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

Purpose

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.

Condition	Intervention	Phase
Myofascial Pain Syndromes	Drug: Botulinum type A toxin (Dysport®)	Phase II

MedlinePlus related topics:

Botox Fibromyalgia

U.S. FDA Resources

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

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

Further study details as provided by Ipsen:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	340
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134810

Locations


Czech Republic
	Dept Neurology, Teaching Hospital Olomouc
	Olomouc, Czech Republic, 775 20
	Institute of Rheumatology
	Praha, Czech Republic, 12850
	Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
	Brno, Czech Republic, 656 91

Germany
	Clinic for Neurology, Westfalische Wilhelmsuniversitat
	Munster, Germany, 48129
	Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
	Bochum, Germany, 44789
	Aukammallee 33
	Wiesbaden, Germany, 65191
	Schmerzzentrum Frankfurt
	Frankfurt am Main, Germany, 60311
	Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel
	Kiel, Germany, 24149
	Klinik fur Anaesthesiologie und Intensivtherapie
	Jena, Germany, 07747
	Schmerzzentrum Goppingen
	Goppingen, Germany, 73033

Italy
	Fondazione Salvatore Maugeri
	Montescano, Italy, 27040
	Azienda Ospedaliera di Padova
	Padova, Italy, 35128

Poland
	Centrum Kliniczno-Badawcze
	Elblag, Poland, 82300
	Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
	Torun, Poland, 87100
	Centrum Medyczne OSTEOMED NZOZ
	Warsaw, Poland, 02341
	Osrodek Badan Klinicznych
	Lublin, Poland, 20022

Portugal
	Hospital de Santa Maria
	Lisbon, Portugal, 1649-035

Spain
	Hospital Morales Meseguer
	Murcia, Spain, 30008
	Hospital Univ Germans Trias i Pujol
	Badalona, Spain, 08916
	Hospital de Traumatologia de la Vall d'Hebrón
	Barcelona, Spain, 08035
	Hospital Universitari de Bellvitge
	Barcelona, Spain, 08907
	Hospedale Clinic I Provincial de Barcelona
	Barcelona, Spain, 08036

Sponsors and Collaborators

Ipsen

Investigators


Principal Investigator:	Harmut Goebel, MD	Kiel Neurological Pain Centre

More Information

Study ID Numbers:	Y-47-52120-722
First Received:	August 23, 2005
Last Updated:	January 9, 2007
ClinicalTrials.gov Identifier:	NCT00134810
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Spain: Ministry of Health; Poland: Ministry of Health; Italy: Ministry of Health; Czech Republic: State Institute for Drug Control; Portugal: National Pharmacy and Medicines Institute

Keywords provided by Ipsen:

Myofascial pain syndrome

Study placed in the following topic categories:

Botulinum Toxins

Muscular Diseases

Neuromuscular Diseases

Musculoskeletal Diseases

Mental Disorders

Myofascial Pain Syndromes

Fibromyalgia

Pain

Rheumatic Diseases

Botulinum Toxin Type A

Somatoform Disorders

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Physiological Effects of Drugs

Nervous System Diseases

Neuromuscular Agents

Peripheral Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00134810