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

Phase 3

Completed

• Conditions: Myofascial Pain Syndromes

• Registration Number: NCT00246142
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-30
• Primary Completion: 2007-06-27
• Study Completion: 2007-06-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of