A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
Information source: Ipsen
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myofascial Pain Syndromes
Intervention: Botulinum type A toxin (Dysport) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Stefan Lempereur, MD, Study Director, Affiliation: Ipsen
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.
Clinical Details
Official title: A 16-Week Prospective Randomised Double-Blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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: Pain threshold measured by pressure algometer.Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information
Starting date: April 2005
Last updated: October 11, 2007
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