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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00149240
First received: September 7, 2005
Last updated: April 17, 2007
Last verified: April 2007
History of Changes
  Purpose

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 Intervention Phase
Myofascial Pain Syndromes
 Drug: Botulinum toxin type A (Dysport)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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).

Estimated Enrollment: 24
Study Start Date: January 2005
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149240

Locations
Spain
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
Ipsen
Investigators
Study Director: Mónica de Abadal, MD Ipsen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149240     History of Changes
Other Study ID Numbers: A-92-52120-089
Study First Received: September 7, 2005
Last Updated: April 17, 2007
Health Authority: Spain: Ministry of Health

Keywords provided by Ipsen:
DYSPORT
botulinum toxin A
myofascial pain syndrome

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders
 Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013