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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01678586|
Recruitment Status : Active, not recruiting
First Posted : September 5, 2012
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Acupuncture Other: Sham Acupuncture Drug: Gabapentin Drug: Sham Gabapentin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Acupuncture and Pain Medication on Radicular Pain Using QST|
|Actual Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Active Comparator: True Acupuncture
Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.
In true acupuncture the needles penetrate the skin.
Sham Comparator: Sham Acupuncture
Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.
Other: Sham Acupuncture
In sham acupuncture the needles do not penetrate the skin.
Active Comparator: Gabapentin
Pain subjects with radicular pain receiving gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
Other Name: Neurontin
Sham Comparator: Sham Gabapentin
Pain subjects with radicular pain receiving sham gabapentin. Medication treatment groups will titrate up to the standard clinical treatment dosage for one week and maintain that dosage for 1.5 weeks.
Drug: Sham Gabapentin
Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
Other Name: Benadryl, diphenhydramine
- 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
|United States, Massachusetts|
|MGH Center for Translational Pain Research|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Jianren Mao, M.D., Ph.D.||Massachusetts General Hospital|