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

This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01094782
First received: March 19, 2010
Last updated: May 23, 2013
Last verified: May 2013

March 19, 2010
May 23, 2013
January 2010
January 2014   (final data collection date for primary outcome measure)
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.
Changes in QST measures in response to acupuncture [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Changes in heat pain threshold and tolerance, as measured by quantitative sensory testing (QST), in response to acupunture treatment
Complete list of historical versions of study NCT01094782 on ClinicalTrials.gov Archive Site
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Evaluating the Effect of Acupuncture on Pain Relief Using Quantitative Sensory Testing (QST)
Evaluating the Effect of Acupuncture on Pain Relief Using QST

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

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Pain
  • 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: Pain Subjects
    Patients with radicular pain receiving acupuncture (Group 1), sham acupuncture (Group 2), or neither acupuncture nor sham acupuncture (Group 3);
    Interventions:
    • Other: Acupuncture, sham acupuncture or neither
    • Other: Acupuncture, sham acupuncture or neither
  • Active Comparator: Healthy Volunteers
    Healthy subjects (no pain) receiving acupuncture (Group 4), sham acupuncture (Group 5), neither acupuncture nor sham acupuncture (Group 6).
    Intervention: Other: Acupuncture, sham acupuncture or neither
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
January 2015
January 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org
Contact: Cynthia Retamozo, B.A. 617-724-6102 cretamozo@partners.org
United States
 
NCT01094782
2009P 0001551, RO1-AT005819
No
Jianren Mao, MD, PhD, Massachusetts General Hospital
Massachusetts General Hospital
National Institutes of Health (NIH)
Principal Investigator: Lucy Chen, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP