Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
Study Details
Study Description
Brief Summary
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).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: True Acupuncture Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments. |
Other: Acupuncture
In true acupuncture the needles penetrate the skin.
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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.
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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. |
Drug: Gabapentin
Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
Other Names:
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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 Names:
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Outcome Measures
Primary Outcome Measures
- Changes in QST measures in response to acupuncture or gabapentin [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject will be between ages 18 to 75 years. Both male and female subjects will be recruited.
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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.
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Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain to worst pain).
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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:
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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.
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Subject has scar tissue, infection, or acute injury at the site of QST.
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Subject is pregnant.
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Subject tests positive for illicit drugs.
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Subject has a pacemaker.
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Subject is currently taking gabapentin.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | MGH Center for Translational Pain Research | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Jianren Mao, M.D., Ph.D., Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2012P-001795
- 5R01AT005819-04