Predicting Analgesic Response to Acupuncture: A Practical Approach

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Low Back Pain, Back Pain

Intervention / Treatment
-----------------
* Other: Real Acupuncture with Electrical Stimulation
* Other: Simulated Acupuncture with Electrical Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum Electroacupuncture<br>Active Intervention | Other: Real Acupuncture with Electrical Stimulation<br>* 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.<br>* Other names: ITO® ES-130® electrical stimulator;|
| Placebo Comparator: Placebo Electroacupuncture<br>Validated Control | Other: Simulated Acupuncture with Electrical Stimulation<br>* 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.<br>* Other names: ITO® ES-130® electrical stimulator;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Sensory Testing | Standardized response to noxious thermal and mechanical stimuli up to 120 seconds. | 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. | 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. | 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. | 1 month | 
| Blood pressure | Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds. | 1 day | 
| Heart Rate Variability | Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes. | 1 month | 
| Heart Rate Variability | Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes. | 1 month | 
| Heart Rate Variability | Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acupuncture, Back Pain, Chronic Pain