Myofascial Pain Syndrome of the Upper TrapeziusNCT01884116
Comparison of NSAID Patch Given in Monotherapy and NSAID Patch in Combination With Transcutaneous Electric Nerve Stimulation, Heating Pad, or Topical Capsaicin in the Treatment of Patients With Myofascial Pain Syndrome of the Upper Trapezius: A Pilot Study
A study testing NSAID patch, NSAID patch + transcutaneous electric nerve stimulation and NSAID patch + heating pad in people with Myofascial Pain Syndrome of the Upper Trapezius, run by Yonsei University at 1 site in South Korea.
Trial summary
Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and various treatment modalities have been introduced. If self-applicable physical modalities and medications that are used for treatment of MPS patients are combined, they may open up new possibilities for effective and practical… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myofascial Pain Syndrome of the Upper Trapezius
- What is being tested?
- NSAID patch, NSAID patch + transcutaneous electric nerve stimulation and NSAID patch + heating pad
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Aug 2012
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 20 years of age with diagnosis of myofascial pain syndrome of the upper trapezius.
- Visual analogue scale (VAS, 0 = no pain, 10 = worst pain) greater than
Who cannot join
- 1. Pregnant or breast feeding women, patients who have taken opioids within seven days, patients with severe disease (heart disease, liver disease, etc) that might affect the results of the study, patients who have participated in another clinical study within 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and various treatment modalities have been introduced. If self-applicable physical modalities and medications that are used for treatment of MPS patients are combined, they may open up new possibilities for effective and practical self-care. The aim of this study is to compared the therapeutic effect of non-steroidal anti-inflammatory drug (NSAID) patch given in monotherapy and NSAID patch in combination with transcutaneous electric nerve stimulation, heating pad, or topical capsaicin in the treatment of patients with MPS of the upper trapezius.
- Being tested
- NSAID patch, NSAID patch + transcutaneous electric nerve stimulation, NSAID patch + heating pad, NSAID patch + topical capsaicin
- Keywords
- Capsaicin, myofascial pain syndrome, non-steroidal anti-inflammatory agents, transcutaneous electric nerve stimulation
- 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.
NSAID patchDrug
NSAID patch + transcutaneous electric nerve stimulationDrug
The patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks.
NSAID patch + heating padDrug
The patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks.
NSAID patch + topical capsaicinDrug
The patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| NSAID patch group | Active comparator | administer the NSAID patch Receives: Drug: NSAID patch |
| NSAID patch + transcutaneous electric nerve stimulation group | Experimental | Not described Receives: Drug: NSAID patch + transcutaneous electric nerve stimulation |
| NSAID patch + heating pad group | Experimental | Not described Receives: Drug: NSAID patch + heating pad |
| NSAID patch + topical capsaicin group | Experimental | Not described Receives: Drug: NSAID patch + topical capsaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of the VAS pain scores
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionAug 2012
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 Syndrome of the Upper TrapeziusStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884116
- Sponsor's protocol ID
- 1-2010-0060
- Status last verified
- Jun 2013
- First submitted
- 14 Jun 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
PubMed 15710025
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of NSAID Patch Given in Monotherapy and NSAID Patch in Combination With Transcutaneous Electric Nerve Stimulation, Heating Pad, or Topical Capsaicin in the Treatment of Patients With Myofascial Pain Syndrome of the Upper Trapezius: A Pilot Study
- ClinicalTrials.gov ID
- NCT01884116
- Acronym / sponsor ID
- 1-2010-0060
- Keywords
- Capsaicin, myofascial pain syndrome, non-steroidal anti-inflammatory agents, transcutaneous electric nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Jun 2013 (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.
Myofascial pain syndrome (MPS) is a common clinical problem of musculoskeletal pain and various treatment modalities have been introduced. If self-applicable physical modalities and medications that are used for treatment of MPS patients are combined, they may open up new possibilities for effective and practical self-care. The aim of this study is to compared the therapeutic effect of non-steroidal anti-inflammatory drug (NSAID) patch given in monotherapy and NSAID patch in combination with transcutaneous electric nerve stimulation, heating pad, or topical capsaicin in the treatment of patients with MPS of the upper trapezius.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NSAID patch group | Active comparator | Drug: NSAID patchadminister the NSAID patch |
| NSAID patch + transcutaneous electric nerve stimulation group | Experimental | Drug: NSAID patch + transcutaneous electric nerve stimulation |
| NSAID patch + heating pad group | Experimental | Drug: NSAID patch + heating pad |
| NSAID patch + topical capsaicin group | Experimental | Drug: NSAID patch + topical capsaicin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 20 years of age with diagnosis of myofascial pain syndrome of the upper trapezius.
- Visual analogue scale (VAS, 0 = no pain, 10 = worst pain) greater than
Key exclusion criteria (1 listed)
- 1. Pregnant or breast feeding women, patients who have taken opioids within seven days, patients with severe disease (heart disease, liver disease, etc) that might affect the results of the study, patients who have participated in another clinical study within 30 days.
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 |
|---|---|---|
| NSAID patch | Drug | NSAID patch group |
| NSAID patch + transcutaneous electric nerve stimulationThe patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks. | Drug | NSAID patch + transcutaneous electric nerve stimulation group |
| NSAID patch + heating padThe patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks. | Drug | NSAID patch + heating pad group |
| NSAID patch + topical capsaicinThe patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks. | Drug | NSAID patch + topical capsaicin group |
Primary outcome
The differences of the VAS pain scores
Time frame: 2weeks
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 21 Jun 2013.
- Background: PubMed 15710025Al-Shaikh B, George William M, Van Zundert AA. Using atmospheric pressure to inflate the cuff of the Portex Laryngeal Mask. Anaesthesia. 2005 Mar;60(3):296-7. doi: 10.1111/j.1365-2044.2005.04135.x. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAID patch, NSAID patch + transcutaneous electric nerve stimulation and NSAID patch + heating pad in people with Myofascial Pain Syndrome of the Upper Trapezius, run by Yonsei University 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 2 inclusion and 1 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 21 Jun 2013. 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.
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?
The differences of the VAS pain scores (time frame: 2weeks). 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 NCT01884116, 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 21 Jun 2013.