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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 16-Week Prospective Randomised Double-Blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.

Brief 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.

Detailed Summary:
Sponsor: Ipsen

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

  • 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.
  • Number of patients in percentage whose pain intensity measured by VAS decreases to less than 50% of baseline.


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Pain threshold measured by pressure algometer at each visit.
  • Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed at each visit.


Information By: Ipsen

Dates:
Date Received: October 27, 2005
Date Started: April 2005
Date Completion:
Last Updated: October 11, 2007
Last Verified: October 2007