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Completed

NCT Number: NCT00246142

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

The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on myofascial pain syndrome.

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Key information

Conditions

Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Pain threshold measured by pressure algometer.

    Time frame: At each visit

  2. Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.

    Time frame: At each visit

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Oct 31, 2005
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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