Clinical trial NCT00134810: Study to Assess the Efficacy and Safety of Dysport® in Upper Back Myofascial Pain Syndrome
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Myofascial Pain Syndromes
Keywords: Myofascial pain syndrome
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in pain score for 'overall pain of the day during activity' between baseline and Week 6
Secondary outcomes:
measure: Change in pain score for 'worst pain of the day during activity' between baseline and Week 6
measure: Change in pain score for 'overall pain of the day at rest' between baseline and Week 6
measure: Spontaneously reported adverse events and changes in physical examination and vital signs
measure: Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16
measure: Time to onset of pain relief
measure: 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
measure: Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline
measure: Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16
measure: Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
city: Olomouc
country: Czechia
facility: Dept Neurology, Teaching Hospital Olomouc
city: Praha
country: Czechia
facility: Institute of Rheumatology
city: Bochum
country: Germany
facility: Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
city: Frankfurt am Main
country: Germany
facility: Schmerzzentrum Frankfurt
city: Goppingen
country: Germany
facility: Schmerzzentrum Goppingen
city: Jena
country: Germany
facility: Klinik fur Anaesthesiologie und Intensivtherapie
city: Kiel
country: Germany
facility: Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel
city: Munster
country: Germany
facility: Clinic for Neurology, Westfalische Wilhelmsuniversitat
city: Wiesbaden
country: Germany
facility: Aukammallee 33
city: Montescano
country: Italy
facility: Fondazione Salvatore Maugeri
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze
city: Lublin
country: Poland
facility: Osrodek Badan Klinicznych
city: Torun
country: Poland
facility: Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
city: Warsaw
country: Poland
facility: Centrum Medyczne OSTEOMED NZOZ
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Badalona
country: Spain
facility: Hospital Univ Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de Traumatologia de la Vall d'Hebrón
city: Barcelona
country: Spain
facility: Hospedale Clinic I Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Murcia
country: Spain
facility: Hospital Morales Meseguer
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: