Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
This study is currently recruiting participants.
Verified February 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by (Responsible Party):
Jianren Mao, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01678586
First received: August 31, 2012
Last updated: February 25, 2013
Last verified: February 2013
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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: | February 2013 |
| Estimated Study Completion Date: | January 2015 |
| 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:
- Subject will be between ages 18 to 65 years. Both male and female subjects will be recruited.
- 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.
- Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain to worst pain).
- 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:
- 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.
- Subject has scar tissue, infection, or acute injury at the site of QST.
- Subject is pregnant.
- Subject tests positive for illicit drugs.
- Subject has a pacemaker.
- Subject is currently taking gabapentin.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678586
Contacts
| Contact: Trang T Vo, B.A. | 617-724-6102 | tvo3@partners.org |
| Contact: Abigail S Cohen, B.A. | 617-724-6102 | acohen18@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: Abigail S Cohen, B.A. 617-724-6102 acohen18@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: | February 25, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Pain Pain management |
Additional relevant MeSH terms:
|
Analgesics Gabapentin Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 23, 2013