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Completed

NCT Number: NCT00149240

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

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.

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Key information

Conditions

Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital "Vall d 'Hebrón". Barcelona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin type A

Biological

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 8, 2005
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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