Skip to main content
OpenTrials
Completed

NCT Number: NCT04746352

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zhongda Hospital

Nanjing, Jiangsu, 210000, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. The change of pain intensity

    Time frame: 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 outcomes

  1. The degree in activation of MTrPs

    Time frame: 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.

  2. Surface electromyography (sEMG) levels of the PFMs

    Time frame: 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.

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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Zhongda Hospital

Other

Registry information

Official study title

Effectiveness of Self-myofascial Release Combined With Biofeedback and Electrical Stimulation for the Management of Myofascial Pelvic Pain

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2021
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.