Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome

Study Overview
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Brief Summary
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The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.

Official Title
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A Phase II Multicentre Multinational Prospective Randomised Double-blind Placebo-controlled Study Assessing the Efficacy and Safety of a Single Application of Three Doses of Dysport® in Patients With Upper Back Myofascial Pain Syndrome

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: Moderate-severe pain in upper back Myofascial pain syndrome for more than 6 months Active trigger points in upper back Exclusion Criteria: Fibromyalgia and other non-myofascial pain conditions of upper back Duration of myofascial pain syndrome no longer than 24 months Steroid injections during previous 3 months Anaesthetic injection at trigger points during previous 1 month

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 |
| --- | --- | --- |
| Change in pain score for 'overall pain of the day during activity' between baseline and Week 6 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score for 'worst pain of the day during activity' between baseline and Week 6 |  |  | 
| Change in pain score for 'overall pain of the day at rest' between baseline and Week 6 |  |  | 
| Spontaneously reported adverse events and changes in physical examination and vital signs |  |  | 
| Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16 |  |  | 
| Time to onset of pain relief |  |  | 
| Change in each of the 8 dimensions of the Short Form Quality of Life questionnaire with 36 items (SF36) at Weeks 6, 12 and 16 from baseline |  |  | 
| Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline |  |  | 
| Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16 |  |  | 
| Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial pain syndrome