Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
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.
Myofascial Pain Syndromes
Drug: Botulinum toxin type A (Dysport)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- 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).
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||September 2005|
|University Hospital "Vall d 'Hebrón". Barcelona|
|Barcelona, Spain, 08035|
|University Hospital of Alcorcón|
|Madrid, Spain, 28922|
|Complexo Médico Quirúrgico del Conxo|
|Santiago de Compostela, Spain, 15706|
|University Hospital "La Fe". Valencia|
|Valencia, Spain, 46009|
|Study Director:||Mónica de Abadal, MD||Ipsen|