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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-06-27

Brief Summary

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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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Detailed Description

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Conditions

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Myofascial Pain Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility 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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No