Central mechanisms of real and sham electroacupuncture in the treatment of chronic low back pain: study protocol for a randomized, placebo-controlled clinical trial

Jiang-Ti Kong, Brandon MacIsaac, Ruti Cogan, Amanda Ng, Christine Sze Wan Law, Joseph Helms, Rosa Schnyer, Nicholas Vasilis Karayannis, Ming-Chih Kao, Lu Tian, Beth D Darnall, James J Gross, Sean Mackey, Rachel Manber, Jiang-Ti Kong, Brandon MacIsaac, Ruti Cogan, Amanda Ng, Christine Sze Wan Law, Joseph Helms, Rosa Schnyer, Nicholas Vasilis Karayannis, Ming-Chih Kao, Lu Tian, Beth D Darnall, James J Gross, Sean Mackey, Rachel Manber

Abstract

Background: Chronic low back pain (CLBP) is the most common chronic pain condition and is often resistant to conventional treatments. Acupuncture is a popular alternative for treating CLBP but its mechanisms of action remain poorly understood. Evidence suggests that pain regulatory mechanisms (particularly the ascending and secondarily the descending pain modulatory pathways) and psychological mechanisms (e.g., expectations, pain catastrophizing and self-efficacy) may be involved in the pathogenesis of CLBP and its response to treatments. We will examine these mechanisms in the treatment of CLBP by electroacupuncture (EA).

Methods: We present the aims and methods of a placebo-controlled, participant-blinded and assessor-blinded mechanistic study. Adult patients with CLBP will be randomized to receiving 16 sessions of real (active) or sham (placebo) EA over the course of 8 weeks. The primary pain regulatory measure for which the study was powered is temporal summation (TS), which approximates ascending pain facilitation. Conditioned pain modulation (CPM), representing a descending pain modulatory pathway, will be our secondary pain regulatory measure. The primary psychological measure is expectations of benefit, and the secondary psychological measures are pain catastrophizing and self-efficacy in managing pain. Main clinical outcomes are back pain bothersomeness on a 0-100 visual analog scale (primary), Roland Morris Disability Questionnaire (secondary), and relevant items from the National Institutes of Health (NIH) Patient-Reported Outcome Measures Information System (secondary). We hypothesize that compared to sham, real EA will lead to greater reduction in TS after 8 treatment sessions (4 weeks); and that reduction in TS (and secondarily, increase in CPM) after 8 treatment sessions will mediate reduction in back pain bothersomeness from baseline to week 10 (clinical response) to EA. We also hypothesize that the three psychological factors are moderators of clinical response. With 100 treatment completers, the study is designed to have 80% power to detect a medium-sized between-group effect (d = 0.5) on temporal summation.

Discussion: To the best of our knowledge, this is the first appropriately powered, placebo-controlled clinical trial evaluating mechanisms of EA in the treatment of CLBP.

Trial registration: ClinicalTrials.gov, NCT02503475 . Registered on 15 July 15 2015. Retrospectively registered.

Keywords: Catastrophizing; Chronic; Conditioned pain modulation; Electrical acupuncture; Electroacupuncture; Expectation; Low back pain; PROMIS; Pressure pain threshold; Quantitative sensory testing; Self-efficacy; Sham acupuncture; Temporal summation.

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved for human subject research by the Stanford University IRB (reference number 22436) and undergoes routine review and resubmissions to the appropriate parties. This trial is registered with Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant timeline. EA, electroacupuncture. Participants are randomized to verum (real) or sham acupuncture
Fig. 2
Fig. 2
Standard protocol items: recommendation for interventional trials (SPIRIT) figure (required for study protocols). Wk, week; MINI, Mini International Neuropsychiatric Interview; QST, quantitative sensory testing; fMRI, functional magnetic resonance imaging

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