Predicting Analgesic Response to Acupuncture: A Practical Approach

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890810
• Other study ID #: 34754
• Secondary ID: 1K23AT008477-01A
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford Systems Neuroscience and Pain Lab (SNAPL)	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Roland Morris Disability Questionnaire	Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.	1 day
Secondary	Quantitative Sensory Testing	Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.	Tests used are typically stable for 1-2 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood pressure	Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.	1 day
Secondary	Heart Rate Variability	Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.	1 month
Secondary	Heart Rate Variability	Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.	1 month
Secondary	Heart Rate Variability	Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.	1 month

External Links

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