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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Syndrome
Somatoform Disorders
Myofascial Pain Syndromes
Fibromyalgia
Disease
Pathologic Processes
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014