NCT02890810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

July 15, 2016

Last Update Submit

January 21, 2021

Conditions

Chronic Low Back PainBack Pain

Keywords

AcupunctureBack PainChronic Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Quantitative Sensory Testing

    Tests used are typically stable for 1-2 weeks

  • Physical exam to determine neurological function

    1 month

  • Physical exam to assess lumbar facet irritation.

    1 month

  • Physical exam to assess lumbar spine range of motion

    1 month

  • Blood pressure

    1 day

  • +3 more secondary outcomes

Study Arms (2)

Verum Electroacupuncture

EXPERIMENTAL

Active Intervention

Other: Real Acupuncture with Electrical Stimulation

Placebo Electroacupuncture

PLACEBO COMPARATOR

Validated Control

Other: Simulated Acupuncture with Electrical Stimulation

Interventions

Real Acupuncture with Electrical StimulationOTHER

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.

Also known as: Verum Electroacupuncture, Traditional acupuncture needles, ITO® ES-130® electrical stimulator
Verum Electroacupuncture
Simulated Acupuncture with Electrical StimulationOTHER

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.

Also known as: Sham Electroacupuncture / Placebo Electroacupuncture, Sterile Acupuncture Needles, ITO® ES-130® electrical stimulator
Placebo Electroacupuncture

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Systems Neuroscience and Pain Lab (SNAPL)

Palo Alto, California, 94304, United States

Location

Related 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.

    PMID: 33107921BACKGROUND

MeSH Terms

Conditions

Back PainChronic Pain

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Instructor - Department of Anesthesia, Pain and Perioperative Medicine

Study Record Dates

First Submitted

July 15, 2016

First Posted

September 7, 2016

Study Start

July 1, 2016

Primary Completion

December 31, 2018

Study Completion

June 30, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)