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Efficacy of Topical Capsaicin on Chronic Neck Pain

Primary Purpose

Chronic Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Capsaicin patch
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring neck pain, capsaicin, dermal patch

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyunghee University East West Neo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

capsaicin patch

Hydrogel patch

Arm Description

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analogue Scale(VAS)

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2010
Last Updated
September 13, 2010
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01200745
Brief Title
Efficacy of Topical Capsaicin on Chronic Neck Pain
Official Title
Efficacy of Topical Capsaicin on Chronic Neck Pain ; Double-blinded Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
Keywords
neck pain, capsaicin, dermal patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
capsaicin patch
Arm Type
Active Comparator
Arm Title
Hydrogel patch
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Capsaicin patch
Other Intervention Name(s)
Hydrogel Patch
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Scores on the Visual Analogue Scale(VAS)
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Neck disability index
Description
Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities
Time Frame
4 week
Title
Beck depression inventory
Description
Beck depression inventory : for assessing depression
Time Frame
4 week
Title
SF-36
Description
questionnaire for measuring health-related quality of life
Time Frame
4 week
Title
EQ-5D(EuroQol-5 dimension)
Description
questionnaire for measuring health-related quality of life
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Jeong Cho
Phone
+82-2-440-7575
Email
jamyunghwa@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mi-Yeon Song, OMD, PhD
Organizational Affiliation
Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyunghee University East West Neo Medical Center
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JaeHeung Cho
Phone
+82-2-440-7581
Email
vetkong95@hanmail.net

12. IPD Sharing Statement

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Efficacy of Topical Capsaicin on Chronic Neck Pain

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