Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
Information source: Ipsen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myofascial Pain Syndromes
Intervention: Botulinum toxin type A (Dysport) (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Mónica de Abadal, MD, Study Director, Affiliation: Ipsen
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.
Clinical Details
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
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
University Hospital "La Fe". Valencia, Valencia 46009, Spain
University Hospital "Vall d 'Hebrón". Barcelona, Barcelona 08035, Spain
Complexo Médico Quirúrgico del Conxo, Santiago de Compostela 15706, Spain
University Hospital of Alcorcón, Madrid 28922, Spain
Additional Information
Starting date: January 2005
Ending date: September 2005
Last updated: April 17, 2007
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