A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.

Ipsen1 site in 1 country76 target enrollmentApril 2005

ConditionsMyofascial Pain Syndromes

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Myofascial Pain Syndromes
Sponsor: Ipsen
Enrollment: 76
Locations: 1
Primary Endpoint: Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2005

End Date

June 27, 2007

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ipsen

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.

Time Frame: Before Dysport® injection and at 16 weeks after injection

Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.

Time Frame: Comparison of VAS will be performed before Dysport® injection and at 16 weeks after injection

Secondary Outcomes

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)