Myofascial Pain SyndromesPhase 3NCT00246142
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.
A Phase 3 study testing Botulinum toxin type A in people with Myofascial Pain Syndromes, run by Ipsen at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Myofascial Pain Syndromes
- What is being tested?
- Botulinum toxin type A
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2005to 27 Jun 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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®
Show all 9Show fewer
- Diffuse tender points, or diagnosed with fibromyalgia
- Previous electrical stimulation
- Previous injection of Dysport® within 6 months of study enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Myofascial Pain Syndromes
- Being tested
- Botulinum toxin type A
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean pain measured by Visual Analogue Scale (VAS) will be assessed.
Measured: 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.
Measured: Before Dysport® injection and at 16 weeks after injection
Secondary outcomes (2)
Pain threshold measured by pressure algometer.
Measured: At each visit
Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
Measured: At each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startApr 2005
- Primary completion27 Jun 2007
- Study completion27 Jun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain SyndromesStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246142
- Sponsor's protocol ID
- A-38-52120-104
- Status last verified
- Jul 2019
- First submitted
- 27 Oct 2005
- Last updated
- 29 Jul 2019
- Results posted
- No
Publications
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.
PubMed 23123438
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 16-week Prospective Randomised Double-blind Study on Facilitation of DYSPORT® Effect on Myofascial Pain Syndrome (MPS) by Electrical Stimulation.
- ClinicalTrials.gov ID
- NCT00246142
- Acronym / sponsor ID
- A-38-52120-104
- Conditions
- Myofascial Pain Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- 27 Jun 2007 (actual)
- Study completion
- 27 Jun 2007 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | – |
Primary outcome
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
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
2 secondary outcomes
Pain threshold measured by pressure algometer.
Time frame: At each visit
Neck Pain and Disability scale (NPAD) and Global Assessment of Impairment Scale (GAS) will be assessed.
Time frame: At each visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 23123438Seo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A in people with Myofascial Pain Syndromes, run by Ipsen at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00246142, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.