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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Experimental: Verum Electroacupuncture
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.
Placebo Comparator: Placebo Electroacupuncture
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.
- 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.
- 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.
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
|Contact: Jiang-Ti Kong, MDemail@example.com|
|Contact: Chelcie Puetz, BSfirstname.lastname@example.org|
|United States, California|
|Stanford Systems Neuroscience and Pain Lab (SNAPL)||Recruiting|
|Palo Alto, California, United States, 94304|
|Contact: Kristen Honesto, BS 650-723-1235 email@example.com|
|Contact: Ratna Jalisatgi, MS 650-725-0450 firstname.lastname@example.org|