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

Primary Purpose

Myofascial Pain Syndromes

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
Ipsen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Myofascial pain syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
  • Dept Neurology, Teaching Hospital Olomouc
  • Institute of Rheumatology
  • Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
  • Schmerzzentrum Frankfurt
  • Schmerzzentrum Goppingen
  • Klinik fur Anaesthesiologie und Intensivtherapie
  • Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel
  • Clinic for Neurology, Westfalische Wilhelmsuniversitat
  • Aukammallee 33
  • Fondazione Salvatore Maugeri
  • Azienda Ospedaliera di Padova
  • Centrum Kliniczno-Badawcze
  • Osrodek Badan Klinicznych
  • Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
  • Centrum Medyczne OSTEOMED NZOZ
  • Hospital de Santa Maria
  • Hospital Univ Germans Trias i Pujol
  • Hospital de Traumatologia de la Vall d'Hebrón
  • Hospedale Clinic I Provincial de Barcelona
  • Hospital Universitari de Bellvitge
  • Hospital Morales Meseguer

Outcomes

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

Full Information

First Posted
August 23, 2005
Last Updated
November 21, 2019
Sponsor
Ipsen
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1. Study Identification

Unique Protocol Identification Number
NCT00134810
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 18, 2006 (Actual)
Study Completion Date
May 18, 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ipsen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes
Keywords
Myofascial pain syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
381 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
Change in pain score for 'overall pain of the day during activity' between baseline and Week 6
Secondary Outcome Measure Information:
Title
Change in pain score for 'worst pain of the day during activity' between baseline and Week 6
Title
Change in pain score for 'overall pain of the day at rest' between baseline and Week 6
Title
Spontaneously reported adverse events and changes in physical examination and vital signs
Title
Change in pain score for 'overall pain during activity' between baseline and Weeks 6, 12 and 16
Title
Time to onset of pain relief
Title
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
Title
Change in the Hospital Anxiety and Depression Scale (HADS) anxiety score, depression score and aggregate score at Weeks 6, 12 and 16 from baseline
Title
Clinical Global Impression of Change (CGIC) assessed using a 7-point numerical rating scale at Week 16
Title
Patient's Global Impression of Change (PGIC) assessed using a 7-point numerical rating scale at Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Pain Treatment Centre, Anesthesiology & Resuscitation, St Ann Teaching Hospital
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Dept Neurology, Teaching Hospital Olomouc
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Institute of Rheumatology
City
Praha
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Neurology Clinic, Klinikum der Ruhr-Universitat Bochum
City
Bochum
ZIP/Postal Code
44789
Country
Germany
Facility Name
Schmerzzentrum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60311
Country
Germany
Facility Name
Schmerzzentrum Goppingen
City
Goppingen
ZIP/Postal Code
73033
Country
Germany
Facility Name
Klinik fur Anaesthesiologie und Intensivtherapie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Neurologisch-Verhaltensmedizinische Schmerzklinik Kiel
City
Kiel
ZIP/Postal Code
24149
Country
Germany
Facility Name
Clinic for Neurology, Westfalische Wilhelmsuniversitat
City
Munster
ZIP/Postal Code
48129
Country
Germany
Facility Name
Aukammallee 33
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Fondazione Salvatore Maugeri
City
Montescano
ZIP/Postal Code
27040
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Centrum Kliniczno-Badawcze
City
Elblag
ZIP/Postal Code
82300
Country
Poland
Facility Name
Osrodek Badan Klinicznych
City
Lublin
ZIP/Postal Code
20022
Country
Poland
Facility Name
Nasz Lekarz NZOZ Praktyka Grupowa Lekarzy
City
Torun
ZIP/Postal Code
87100
Country
Poland
Facility Name
Centrum Medyczne OSTEOMED NZOZ
City
Warsaw
ZIP/Postal Code
02341
Country
Poland
Facility Name
Hospital de Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Univ Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital de Traumatologia de la Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospedale Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain

12. IPD Sharing Statement

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

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