Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890810
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : July 12, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Jiang-Ti Kong, Stanford University

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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Back Pain Other: Real Acupuncture with Electrical Stimulation Other: Simulated Acupuncture with Electrical Stimulation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Blood pressure [ Time Frame: 1 day ]
    Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.

  6. Heart Rate Variability [ Time Frame: 1 month ]
    Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.

  7. Heart Rate Variability [ Time Frame: 1 month ]
    Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.

  8. Heart Rate Variability [ Time Frame: 1 month ]
    Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02890810


Contacts
Layout table for location contacts
Contact: Jiang-Ti Kong, MD 650-497-0493 jtkong@stanford.edu
Contact: Chelcie Puetz, BS 650-724-8735 cpuetz@stanford.edu

Locations
Layout table for location information
United States, California
Stanford Systems Neuroscience and Pain Lab (SNAPL) Recruiting
Palo Alto, California, United States, 94304
Contact: Kristen Honesto, BS    650-723-1235    khonesto@stanford.edu   
Contact: Ratna Jalisatgi, MS    650-725-0450    rjalisat@stanford.edu   
Sponsors and Collaborators
Stanford University
National Center for Complementary and Integrative Health (NCCIH)

Layout table for additonal information
Responsible Party: Jiang-Ti Kong, Principal Investigator, Instructor - Department of Anesthesia, Pain and Perioperative Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02890810     History of Changes
Other Study ID Numbers: 34754
1K23AT008477-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jiang-Ti Kong, Stanford University:
Acupuncture
Back Pain
Chronic Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs