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

June 18, 2013 updated by: Yonsei University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The differences of the VAS pain scores
Time Frame: 2weeks
2weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

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.

General Publications

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

March 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

June 14, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2010-0060

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.

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