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

NCT04401566 | Completed

• 1 other identifier: :60116787-020/47015
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Pain; Pelvic Floor; Relaxation; Myofascial Trigger Point Pain

Keywords

pelvic pain; myofascial trigger point release; transperineal ultrasound

Outcome Measures

Primary Outcomes (2)

• Transperineal ultrasound measures

  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

  6 months

• Perineometer measurements

  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

  6 months

Secondary Outcomes (1)

• Pelvic floor muscle tenderness scale

  6 months

Study Arms (3)

Internal Myofascial Release Group

EXPERIMENTAL

Internal myofascial trigger point release therapy consists of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial release techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point. Releasing pelvic muscle tension includes applying varying amounts of pressure, sometimes gradually stroking and strumming the muscle region while systematically contracting and relaxing the affected muscles to aid in a trigger point release.

Other: Internal myofascial release

External Myofascial Release Group

EXPERIMENTAL

Eksternal myofascial trigger point release therapy consists of 30 minutes massage to the abdominal wall, gluteal area and abductors, and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and the lower extremity of the muscle.

Other: External myofascial release

Control Group

OTHER

The Control group will have a video about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breathing, pelvic floor muscle stretching, and releasing.

Other: Control Group

Interventions

Internal myofascial release OTHER

Internal myofascial trigger point release therapy consist of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial relase techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point

Internal Myofascial Release Group

External myofascial release OTHER

Eksternal myofascial trigger point release therapy consist 30 minutes massage to the abdominal wall, gluteal area and adductors and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and lower extremity of the muscle.

External Myofascial Release Group

Control Group OTHER

The Control group will have a paper about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breating, pelvic floor muscle stretching and releasing.

Control Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to have chronic pelvic pain for more than six months,
• to have 5 pelvic pain orthopedic tests (active straight leg raise (ASLR), flexion abduction external rotation (FABER), pelvic pain provocation (P4), long dorsal ligament palpation (LDL), The Gaenslen Test) and at least three of the tests are positive,
• to have good communication skills and accept to attend the study.

You may not qualify if:

• pregnant women who have had a pregnancy in the last year or who are breastfeeding;
• other causes of pain (eg pain unrelated to pelvic region relations, dermatological conditions, herpes, vulvovaginal atrophy);
• menopause;
• urogynecological conditions (i.e. pelvic prolapse grade \>3 according to the Pelvic Organ Prolapse - Quantification method (POP-Q) or a urinary or vaginal infection active or present in the last 3 months);
• history of pelvic floor surgery (e.g. corrective surgery for organ descent, urinary incontinence, hysterectomy, mesh surgery,TVT,TOT);
• previous pelvic floor rehabilitation treatments; 7) expected changes in medication that may affect the perception of pain (eg pain relievers, antidepressants);
• any other medical conditions that may interfere with the study procedures (eg hormonal, psychological, cardiovascular, hematological, neurological, pulmonary or renal);
• refusal to abstain from other treatments until the end of their participation in the study.

Sponsors & Collaborators

• Akdeniz University: lead
• Pamukkale University: collaborator

Study Sites (1)

Alime Buyuk

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

• Stuge B, Saetre K, Braekken IH. The association between pelvic floor muscle function and pelvic girdle pain--a matched case control 3D ultrasound study. Man Ther. 2012 Apr;17(2):150-6. doi: 10.1016/j.math.2011.12.004. Epub 2012 Jan 15.

  PMID: 22245422 RESULT

• Thibault-Gagnon S, Goldfinger C, Pukall C, Chamberlain S, McLean L. Relationships Between 3-Dimensional Transperineal Ultrasound Imaging and Digital Intravaginal Palpation Assessments of the Pelvic Floor Muscles in Women With and Without Provoked Vestibulodynia. J Sex Med. 2018 Mar;15(3):346-360. doi: 10.1016/j.jsxm.2017.12.017.

  PMID: 29502982 RESULT

MeSH Terms

Conditions

Pelvic Pain; Myofascial Pain Syndromes

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Mehmet Sakıncı, Assos.Prof.

  Akdeniz University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The gynecologist was blind about treatment and the investigator was blind about assesment.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 26, 2020
• Study Start: August 21, 2018
• Primary Completion: August 21, 2020
• Study Completion: May 2, 2021
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

TU (1)