World Federation of Acupuncture-Moxibustion Societies Clinical Practice Guideline on Acupuncture-Moxibustion: Non-Specific Low Back Pain recommendation summaries ☆

Abstract

Clinical Practice Guideline on Acupuncture and Moxibustion: Nonspecific low back pain was revised and released by the Standards Working Committee of World Federation of Acupuncture-Moxibustion Societies (WFAS) on October 9, 2023. This is the first clinical practice guideline (CPG) on acupuncture and moxibustion for nonspecific low back pain approved by an international academic organization, which provides the evidence-based recommendations and practical therapeutic protocols for international acupuncture practitioners. This CPG was developed by following Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology, and the Principles of the World Health Organization Handbook for Guideline Development. The guideline development group (GDG) from different countries, with different professions, played a critical role in the formulation of clinical questions, recommendations, and therapeutic protocols. Recommendations are the key content of a CPG and the direct answers to clinical questions. Hence, this article focuses on the recommendations of this CPG. The recommendations were formulated using the modified Delphi method and the GRADE grid rules, based on the updated systematic reviews of clinical evidence. A total of seven recommendations for ten clinical questions were formulated in this CPG, including one conditional recommendation for either the intervention or the comparison based on very low quality of evidence, and six conditional recommendations for the intervention based on very low quality of evidence.

Headnote

ABSTRACT

Clinical Practice Guideline on Acupuncture and Moxibustion: Nonspecific low back pain was revised and released by the Standards Working Committee of World Federation of Acupuncture-Moxibustion Societies (WFAS) on October 9, 2023. This is the first clinical practice guideline (CPG) on acupuncture and moxibustion for nonspecific low back pain approved by an international academic organization, which provides the evidence-based recommendations and practical therapeutic protocols for international acupuncture practitioners. This CPG was developed by following Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) methodology, and the Principles of the World Health Organization Handbook for Guideline Development. The guideline development group (GDG) from different countries, with different professions, played a critical role in the formulation of clinical questions, recommendations, and therapeutic protocols. Recommendations are the key content of a CPG and the direct answers to clinical questions. Hence, this article focuses on the recommendations of this CPG. The recommendations were formulated using the modified Delphi method and the GRADE grid rules, based on the updated systematic reviews of clinical evidence. A total of seven recommendations for ten clinical questions were formulated in this CPG, including one conditional recommendation for either the intervention or the comparison based on very low quality of evidence, and six conditional recommendations for the intervention based on very low quality of evidence.

Keywords:

Nonspecific low back pain

Acupuncture

Moxibustion

Clinical practice guideline

Recommendations

1. Introduction

Nonspecific low back pain (NSLBP) is defined as pain and discomfort below the costal margins, above the transverse gluteal line, and in the area between the midaxillary lines on both sides, with or without thigh-referred pain, of unknown aetiology, caused by the causes other than spine-specific disorders and radicular pain [1,2]. A study has reported that 90–95 % of patients with low back pain belong to NSLBP [3]. It is the leading cause of disability in the elderly [4]. Another Saskatchewan survey found that 84 % of people have experienced back problems at least once in their lives [5]. In conclusion, low back pain seriously affects people's daily lives. Therefore, it is necessary to use effective treatments to reduce the impact of it on people and society.

Acupuncture, a traditional Chinese medicine therapy, has been used for thousands of years to treat low back pain and has been well-trusted by the medical communities. Currently, European and American countries, as well as China, have developed various clinical guidelines for low back pain. However, most of them only describe whether acupuncture is recommended or not rather than mentioning the specific needling method. In 2014, the China Association of Acupuncture and Moxibustion published the first clinical practice guidelines for the treatment of low back pain with acupuncture [6], which recommended several different acupuncture therapies for acute and chronic low back pain to define the treatment schedule of acupuncture. Since its release, numerous clinics have followed its protocol and large numbers of clinical studies on acupuncture for low back pain have emerged. As time goes by, acupuncture practitioners and healthcare administrators have become more and more meticulous about acupuncture standards. Existing guidelines no longer meet their needs, and acupuncture's international recognition and application are increasing daily.

Based on the above, it is necessary to collect the latest evidence, using the WHO guidelines [7] as a model and fully consider the international applicability and demand to develop, for the first time, an international evidence-based clinical practice guideline for the treatment of NSLBP with acupuncture therapy.

The clinical practice guideline for acupuncture and moxibustion of NSLBP (hereinafter referred to as the guideline) was approved by the World Federation of Acupuncture-Moxibustion Societies (WFAS) on September 30, 2020, and has been finalized now. The complete edition of World Federation of AcupunctureMoxibustion Societies Clinical practice guideline on acupuncturemoxibustion: non-Specific low back pain was published as a book in 2024 by Standard Press of China. While, this article introduces the recommendation summaries and related issues by following the requirements of a journal article.

2. Methods

2.1. The participants

The participants in the consensus meeting were the members of the guideline development panel. The obstetriciansgynecologists and the patients with NSLBP in pregnancy were invited to a consensus session for the discussion of the clinical questions. None of these experts has a conflict of interest.

2.2. Definition of "consensus reached"

The working group uses the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) grid consensus rule [8] to reach consensus. The details are as follows:

1 For recommending or opposing an intervention (compared with a specific control measure), it requires at least 50 % of the participants should be for approval, and less than 20 % of them choose the control measure. A "conditionally recommended intervention or control" will be generated if this criterion is unmet.

2 If a recommendation is listed as strong rather than weak, it must be strongly recommended by at least 70 % of the participants.

2.3. Development of recommendations

After the panel in the guideline development group (GDG) had fully collected the evidences, the recommendations were generated through the consensus of the modified Delphi method. First, after thoroughly reading the evidence body of each clinical question (including the literature information table, risk of bias assessment table, summary of finding table, and evidence to decision framework[EtD]) and the consensus rules, the judgments were made around the twelve dimensions of the EtD framework, the recommended direction and strength of each clinical question were provided. The working group made statistics on the results of the first round of the modified Delphi survey on the EtD framework and recommendations. Second, the panel consensus meeting was held. The evidence body, consensus rules, and the statistical results of the first round of modified Delphi voting were introduced during the meeting, and panels discussed the framework of each clinical question. After a complete discussion, the panel voted again on the EtD framework and recommendations. Finally, the working group formed recommendations based on the results of the second round of the modified Delphi survey and the GRADE grid consensus rules. The general flow can be seen in Fig. 1.

2.4. Formulation of acupuncture treatment regimen

The guideline's acupuncture treatment protocols were determined by acupoint selection, manipulation, and stimulation methods in the studies with positive key outcomes, as well as the empirical evidences from the records in ancient books and the practice of acupuncture experts in the modern time.

The regimens that had positive key outcome indicators but had unclear or were not applicable for recommendation were not conductive to clinical regimens. Expert interviews were involved, and the recommended regimens were generated after expert consensus. If there was lack of literature supports, the acupuncture regimen based on expert experience would be adopted as an accessory one, and then the recommendation was generated through expert consensus.

After interviewed Su-yun LI by the guideline working group, the evidences from ancient books for this guideline were determined in terms of the scope and search terms of acupuncture and moxibustion for literature search. Mr. Jing-hua LI from Institute of Information on Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, was responsible for searching and selecting the evidences. The evidences of acupuncture-moxibustion experts in the modern time were determined through expert meetings organized by the guideline working group, and Institute of Information on traditional Chinese Medicine, China Academy of Chinese Medical Sciences, was responsible for retrieval and selection. The acupuncture treatment protocols included in this guideline were voted on by seven acupuncture experts.

3. Recommendations

A total of seven recommendations for ten clinical questions were formulated in this CPG (Table 1). No recommendations were made for the last three questions.

3.1. Clinical question 1

Is filiform needle therapy more effective than oral administration of western medicine for patients with acute/subacute NSLBP? (Filiform needle therapy includes: acupuncture or electroacupuncture; oral administration of western medicine includes: non-steroidal anti-inflammatory drugs, muscle relaxants)

3.1.1. Recommendation

For patients with acute/subacute non-specific low back pain, compared with oral administration of western medicine (nonsteroidal anti-inflammatory drugs, muscle relaxants), the filiform needle therapy is of the priority.

3.1.2. Remarks

A total of 14 studies [9-22] involving 5 outcomes were included in this question.

This opinion only applies to the comparison of filiform needle therapy with simple oral administration of western medicine, rather than that between acupuncture and compound western medicines.

The decision-making between patients and clinicians is needed when implementing this recommendation, especially considering the low certainty of evidence on benefit and differences in shortterm and long-term cost-effectiveness.

Special consultation is suggested for the patients with acute/subacute NSLBP combined with the following conditions, including thoracolumbar fractures, local infection of the thoracolumbar spine, e.g. lumbar tuberculosis; low back pain combined with acute aggravating neurological symptoms, e.g. decreased muscle strength of lower limbs, weakened or disappearing tendon re flex, reduced sensation in the perineum, abnormal urination or/and defecation function.

Motion-combined acupuncture is not recommended for the patients with severe lumbar disc prolapse, severe lumbar spondylolisthesis, lumbar space occupying, lumbar fracture, and severe osteoporosis.

Motion-combined acupuncture treatment is recommended for the patients with a course of illness ≤ 7days; this regimen is applicable for those with a course > 7days based on experts' decision.

3.1.3. Research priorities

It is considered that the studies in future should focus on the the effect and safety in comparison between filiform needle therapy and oral administration of western medicine among pregnant women or the elderly with acute or subacute NSLBP. In addition, clinical studies are required to improve the study design and quality.

3.1.4. Recommended treatment protocol

Protocol 1: Electroacupuncture on three special acupoints at the lumbar region combined with distal points

(1) Acupoints

Shenshu (BL23) (bilateral), Dachangshu (BL25) (bilateral), Weizhong (BL40) (bilateral), Ashi points(lumbosacral tenderness points).

(2) Manipulation

The conventional needling direction and depth were applicable. The positive and negative electrodes of the electroacupuncture therapeutic apparatus were attached after deqi, at the two pairs of acupoints on the affected side, BL23 and BL25, and BL40 and Ashi point. The electric stimulation was delivered at continuous wave, with a frequency of 20 Hz or less than it, and the intensity depending on the patient's tolerance and local muscle micro-vibration.

Reinforcing and reducing manipulation: Even needling technique was applicable.

Needle retention time: 20 to 30 min.

(3) Treatment frequency

It is suggested to be 3 treatments a week and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4) Treatment course

It is suggested to be 1 to 2 weeks and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

Protocol 2: Motion-combined acupuncture at Yaotongdian(EXUE7)

(1) Acupoint

EX-UE7. Location: On the dorsum of the hand, between the 2nd and 3rd and between the 4th and 5th metacarpal bones, at the midpoint of the line joining the distal dorsal wrist transverse crease and the metacarpophalangeal joint, including 2 acupoints.

(2) Manipulation

Perpendicularly insertion is used at the acupoint, 0.2 to 0.5 cun in depth. Reducing technique by lifting-thrusting needle is operated in a small range. The patient may feel the needling sensation, e.g. soreness or distension, can be spread to the whole hand.

Needle retention time: 20 to 30 min.

Lumbar movement of patient while the delivery of acupuncture:

In a standing position, during needling and needle retention at the distal acupoints, the lumbar movement is operated in combination, including lumbar extension to four directions and in a small range; and lumbar rotation at 360° starting from the free of movement side, going round to the motion limitation side, and the rotation amplitude increases gradually and accordingly.

(3) Treatment frequencyIt is suggested to be about 3 treatments a week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4) Treatment courseIt is suggested to be 1 week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(5) Notice

The acupuncture stimulation intensity should increase gradually according to the patient's tolerance to prevent fainting during acupuncture.

3.2. Clinical question 2

Is filiform needle therapy more effective than other nonpharmacological treatments for patients with acute/subacute NSLBP? (Filiform needle therapy includes: acupuncture or electroacupuncture; non-pharmacological treatment includes physical therapy, bed rest, or tuina)

3.2.1. Recommendation

For patients with acute or subacute non-specific low back pain, compared with other non-pharmacological treatments (physical therapy, bed rest, tuina), filiform needle therapy is prioritized.

3.2.2. Remarks

A total of 9 studies[23-31] involving 3 outcomes were included in this question.

When implementing this recommendation, especially considering the various cost and the very low certainty of evidence on benefit, the decision should be co-determined between patients and clinicians.

Special consultation is suggested for the patients with acute/subacute NSLBP combined with the following conditions, including thoracolumbar fractures, local infection of the thoracolumbar spine, e.g. lumbar tuberculosis; low back pain combined with acute aggravating neurological symptoms, e.g. decreased muscle strength of lower limbs, weakened or disappearing tendon reflex, reduced sensation in the perineum, abnormal urination or/and defecation function.

3.2.3. Research priorities

Regarding the lack of the evidences for the safety, high-quality research should be undertaken to assess the safety of filiform needle therapy compared with non-pharmacological therapy for acute or subacute NSLBP. In the future, the studies should focus on the effect and safety in comparison before filiform needle therapy and non-pharmacological therapy in treatment of pregnant women or the elderly with acute or subacute NSLBP. The Health economic studies should be conducted in terms of health economic and long-term effect in the future in comparison between filiform needle therapy and non-pharmacological therapy for the patients with acute/subacute NSLBP. In addition, clinical studies are considered for the improvement of the study design and quality.

3.2.4. Recommended treatment protocol

(1) Acupoints

BL23 (bilateral), Mingmen (GV4), Yaoyangguan (GV3), BL25 (bilateral), BL40 (bilateral), Ashi (lumbosacral tenderness point)

(2) Manipulation

Same to the conventional needling direction and depth.

Reinforcing and reducing manipulation: lifting, thrusting, and twirling of needle should be applied slowly and evenly until deqi. Needle retention time: 20 to 30 min.

(3) Treatment frequency

It is suggested to be about 3 times a week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4) Treatment course

It is suggested to be 1 to 2 weeks, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

3.3. Clinical question 3

Is the comprehensive therapy of acupuncture more effective than oral western medicine for patients with acute/subacute NSLBP? (Comprehensive therapy of acupuncture includes: acupuncture plus moxibustion, acupuncture plus cupping, acupuncture plus moxibustion and cupping; oral western medicine includes: non-steroidal anti-inflammatory drugs, muscle relaxants)

3.3.1. Recommendations

For patients with acute/subacute non-specific low back pain, compared with oral western medicine (non-steroidal anti-inflammatory drugs, muscle relaxants), the comprehensive therapy of acupuncture is recommended in priority.

3.3.2. Remarks

It was found through systematic search that no evidence was directly consistent with this clinical problem. Therefore, we analyzed the RCT literature of the patients with acute lumbar sprain [32] so as to collect the indirect evidences.

When implementing this recommendation, the decision should be co-determined between patients and clinicians, especially in terms of very low-quality indirect evidence and expert experience, the impacts of low certainty of indirect evidence on benefit, and differences in short-term and long-term cost-effectiveness.

Special consultation is suggested for the patients with acute/subacute NSLBP combined with the following conditions, including thoracolumbar fractures, local infection of the thoracolumbar spine, e.g. lumbar tuberculosis; low back pain combined with acute aggravating neurological symptoms, e.g. decreased muscle strength of lower limbs, weakened or disappearing tendon reflex, reduced sensation in the perineum, abnormal urination or/and defecation function.

The accessibility of moxibustion and patients' acceptability of moxibustion should be considered. Smoke exhaust facility should be applied in the setting where moxibustion is implemented.

3.3.3. Research priorities

It is recommended that high-quality evidence research should be undertaken to assess the effectiveness and safety of the comprehensive therapy of acupuncture versus oral western medications when treating patients with acute or subacute NSLBP; health economic studies be conducted in the future to compare acupuncture combination therapy with oral western medications for patients with acute or subacute NSLBP. In addition, clinical studies are considered for the improvement of the study design and quality.

3.3.4. Recommended treatment protocol (This treatment protocol applies to cold-dampness type)

(1) Acupoints

Main acupoints: BL23 (bilateral), GV3, BL40 (bilateral), BL25 (bilateral), Guanyuanshu (BL26) (bilateral), Ashi (lumbosacral tenderness point).

Cupping acupoints: BL23, BL25, Ashi (lumbosacral tenderness point).

Moxibustion acupoints: BL23, GV3, BL25, BL26 (bilateral).

(2) Acupuncture and moxibustion manipulation

At Weizhong(BL40), with Cheng's Sancai method used [33,34], perpendicular needling is adopted for a depth of 1.2 to 1.5 cun, vibrating technique is used to promote deqi, and whirling the needle is to achive the reinforcing. The other points are stimulated with conventional needling direction and depth, and even needling technique is applied. Additionally, suspending moxibustion, with one end of moxa stick ignited is delivered over the acupoints, 2–3 cm far from the skin. The duration of moxibustion is 10–20 min until the skin turns warm and red, avoiding burning. Moxibustion can be applied during needle retention. After needle withdrawal, cupping is followed in the lumbar region where the acupoints are located.

Retention time of needles: 20 to 30 min. Retention time of cups: about 5 min.

(3) Treatment frequency

It is suggested to be about 3 times a week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4) Treatment course

It is suggested to be 1 to 2 weeks, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

3.4. Clinical question 4

Is the comprehensive therapy of acupuncture more effective than other non-pharmacological treatments for patients with acute/subacute NSLBP? (Comprehensive therapy of acupuncture includes acupuncture plus moxibustion, acupuncture plus cupping, acupuncture plus moxibustion and cupping; other nonpharmacological treatments include: tuina)

3.4.1. Recommendation

For patients with acute/subacute NSLBP, compared with other non-pharmacological treatments (tuina), the comprehensive therapy of acupuncture is recommended in priority

3.4.2. Remarks

It was found through systematic search that no evidence was directly consistent with this clinical problem. Therefore, we analyzed the RCT literature of the patients with acute, subacute and chronic disorders [35] so as to collect the indirect evidences.

When implementing this recommendation, the decision should be co-determined between patients and clinicians, especially in terms of very low-quality indirect evidence and expert experience, the impacts of low certainty of indirect evidence on benefit, and differences in short-term and long-term cost-effectiveness.

Special consultation is suggested for the patients with acute/subacute NSLBP combined with the following conditions, including thoracolumbar fractures, local infection of the thoracolumbar spine, e.g. lumbar tuberculosis; low back pain combined with acute aggravating neurological symptoms, e.g. decreased muscle strength of lower limbs, weakened or disappearing tendon reflex, reduced sensation in the perineum, abnormal urination or/and defecation function.

It is necessary to consider the accessibility of moxibustion therapy and patients' acceptability of moxibustion therapy. Smoke exhaust facility should be applied in the setting where moxibustion is implemented.

3.4.3. Research priorities

It is recommended that high-quality evidence research should be undertaken to assess the effectiveness and safety of the comprehensive therapy of acupuncture versus other nonpharmacological therapies when treating acute or subacute NSLBP in patients. In future, the studies should focus on the comparion of the efficacy and safety between acupuncture combination therapy and other non-pharmacological therapies in treatment of the elderly with acute or subacute NSLBP. The studies on health economics studies should be conducted in comparison between acupuncture combination therapy and other non-pharmacological therapies for patients with acute or subacute NSLBP. In addition, clinical studies are considered for the improvement of the study design and quality.

3.4.4. Recommended treatment protocol

(1) Acupoints

Main acupoints: BL23 (bilateral), BL26 (bilateral), GV4, GV43, Zhishi (BL52) (bilateral), Jiaji (EX-B2) (bilateral), Zhibian (BL54) (bilateral) and BL40 (bilateral).

Supplementary acupoints: Cold-dampness type, kidney deficiency type: Baihui (GV20), Dazhui (GV14), Shenzhu (GV12), Zhiyang (GV9), Sanyinjiao (SP6) (bilateral), Taixi (Kl3) (bilateral). Blood stasis type: Geshu (BL17) (bilateral), Xuehai (SP10) (bilateral), Fengshi (GB31), Yanglingquan (GB34), Fenglong (ST40), Zusanli(ST36).

Comprehensive method: Moxibustion with moxa burner can be applied on the lumbar region. For acute low back pain, the oblique insertion of needle is used at Cuanzhu (BL2) (bilateral), towards the upward along the meridian, and the movement acupuncture therapy is delivered before the other acupoints are stimulated.

(2) Manipulation

Oblique needling is often used at the acupoints located on the lumbar region, with the needle towards the downward along the meridian, the needle tip slightly towards the spine, 1 cun to 1.2 cun in depth. The conventional direction and depth of acupuncture is delivered at the other points. In moxibustion, two sections of moxa stick, with a length of about 1 cun are ignited and put in a moxa burner at the lumbosacral region, for about 15 to 20 min.

Reinforcing and reducing manipulation: Deficiency syndrome is treated with a reinforcing or even reinforcing-reducing method, and the excess syndrome is with a reducing or even reinforcingreducing method.

Needle retention time: 20 to 30 min.

(3) Treatment frequency

It is suggested to be about 2 to 3 times a week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4) Treatment course

It is suggested to be 1 to 2 weeks, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(5) Precautions

Moxibustion is delivered until the skin turned to be warm and red, avoiding skin burns.

3.5. Clinical question 5

Is the comprehensive therapy of acupuncture more effective than filiform needle therapy for the patients with acute/subacute NSLBP? (Comprehensive therapy of acupuncture includes: acupuncture plus moxibustion, acupuncture plus cupping, acupuncture plus moxibustion and cupping; filiform needle therapy includes: acupuncture or electroacupuncture)

3.5.1. Recommendations

For patients with acute/subacute NSLBP, the comprehensive therapy of acupuncture and filiform needle therapy are recommended.

3.5.2. Remarks

It was found through systematic search that no evidence was directly consistent with this clinical problem. Therefore, we analyzed the RCT literature of the patients with acute, subacute and chronic disorders [36] so as to collect the indirect evidences.

When implementing this recommendation, the decision should be co-determined between patients and clinicians, especially in terms of very low-quality indirect evidence and expert experience, the impacts of low certainty of indirect evidence on benefit, and differences in short-term and long-term cost-effectiveness.

Special consultation is suggested for the patients with acute/subacute NSLBP combined with the following conditions, including thoracolumbar fractures, local infection of the thoracolumbar spine, e.g. lumbar tuberculosis; low back pain combined with acute aggravating neurological symptoms, e.g. decreased muscle strength of lower limbs, weakened or disappearing tendon reflex, reduced sensation in the perineum, abnormal urination or/and defecation function.

The accessibility of moxibustion and patients' acceptability of moxibustion should be considered. Smoke exhaust facility should be applied in the setting where moxibustion is implemented.

3.5.3. Research priorities

It is recommended that high-quality evidence research should be be undertaken to assess the effectiveness and safety of the comprehensive therapy of acupuncture versus filiform needle therapy when treating patients with acute or subacute NSLBP, as well as in terms of health economics studies. In addition, clinical studies are considered for the improvement of the study design and quality.

3.6. Clinical question 6

Is filiform needle therapy more effective than other nonpharmacological treatments for the patients with chronic NSLBP? (Filiform needle therapy includes acupuncture or electroacupuncture; non-pharmacological treatments include tuina, core stability training, or physical therapy plus exercise).

3.6.1. Recommendations

For patients with chronic NSLBP, compared with other nonpharmacological treatments (tuina, physical therapy plus exercise, and core stability training), filiform needle therapy is prioritized.

3.6.2. Remarks

A total of 3 studies [37-39] involving 3 outcomes were included for this question. When implementing this recommendation, the decision should be co-made between patients and clinicians, especially considering the impacts of the very low certainty of evidence, and difference in the short term and long term cost-benefit.

Special consultation is suggested for the patients with acute/subacute NSLBP combined with the following conditions, including thoracolumbar fractures, local infection of the thoracolumbar spine, e.g. lumbar tuberculosis; low back pain combined with acute aggravating neurological symptoms, e.g. decreased muscle strength of lower limbs, weakened or disappearing tendon reflex, reduced sensation in the perineum, abnormal urination or/and defecation function.

3.6.3. Research priorities

In terms of the safty and for pregnant women and the elderly suffering from chronic non-specific low back pain, clinical studies should be followed in comparison of filiform needle therapy with non-pharmacological treatments. For the patients with chronic NSLBP, the studies should be conducted to compare the outcomes of health economics between filiform needle therapy and non-pharmacological treatments, as well as the effect. In addition, clinical studies are considered for the improvement of the study design and quality.

3.6.4. Recommended treatment protocol

(1) Acupoints

Main acupoints: BL23 (bilateral), BL40 (bilateral), Kunlun (BL60) (bilateral), Kl3 (bilateral).

Supplementary acupoints:

1 Nearby acupoints: Ashi (lumbosacral tenderness point).

2 Acupoints selected according to the location of pain: For back pain: adding the acupoints of bladder meridian of foot-taiyang (Dachangshu [BL25], Guanyuanshu [BL26]); for the pain on the lateral side of the lubmar region: adding the acupoints of gallbladder meridian of foot-shaoyang (Fengshi [GB31], Yanglingqun [GB34]); for pain radiating to the anterior of the lower limbs: adding the acupoints of stomach meridian of foot-yangming (Biguan [ST31], Futu [ST32])

3 Acupoints selected according to syndrome differentiation: Add GV4 for kidney yang deficiency, Fuliu (KT7) for kidney yin deficiency, add GB34 (bilateral) and Pishu (BL20) (bilateral) for colddamp syndrome, and BL17 (bilateral) for blood stagnation.

(2) Manipulation

Acupoints are punctured with the conventional direction and depth, and manipulated until deqi.

Needle retention time: 20 to 30 min.

(3) Treatment frequency

It is suggested to be about 2 times a week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4) Treatment course

It is suggested to be 2 to 4 weeks, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

3.7. Clinical question 7

Is acupuncture combination therapy more effective than filiform needle therapy for patients with chronic NSLBP? (Comprehensive therapy of acupuncture includes acupuncture plus moxibustion, acupuncture plus cupping, or acupuncture plus moxibustion and cupping; filiform needle therapy includes acupuncture or electroacupuncture)

3.7.1. Recommendations

For the patients with chronic NSLBP, compared with filiform needle therapy, the comprehensive therapy of acupuncture is recommended in priority

3.7.2. Remarks

One study [40], involving 2 outcomes, was included for this question. When implementing this recommendation, the decision should be co-made between patients and clinicians, especially considering the impacts of the very low certainty of evidence, and difference in the short term and long term cost-benefit.

The acceptability of moxibustion therapy in different countries and patients should be considered. Smoke exhaust facility should be applied in the setting where moxibustion is implemented.

For the patients with temperature sensation disturbance, moxibustion should be carried out cautiously.

3.7.3. Research priorities

It is recommended that high-quality evidence research should be undertaken to assess the effectiveness and safety of the comprehensive therapy of acupuncture in comparison with filiform needle treatment when treating chronic NSLBP in patients, as well as the exploration on health economics. In addition, clinical studies are considered for the improvement of the study design and quality.

3.7.4. Recommended treatment protocol

(1) Acupoints

Acupoints of cold-dampness type: BL23 (bilateral), GV3, BL25 (bilateral), BL26 (bilateral), BL40 (bilateral).

Acupoints of kidney deficiency type: BL23 (bilateral), GV3, GV4, BL40 (bilateral), BL52 (bilateral), Kl3 (bilateral).

(2) Manipulation

Cold-dampness type: For BL40, Cheng's Sancai method should be used. Perpendicular needling at Dicai for a depth of 1.2 to 1.5 cun, shaking the needle to promote deqi. The other points were operated according to the conventional acupuncture direction and depth, even reinforcing and reducing manipulation. A moxa stick should be ignited and suspended on the acupoints[BL23 (bilateral), GV3, BL25 (bilateral), BL26 (bilateral)] for 2 to 3 cm above the skin, the time should be 10 to 20 min.

Kidney deficiency type: For BL40, Cheng's Sancai method should be used. Perpendicular needling at Dicai for a depth of 1.2 to 1.5 cun, shaking the needle to promote deqi. For BL52, Cheng's Sancai method should be used. Perpendicular needling at Dicai for a depth of 1.2 to 1.5 cun, shaking the needle to promote deqi. For Kl3, Cheng's Sancai method should be used. Perpendicular needling at Rencai for a depth of 0.3 cun to 0.6 cun, shaking the needle to promote deqi. The other points were operated according to the conventional acupuncture direction and depth, even reinforcing and reducing manipulation. A moxa stick should be ignited and suspended on the acupoints[BL23 (bilateral), GV3, GV4] for 2–3 cm above the skin, the time should be 10–20 min.

Reinforcing and reducing manipulation: Please refer to the reference for specific operations [33,34]

Needle retention time: 20 to 30 minutes.

(3) Treatment frequency

It is suggested to be about 2 times a week, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(4)Treatment course

It is suggested to be 2 to 4 weeks, and co-decided by the doctor and patient according to the improvements in illness and the delivery of treatment.

(5) Precautions

Moxibustion is delivered until the skin turned to be warm and red, avoiding skin burns.

3.8. Clinical question 8

What is the effect and safety of acupuncture for pregnant women with NSLBP?

3.8.1. Recommendations

No consensus was made for recommendation.

3.8.2. Explanation

After investigated by the working group, the reasons for failure of consensus are as follows.

Acupuncture treatment For the pregnant women with nonspecific low back pain, acupuncture should be delivered cautiously and the risk of safety may be induced if the acupoints are not selected properly, as well as the manipulation.

The treatment protocol varies greatly. It is recommended that acupoints on the abdomen should not be used in the process of acupuncture (12/13, 92.31 %) if acupuncture is considered after the communication between doctor and patient. The consensus was not reached by the panel on whether lumbosacral or distal special the acupoints on the lumbosacral region or the specific distal ones (such as SP6 and LI4) can be used. If these acupoints should be used accordingly, shallow acupuncture is recommened (12/13,92.31 %).

Acupuncture operators are different in the clinical experience. If the decision is co-made by the doctor and patient for acupuncture treatment, the following criteria should be met for the operators:1 being qualified for the senior or the superior medical license (12/13, 92.31 %);2 more than 5 years of clinical experience (10/13, 76.92 %); and3 clinical experience in obstetrics and pregnancy (12/13, 92.31 %).

The materinity of pregnant women is complicated. If the decision is co-made by the doctor and patient for acupuncture treatment, the following criteria should be met for pregnant women:1 no symptoms of threatened abortion (10/13, 76.92 %);2 no severe complications (9/13, 69.23 %); and3 no consensus on the course of pregnancy.

3.9. Question 9 and question 10

Question 9: What frequency acupuncture treatment should be recommended first for the patients with acute/subacute NSLBP? (1 time, 2 times, 3 times or more times per week)

Question 10: What frequency of acupuncture treatment should be recommended first for the patients with chronic NSLBP? (1 time, 2 times, or more times per week)

Recommendations

No consensus was made for recommendation.

4. Conclusions

This guideline was developed based on available clinical evidences, the characteristics of acupuncture and the current international demands for acupuncture treatment of NSLBP and clinical questions, with GRADE adopted and WFAS guideline formulation process followed. With consideration of international applicability, this guideline was developed to provide the best solutions for clinicians, medical researchers, and medical policymakers in different countries and regions. However, there are many limitations. First of all, based on the clinical needs of the target users, the clinical questions and recommendations developed in this guideline are only focused on the most concerned interventions (filiform needle therapy and acupuncture combination therapy). Other effective acupuncture methods for NSLBP, e.g. moxibustion, cupping and auricular point pressing have not been involved. Besides, the panel of this guideline was composed of the experts from China, Switzerland, Japan, Korea, Canada and New Zealand. The experts from more countries should be invited to update this guideline in future. Last but not least, the clinical questions were formed based on the results of questionaire of clinical demands, but there were lack of literature supports for some questions, especially the high-quality literature. It is suggested that the higher-quality clinical studies should be conducted according to these clinical questions in the future to provide the more evidences for acupuncture practitioners and solve the clinical demands.

Acknowledgement

d suggestions on the CPG. The clinical questions, recommendations, and specific treatment protocols were formulated according to the consensus of the GDG members[ Hong-guang DONG (University of Geneva, Geneva, Switzerland); Xiao-ming WANG (Teikyo Heisei University, Tokyo, Japan); Nam Dong-woo(Medical School of Kyung Hee University, Seoul, South Korea), Wu LIN (Athlete Health Sports Medical Center, Toronto, Canada); Shi-hui ZHAO(Yan' s Chinese Medicine, Auckland, New Zealand); Zhi-sun LIU(Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China); Jin-xiu DUAN (Fangzhuang Community Health Service Center, Fengtai District, Beijing, China); Yu-tong FEI(Beijing University of Chinese Medicine, Beijing, China); Li-min XIE(Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China); Xu CHEN(Chinese PLA General Hospital, Beijing, China); Yin-qiu GAO(Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China); Cui MA(Guanganmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China)]. The author also would like to appreciate patient representative Ms. JIANG.

CRediT authorship contribution statement

Xiao-xu LIU: Conceptualization, Methodology, Validation, Writing – original draft, Writing – review & editing. Ying-ying GUO: Conceptualization, Methodology, Visualization, Validation, Writing – original draft, Writing – review & editing. Yu-tong FEI: Conceptualization, Methodology, Writing – review & editing, Supervision. Man HUANG: Validation, Writing – original draft, Writing – review & editing. Yong-ming YE: Validation, Writing – original draft, Writing – review & editing. Jin-na YU: Conceptualization, Methodology, Writing – review & editing. Hui-ze LIN: Data curation, Formal analysis, Software. Wen-xi YAN: Data curation, Formal analysis, Software. Lan-ping LIU: Data curation, Formal analysis, Software. Ke-xin ZHU: Data curation, Formal analysis, Software. Jun LIANG: Conceptualization, Methodology, Validation, Writing – original draft, Writing – review & editing, Supervision. Tao YANG: Conceptualization, Methodology, Validation, Writing – original draft, Writing – review & editing, Funding acquisition, Supervision.

Role of the funder/sponsor

The research was financially funded by the National Key R&D Program of China (No. 2019YFC1712200; 2019YFC1712203). The funder is the Ministry of Science and Technology of the People's Republic of China. This funding supports the collection, management and analyses of data. The funder is not involved in any other aspect of the project, such as the design of the project's protocol and analysis plan, the collection and analyses. The funder will have no input on the interpretation or publication of the study results.

Declaration of competing interest

The authors declare that there is no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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ARTICLE INFO

Article history:

Received 1 March 2024

Revised 30 April 2024

Accepted 3 June 2024

Available online 10 July 2024

Footnote

☆ Supported by the National Key Research and Development Program of China: 2019YFC1712200; 2019YFC1712203.

* Corresponding authors.

E-mail addresses: [email protected] (J. LIANG), [email protected] (T. YANG).

1 These authors contributed equally to this work.

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