Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Study Overview
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Brief Summary
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In this aim, we propose to conduct a double blinded, 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).

Official Title
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Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Conditions
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Pain

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham Acupuncture
* Drug: Gabapentin
* Drug: Sham Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be between ages 18 to 75 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: True Acupuncture<br>Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. | Other: Acupuncture<br>* In true acupuncture the needles penetrate the skin.<br>|
| Sham Comparator: Sham Acupuncture<br>Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments. | Other: Sham Acupuncture<br>* In sham acupuncture the needles do not penetrate the skin.<br>|
| Active Comparator: Gabapentin<br>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. | Drug: Gabapentin<br>* Gabapentin is a commonly prescribed drug used to treat neuropathic pain.<br>* Other names: Neurontin;|
| Sham Comparator: Sham Gabapentin<br>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<br>* Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)<br>* Other names: Benadryl, diphenhydramine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in QST measures in response to acupuncture or gabapentin | 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. | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Pain management