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

Condition(s) targeted: Myofascial Pain Syndromes

Intervention: Botulinum type A toxin (Dysport®) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Harmut Goebel, MD, Principal Investigator, Affiliation: Kiel Neurological Pain Centre

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.

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

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Change in pain score for ‘overall pain of the day during activity’ between baseline and Week 6

Secondary outcome:

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

Minimum age: 18 Years. Gender(s): Both.

Criteria:

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

Klinik fur Anaesthesiologie und Intensivtherapie, Jena 07747, Germany

Hospital de Traumatologia de la Vall d'Hebrón, Barcelona 08035, Spain

Institute of Rheumatology, Praha 12850, Czech Republic

Schmerzzentrum Frankfurt, Frankfurt am Main 60311, Germany

Centrum Kliniczno-Badawcze, Elblag 82300, Poland

Aukammallee 33, Wiesbaden 65191, Germany

Hospital Universitari de Bellvitge, Barcelona 08907, Spain

Centrum Medyczne OSTEOMED NZOZ, Warsaw 02341, Poland

Azienda Ospedaliera di Padova, Padova 35128, Italy

Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy, Torun 87100, Poland

Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel, Kiel 24149, Germany

Hospital Univ Germans Trias i Pujol, Badalona 08916, Spain

Schmerzzentrum Goppingen, Goppingen 73033, Germany

Neurology Clinic, Klinikum der Ruhr-Universitat Bochum, Bochum 44789, Germany

Hospital de Santa Maria, Lisbon 1649-035, Portugal

Hospital Morales Meseguer, Murcia 30008, Spain

Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital, Brno 656 91, Czech Republic

Clinic for Neurology, Westfalische Wilhelmsuniversitat, Munster 48129, Germany

Fondazione Salvatore Maugeri, Montescano 27040, Italy

Hospedale Clinic I Provincial de Barcelona, Barcelona 08036, Spain

Osrodek Badan Klinicznych, Lublin 20022, Poland

Dept Neurology, Teaching Hospital Olomouc, Olomouc 775 20, Czech Republic

Starting date: March 2005
Ending date: May 2006
Last updated: January 9, 2007