BTA vs Baclofen for Pelvic Myofascial Pain Syndrome
Unknown statusNCT05617118
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Evaluation of Efficacy and Safety of Oral Baclofen Taking in Comparison With Botulinum Toxin A Injections in Myofascial Pelvic Pain Syndrome. Prospective Multicenter Cohort Study.
- Conditions
- Chronic Pain
- Chronic Pelvic Pain Syndrome
- Myofascial Pain Syndrome
- Myofascial Trigger Point Pain
- Pelvic Floor Disorders
- Interventions
- Drug: Baclofen 10mg
- Drug: Botulinum toxin type A
- Sponsor
- Saint Petersburg State University, Russia
- Collaborators
- Ural State Medical University
- Start date
- 2022-12-01
- Primary completion
- 2023-12-31
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- Russia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05617118