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

Myofascial Pain Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149240
• Other study ID #: A-92-52120-089
• Secondary ID: 2004-001443-29
• Status: Completed
• Phase: Phase 2
• Start date: January 2005
• Est. completion date: February 2, 2006

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2, 2006
• Est. primary completion date: February 2, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Syndrome

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
Spain	University Hospital "Vall d 'Hebrón". Barcelona	Barcelona
Spain	University Hospital of Alcorcón	Madrid
Spain	Complexo Médico Quirúrgico del Conxo	Santiago de Compostela
Spain	University Hospital "La Fe". Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study:
Primary	Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
Primary	Pain evaluated by the patient through a visual analog scale.
Primary	Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient.
Primary	Usual analgesic intake modification (on a daily basis by filling out a Patient's diary).