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

Myofascial Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246142
• Other study ID #: A-38-52120-104
• Status: Completed
• Phase: Phase 3
• Start date: April 2005
• Est. completion date: June 27, 2007

Study information

• Verified date: July 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 27, 2007
• Est. primary completion date: June 27, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Somatoform Disorders
• Syndrome

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Pain threshold measured by pressure algometer.		At each visit
Secondary	Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.		At each visit