Clinical trial NCT05232487: Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain
Official title: Comparison of Swiss Versus Standard Low Back Acupuncture in Patients With Chronic Low Back Pain. A Randomized, Controlled, Single-blind, Monocentric Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: chronic low back pain
Acupuncture
Standard acupuncture
Swiss low back acupuncture
Lead sponsor: TCM Ming Dao
Sponsor class: OTHER
Collaborators: name: Swiss University for Traditional Chinese Medicine
First posted: 2022-02-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Severeity rated by 11-Point Numerical Rating Scale
timeFrame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
Secondary outcomes:
measure: Changes in biopsychosocial health and quality of life
timeFrame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
measure: Changes in symptomatic distress
timeFrame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
measure: Changes in functional status and disability
timeFrame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy; after 3 and 6 months follow-up.
measure: Multidimensional Pain Inventory (MPI) - pain severity score
timeFrame: Difference in change between 9 weeks of treatment with SLBA compared to SA therapy.
measure: Pain diary
timeFrame: During the 9 weeks of treatment with SLBA compared to SA therapy.
Other outcomes:
Locations:
city: Bad Zurzach
country: Switzerland
facility: Swiss TCM UNI
state: Aargau
Study officials:
affiliation: Swiss University for Traditional Chinese Medicine
name: Michael Furain, PhD
role: PRINCIPAL_INVESTIGATOR
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