Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome

Study Overview
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Brief Summary
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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 type of back pain called primary myofascial pain syndrome.

Official Title
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A Phase II, Multicentre, Randomised, Double-blind, Parallel and Controlled With Placebo Pilot Study to Evaluate the Efficacy and Safety of a Single Dose of Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment, in Patients With Primary Myofascial Syndrome of Cervical and Dorsal Localisation

Conditions
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Myofascial Pain Syndromes

Intervention / Treatment
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* Biological: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Botulinum toxin type A|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study: |  |  | 
| Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point. |  |  | 
| Pain evaluated by the patient through a visual analog scale. |  |  | 
| Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient. |  |  | 
| Usual analgesic intake modification (on a daily basis by filling out a Patient's diary). |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DYSPORT, botulinum toxin A, myofascial pain syndrome