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

NCT ID: NCT04746352

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-12-31

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).

Conditions

Myofascial Pelvic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BES-SMFR group

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.

Group Type: EXPERIMENTAL

BES-SMFR

Intervention Type: 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 group

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.

Group Type: ACTIVE_COMPARATOR

BES

Intervention Type: 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.

Interventions

BES-SMFR

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.

Intervention Type: PROCEDURE

BES

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yang Shen

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yang Shen, MD,PhD

Role: STUDY_DIRECTOR

Zhongda Hospital

Locations

Zhongda Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

Zhongda Hospital

Identifier Type: -

Identifier Source: org_study_id