Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome

Phase 2

Completed

• Conditions: Myofascial Pain Syndromes

• Registration Number: NCT00149240
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2006-02-02
• Study Completion: 2006-02-02
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study:
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).
Pain evaluated by the patient through a visual analog scale.
Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.

Trial Locations

Locations (4)

University Hospital of Alcorcón; 🇪🇸 Madrid, Spain

University Hospital "La Fe". Valencia; 🇪🇸 Valencia, Spain

University Hospital "Vall d 'Hebrón". Barcelona; 🇪🇸 Barcelona, Spain

Complexo Médico Quirúrgico del Conxo; 🇪🇸 Santiago de Compostela, Spain