BTA vs Baclofen for Pelvic Myofascial Pain Syndrome (NCT05617118) | Clinical Trial Compass
UnknownNot Applicable
BTA vs Baclofen for Pelvic Myofascial Pain Syndrome
Russia52 participantsStarted 2022-12-01
Plain-language summary
The aim of the study is to test the hypothesis that oral taking of baclofen in therapeutic dosage for 60 days is equally effective as injection of botulinum toxin type "A" in the area of trigger points of the pelvic muscles.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Myofascial pain syndrome (presence of trigger points), confirmed by palpation during examination.
* Ineffectiveness (with subsequent discontinuation) of at least one treatment method, including outpatient physiotherapy and /or oral analgesics, or NSAIDs.
Exclusion Criteria:
* The presence of any organic disease of the pelvic organs requiring active treatment, confirmed by anamnesis, consultation of a specialist (urologist, proctologist, gynecologist) and one of the objective imaging methods: CT, MRI, endoscopical or laboratory methods: general urine analysis or prostate secretion analysis. Such diseases include interstitial cystitis / SBMP, chronic prostatitis types I, II, IIIA according to the NIH classification.
* The presence in the anamnesis of the fact of previously conducted therapy with baclofen or injection of botulinum toxin type "A" into the pelvic floor muscles.
* Individual intolerance to botulinum toxin type "A" and /or baclofen.
* Pregnancy