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Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

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ClinicalTrials.gov Identifier: NCT01678586
Recruitment Status : Recruiting
First Posted : September 5, 2012
Last Update Posted : August 3, 2016
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital

Brief Summary:
In this aim, we propose to conduct a double blinded, placebo-controlled, and randomized clinical trial to compare the clinical effectiveness of radicular pain relief by either acupuncture therapy or a course of pain medication (e.g., Gabapentin) using Quantitative Sensory Testing (QST).

Condition or disease Intervention/treatment
Pain Other: Acupuncture or Sham Acupuncture Other: Gabapentin or Placebo

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Official Title: Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
Study Start Date : December 2012
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Pain subjects receiving acupuncture
Pain subjects with radicular pain receiving acupuncture or sham acupuncture.
Other: Acupuncture or Sham Acupuncture
Acupuncture is when the needles go into the skin. Sham acupuncture is when the needles do not go into the skin. We will compare results between the two acupuncture therapy groups.
Active Comparator: Pain subjects receiving gabapentin
Pain subjects with radicular pain receiving gabapentin or placebo. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Other: Gabapentin or Placebo
Gabapentin is a commonly prescribed drug used to treat neuropathic pain. The placebo will be used to mimic side effects common to gabapentin. The two medication treatment groups' results will be compared to each other.
Other Name: neurontin

Primary Outcome Measures :
  1. Changes in QST measures in response to acupuncture or gabapentin [ Time Frame: 3 weeks ]
    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 acupuncture treatment and throughout the gabapentin medication regimen.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject will be between ages 18 to 75 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.

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 pregnant.
  4. Subject tests positive for illicit drugs.
  5. Subject has a pacemaker.
  6. Subject is currently taking gabapentin.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678586

Contact: Arissa Opalacz, B.A. 617-724-6102 aopalacz@partners.org

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   
Principal Investigator: Lucy Chen, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital

Responsible Party: Jianren Mao, MD, PhD, M.D., Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01678586     History of Changes
Other Study ID Numbers: 2012P-001795
5R01AT005819-04 ( U.S. NIH Grant/Contract )
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Jianren Mao, MD, PhD, Massachusetts General Hospital:
Pain management

Additional relevant MeSH terms:
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents