Journal of Pain Research (Dec 2022)
Comparison of Swiss versus Standard Acupuncture in Patients with Chronic Low Back Pain. A Study Protocol for a Randomized, Controlled, Single-Blind, Parallel Trial
Abstract
Saroj K Pradhan,1– 3 Felix Angst,2 Jie Xu,1,3 Andreas R Gantenbein,4 Susanne Lehmann,2 Peter S Sandor,4 Yiming Li,1– 3 Michael Furian1 1Research Department, Swiss University of Traditional Chinese Medicine, Bad Zurzach, Switzerland; 2Research Department, Rehaklinik Bad Zurzach, Bad Zurzach, Switzerland; 3TCM Ming Dao, Bad Zurzach, Switzerland; 4Neurorehabilitation & Research Department, Rehaklinik Bad Zurzach, Bad Zurzach, SwitzerlandCorrespondence: Michael Furian, Swiss University of Traditional Chinese Medicine, Langwiesstrasse 7, Bad Zurzach, 5330, Switzerland, Tel +41 79 403 75 86, Email [email protected]: Chronic low back pain (CLBP) cannot sufficiently be treated by pharmacological therapy and generates substantial health-care costs worldwide. Acupuncture, a cost-effective, safe and non-pharmacological therapy, has shown promising results in relieving acute low back pain; however, the optimal acupuncture therapy for CLBP remains controversial. This study will compare two acupuncture methods for pain relief in CLBP.Methods and Analysis: This randomized, controlled, single-blind, parallel trial will be conducted in patients with clinically diagnosed CLBP with a disease duration ≥ 3 months and an average pain intensity of ≥ 4 points on an 11-point Pain Intensity Numerical Rating Scale (pain-NRS) on the previous 7 days. Patients will be randomized to 9-week acupuncture therapy using Jiu Gong Points (termed Swiss low back acupuncture, SLBA) or standard acupuncture (SA) therapy (weeks 1– 6: two sessions/week, weeks 7– 9: one session/week, 15 sessions/patient in total). Measurements will be conducted before the first session (T1), at the end of the 9-week therapy (T2) and after 3- and 6-month follow-up (T3 and T4). The primary hypothesis is that 9 weeks of SLBA will be superior in reducing the pain severity assessed by the pain-NRS compared to SA therapy for CLBP. Secondary outcomes will be derived from the Short-Form 36, Oswestry Disability Index, Multidimensional Pain Inventory questionnaire, Symptom Checklist-90 – Revised questionnaire and a daily pain diary. Assuming a minimal clinically important difference in the pain-NRS of 0.39 and an effect size of ≥ 0.6 between SLBA and SA, 80% power, 0.05 alpha level and 20% dropouts, a total of 55 patients/arm will be required. The primary outcome will be analyzed in the intention-to-treat population using chained linear regression models. Patients, outcome assessors and data analysts will be blinded to the treatment arm.Trial Registration: Clinicaltrials.gov Identifier: NCT05232487.Keywords: Chinese medicine, chronic disease, pain, Pain Intensity Numerical Rating Scale, Multidimensional Pain Inventory, Oswestry Disability Index, Randomized clinical trial
