Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Mass General Brigham

Status: Completed

Conditions: Pain

Treatments: Other: Sham Acupuncture; Other: Acupuncture; Drug: Gabapentin; Drug: Sham Gabapentin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01678586

5R01AT005819-04 (U.S. NIH Grant/Contract)

2012P-001795

Details and patient eligibility

About

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).

Enrollment: 56 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 4 patient groups

True Acupuncture

Active Comparator group

Description:

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

Treatment:

Other: Acupuncture

Sham Acupuncture

Sham Comparator group

Description:

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

Treatment:

Other: Sham Acupuncture

Gabapentin

Active Comparator group

Description:

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.

Treatment:

Drug: Gabapentin

Sham Gabapentin

Sham Comparator group

Description:

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.

Treatment:

Drug: Sham Gabapentin