Efficacy of Topical Capsaicin on Chronic Neck Pain

Chronic Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01200745
• Other study ID #: KHU 20100675
• Status: Not yet recruiting
• Phase: N/A
• First received: September 2, 2010
• Last updated: September 13, 2010
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: September 2010
• Source: Kyunghee University Medical Center
• Contact: Yu-Jeong Cho
• Phone: +82-2-440-7575
• Email: jamyunghwa[@]hotmail.com
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Kyunghee University East West Neo Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores on the Visual Analogue Scale(VAS)		4 week	No
Secondary	Neck disability index	Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities	4 week	No
Secondary	Beck depression inventory	Beck depression inventory : for assessing depression	4 week	No
Secondary	SF-36	questionnaire for measuring health-related quality of life	4 week	No
Secondary	EQ-5D(EuroQol-5 dimension)	questionnaire for measuring health-related quality of life	4 week	No