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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00246142
First received: October 27, 2005
Last updated: October 11, 2007
Last verified: October 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
  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 by Ipsen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00246142     History of Changes
Other Study ID Numbers: A-38-52120-104
Study First Received: October 27, 2005
Last Updated: October 11, 2007
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014