Back to resultsA Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes
Eligibility Criteria
Inclusion Criteria: Chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments Presents at baseline with pain score greater than 50mm on 100mm length VAS. Pain score will be measured as overall pain over the 7 days preceding the visit during activities Active trigger point (TrP) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness AND referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation AND preferably local twitch response at palpation AND/OR jump sign at palpation Exclusion Criteria: Disc/bone disease History of surgery on neck Neurological deficits, neuromuscular junction disorder, Motor Neuron disease Patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months Systemic inflammatory disease Hypersensitivity to Dysport® Diffuse tender points, or diagnosed with fibromyalgia Previous electrical stimulation Previous injection of Dysport® within 6 months of study enrolment
Sites / Locations
- Seoul National University Hospital
Outcomes
Primary Outcome Measures
Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.
Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
Secondary Outcome Measures
Pain threshold measured by pressure algometer.
Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00246142
Brief Title
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
Official Title
A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
June 27, 2007 (Actual)
Study Completion Date
June 27, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
76 (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
Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.
Time Frame
Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection
Title
Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
Time Frame
Before Dysport® injection and at 16 weeks after injection
Secondary Outcome Measure Information:
Title
Pain threshold measured by pressure algometer.
Time Frame
At each visit
Title
Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
Time Frame
At each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments
Presents at baseline with pain score greater than 50mm on 100mm length VAS. Pain score will be measured as overall pain over the 7 days preceding the visit during activities
Active trigger point (TrP) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness AND referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation AND preferably local twitch response at palpation AND/OR jump sign at palpation
Exclusion Criteria:
Disc/bone disease
History of surgery on neck
Neurological deficits, neuromuscular junction disorder, Motor Neuron disease
Patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months
Systemic inflammatory disease
Hypersensitivity to Dysport®
Diffuse tender points, or diagnosed with fibromyalgia
Previous electrical stimulation
Previous injection of Dysport® within 6 months of study enrolment
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
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23123438
Citation
Seo HG, Bang MS, Chung SG, Jung SH, Lee SU. Effect of electrical stimulation on botulinum toxin a therapy in patients with chronic myofascial pain syndrome: a 16-week randomized double-blinded study. Arch Phys Med Rehabil. 2013 Mar;94(3):412-8. doi: 10.1016/j.apmr.2012.09.034. Epub 2012 Nov 1.
Results Reference
derived
Learn more about this trial
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
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