Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2021-12-31

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).

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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True Acupuncture

Pain subjects with radicular pain receiving 6, 30 minute acupuncture treatments.

Group Type ACTIVE_COMPARATOR

Acupuncture

Intervention Type OTHER

In true acupuncture the needles penetrate the skin.

Sham Acupuncture

Pain subjects with radicular pain receiving 6, 30 minute sham acupuncture treatments.

Group Type SHAM_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

In sham acupuncture the needles do not penetrate the skin.

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.

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

Gabapentin is a commonly prescribed drug used to treat neuropathic pain.

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.

Group Type SHAM_COMPARATOR

Sham Gabapentin

Intervention Type DRUG

Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)

Interventions

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Acupuncture

In true acupuncture the needles penetrate the skin.

Intervention Type OTHER

Sham Acupuncture

In sham acupuncture the needles do not penetrate the skin.

Intervention Type OTHER

Gabapentin

Gabapentin is a commonly prescribed drug used to treat neuropathic pain.

Intervention Type 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)

Intervention Type DRUG

Other Intervention Names

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Neurontin Benadryl, diphenhydramine

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No