Predicting Analgesic Response to Acupuncture: A Practical Approach

Not Applicable

Completed

• Conditions: Chronic Low Back Pain; Back Pain
• Interventions: Other: Simulated Acupuncture with Electrical Stimulation; Other: Real Acupuncture with Electrical Stimulation

• Registration Number: NCT02890810
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-08-31
• Study First Posted: 2016-09-07
• Primary Completion: 2018-12-31
• Study Completion: 2020-06-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Electroacupuncture	Simulated Acupuncture with Electrical Stimulation	Validated Control
Verum Electroacupuncture	Real Acupuncture with Electrical Stimulation	Active Intervention

Primary Outcome Measures

Name	Time	Method
Mean back pain intensity by patient-report	7 days	Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
Roland Morris Disability Questionnaire	1 day	Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	1 day	Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.
Quantitative Sensory Testing	Tests used are typically stable for 1-2 weeks	Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.
Physical exam to determine neurological function	1 month	Physical exam assessing neurological function (recorded as presence or absence of light touch sensation, and stretch reflexes at the knees and ankles) in up to 5min.
Physical exam to assess lumbar facet irritation.	1 month	Physical exam assessing facet irritation via positive or negative response to lumbar facet maneuver in up to 5 minutes.
Physical exam to assess lumbar spine range of motion	1 month	Physical exam assessing range of motion in lumbar spine (measured in degrees) in up to 5 minutes.
Heart Rate Variability	1 month	Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.

Trial Locations

Locations (1)

Stanford Systems Neuroscience and Pain Lab (SNAPL); 🇺🇸 Palo Alto, California, United States