Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
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).
|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|
- 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.
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678586
|Contact: Trang T Vo, B.A.||email@example.com|
|United States, Massachusetts|
|MGH Center for Translational Pain Research||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Trang T Vo, B.A. 617-724-6102 firstname.lastname@example.org|
|Principal Investigator: Lucy Chen, M.D.|
|Principal Investigator:||Jianren Mao, M.D., Ph.D.||Massachusetts General Hospital|