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

Ipsen4 sites in 1 country24 target enrollmentJanuary 2005

ConditionsMyofascial Pain Syndromes

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Myofascial Pain Syndromes
Sponsor: Ipsen
Enrollment: 24
Locations: 4
Primary Endpoint: Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

February 2, 2006

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ipsen

Eligibility Criteria

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.