Efficacy of Topical Capsaicin on Chronic Neck Pain

September 13, 2010 updated by: Kyunghee University Medical Center

Efficacy of Topical Capsaicin on Chronic Neck Pain ; Double-blinded Randomized Trial

The purpose of this study is to determine whether topical capsaicin patch can effectively reduce chronic neck pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  • Design: This is a double-blind, randomized, controlled study. Participants: Sixty participants with chronic neck pain are recruited and randomly assigned to two groups.
  • Intervention: Over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives Hydrogel patch instead of capsaicin patch.

Study Type

Interventional

Enrollment (Anticipated)

60

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

  • Korea, Republic of
      • Seoul, Korea, Republic of, 134-727
        • Kyunghee University East West Neo Medical Center

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Korean participants with Chronic neck pain are enrolled in our study

Exclusion Criteria:

  • Participants with coagulation deficiencies, infections, hypertension, diabetes, heart disease, renal disease, liver disease, cancer, myelopathy, hypersensitivity of drugs, other skeletomuscular disease, allergic response to capsaicin, pregnancy and nursing are excluded

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: capsaicin patch
Drug: Capsaicin patch
Over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives Hydrogel patch instead of capsaicin patch.
Other Names:
  • Hydrogel Patch
PLACEBO_COMPARATOR: Hydrogel patch
Drug: Capsaicin patch
Over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives Hydrogel patch instead of capsaicin patch.
Other Names:
  • Hydrogel Patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Scores on the Visual Analogue Scale(VAS)
Time Frame: 4 week
4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck disability index
Time Frame: 4 week
Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities
4 week
Beck depression inventory
Time Frame: 4 week
Beck depression inventory : for assessing depression
4 week
SF-36
Time Frame: 4 week
questionnaire for measuring health-related quality of life
4 week
EQ-5D(EuroQol-5 dimension)
Time Frame: 4 week
questionnaire for measuring health-related quality of life
4 week

Collaborators and Investigators

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

Sponsor

Kyunghee University Medical Center

Investigators

  • Principal Investigator: Mi-Yeon Song, OMD, PhD, Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University

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

September 1, 2010

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

February 1, 2011

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 13, 2010

First Posted (ESTIMATE)

September 14, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 14, 2010

Last Update Submitted That Met QC Criteria

September 13, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KHU 20100675

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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