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

This study has been completed.
Information provided by:
Ipsen Identifier:
First received: October 27, 2005
Last updated: October 11, 2007
Last verified: October 2007
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:

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

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00246142

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Study Director: Stefan Lempereur, MD Ipsen
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00246142     History of Changes
Other Study ID Numbers: A-38-52120-104
Study First Received: October 27, 2005
Last Updated: October 11, 2007

Additional relevant MeSH terms:
Somatoform Disorders
Myofascial Pain Syndromes
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on August 17, 2017