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

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Ipsen

Status and phase

Completed
Phase 2

Conditions

Myofascial Pain Syndromes

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00149240
2004-001443-29 (EudraCT Number)
A-92-52120-089

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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