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NCT01884116 Clinical Trial

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

Myofascial Pain Syndrome of the Upper Trapezius Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01884116
Other study ID # 1-2010-0060
Secondary ID
Status Completed
Phase N/A
First received June 14, 2013
Last updated June 18, 2013
Start date March 2011
Est. completion date August 2012

Study information
Verified date June 2013
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date August 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• NSAID patch

• 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.
• 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.
• 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.

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The differences of the VAS pain scores 2weeks No