Status:
COMPLETED
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
Lead Sponsor:
Ipsen
Conditions:
Myofascial Pain Syndromes
Eligibility:
All Genders
21+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2007
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00246142
Start Date
April 1 2005
End Date
June 27 2007
Last Update
July 29 2019
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744