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

Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain. A Randomized, Controlled, Single-blind, Monocentric Clinical Study

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: Swiss low back acupuncture (SLBA); Other: Standard acupuncture (SA)

Detailed Description

Low back pain (LBP) is a common, widespread and multifaceted syndrome and represents one of the leading sources of years lived with disability. In Switzerland, patients with LBP generated mean annual costs of 467 million Euro in 2016 and 2017, respectively. Moreover, quantity of prescriptions per patient was reported to be 5 - 6 per year, causing pain medication costs of 4.7 million Euro. It is estimated that 20% of acute LBP can manifest as chronic LBP (CLBP), defined as pain lasting longer than three months. CLBP does not only negatively impact the quality of life, functional status, and working capability of those suffering, but also plays a pivotal role of the large annual health care costs for LBP in Switzerland and worldwide. Pharmacological therapies with at least a small magnitude of effect for pain relief in CLBP include non-steroidal anti-inflammatory drugs, opioids, Tramadol and antidepressants. Additionally, non-pharmacological therapies with at least a small magnitude of effect for pain relief in CLBP include exercise, motor control exercise, Yoga, mindfulness-based stress reduction, electromyography biofeedback, cognitive-behavioral therapy, multidisciplinary rehabilitation and acupuncture.

In this context and during the last decades and centuries, different acupuncture methods evolved, among others, the acupuncture method newly termed "Swiss low back acupuncture" (SLBA). The SLBA originates from Jiu Gong Points (九宫穴), which is the abbreviation for "Nine Spinal Points" (脊椎九宫穴). The particular sites of Jiu Gong Points were evolved from the eight trigrams and nine palaces square (Ba Gua Jiu Gong fang 八卦九宫方). The eight trigrams (Ba Gua 八卦) are a set of metaphysical and philosophical sigmas composed of three components of yin and yang, which are the essential concept of all-natural phenomena. Nine palaces (Jiu Gong, 九宫), an element of the eight trigrams, correspond to the nine regions in ancient China (Jiu Ye, 九野). They represent the four main (North=kidney; South=heart; East=liver; West=lung; Earth=spleen) and four secondary cardinal points and the earth as the center. In 825 patients with LBP due to lumbar herniated disc, it has been shown that hot needle acupuncture (热针) using Jiu Gong Points around the most significant lesion of the lumbar vertebrae results in good improvements of pain. The uncontrolled study reported a cure of LBP in 65.2% of cases and an improvement of clinical symptoms of 32.4%. Due to the positive report, the hot needle acupuncture using Jiu Gong Points has further evolved in Switzerland and might be a promising tool to treat CLBP, since the optimal method of acupuncture against CLBP remains to be elucidated. However, the efficacy of SLBA has never been quantitatively compared to SA and a randomized clinical trial is warranted to provide first robust evidence on its performance in CLBP.

Therefore, the purpose of this study is to conduct the first randomized clinical trial comparing SLBA and SA on pain relief in patients with CLBP.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Furian, PhD; Phone Number: + 41 079 403 75 86; Email: michael.furian@usz.ch

Study Locations

• Switzerland
  • Aargau
    • Bad Zurzach, Aargau, Switzerland, 5330
      • Recruiting
      • Swiss TCM UNI
      • Contact: Michael Furian, Phd; Phone Number: +41 78 209 81 42; Email: michael.furian@tcmuni.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• All participants who do not meet the above-mentioned inclusion criteria;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Swiss low back acupuncture group; Participants in this group will be treated with the Swiss low back acupuncture method.	Other: Swiss low back acupuncture (SLBA); 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).
Active Comparator: Standard acupuncture group; Participants in this group will be treated with the standard acupuncture method.	Other: Standard acupuncture (SA); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in biopsychosocial health and quality of life	The Short Form 36 will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).	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	The SCL-90 R. Scales of Anxiety (10 items), Depression (13 items), and Somatization (12 items) will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).	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	The score of the Oswestry Disability Index will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).	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	Pain severity score will be calculated from 3 items: Rate the severity of your current pain (now, at the moment).; How severe was your pain in the last week? (average); How much do you suffer from your pain? The total score will be transformed into 0 (maximal pain) to 100 points (no pain) by the following equation: 100 - (scored points)/18 ×100 MPI will be assessed at the start of the intervention (T1) and after completion of the last intervention (T2), as well as at follow-up (3 months after the end of intervention [T3] / 6 months after the end of intervention [T4]).	Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
Pain diary	Patients will be asked to complete a daily pain diary during the 9-weeks of acupuncture therapy (completed at the end of each day, before going to bed). In this diary, the patients will rate their perceived pain severity from 0 (none) to 5 (almost intolerable pain) during pre-defined periods of the day. Furthermore, drug intake related to pain relief will be documented.	During the 9 weeks of treatment with SLBA compared to SA therapy.

Collaborators and Investigators

• Sponsor: Li Yiming
• Collaborators: Swiss University for Traditional Chinese Medicine
• Investigators: Principal Investigator: Michael Furain, PhD, Swiss University for Traditional Chinese Medicine

Publications and helpful links

General Publications

• Vickers AJ, Vertosick EA, Lewith G, MacPherson H, Foster NE, Sherman KJ, Irnich D, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis. J Pain. 2018 May;19(5):455-474. doi: 10.1016/j.jpain.2017.11.005. Epub 2017 Dec 2.
• Kim J, Shin W. How to do random allocation (randomization). Clin Orthop Surg. 2014 Mar;6(1):103-9. doi: 10.4055/cios.2014.6.1.103. Epub 2014 Feb 14.
• Angst F, Verra ML, Lehmann S, Aeschlimann A. Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain. BMC Med Res Methodol. 2008 Apr 25;8:26. doi: 10.1186/1471-2288-8-26.
• Angst F, Verra ML, Lehmann S, Aeschlimann A, Angst J. Refined insights into the pain-depression association in chronic pain patients. Clin J Pain. 2008 Nov-Dec;24(9):808-16. doi: 10.1097/AJP.0b013e31817bcc5f.
• Benz T, Lehmann S, Elfering A, Sandor PS, Angst F. Comprehensiveness and validity of a multidimensional assessment in patients with chronic low back pain: a prospective cohort study. BMC Musculoskelet Disord. 2021 Mar 20;22(1):291. doi: 10.1186/s12891-021-04130-x.
• Chan MWC, Wu XY, Wu JCY, Wong SYS, Chung VCH. Safety of Acupuncture: Overview of Systematic Reviews. Sci Rep. 2017 Jun 13;7(1):3369. doi: 10.1038/s41598-017-03272-0.
• Hasenbring, M. (2004). Rückenschmerzen: Der Chronifizierung frühzeitig entgegenwirken. In Neuroorthopädie (pp. 13-21). Steinkopff. https://doi.org/10.1007/978-3-7985-1949-7_3
• Labots G, Jones A, de Visser SJ, Rissmann R, Burggraaf J. Gender differences in clinical registration trials: is there a real problem? Br J Clin Pharmacol. 2018 Apr;84(4):700-707. doi: 10.1111/bcp.13497. Epub 2018 Feb 12.
• Lee CP, Fu TS, Liu CY, Hung CI. Psychometric evaluation of the Oswestry Disability Index in patients with chronic low back pain: factor and Mokken analyses. Health Qual Life Outcomes. 2017 Oct 3;15(1):192. doi: 10.1186/s12955-017-0768-8.
• Leem J. Does acupuncture increase the risk of bleeding in patients taking warfarin? Integr Med Res. 2015 Jun;4(2):119-121. doi: 10.1016/j.imr.2015.04.001. Epub 2015 Apr 22. No abstract available.
• Mcculloch M, Nachat A, Schwartz J, Casella-Gordon V, Cook J. Acupuncture safety in patients receiving anticoagulants: a systematic review. Perm J. 2015 Winter;19(1):68-73. doi: 10.7812/TPP/14-057. Epub 2014 Nov 24.
• Mu J, Furlan AD, Lam WY, Hsu MY, Ning Z, Lao L. Acupuncture for chronic nonspecific low back pain. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD013814. doi: 10.1002/14651858.CD013814.
• Pignon JP, Arriagada R. Early stopping rules and long-term follow-up in phase III trials. Lung Cancer. 1994 Mar;10 Suppl 1:S151-9. doi: 10.1016/0169-5002(94)91677-2.
• Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
• Schmitz N, Hartkamp N, Kiuse J, Franke GH, Reister G, Tress W. The Symptom Check-List-90-R (SCL-90-R): a German validation study. Qual Life Res. 2000 Mar;9(2):185-93. doi: 10.1023/a:1008931926181.
• Witt CM, Pach D, Brinkhaus B, Wruck K, Tag B, Mank S, Willich SN. Safety of acupuncture: results of a prospective observational study with 229,230 patients and introduction of a medical information and consent form. Forsch Komplementmed. 2009 Apr;16(2):91-7. doi: 10.1159/000209315. Epub 2009 Apr 9.
• von der Heyde, R. (2007). Assessment of Functional Outcomes. In Fundamentals of Hand Therapy (pp. 98-113). Elsevier. https://doi.org/10.1016/B0-32-303386-5/50009-6
• Xiang Y, He JY, Tian HH, Cao BY, Li R. Evidence of efficacy of acupuncture in the management of low back pain: a systematic review and meta-analysis of randomised placebo- or sham-controlled trials. Acupunct Med. 2020 Feb;38(1):15-24. doi: 10.1136/acupmed-2017-011445. Epub 2019 Sep 16.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture; chronic low back pain; Standard acupuncture; Swiss low back acupuncture
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Study ID: TCM_AKU01/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with an academic interest in LBP. Data or samples shared will be coded, with no Protected Health Information included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
• IPD Sharing 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.
• IPD Sharing 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No