Last updated: April 10, 2023
Sponsor: Saint Petersburg State University, Russia
Overall Status: Active - Recruiting
Phase
N/A
Condition
Mood Disorders
Fibromyalgia
Chronic Pain
Treatment
N/AClinical Study ID
NCT05617118
22/30 301
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Myofascial pain syndrome (presence of trigger points), confirmed by palpation duringexamination.
- Ineffectiveness (with subsequent discontinuation) of at least one treatment method,including outpatient physiotherapy and /or oral analgesics, or NSAIDs.
Exclusion
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 orlaboratory methods: general urine analysis or prostate secretion analysis. Suchdiseases include interstitial cystitis / SBMP, chronic prostatitis types I, II, IIIAaccording to the NIH classification.
- The presence in the anamnesis of the fact of previously conducted therapy withbaclofen or injection of botulinum toxin type "A" into the pelvic floor muscles.
- Individual intolerance to botulinum toxin type "A" and /or baclofen.
- Pregnancy
Study Design
Total Participants: 52
Study Start date:
December 01, 2022
Estimated Completion Date:
May 01, 2024
Study Description
Connect with a study center
SBPSU
Saint Petersburg,
Russian FederationActive - Recruiting

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