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

Pelvic Pain Clinical Trial

Official title:

Investigation of Acute Effects of Myofascial Trigger Point Release Techniques Using Transperineal Ultrasound in Women With Chronic Pelvic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04401566
• Other study ID #: :60116787-020/47015
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: May 2, 2021

Study information

• Verified date: December 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 2, 2021
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

The 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.

The 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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Alime Buyuk	Antalya

Sponsors (2)

Lead Sponsor	Collaborator
Akdeniz University	Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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 Vestibul — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pelvic floor muscle tenderness scale	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	6 months