Myofascial Pain Syndromes
Conditions
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.
Interventions
BIOLOGICALBotulinum toxin type A
Sponsors
Ipsen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed. | Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection |
| Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline. | Before Dysport® injection and at 16 weeks after injection |
Secondary
| Measure | Time frame |
|---|---|
| Pain threshold measured by pressure algometer. | At each visit |
| Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed. | At each visit |
Countries
South Korea
Outcome results
None listed