A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome. (NCT00246142) | Clinical Trial Compass
CompletedPhase 3
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
South Korea76 participantsStarted 2005-04
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.
Timeframe: Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection
2
Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
Timeframe: Before Dysport® injection and at 16 weeks after injection