Clinical trial NCT02890810: Predicting Analgesic Response to Acupuncture: A Practical Approach
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Back Pain
Keywords: Acupuncture
Back Pain
Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-09-07
Enrollment: 121
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mean back pain intensity by patient-report
timeFrame: 7 days
measure: Roland Morris Disability Questionnaire
timeFrame: 1 day
Secondary outcomes:
measure: Quantitative Sensory Testing
timeFrame: Tests used are typically stable for 1-2 weeks
measure: Physical exam to determine neurological function
timeFrame: 1 month
measure: Physical exam to assess lumbar facet irritation.
timeFrame: 1 month
measure: Physical exam to assess lumbar spine range of motion
timeFrame: 1 month
measure: Blood pressure
timeFrame: 1 day
measure: Heart Rate Variability
timeFrame: 1 month
measure: Heart Rate Variability
timeFrame: 1 month
measure: Heart Rate Variability
timeFrame: 1 month
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Systems Neuroscience and Pain Lab (SNAPL)
state: California
Study officials:
References:
citation: 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.