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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Myofascial Pain Syndromes

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00246142

A-38-52120-104

Details and patient eligibility

About

The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on myofascial pain syndrome.

Enrollment

76 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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