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

Myofascial Pain Syndromes Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00134810
• Other study ID #: Y-47-52120-722
• Secondary ID: 2004-001845-13
• Status: Completed
• Phase: Phase 2
• Start date: March 2005
• Est. completion date: May 18, 2006

Study information

• Verified date: November 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 381
• Est. completion date: May 18, 2006
• Est. primary completion date: May 18, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
Czechia	Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital	Brno
Czechia	Dept Neurology, Teaching Hospital Olomouc	Olomouc
Czechia	Institute of Rheumatology	Praha
Germany	Neurology Clinic, Klinikum der Ruhr-Universitat Bochum	Bochum
Germany	Schmerzzentrum Frankfurt	Frankfurt am Main
Germany	Schmerzzentrum Goppingen	Goppingen
Germany	Klinik fur Anaesthesiologie und Intensivtherapie	Jena
Germany	Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel	Kiel
Germany	Clinic for Neurology, Westfalische Wilhelmsuniversitat	Munster
Germany	Aukammallee 33	Wiesbaden
Italy	Fondazione Salvatore Maugeri	Montescano
Italy	Azienda Ospedaliera di Padova	Padova
Poland	Centrum Kliniczno-Badawcze	Elblag
Poland	Osrodek Badan Klinicznych	Lublin
Poland	Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy	Torun
Poland	Centrum Medyczne OSTEOMED NZOZ	Warsaw
Portugal	Hospital de Santa Maria	Lisbon
Spain	Hospital Univ Germans Trias i Pujol	Badalona
Spain	Hospedale Clinic I Provincial de Barcelona	Barcelona
Spain	Hospital de Traumatologia de la Vall d'Hebrón	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Spain	Hospital Morales Meseguer	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Czechia,  Germany,  Italy,  Poland,  Portugal,  Spain, 

Outcome

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