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

NCT ID: NCT04401566

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-21
• Study Completion Date: 2021-05-02

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Internal Myofascial Release Group

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.

Group Type: EXPERIMENTAL

Internal myofascial release

Intervention Type: 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

External Myofascial Release Group

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.

Group Type: EXPERIMENTAL

External myofascial release

Intervention Type: 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.

Control Group

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.

Group Type: OTHER

Control Group

Intervention Type: 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.

Interventions

Internal myofascial release

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

Intervention Type: OTHER

External myofascial release

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.

Intervention Type: OTHER

Control Group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: collaborator

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Alime Buyuk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Sakıncı, Assos.Prof.

Role: STUDY_CHAIR

Akdeniz University

Locations

Alime Buyuk

Antalya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 22245422 (View on PubMed)

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.

Reference Type: RESULT

PMID: 29502982 (View on PubMed)

Other Identifiers

:60116787-020/47015

Identifier Type: -

Identifier Source: org_study_id