Pain caused by primary myofascial syndrome of cervical and dorsal localization
Conditions
Interventions
Trade Name: Dysport
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: 52120
Other descriptive name: Clostridium botulinum type A toxin-haemaglutinin complex
Concentration ty
Sponsors
Ipsen Pharma, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The patient must give written informed consent, for taking part in the study, prior to any study-related procedure. - Patients from both genders and over 18 years of age. - The patient must be able to understand and comply with the requirements of the study. - Patients with primary myofascial 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. - Patients with medium intensity pain in neck and/or back, with a punctuation of = 4 cm in a 10 cm visual analog scale. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients diagnosed of fibromyalgia or with a spread pain. - Patients with a tumour, rheumatologic, degenerative pathology or any other disease that may justify these symptoms. - Patients with disorders affecting the neuromuscular junction or motor neuron disease. - Neurological deficit involving the painful area. - Patients having received previously botulinum toxin. - Patients having received anesthetic injections at the trigger points within the month before the selection visit. - Patients having received corticosteroids injections at the trigger points within three months before the selection visit. - Breast-feeding or pregnant women (ß-HCG will be measured before the patients are included) or high risk of getting pregnant due to inadequate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy and safety of a single dose of botulinum toxin associated with rehabilitation treatment, on pain control in patients with primary myofascial syndrome of cervical and dorsal localization. ;Secondary Objective: ;Primary end point(s): | — |
Countries
Spain
Outcome results
None listed