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

This study has been completed.

First Received: October 27, 2005 Last Updated: October 11, 2007 History of Changes

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00246142

Purpose

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

Condition	Intervention	Phase
Myofascial Pain Syndromes	Drug: Botulinum type A toxin (Dysport)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 16-Week Prospective Randomised Double-Blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.

Resource links provided by NLM:

MedlinePlus related topics: Botox Fibromyalgia

U.S. FDA Resources

Further study details as provided by Ipsen:

Primary Outcome Measures:

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 ]
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 ]

Secondary Outcome Measures:

Pain threshold measured by pressure algometer. [ Time Frame: At each visit ]
Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed. [ Time Frame: At each visit ]

Estimated Enrollment:	68
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246142

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744

Sponsors and Collaborators

Ipsen

Investigators

Study Director:

Stefan Lempereur, MD

Ipsen

More Information

No publications provided

Study ID Numbers:	A-38-52120-104
Study First Received:	October 27, 2005
Last Updated:	October 11, 2007
ClinicalTrials.gov Identifier:	NCT00246142 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Botulinum Toxins
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Mental Disorders
Myofascial Pain Syndromes

Fibromyalgia
Pain
Peripheral Nervous System Agents
Rheumatic Diseases
Botulinum Toxin Type A
Somatoform Disorders

Additional relevant MeSH terms:

Disease
Myofascial Pain Syndromes
Fibromyalgia
Physiological Effects of Drugs
Nervous System Diseases
Neuromuscular Agents
Rheumatic Diseases
Pharmacologic Actions
Muscular Diseases

Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Mental Disorders
Syndrome
Peripheral Nervous System Agents
Somatoform Disorders
Botulinum Toxin Type A

ClinicalTrials.gov processed this record on September 10, 2009