Investigation of Acute Effects of Myofascial Trigger Point Release in Women With Chronic Pelvic Pain

Not Applicable

Completed

• Conditions: Myofascial Trigger Point Pain; Pelvic Floor; Relaxation; Pelvic Pain

• Registration Number: NCT04401566
• Lead Sponsor: Akdeniz University

Brief Summary

The patients diagnosed with pelvic pain will be included in the study. Orthopedic tests for pelvic pain were performed after routine gynecological examinations. After perineometer measurement, pelvic floor muscle sensitivity grading, ultrasound, and pain score evaluation, participants will be randomized and divided into 3 groups. According to a randomization plan the first group will be instructed by a physiotherapist to receive an internal myofascial trigger point release technique, the second group receive an external myofascial trigger point release technique, and the third group receive a video of relaxation exercises related to pelvic pain. After the application, measurement of perineometer and pelvic floor muscle sensitivity grading, ultrasound, and pain evaluations will be repeated.

Detailed Description

Turkey has been affected country from a busy and stressful lifestyle in our changing world and that leads to pelvic floor dysfunction has increased rapidly in Turkey. Pelvic pain that has in 1 out of every 7 women causes overactivity of pelvic floor muscles with increasing stress factors. In addition, it becomes chronic due to both the diagnosis process and the time-out of the right treatment and deteriorates the quality of life of women. There is no special pelvic floor physiotherapy for the management of pelvic pain in our country, which also causes psychosocial problems. On the other hand, myofascial trigger point release technique, which is proposed in addition to medical treatment alone or in pelvic floor physiotherapy, has been one of the current research areas in the world. However, there is no study in the national and international literature comparing internal and external myofascial trigger point relaxation techniques and also evaluating transperineal ultrasound. This study is unique in terms of comparing two different applications (internal and external trigger point relaxation technique) with ultrasound measurements in the literature.

33 women diagnosed with pelvic pain between the ages of 18-55 will be included in this study. Orthopedic tests for pelvic pain will be performed after routine gynecological examinations. After perineometer measurement, pelvic floor muscle sensitivity grading, ultrasound and pain score evaluation, participants will be randomized and divided into 3 groups. The first group will receive internal myofascial trigger point release technique, the second group will receive external myofascial trigger point release technique, and the third group will be shown a video of relaxation exercises related to pelvic pain. After the application, measurement of perineometer and pelvic floor muscle sensitivity grading, ultrasound and pain evaluations will be repeated.

Study Timeline

• Study Start: 2018-08-21
• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-21
• Study First Posted: 2020-05-26
• Primary Completion: 2020-08-21
• Study Completion: 2021-05-02
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transperineal ultrasound measures	6 months	Transperineal ultrasound (Voluson E8 Expert from GE Healthcare with a convex RM6C probe ranging from 2 to 6 Megahertz) will be used to measure the function of the pelvic floor muscles indirectly through morphometry at rest, valsalva and at maximum contraction. This imaging will measure the position of the bladder neck relative to the pubis, the anorectal angle formed by the anus and rectum, the angle formed by the pelvic floor muscles and a horizontal reference line (parallel to the ground ) in addition to the dimensions of the urogenital hiatus which is delimited by the puborectal muscle and which includes the urethra, the vagina and the anus. This method has been evaluated in several studies and demonstrates good intra- and inter-rater fidelity
Perineometer measurements	6 months	Before starting the assessments as suggested by the International Continence Society, the physiotherapist will check via vaginal palpation the participant's ability to contract and relax the pelvic floor muscles. Afterwords, pelvic examination vaginal manometry (using a Peritron perineometer; Cadio Design, Australia) will be performed to measure resting and maximum contraction of the PFMs

Secondary Outcome Measures

Name	Time	Method
Pelvic floor muscle tenderness scale	6 months	Tenderness of each of the PFMs (pubococcygeus, iliococcygeus, coccygeus, and obturator internus muscles) was assessed using a nonvalidated scale from 0 to 4 (0, no pressure or pain; 1, pressure but no pain; 2, pressure with discomfort; 3, moderate pain intensified with muscle contraction; 4, severe pain or inability to perform muscle contraction because of pain). Manometry and the tenderness assessments will be repeated after 60 minutes from the first assessments

Trial Locations

Locations (1)

Alime Buyuk; 🇹🇷 Antalya, Turkey