NCT01200745

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

September 14, 2010

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

September 2, 2010

Last Update Submit

September 13, 2010

Conditions

Chronic Neck Pain

Keywords

neck paincapsaicindermal patch

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analogue Scale(VAS)

    4 week

Secondary Outcomes (4)

  • Neck disability index

    4 week

  • Beck depression inventory

    4 week

  • SF-36

    4 week

  • EQ-5D(EuroQol-5 dimension)

    4 week

Study Arms (2)

capsaicin patch

ACTIVE COMPARATOR
Drug: Capsaicin patch

Hydrogel patch

PLACEBO COMPARATOR
Drug: Capsaicin patch

Interventions

Capsaicin patchDRUG

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.

Also known as: Hydrogel Patch
Hydrogel patchcapsaicin patch

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyunghee University East West Neo Medical Center

Seoul, 134-727, South Korea

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mi-Yeon Song, OMD, PhD

    Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Jeong Cho

CONTACT

+82-2-440-7575jamyunghwa@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 14, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

September 14, 2010

Record last verified: 2010-09

Locations

KR(1)