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

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

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.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndromes
• Intervention / Treatment: Biological: Botulinum toxin type A

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 2

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 656 91
    • Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
  • Olomouc, Czechia, 775 20
    • Dept Neurology, Teaching Hospital Olomouc
  • Praha, Czechia, 12850
    • Institute of Rheumatology
• Germany
  • Bochum, Germany, 44789
    • Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
  • Frankfurt am Main, Germany, 60311
    • Schmerzzentrum Frankfurt
  • Goppingen, Germany, 73033
    • Schmerzzentrum Goppingen
  • Jena, Germany, 07747
    • Klinik fur Anaesthesiologie und Intensivtherapie
  • Kiel, Germany, 24149
    • Neurologisch-verhaltensmedizinische Schmerzklinik Kiel
  • Munster, Germany, 48129
    • Clinic for Neurology, Westfalische Wilhelmsuniversitat
  • Wiesbaden, Germany, 65191
    • Aukammallee 33
• Italy
  • Montescano, Italy, 27040
    • Fondazione Salvatore Maugeri
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
• Poland
  • Elblag, Poland, 82300
    • Centrum Kliniczno-Badawcze
  • Lublin, Poland, 20022
    • Osrodek Badan Klinicznych
  • Torun, Poland, 87100
    • Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
  • Warsaw, Poland, 02341
    • Centrum Medyczne OSTEOMED NZOZ
• Portugal
  • Lisbon, Portugal, 1649-035
    • Hospital de Santa Maria
• Spain
  • Badalona, Spain, 08916
    • Hospital Univ Germans Trias i Pujol
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain, 08035
    • Hospital de Traumatologia de la Vall d'Hebrón
  • Barcelona, Spain, 08036
    • Hospedale Clinic I Provincial de Barcelona
  • Murcia, Spain, 30008
    • Hospital Morales Meseguer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Change in pain score for 'worst pain of the day during activity' between baseline and Week 6
Change in pain score for 'overall pain of the day at rest' between baseline and Week 6
Spontaneously reported adverse events and changes in physical examination and vital signs
Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16
Time to onset of pain relief
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
Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline
Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16
Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (ACTUAL): May 18, 2006
• Study Completion (ACTUAL): May 18, 2006

Study Registration Dates

• First Submitted: August 23, 2005
• First Submitted That Met QC Criteria: August 23, 2005
• First Posted (ESTIMATE): August 25, 2005

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Myofascial pain syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Syndrome; Fibromyalgia; Somatoform Disorders; Myofascial Pain Syndromes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: Y-47-52120-722; 2004-001845-13 (EUDRACT_NUMBER)