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Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01678586
First received: August 31, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

In this aim, we propose to conduct a double blind, 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 Intervention
Pain
Other: Acupuncture or Sham Acupuncture
Other: Gabapentin or Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes in QST measures in response to acupuncture or gabapentin [ 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 acupuncture treatment and throughout the gabapentin medication regimen.


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678586

Contacts
Contact: Trang T Vo, B.A. 617-724-6102 tvo3@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   
Principal Investigator: Lucy Chen, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jianren Mao, M.D., Ph.D. Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

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
Study First Received: August 31, 2012
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pain
Pain management

Additional relevant MeSH terms:
Analgesics
Gabapentin
Anti-Anxiety Agents
Anti-Dyskinesia Agents
Anticonvulsants
Antimanic Agents
Antiparkinson Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 24, 2014