, a little worse, no change, a little better, much better or very much better, with lower scores indicating more favorable outcomes. Better response to treatment was considered when a PGI-I score \< 3 (very much better or much better).
Surface electromyography (sEMG) levels of the PFMs	Up to 12 weeks	The PFMs sEMG assessment was performed based on Glazer protocol by using the device of Vishee neuro-muscle stimulator (MyoTrac Infiniti, model SA9800, Thought Technology Ltd., Montreal, Canada). The sEMG amplitude mean value based on Glazer protocols for selected tasks were follows: 60-s pretest resting baseline, assessing the resting amplitude of PFM before the test sequence; 5 rapid contractions (quick flicks), assessing fast muscles function; 60-s endurance contraction, assessing slow muscles function; 60-s posttest resting baseline, assessing the resting amplitude of PFM after the test sequence.

Trial Locations

Locations (1)

Zhongda Hospital; 🇨🇳 Nanjing, Jiangsu, China