Efficacy of Topical Capsaicin on Chronic Neck Pain | NCT01200745

Studies
Efficacy of Topical Capsaicin on Chronic Neck Pain

NCT01200745

Sponsor

Kyunghee University Medical Center

Status

Unknown status

Last Update Posted

Sep 14, 2010Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Chronic Neck Pain

Interventions

Capsaicin patch

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Jan 2011Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Sep 2, 2010

First Submission Date that Met QC Criteria

Sep 13, 2010

First Posted Date

Sep 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2010

Last Update Posted Date

Sep 14, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
capsaicin patch	Active Comparator		Drug: Capsaicin patch
Hydrogel patch	Placebo Comparator		Drug: Capsaicin patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capsaicin patch	Drug	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Neck disability index	Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities	4 week
Beck depression inventory	Beck depression inventory : for assessing depression

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yu-Jeong Cho	Contact	+82-2-440-7575		jamyunghwa@hotmail.com

Overall Officials

Name	Affiliation	Role
Mi-Yeon Song, OMD, PhD	Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kyunghee University East West Neo Medical Center		Seoul		134-727	South Korea

Type	Date	Date Unknown
Release	Mar 19, 2023
Reset	Jan 4, 2024

Submission Tracking

Estimated Results First Submitted Date

Mar 19, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 19, 2023			Jan 4, 2024

Condition Browse Module

MeSH Terms

ID	Term
D019547	Neck Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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