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Efficacy of Topical Capsaicin on Chronic Neck Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Kyunghee University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01200745
First received: September 2, 2010
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention
Chronic Neck Pain
 Drug: Capsaicin patch

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Topical Capsaicin on Chronic Neck Pain ; Double-blinded Randomized Trial

Resource links provided by NLM:

Drug Information available for: Capsaicin
U.S. FDA Resources

Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Pain Scores on the Visual Analogue Scale(VAS) [ Time Frame: 4 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neck disability index [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    Neck disability index : questionnaire for measuring how much neck pain affects ability of daily activities

  • Beck depression inventory [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    Beck depression inventory : for assessing depression

  • SF-36 [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    questionnaire for measuring health-related quality of life

  • EQ-5D(EuroQol-5 dimension) [ Time Frame: 4 week ] [ Designated as safety issue: No ]
    questionnaire for measuring health-related quality of life


Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Capsaicin Patch
  • 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:
  • Capsaicin Patch
  • Hydrogel Patch

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200745

Contacts
Contact: Yu-Jeong Cho +82-2-440-7575 jamyunghwa@hotmail.com

Locations
Korea, Republic of
Kyunghee University East West Neo Medical Center Not yet recruiting
Seoul, Korea, Republic of, 134-727
Contact: JaeHeung Cho     +82-2-440-7581     vetkong95@hanmail.net    
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Mi-Yeon Song, OMD, PhD Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
  More Information

No publications provided

Responsible Party: Mi-Yeon Song / Department of Oriental Rehabilitation Medicine, College of Oriental Medicine, Kyung Hee University
ClinicalTrials.gov Identifier: NCT01200745     History of Changes
Other Study ID Numbers: KHU 20100675
Study First Received: September 2, 2010
Last Updated: September 13, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Kyunghee University Medical Center:
neck pain
capsaicin
dermal patch

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Capsaicin
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013