Overview

Effect of Acupuncture and Pain Medication on Radicular Pain Using QST

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Massachusetts General Hospital
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Treatments:
Diphenhydramine
Gabapentin
Criteria
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.