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

Study Overview
=================
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.

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

Conditions
-----------------
Chronic Low-back Pain

Intervention / Treatment
-----------------
* Other: Swiss low back acupuncture (SLBA)
* Other: Standard acupuncture (SA)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Swiss low back acupuncture, chronic low back pain, Acupuncture, Standard acupuncture