Predicting Analgesic Response to Acupuncture: A Practical Approach
Completed · Not applicable · Has a placebo group
Conditions studied: Chronic Low Back Pain, Back Pain
In brief
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.
Key facts
- Study ID
- NCT02890810
- Run by
- Stanford University
- People needed
- 121
- Starts
- 2016-07-01
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2021-01-25
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Stanford Systems Neuroscience and Pain Lab (SNAPL) — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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