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

NCT00246142 | Completed Phase 3

• 1 other identifier: A-38-52120-104
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  Before Dysport® injection and at 16 weeks after injection

Secondary Outcomes (2)

• 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

Interventions

Botulinum toxin type A BIOLOGICAL

Also known as: AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

• Seo HG, Bang MS, Chung SG, Jung SH, Lee SU. Effect of electrical stimulation on botulinum toxin a therapy in patients with chronic myofascial pain syndrome: a 16-week randomized double-blinded study. Arch Phys Med Rehabil. 2013 Mar;94(3):412-8. doi: 10.1016/j.apmr.2012.09.034. Epub 2012 Nov 1.

  PMID: 23123438 DERIVED

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: April 1, 2005
• Primary Completion: June 27, 2007
• Study Completion: June 27, 2007
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

KR (1)