Predicting Analgesic Response to Acupuncture: A Practical Approach

Predicting Analgesic Response to Acupuncture: A Randomized, Placebo-Controlled, Subject and Assessor Blinded, 100-Subject Clinical Trial of Electro-Acupuncture in the Treatment of Chronic Low Back Pain

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Chronic Low Back Pain
• Intervention / Treatment: Other: Real Acupuncture with Electrical Stimulation; Other: Simulated Acupuncture with Electrical Stimulation

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford Systems Neuroscience and Pain Lab (SNAPL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Verum Electroacupuncture; Active Intervention	Other: Real Acupuncture with Electrical Stimulation; Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.; Other Names: Verum Electroacupuncture; Traditional acupuncture needles; ITO® ES-130® electrical stimulator
Placebo Comparator: Placebo Electroacupuncture; Validated Control	Other: Simulated Acupuncture with Electrical Stimulation; This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.; Other Names: ITO® ES-130® electrical stimulator; Sham Electroacupuncture / Placebo Electroacupuncture; Sterile Acupuncture Needles

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Sensory Testing	Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.	Tests used are typically stable for 1-2 weeks
Physical exam to determine neurological function	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.	1 month
Physical exam to assess lumbar facet irritation.	Physical exam assessing facet irritation via positive or negative response to lumbar facet maneuver in up to 5 minutes.	1 month
Physical exam to assess lumbar spine range of motion	Physical exam assessing range of motion in lumbar spine (measured in degrees) in up to 5 minutes.	1 month
Blood pressure	Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.	1 day
Heart Rate Variability	Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.	1 month
Heart Rate Variability	Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.	1 month
Heart Rate Variability	Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.	1 month

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

General Publications

• Kong JT, Puetz C, Tian L, Haynes I, Lee E, Stafford RS, Manber R, Mackey S. Effect of Electroacupuncture vs Sham Treatment on Change in Pain Severity Among Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2022787. doi: 10.1001/jamanetworkopen.2020.22787. Erratum In: JAMA Netw Open. 2022 Apr 1;5(4):e229687.

Helpful Links

• Our study was featured by New York Times
• The original paper on JAMA

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: August 31, 2016
• First Posted (Estimate): September 7, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Pain; Acupuncture; Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 34754; 1K23AT008477-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO