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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

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ClinicalTrials.gov Identifier: NCT01884116
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndrome of the Upper Trapezius Drug: NSAID patch Drug: NSAID patch + transcutaneous electric nerve stimulation Drug: NSAID patch + heating pad Drug: NSAID patch + topical capsaicin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Study Start Date : March 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Capsaicin

Arm Intervention/treatment
Active Comparator: NSAID patch group
administer the NSAID patch
Drug: NSAID patch
Experimental: NSAID patch + transcutaneous electric nerve stimulation group Drug: NSAID patch + transcutaneous electric nerve stimulation
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.

Experimental: NSAID patch + heating pad group Drug: NSAID patch + heating pad
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.

Experimental: NSAID patch + topical capsaicin group Drug: NSAID patch + topical capsaicin
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.




Primary Outcome Measures :
  1. The differences of the VAS pain scores [ Time Frame: 2weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients over 20 years of age with diagnosis of myofascial pain syndrome of the upper trapezius.
  2. Visual analogue scale (VAS, 0 = no pain, 10 = worst pain) greater than

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884116


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01884116    
Other Study ID Numbers: 1-2010-0060
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Yonsei University:
Capsaicin
myofascial pain syndrome
non-steroidal anti-inflammatory agents
transcutaneous electric nerve stimulation
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents