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Predicting Analgesic Response to Acupuncture: A Practical Approach

Primary Purpose

Chronic Low Back Pain, Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Real Acupuncture with Electrical Stimulation

Simulated Acupuncture with Electrical Stimulation

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Acupuncture, Back Pain, Chronic Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 21-65
English Fluency
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
Average pain over the last month ≥ 5/10

Exclusion Criteria:

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.
Pending litigation or Worker's compensation related to the low back pain.
Currently pregnant or planning to become pregnant (in next 6 months)
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).
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.
Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids.
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
Bleeding disorders at the discretion of the study team.
Previous acupuncture treatment in the past 10 years.
Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team

Sites / Locations

Stanford Systems Neuroscience and Pain Lab (SNAPL)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum Electroacupuncture

Placebo Electroacupuncture

Arm Description

Active Intervention

Validated Control

Outcomes

Primary Outcome Measures

Mean back pain intensity by patient-report

Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).

Roland Morris Disability Questionnaire

Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.

Secondary Outcome Measures

Quantitative Sensory Testing

Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.

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.

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.

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.

Blood pressure

Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.

Heart Rate Variability

Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.

Heart Rate Variability

Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.

Heart Rate Variability

Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.

Full Information

NCT ID

NCT02890810

First Posted

July 15, 2016

Last Updated

January 21, 2021

Sponsor

Stanford University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT02890810

Brief Title

Predicting Analgesic Response to Acupuncture: A Practical Approach

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

July 2016 (Actual)

Primary Completion Date

December 31, 2018 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Low Back Pain, Back Pain

Keywords

Acupuncture, Back Pain, Chronic Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

121 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum Electroacupuncture

Arm Type

Experimental

Arm Description

Active Intervention

Arm Title

Placebo Electroacupuncture

Arm Type

Placebo Comparator

Arm Description

Validated Control

Intervention Type

Other

Intervention Name(s)

Real Acupuncture with Electrical Stimulation

Other Intervention Name(s)

Verum Electroacupuncture, Traditional acupuncture needles, ITO® ES-130® electrical stimulator

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Simulated Acupuncture with Electrical Stimulation

Other Intervention Name(s)

Sham Electroacupuncture / Placebo Electroacupuncture, Sterile Acupuncture Needles, ITO® ES-130® electrical stimulator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean back pain intensity by patient-report

Description

Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).

Time Frame

7 days

Title

Roland Morris Disability Questionnaire

Description

Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Quantitative Sensory Testing

Description

Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.

Time Frame

Tests used are typically stable for 1-2 weeks

Title

Physical exam to determine neurological function

Description

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.

Time Frame

1 month

Title

Physical exam to assess lumbar facet irritation.

Description

Physical exam assessing facet irritation via positive or negative response to lumbar facet maneuver in up to 5 minutes.

Time Frame

1 month

Title

Physical exam to assess lumbar spine range of motion

Description

Physical exam assessing range of motion in lumbar spine (measured in degrees) in up to 5 minutes.

Time Frame

1 month

Title

Blood pressure

Description

Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.

Time Frame

1 day

Title

Heart Rate Variability

Description

Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.

Time Frame

1 month

Title

Heart Rate Variability

Description

Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.

Time Frame

1 month

Title

Heart Rate Variability

Description

Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 21-65 English Fluency Chronic LBP for ≥ 6 Months 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." Location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold Average pain over the last month ≥ 5/10 Exclusion Criteria: 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. Pending litigation or Worker's compensation related to the low back pain. Currently pregnant or planning to become pregnant (in next 6 months) 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). 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. Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids. Prohibited interventions: during the study period, the following are not permitted Back surgeries Injections with local anesthetics or steroids to the back New chiropractic maneuvers New physical therapy programs New medications for back pain Bleeding disorders at the discretion of the study team. Previous acupuncture treatment in the past 10 years. Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team

Facility Information:

Facility Name

Stanford Systems Neuroscience and Pain Lab (SNAPL)

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33107921

Citation

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.

Results Reference

background

Links:

URL

https://www.nytimes.com/2020/10/30/well/live/acupuncture-helped-people-with-back-pain-walk-and-bend-better.html

Description

Our study was featured by New York Times

URL

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2772250

Description

The original paper on JAMA

Learn more about this trial

Predicting Analgesic Response to Acupuncture: A Practical Approach

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