Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01678586
Collaborator
National Center for Complementary and Integrative Health (NCCIH) (NIH)
47
1
4
108
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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
  • Other: Acupuncture
  • Other: Sham Acupuncture
  • Drug: Gabapentin
  • Drug: Sham Gabapentin
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Other
Official Title:
Effect of Acupuncture and Pain Medication on Radicular Pain Using QST
Actual Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Drug: Gabapentin
Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
Other Names:
  • 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 Names:
  • Benadryl, diphenhydramine
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Subject will be between ages 18 to 75 years. Both male and female subjects will be recruited.

    2. 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.

    3. Subject has a pain score of 4 or above (visual analog scale, VAS: 0 - 10 from no pain to worst pain).

    4. 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:
    1. 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.

    2. Subject has scar tissue, infection, or acute injury at the site of QST.

    3. Subject is pregnant.

    4. Subject tests positive for illicit drugs.

    5. Subject has a pacemaker.

    6. Subject is currently taking gabapentin.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    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.
    Responsible Party:
    Jianren Mao, MD, PhD, M.D., Ph.D., Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT01678586
    Other Study ID Numbers:
    • 2012P-001795
    • 5R01AT005819-04
    First Posted:
    Sep 5, 2012
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Jianren Mao, MD, PhD, M.D., Ph.D., Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 6, 2022