Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01678586|
Recruitment Status : Recruiting
First Posted : September 5, 2012
Last Update Posted : August 3, 2016
|Condition or disease||Intervention/treatment|
|Pain||Other: Acupuncture or Sham Acupuncture Other: Gabapentin or Placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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
- 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.
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.||firstname.lastname@example.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 email@example.com|
|Principal Investigator: Lucy Chen, M.D.|
|Principal Investigator:||Jianren Mao, M.D., Ph.D.||Massachusetts General Hospital|