Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain

NCT05232487 | Unknown DMC

• 1 other identifier: Study ID: TCM_AKU01/2021
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is very common, widespread, and represents a multidimensional syndrome. It affects physical activity and function, health-related quality of life, and employment status. The lifetime prevalence of acute low back pain is approximately 80%. The prevalence of chronic low back pain (CLBP) in the general population is reported to be 8% to 21%. Several clinical trials have provided evidence to support the efficacy of acupuncture in the treatment of LBP, however, the optimal acupuncture treatment for CLBP has not been extensively studied.

Conditions

Chronic Low-back Pain

Keywords

chronic low back pain; Acupuncture; Standard acupuncture; Swiss low back acupuncture

Outcome Measures

Primary Outcomes (1)

• Pain Severeity rated by 11-Point Numerical Rating Scale

  Pain severity will be assessed by the 11-point numerical rating scale, ranging from 0 "No pain" to 10 "maximal pain".

  Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.

Secondary Outcomes (5)

• Changes in biopsychosocial health and quality of life

  Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.

• Changes in symptomatic distress

  Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.

• Changes in functional status and disability

  Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.

• Multidimensional Pain Inventory (MPI) - pain severity score

  Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.

• Pain diary

  During the 9 weeks of treatment with SLBA compared to SA therapy.

Study Arms (2)

Swiss low back acupuncture group

EXPERIMENTAL

Participants in this group will be treated with the Swiss low back acupuncture method.

Other: Swiss low back acupuncture (SLBA)

Standard acupuncture group

ACTIVE COMPARATOR

Participants in this group will be treated with the standard acupuncture method.

Other: Standard acupuncture (SA)

Interventions

Swiss low back acupuncture (SLBA) OTHER

Participants are placed in the prone position (if required with a pillow under the abdomen). Then acupuncture is applied to the back of the body. The treatment takes place for the duration of 9 weeks (2x per week from week 1 to 6 and 1x a week from week 7 to 9). One treatment session lasts about 50-60 minutes. Swiss low back pain acupuncture The SLBA method is a further developed method from the Jiu Gong acupuncture technique, also known as the Nine Palace-Points on the spine. The following acupuncture points will be used: LV3/ LV5, Tai Xi (Kl 3), Fe Yang (BL 58), Tai Chong (LR 3), Guang Ming (GB 37), Tai Xi (Kl 3) and Fe Yang (BL 58).

Swiss low back acupuncture group

Standard acupuncture (SA) OTHER

Participants are placed in the prone position (if required with a pillow under the abdomen). Then acupuncture is applied to the back of the body. The treatment takes place for the duration of 9 weeks (2x per week from week 1 to 6 and 1x a week from week 7 to 9). One treatment session lasts about 50-60 minutes. The SA method is described in the acupuncture textbook for TCM in China and all acupuncture points are selected based on TCM principles, international literature, and the opinion of national and international TCM experts. The following points have been selected: Ming Men (GV 4), Zhi Shi (BL 52), Tai Xi (KI 3) Yao Guan (GV 3), Guan Yuan Shu (BL 26), Ge Shu (BL 17), Ci Liao (BL 32), Wei Zhong (BL 40), Ji Zhong (GV 6), Yao Yang Guan (GV 3), Shen Shu (BL 23), Da Chang Shu (BL 25) and A-Shi points.

Standard acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male participants;
• Age between 18 and 75 years;
• Clinical diagnosis of CLBP with a disease duration of more than 3 months and an average pain intensity of minimally 4 points on a 11-point pain-numerical rating scale (pain-NRS) on the previous 7 days;
• Sufficient knowledge of German to complete the questionnaires.

You may not qualify if:

• History or known severe concomitant diseases (e.g. abdominal aortic aneurysm, heart disease, cancer, psychiatric disorders).
• Other causes of low back pain not related to the clinical diagnosis of CLBP including inflammatory, malignant, or autoimmune disease;
• Planned or previous back surgery within 6 months
• Use of corticosteroids and/or other pain-relieving drugs that act through the central nervous system;
• Initiation of another therapy for CLBP within the last 4 weeks, e.g. physiotherapy;
• Preceding acupuncture treatment for CLBP during the past 6 months;
• Pregnancy;
• Participation in another clinical trial.

Sponsors & Collaborators

• Li Yiming: lead
• Swiss University for Traditional Chinese Medicine: collaborator

Study Sites (1)

Swiss TCM UNI

Bad Zurzach, Canton of Aargau, 5330, Switzerland

RECRUITING

Related Publications (19)

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• Pradhan SK, Angst F, Xu J, Gantenbein AR, Lehmann S, Sandor PS, Li Y, Furian M. Comparison of Swiss versus Standard Acupuncture in Patients with Chronic Low Back Pain. A Study Protocol for a Randomized, Controlled, Single-Blind, Parallel Trial. J Pain Res. 2022 Dec 22;15:4055-4064. doi: 10.2147/JPR.S388558. eCollection 2022.

  PMID: 36579179 DERIVED

Study Officials

• Michael Furain, PhD

  Swiss University for Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Furian, PhD

CONTACT

+ 41 079 403 75 86; michael.furian@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized by using the web-based secuTrial randomization tool and by applying an allocation ratio of 1:1 to SLBA and SA therapy. Patients and data analysts will be blinded to the intervention (SLBA or SA), however, acupuncturists performing the acupuncture sessions will not be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Yiming Li, Prof. Dr. TCM univ. (CN) Dr. med.

Model Details: This study is a randomized, controlled, single-blind, parallel trial, allocating patients with CLBP 1:1 to either 9 weeks of SLBA or SA therapy.

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: February 9, 2022
• Study Start: January 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 12 months after article publication, and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact: michael.furian@usz.ch

Locations

CH (1)