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Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01094782
First received: March 19, 2010
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to explore a new approach to assessing the effectiveness of acupuncture therapy in the treatment chronic pain conditions.


Condition Intervention
Pain
 Other: Acupuncture, sham acupuncture or neither

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Evaluating the Effect of Acupuncture on Pain Relief Using QST

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes in QST measures in response to acupuncture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Changes in response to heat stimulation stated as pain, sensitivity and tolerance. Responses are measured with a quantitative sensory testing (QST) device. Measurements are taken before, during, and after acupunture treatment.


Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pain Subjects
Patients with radicular pain receiving acupuncture (Group 1), sham acupuncture (Group 2), or neither acupuncture nor sham acupuncture (Group 3);
 Other: Acupuncture, sham acupuncture or neither
Patients with radicular pain receiving acupuncture (Group 1), sham acupuncture (Group 2), or neither acupuncture nor sham acupuncture (Group 3);
Other: Acupuncture, sham acupuncture or neither
Healthy subjects (no pain) receiving acupuncture (Group 4), sham acupuncture (Group 5), neither acupuncture nor sham acupuncture (Group 6).
Active Comparator: Healthy Volunteers
Healthy subjects (no pain) receiving acupuncture (Group 4), sham acupuncture (Group 5), neither acupuncture nor sham acupuncture (Group 6).
 Other: Acupuncture, sham acupuncture or neither
Healthy subjects (no pain) receiving acupuncture (Group 4), sham acupuncture (Group 5), neither acupuncture nor sham acupuncture (Group 6).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
  2. Subject should have had cervical or lumbar radicular pain for at least two months. This requirement is to avoid the uncertainty of an unstable pain condition and to minimize the study variation.
  3. Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain to worst pain).
  4. Cervical or lumbar radicular pain will include, but is not limited to, such clinical conditions as disk herniation, spinal stenosis, and post-laminectomy syndrome.
  5. For controls, healthy subjects without radicular pain for at least three months will be recruited.

Exclusion Criteria:

  1. Subject has detectable sensory deficits at the site of QST. Sensory deficits refer to such conditions resulting from neurological diseases or medical conditions causing peripheral polyneuropathy and sensory changes, which include but are not limited to diabetic neuropathy, alcoholic neuropathy, AIDS neuropathy, severe thyroid disease, and severe liver or kidney disorders.
  2. Subject has scar tissue, infection, or acute injury at the site of QST.
  3. Subject is on anticoagulation therapy.
  4. Subject is pregnant.
  5. Subject is tested positive on illicit drugs.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094782

Contacts
Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org
Contact: Cynthia Retamozo, B.A. 617-724-6102 cretamozo@partners.org

Locations
United States, Massachusetts
MGH Center for Translational Pain Research Recruiting
Boston, Massachusetts, United States, 02114
Contact: Trang T. Vo, B.A.     617-724-6102     tvo3@partners.org    
Contact: Cynthia Retamozo, B.A.     617-724-6102     cretamozo@partners.org    
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Lucy Chen, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jianren Mao, MD, PhD, Director, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01094782     History of Changes
Other Study ID Numbers: 2009P 0001551, RO1-AT005819
Study First Received: March 19, 2010
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pain
Pain management

ClinicalTrials.gov processed this record on May 16, 2013