A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 68
• Participant gender: Both

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2007-10-11

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