Myofascial Pain Syndromes
Conditions
Keywords
DYSPORT, botulinum toxin A, myofascial pain syndrome
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 type of back pain called primary myofascial pain syndrome.
Interventions
BIOLOGICALBotulinum toxin type A
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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). | — |
Countries
Spain
Outcome results
None listed