Back to resultsBotulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring DYSPORT, botulinum toxin A, myofascial pain syndrome
Eligibility Criteria
Inclusion Criteria: Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days. Punctuation of 4cm or more in a 10cm visual analog scale. Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point. Exclusion Criteria: Patients diagnosed with fibromyalgia or with a spread pain. Patients having received previously botulinum toxin. Patients having received anesthetic injections at the trigger points within the month before the visit. Patients having received corticosteroids injections at the trigger points within three months before the selection visit.
Sites / Locations
- University Hospital "Vall d 'Hebrón". Barcelona
- University Hospital of Alcorcón
- Complexo Médico Quirúrgico del Conxo
- University Hospital "La Fe". Valencia
Outcomes
Primary Outcome Measures
The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study:
Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
Pain evaluated by the patient through a visual analog scale.
Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient.
Usual analgesic intake modification (on a daily basis by filling out a Patient's diary).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00149240
Brief Title
Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
Official Title
A Phase II, Multicentre, Randomised, Double-blind, Parallel and Controlled With Placebo Pilot Study to Evaluate the Efficacy and Safety of a Single Dose of Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment, in Patients With Primary Myofascial Syndrome of Cervical and Dorsal Localisation
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2, 2006 (Actual)
Study Completion Date
February 2, 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 the effectiveness and safety of one dose of botulinum toxin type A (Dysport) associated with rehabilitation treatment on pain control in patients with a type of back pain called primary myofascial pain syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes
Keywords
DYSPORT, botulinum toxin A, myofascial pain syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Primary Outcome Measure Information:
Title
The following parameters are measured at Inclusion, Week 2, Week 4, Week 8 and Week 12 of the study:
Title
Pain evaluated by the Investigator through the determination of threshold of pain by pressure algometry for each trigger point.
Title
Pain evaluated by the patient through a visual analog scale.
Title
Evaluation of the Clinical Global Impressions of Change by the Investigator and by the patient.
Title
Usual analgesic intake modification (on a daily basis by filling out a Patient's diary).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with primary myofascial pain syndrome of cervical and dorsal localization, less than two years of length, who must have been diagnosed with the evidence of "trigger points" in which conventional treatment with oral analgesia, rehabilitation and local anesthesia has not been clinically successful for more than 15 days.
Punctuation of 4cm or more in a 10cm visual analog scale.
Previous positive response (self-limited reduction -less than 15 days- of pain) after an anaesthetic infiltration in the trigger point.
Exclusion Criteria:
Patients diagnosed with fibromyalgia or with a spread pain.
Patients having received previously botulinum toxin.
Patients having received anesthetic injections at the trigger points within the month before the visit.
Patients having received corticosteroids injections at the trigger points within three months before the selection visit.
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
University Hospital "Vall d 'Hebrón". Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
University Hospital of Alcorcón
City
Madrid
ZIP/Postal Code
28922
Country
Spain
Facility Name
Complexo Médico Quirúrgico del Conxo
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
University Hospital "La Fe". Valencia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Botulinum Toxin Type A (Dysport) Associated With Rehabilitation Treatment in Patients With Primary Myofascial Pain Syndrome
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