- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00246142
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
July 25, 2019 updated by: Ipsen
A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.
The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on myofascial pain syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Before Dysport® injection and at 16 weeks after injection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain threshold measured by pressure algometer.
Time Frame: At each visit
|
At each visit
|
Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
Time Frame: At each visit
|
At each visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
June 27, 2007
Study Completion (Actual)
June 27, 2007
Study Registration Dates
First Submitted
October 27, 2005
First Submitted That Met QC Criteria
October 27, 2005
First Posted (Estimate)
October 30, 2005
Study Record Updates
Last Update Posted (Actual)
July 29, 2019
Last Update Submitted That Met QC Criteria
July 25, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Disease
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Syndrome
- Fibromyalgia
- Somatoform Disorders
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- A-38-52120-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myofascial Pain Syndromes
-
Bozyaka Training and Research HospitalEnrolling by invitationMyofascial Pain | Trigger Point Pain, Myofascial | Myofascial Trigger Point PainTurkey
-
Washington University School of MedicineRecruitingMyofascial Pain | Pelvic Pain | Pelvic Floor Myofascial PainUnited States
-
Beth Israel Deaconess Medical CenterMassachusetts General HospitalRecruitingMyofascial Pain | Trigger Point Pain, MyofascialUnited States
-
University of ArizonaEnrolling by invitationMyofascial Pain | Myofascial Trigger Point PainUnited States
-
Universidad Complutense de MadridCompletedMyofascial Pain | Trigger Point Pain, MyofascialSpain
-
Quiropraxia y EquilibrioUniversidad Nacional Andres BelloCompletedMyofascial Trigger Point Pain (MTrP)Chile
-
Indonesia UniversityCompletedMyofascial Pain of Upper Trapezius MuscleIndonesia
-
Washington University School of MedicineNational Center for Complementary and Integrative Health (NCCIH)Recruiting
-
Quiropraxia y EquilibrioNot yet recruitingMyofascial Trigger Point Pain (MTrP)Chile
-
Lithuanian University of Health SciencesCompleted
Clinical Trials on Botulinum toxin type A
-
AllerganTerminatedOveractive BladderSerbia, Turkey, Greece, Egypt, Lebanon, India
-
Daewoong Pharmaceutical Co. LTD.Completed
-
AllerganCompletedOveractive BladderPortugal, South Africa, Netherlands, Canada, Singapore, Brazil, United States, Taiwan, Italy, United Kingdom, France, Spain
-
AllerganCompletedOveractive BladderUnited Kingdom, Belgium, New Zealand, France, Russian Federation, Czech Republic, United States, Germany, Austria, Poland, Slovakia, Ukraine, Canada, Australia
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar RhytidesUnited States
-
Brazilan Center for Studies in DermatologyCompletedWrinkles in Frontal AreaBrazil
-
HugelCompletedBenign Masseteric HypertrophyKorea, Republic of
-
Mentor Worldwide, LLCSynteract, Inc.CompletedGlabellar Rhytides | Frown Lines Between the EyebrowsUnited States
-
Medy-ToxCompletedCervical Dystonia
-
Seton Healthcare FamilyCompleted