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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149240
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : October 1, 2015
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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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndromes Drug: Botulinum toxin type A (Dysport) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149240

University Hospital "Vall d 'Hebrón". Barcelona
Barcelona, Spain, 08035
University Hospital of Alcorcón
Madrid, Spain, 28922
Complexo Médico Quirúrgico del Conxo
Santiago de Compostela, Spain, 15706
University Hospital "La Fe". Valencia
Valencia, Spain, 46009
Sponsors and Collaborators
Study Director: Mónica de Abadal, MD Ipsen Identifier: NCT00149240     History of Changes
Other Study ID Numbers: A-92-52120-089
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: July 2007

Keywords provided by Ipsen:
botulinum toxin A
myofascial pain syndrome

Additional relevant MeSH terms:
Somatoform Disorders
Myofascial Pain Syndromes
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents