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OpenTrials
Completed

NCT Number: NCT00134810

Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome

The main purpose of this study is to determine which is the best dose of a drug known as Dysport to give when treating one's type of upper back pain. The study will also examine the side effects of this treatment and its overall effect on one's disorder.

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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

Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate-severe pain in upper back
  • Myofascial pain syndrome for more than 6 months
  • Active trigger points in upper back

Exclusion criteria

  • Fibromyalgia and other non-myofascial pain conditions of upper back
  • Duration of myofascial pain syndrome no longer than 24 months
  • Steroid injections during previous 3 months
  • Anaesthetic injection at trigger points during previous 1 month

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. Change in pain score for 'overall pain of the day during activity' between baseline and Week 6

Secondary outcomes

  1. Change in pain score for 'worst pain of the day during activity' between baseline and Week 6

  2. Change in pain score for 'overall pain of the day at rest' between baseline and Week 6

  3. Spontaneously reported adverse events and changes in physical examination and vital signs

  4. Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16

  5. Time to onset of pain relief

  6. Change in each of the 8 dimensions of the Short Form Quality of Life questionnaire with 36 items (SF36) at Weeks 6, 12 and 16 from baseline

  7. Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline

  8. Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16

  9. Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Phase II Multicentre Multinational Prospective Randomised Double-blind Placebo-controlled Study Assessing the Efficacy and Safety of a Single Application of Three Doses of Dysport® in Patients With Upper Back Myofascial Pain Syndrome

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 25, 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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