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