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Predicting Analgesic Response to Acupuncture: A Practical Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890810
Recruitment Status : Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jiang-Ti Kong, Stanford University

Tracking Information
First Submitted Date  ICMJE July 15, 2016
First Posted Date  ICMJE September 7, 2016
Last Update Posted Date November 8, 2019
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
  • Mean back pain intensity by patient-report [ Time Frame: 7 days ]
    Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
  • Roland Morris Disability Questionnaire [ Time Frame: 1 day ]
    Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2016)
  • Quantitative Sensory Testing [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 1 month ]
    Physical exam assessing range of motion in lumbar spine (measured in degrees) in up to 5 minutes.
  • Blood pressure [ Time Frame: 1 day ]
    Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.
  • Heart Rate Variability [ Time Frame: 1 month ]
    Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.
  • Heart Rate Variability [ Time Frame: 1 month ]
    Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.
  • Heart Rate Variability [ Time Frame: 1 month ]
    Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Predicting Analgesic Response to Acupuncture: A Practical Approach
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Low Back Pain
  • Back Pain
Intervention  ICMJE
  • 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
  • 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:
    • Sham Electroacupuncture / Placebo Electroacupuncture
    • Sterile Acupuncture Needles
    • ITO® ES-130® electrical stimulator
Study Arms  ICMJE
  • Experimental: Verum Electroacupuncture
    Active Intervention
    Intervention: Other: Real Acupuncture with Electrical Stimulation
  • Placebo Comparator: Placebo Electroacupuncture
    Validated Control
    Intervention: Other: Simulated Acupuncture with Electrical Stimulation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 6, 2019)
121
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2016)
100
Estimated Study Completion Date  ICMJE June 30, 2020
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02890810
Other Study ID Numbers  ICMJE 34754
1K23AT008477-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jiang-Ti Kong, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP