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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
121
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.
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.
Stanford Systems Neuroscience and Pain Lab (SNAPL)
Palo Alto, California, United States
Mean back pain intensity by patient-report
Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
Time frame: 7 days
Roland Morris Disability Questionnaire
Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.
Time frame: 1 day
Quantitative Sensory Testing
Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.
Time frame: Tests used are typically stable for 1-2 weeks
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
Blood pressure
Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.
Time frame: 1 day
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Heart Rate Variability
Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.
Time frame: 1 month
Heart Rate Variability
Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.
Time frame: 1 month
Heart Rate Variability
Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.
Time frame: 1 month