Predicting Analgesic Response to Acupuncture: A Practical Approach

Stanford University

Status: Completed

Conditions: Chronic Low Back Pain; Back Pain

Treatments: Other: Simulated Acupuncture with Electrical Stimulation; Other: Real Acupuncture with Electrical Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02890810

1K23AT008477-01A1 (U.S. NIH Grant/Contract)

34754

Details and patient eligibility

About

In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. The investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.

Enrollment: 121 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 21-65

2. English Fluency

3. Chronic LBP for ≥ 6 Months

   1. Chronicity: cLBP "defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months."
   2. Location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold

4. Average pain over the last month ≥ 5/10

Exclusion criteria

1. Radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. Radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. Radicular back pain may also be accompanied by MRI evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots.

2. Pending litigation or Worker's compensation related to the low back pain.

3. Currently pregnant or planning to become pregnant (in next 6 months)

4. American Society of Anesthesiologist (ASA) class III or above physical status. ASA class III is defined as "a patient with severe systemic disease." Examples would include poorly controlled diabetes, hypertension, COPD or morbid obesity (BMI ≥ 40).

5. Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. For example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. These will be assessed by the MINI.

6. Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids.

7. Prohibited interventions: during the study period, the following are not permitted

   1. Back surgeries
   2. Injections with local anesthetics or steroids to the back
   3. New chiropractic maneuvers
   4. New physical therapy programs
   5. New medications for back pain

8. Bleeding disorders at the discretion of the study team.

9. Previous acupuncture treatment in the past 10 years.

10. Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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121 participants in 2 patient groups, including a placebo group

Verum Electroacupuncture

Experimental group

Description:

Active Intervention

Treatment:

Other: Real Acupuncture with Electrical Stimulation

Placebo Electroacupuncture

Placebo Comparator group

Description:

Validated Control

Treatment:

Other: Simulated Acupuncture with Electrical Stimulation