Status:
COMPLETED
Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
Lead Sponsor:
Ipsen
Conditions:
Myofascial Pain Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to determine the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a ...
Eligibility Criteria
Inclusion
- Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days.
- Punctuation of 4cm or more in a 10cm visual analog scale.
- Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point.
Exclusion
- Patients diagnosed with fibromyalgia or with a spread pain.
- Patients having received previously botulinum toxin.
- Patients having received anesthetic injections at the trigger points within the month before the visit.
- Patients having received corticosteroids injections at the trigger points within three months before the selection visit.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00149240
Start Date
January 1 2005
End Date
February 2 2006
Last Update
November 22 2019
Active Locations (4)
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1
University Hospital "Vall d 'Hebrón". Barcelona
Barcelona, Spain, 08035
2
University Hospital of Alcorcón
Madrid, Spain, 28922
3
Complexo Médico Quirúrgico del Conxo
Santiago de Compostela, Spain, 15706
4
University Hospital "La Fe". Valencia
Valencia, Spain, 46009