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

Li Yiming

Status: Enrolling

Conditions: Chronic Low-back Pain

Treatments: Other: Swiss low back acupuncture (SLBA); Other: Standard acupuncture (SA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05232487

Study ID: TCM_AKU01/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 2 patient groups

Swiss low back acupuncture group

Experimental group

Description:

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

Treatment:

Other: Swiss low back acupuncture (SLBA)

Standard acupuncture group

Active Comparator group

Description:

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

Treatment:

Other: Standard acupuncture (SA)