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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00246142 |
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Date of registration:
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27/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
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Scientific title:
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A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation. |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00246142 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Ipsen Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ipsen |
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Key inclusion & exclusion criteria
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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
Age minimum:
21 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myofascial Pain Syndromes
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Intervention(s)
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Biological: Botulinum toxin type A
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Primary Outcome(s)
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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]
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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]
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Secondary Outcome(s)
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Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
[Time Frame: At each visit]
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Pain threshold measured by pressure algometer.
[Time Frame: At each visit]
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Secondary ID(s)
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A-38-52120-104
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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