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

Phase 2

Completed

• Conditions: Myofascial Pain Syndromes

• Registration Number: NCT00134810
• Lead Sponsor: Ipsen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-08-23
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-25
• Primary Completion: 2006-05-18
• Study Completion: 2006-05-18
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 381

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pain score for 'overall pain of the day during activity' between baseline and Week 6

Secondary Outcome Measures

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

Trial Locations

Locations (22)

Hospital de Santa Maria; 🇵🇹 Lisbon, Portugal

Clinic for Neurology, Westfalische Wilhelmsuniversitat; 🇩🇪 Munster, Germany

Schmerzzentrum Frankfurt; 🇩🇪 Frankfurt am Main, Germany

Schmerzzentrum Goppingen; 🇩🇪 Goppingen, Germany

Klinik fur Anaesthesiologie und Intensivtherapie; 🇩🇪 Jena, Germany

Institute of Rheumatology; 🇨🇿 Praha, Czechia

Dept Neurology, Teaching Hospital Olomouc; 🇨🇿 Olomouc, Czechia

Neurology Clinic, Klinikum der Ruhr-Universitat Bochum; 🇩🇪 Bochum, Germany

Aukammallee 33; 🇩🇪 Wiesbaden, Germany

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Italy

Fondazione Salvatore Maugeri; 🇮🇹 Montescano, Italy

Centrum Kliniczno-Badawcze; 🇵🇱 Elblag, Poland

Osrodek Badan Klinicznych; 🇵🇱 Lublin, Poland

Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy; 🇵🇱 Torun, Poland

Centrum Medyczne OSTEOMED NZOZ; 🇵🇱 Warsaw, Poland

Hospital Univ Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospital de Traumatologia de la Vall d'Hebrón; 🇪🇸 Barcelona, Spain

Hospedale Clinic I Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Morales Meseguer; 🇪🇸 Murcia, Spain

Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel; 🇩🇪 Kiel, Germany

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