Effects of acupuncture and mindfulness-based stress reduction for chronic non-specific low back pain: study protocol for a 2×2 factorial randomised controlled trial

Abstract

Background

Chronic non-specific low back pain (CNLBP) is a multifactorial disease involving physical dysfunction and psychological distress. Acupuncture and mindfulness-based stress reduction (MBSR) are two non-pharmacological therapies recommended by guidelines, which have been proven effective in improving the clinical symptoms of CNLBP. However, the efficacy of their combined use has yet to be explored. This study aims to explore whether the combination of acupuncture and MBSR would have different synergistic effects in patients with CNLBP compared with acupuncture or MBSR alone.

Methods and analysis

This protocol describes a randomised controlled trial with a 2×2 factorial design involving 120 CNLBP patients. Participants will be randomly allocated to four groups: (1) acupuncture, (2) MBSR, (3) acupuncture combined with MBSR, and (4) health education. The intervention period is 6 weeks. The outcome measurements will include the Visual Analogue Scale (VAS), Tactile Acuity Test, Short-form of McGill Pain Questionnairethe(SF-MPQ); Roland-Morris Functional Disability Questionnaire (RMDQ), Oswestry Disability Index(ODI), the Five Facet Mindfulness Questionnaire (FFMQ), the 21-item Depression Anxiety Stress Scales (DASS-21), the Regulatory Self-Efficacy Scale (RESE), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS);Pain Sensitivity Questionnaire(PSQ); Pittsburgh Sleep Quality Index(PSQI). All evaluations will be conducted at the baseline stage as well as 6 weeks and 4 months after the implementation of the intervention measures.

Ethics and dissemination

Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine (2024KY-041-04). The results of the study will be disseminated through peer-reviewed publications and at scientific conferences.

Trial registration number

ITMCTR2025000764.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study adopts a 2×2 factorial randomised controlled design, enabling estimation of both main effects and interaction effects between acupuncture and mindfulness-based stress reduction.

• Standardised intervention protocols and concealed allocation are used to reduce selection bias and enhance internal validity.

• Outcome assessors and data analysts are blinded to group allocation, minimising detection and analysis bias.

• Multiple validated patient-reported outcome measures are employed to capture pain, functional and psychosocial dimensions of chronic non-specific low back pain.

• Blinding of participants is not feasible due to the nature of the interventions, which may introduce performance and expectation bias.

Introduction

Chronic non-specific low back pain (CNLBP) is a complex disease influenced by multiple factors. As a common type of chronic low back pain in clinical practice, it accounts for approximately 80%–90% of all chronic low back pain cases, imposing a substantial burden on individuals and society.1,3 It is characterised by persistent pain in the lower back region for more than 12 weeks, without a specific identifiable cause such as spinal pathology or systemic disease.^{4 5} CNLBP often leads to functional limitations, reduced quality of life, psychological problems and increased healthcare utilisation.^{6 7} Current clinical guidelines emphasise non-pharmaceutical treatment methods, including drug intervention and physical therapy, which have shown limited efficacy in providing long-term remission and improving functional outcomes for patients with CNLBP.^{8 9} Despite this, the evidence regarding the combined non-pharmaceutical strategy remains limited. Acupuncture and mindfulness-based stress reduction (MBSR) therapy, as two non-pharmacological treatment methods recommended by the guidelines,¹⁰ have proven effective in improving the clinical symptoms of CNLBP.^{11 12}

In recent years, numerous studies have confirmed the clinical efficacy of acupuncture in treating chronic low back pain. Acupuncture, by stimulating specific acupoints, can induce rhythmic contractions and relaxations of local muscle fibres, promoting local microcirculation and the clearance of metabolic products, thereby alleviating muscle stiffness and pain sensitivity.13,15 Studies have shown that compared with sham acupuncture, acupuncture not only alleviates the pain distress of patients with chronic low back pain but also significantly improves their physical functions.^{16 17} O'Neill et al¹⁸ found that the pain scores of patients with chronic low back pain after acupuncture significantly decreased, and their tactile sensitivity in the waist and lumbar flexion range of motion increased. In addition, a meta-analysis¹⁹ showed that compared with the control group, acupuncture could significantly improve pain and physical dysfunction in the short term; compared with conventional care, acupuncture treatment could improve function and significantly enhance the quality of life.

MBSR is a comprehensive physical and mental intervention method centred on mindfulness breathing, body scanning, mindfulness stretching and mindfulness walking. It has become one of the recommended treatment options for chronic low back pain.^{10 20 21} MBSR can enhance attention control, reduce mind-wandering and alleviate emotional dysregulation.²² Pei et al²³ found that MBSR can effectively alleviate the depressive mood of patients with chronic low back pain and improve their mindfulness levels. Ploutarchou et al²⁴ discovered that MBSR can improve the pain scores of patients with chronic low back pain as well as their levels of depression, anxiety and pain catastrophisation. Meta-analysis²⁵ indicates that MBSR, as an adjunctive treatment for chronic low back pain, may bring long-term clinical benefits. Thus, it can be seen that MBSR demonstrates sustained efficacy in improving the clinical symptoms of chronic low back pain and is an effective choice for treating it.

However, although existing studies have confirmed the clinical efficacy of acupuncture and MBSR, there is still limited evidence regarding the combined therapeutic effect of the two in improving the clinical symptoms of CNLBP, or the potential interaction between them. Therefore, acupuncture combined with MBSR may offer a new treatment option for improving pain, functional disorders and psychosocial symptoms in patients with CNLBP. Acupuncture mainly acts on the physical dimension by relieving pain, improving spinal range of motion and restoring musculoskeletal function, and there is already evidence to support its rapid and short-term effects.26,28 In contrast, MBSR targets the psychological and behavioural dimensions of pain by reducing stress, alleviating anxiety and depression, and enhancing coping strategies.^{29 30} Its benefits usually require continuous practice to accumulate. Combining these two therapies may offer broader and more lasting improvements, addressing both the physical and psychological aspects of chronic non-specific low back pain, and promoting long-term recovery through a ‘mind-body integration’ approach.

To verify this hypothesis, we designed a 2×2 factorial randomised controlled trial to evaluate the individual and combined effects of acupuncture and MBSR on pain, function and related psychosocial outcomes. The main objective is to determine whether combined intervention brings more superior improvement effects than individual intervention.

Methods and analysis

Patient and public involvement

Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Trial design

An RCT with a 2×2 factorial design will be used to evaluate the clinical effectiveness of acupuncture combined with MBSR in patients with CNLBP. A total of 120 eligible participants will be randomly divided into the following four groups: (1) acupuncture, (2) MBSR, (3) acupuncture combined with MBSR and (4) health education. A flow diagram of this trial is presented in figure 1, and the enrolment, intervention and assessment schedules for this study are shown in table 1/figure 2. The Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine (FJTCM) (2024KY-041-04) approved the trial. The trial is registered at International Traditional Medicine Clinical Trial Registry (ITMCTR2025000764).

Figure 1. CONSORT flow chart of study design. CONSORT, Consolidated Standards of Reporting Trials; MBSR, mindfulness-based stress reduction.

Table 1. Schedule of enrolment, interventions and assessments.

Timepoint	Study period
	Enrolment	Allocation	Intervention	Outcome assessment
	Week −2-(−1)	Week 0	Week 1–6	Week 7	Month 4
Enrolment
Eligibility screen	×
Informed consent	×
Allocation		×
Interventions
Acupuncture group			×
MBSR group			×
Acupuncture combined with MBSR group			×
Health education group			×
Assessments
Baseline characteristics	×
Tactile Acuity Test	×			×
VAS	×			×	×
SF-MPQ	×			×	×
RMDQ	×			×	×
ODI	×			×	×
FFMQ	×			×	×
DASS-21	×			×	×
RESE	×			×	×
BDI-II	×			×	×
BAI	×			×	×
FABQ	×			×	×
PCS	×			×	×
PSQ	×			×	×
PSQI	×			×	×
Adverse events			×
Reasons for drop-out and withdrawals			×

BAI, Beck Anxiety Inventory; BDI, Beck Depression Inventory; DASS-21, 21-item Depression Anxiety Stress Scales; FABQ, Fear-Avoidance Beliefs Questionnaire; FFMQ, Five Facet Mindfulness Questionnaire; MBSR, mindfulness-based stress reduction; ODI, Oswestry Disability Index; PCS, Pain Catastrophizing Scale; PSQ, Pain Sensitivity Questionnaire; PSQI, Pittsburgh Sleep Quality Index; RESE, Regulatory Self-Efficacy Scale; RMDQ, Roland-Morris Disability Questionnaire; SF-MPQ, Short-form of McGill Pain Questionnaire; VAS, Visual Analogue Scale.

Figure 2. Timeline of enrolment, interventions and assessments. BAI, Beck Anxiety Inventory; BDI-II, Beck Depression Inventory; DASS-21, Depression Anxiety Stress Scales-21; FABQ, Fear-Avoidance Beliefs Questionnaire; FFMQ, Five Facet Mindfulness Questionnaire; ODI, Oswestry Disability Index; PCS, Pain Catastrophizing Scale; PSQ, Pain Sensitivity Questionnaire; PSQI, Pittsburgh Sleep Quality Index; RESE, Regulatory Self-Efficacy Scale; RMDQ, Roland-Morris Disability Questionnaire; SF-MPQ, Short-form of McGill Pain Questionnaire; VAS, Visual Analogue Scale.

Sample size

The sample size calculation for this study uses the Visual Analogue Scale (VAS) as the primary outcome measure to assess symptom improvement in patients with CNLBP. Preliminary data from our previous pilot experiment mean VAS scores of 2.25±1.24 for the intervention group and 3.67±2.09 for the control group. These values were entered into G*Power version 3.1.9.2 to determine the sample size. Using a two-tailed test with a significance level (α) of 0.05, a power (1 - β) of 0.80 and an effect size of 0.83—each group requires 24 participants. To account for an anticipated dropout rate of 20%, the sample size was adjusted to 30 participants per group, resulting in a total of 120 participants across four study groups.

Participants

Diagnostic criteria

CNLBP will be determined using the consensus on the assessment and treatment of chronic non-specific low back pain established by the Chinese Pain Research Association:³ it refers to pain and discomfort in the area below the rib cage, above the gluteal fold, and between the mid-axillary lines on both sides, caused by unknown reasons, lasting more than 12 weeks, excluding spinal-specific diseases and radicular pain. It may also involve pain in the thighs above the knee.

Inclusion criteria

Ages between 18 years and 70 years; (2) right-handed (determined by the Edinburgh Handedness Inventory); (3) at least one episode in the past 2 weeks; (4) average VAS score for the lower back in the past 7 days ≥3 and <7; (5) the subject agrees to participate in this study and signs an informed consent form.

Exclusion criteria

Pregnant or breastfeeding women; (2) history of spinal fractures, surgeries, cancer, severe osteoporosis, infections, dislocations or severe trauma; (3) history of alcohol or substance abuse, mental disorders, or family history of such disorders; (4) systemic, degenerative or neurological diseases; (5) claustrophobia or metal implants contraindicated for Magnetic Resonance Imaging (MRI); (6) received medication or rehabilitation therapy in the past 2 weeks; (7) allergies to medical alcohol, coupling agents, tape or electrode patches; (8) participating in other clinical trials that may affect the study outcomes; (9) Beck Depression Inventory (BDI-II) score >14.

Recruitment and screening

The recruitment will be conducted at the outpatient department of the Fujian University of Traditional Chinese Medicine Rehabilitation Hospital and in the surrounding communities of the Fujian University of Traditional Chinese Medicine Pingshan Campus. Participants aged 18–70 were recruited through social media advertisements (WeChat and QQ) and flyers advertised at community centres and medical institutions. Interested participants contacted the recruitment staff by phone, after which professional assessors conducted detailed medical history collection and physical examinations. Screening was performed based on diagnostic criteria, inclusion criteria and exclusion criteria. Eligible participants will be provided with specific information about the trial. Patients who participate in this study will provide written informed consent and will be informed that they can withdraw anytime during the trial.

Randomisation and allocation concealment, and blinding

Participants will be sequentially randomised into four groups (acupuncture, MBSR, acupuncture combined with MBSR, health education) using block randomisation with alternating block sizes of 6 and 8. The randomisation sequence will be generated in R (v12.0) with the blockrand package (v1.5), using a fixed random seed (2024) to ensure reproducibility. Allocation concealment will be maintained through sequentially numbered opaque sealed envelopes, opened only after baseline data collection. Investigators performing outcome assessments will be blinded to group assignments throughout the study.

In this study, a single-blind method was adopted to blind the outcome evaluators and the statistical analysts. The groups were denoted by letters A, B, C and D. The blind cover was set using the SPSS 25.0 software, and a password was set for the blind cover file, which was then kept by the random sequence custodian. After the final data statistical analysis was completed, the blind was lifted by the random sequence custodian.

Reasons for dropout and withdrawals

The reasons for dropouts and withdrawals could be as follows: (1) if a serious adverse event or complications occur, the participant should not continue in the experiment and should be considered for withdrawal from the study and (2) participants may withdraw from the trial by themselves.

Intervention

After the baseline data collection was completed, all groups will simultaneously commence a 6-week intervention

Acupuncture combined with MBSR group

The acupuncture treatment will last for 6 weeks, with 3 sessions of 30-min treatments each week. The locations of the selected acupoints are illustrated in figure 3. The main acupoints selected include Shenshu (BL23) and Weizhong (BL40), with supplementary points including Dachangshu (BL25), Ashi points (tender points in the lumbosacral region), and Huatuojiaji points (L1-L5). All points will be located according to the ‘WHO Standard Acupuncture Point Locations.³¹’ Licensed acupuncturists with medical qualifications will perform the treatments using Huatuo brand disposable sterile acupuncture needles (specifications: 0.3×40 mm, 0.3×60 mm and 0.3×75 mm). Acupuncturists will instruct patients to lie in a prone position, disinfect the target areas with sterile forceps and cotton balls soaked in 75% alcohol, and then apply acupuncture techniques to ensure the achievement of ‘De Qi’ sensation (a comprehensive feeling including soreness, numbness, distension, heaviness and other sensations), which is considered an essential component of acupuncture efficacy.

Figure 3. Locations of acupoints. Shenshu (BL23): On the back, 1.5 cun lateral to the lower border of the spinous process of the second lumbar vertebra. Dachangshu (BL25): On the back, 1.5 cun lateral to the lower border of the spinous process of the fourth lumbar vertebra. Huatuojiaji points (L1–L5): On both sides of the spine, 0.5 cun lateral to the lower border of the spinous processes of the first to fifth lumbar vertebrae. Ashi points: Tender points located in the lumbar region, selected according to individual pain distribution. Weizhong (BL40): On the posterior aspect of the knee, at the midpoint of the transverse crease of the popliteal fossa, between the tendons of biceps femoris and semitendinosus.

The MBSR will last for 6 weeks, with 2.5 hours of sessions per week. A standardised mindfulness meditation programme will be implemented according to the protocol of Wells et al.³² It will include mindfulness meditation guidance and group discussion for reflection. Participants will complete formal mindfulness practice assignments every day (30 min, 5 days a week), such as body scans and mindfulness breathing exercises, as well as informal mindfulness practice (15 min, 5 days a week), integrating awareness into daily activities.

Acupuncture group

The acupuncture group will receive the same acupuncture treatment as the combined intervention group, three times a week, for a total of 6 weeks.

MBSR group

The MBSR group will receive the same mindfulness training as the combined intervention group, once a week, for a total of 6 weeks.

Health education group

Participants will receive health education once a week for a total of 6 weeks.

Outcome assessment

This study will evaluate various indicators, including baseline data, primary and secondary outcomes. Baseline data will include participants’ age, sex, occupation, education level and medical history. The study period is 6 weeks, with outcomes assessed at baseline and after the 6-week intervention. A follow-up visit will be conducted 4 months after the completion of the intervention assessment. All outcomes will be measured by experienced evaluators who will be blinded to group allocation.

Primary outcomes

VAS^{33 34}: a 10-point sliding scale marked with 10 levels, measuring 10 centimeters in length, will be used. The scale ranges from ‘0’ at one end (indicating no pain) to ‘10’ at the other end (representing the most severe, unbearable pain). Participants will indicate the intensity of their pain by placing a mark on this continuum.

Secondary outcomes

Short Form McGill Pain Questionnaire (SF-MPQ)^{35 36}: SF-MPQ is comprised of three subscales, with higher total scores indicating more severe pain. The components of the SF-MPQ include: (1) Pain Rating Index (PRI), which consists of 11 sensory pain items (Sensory Pain Score, PRI-S) and 4 affective pain items (Affective Pain Score, PRI-A), scored from 0 (no pain) to 3 (severe pain); (2) VAS records patients' self-reported pain intensity; and (3) Present Pain Intensity (PPI), categorized into six levels of pain: none, mild discomfort, discomfort, distress, awful pain, and excruciating pain, scored as 0, 1, 2, 3, 4, and 5, respectively.

Tactile Acuity Test: In this study, three complementary tests—Two-Point Discrimination (TPD), Point-to-Point Perception (PTP) and Tactile Point Estimation (TPE)—will be employed to evaluate tactile acuity in the lumbar region using calibrated callipers. All assessments will be conducted with participants in a prone position. Each measurement will be performed in triplicate, and the mean value will be recorded.

TPD Test³⁷：Place the tips of the calliper on the test area until the skin blanches. Gradually increase the distance between the two calliper tips starting from 20 mm until the subject perceives two distinct points, and record the corresponding distance. Then, progressively decrease the separation until the subject reports feeling a single point, again noting the distance between the tips. This procedure is repeated three times, and the average value is calculated. A lower TPD value indicates superior composite sensory acuity.

PTP Test³⁸：The examiner placed one end of the vernier calliper on the test site until the skin blanched, then removed the calliper. The subject was asked to indicate the stimulated point with a pen, and the distance between the stimulated point and the indicated point was measured using a tape measure. This procedure was repeated three times, and the average value was calculated. A lower PTP value indicates a higher level of composite sensory acuity.

TPE Test³⁹：Two vernier callipers were employed, one for the tester and one for the subject. The tester set the distance between the two tips of the calliper to 120 mm and then applied the stimulus to the test area until the skin blanched, after which the calliper was removed. The subject was instructed to manually adjust the upper slider of the calliper on the reverse side (where the distance scale and electronic display were not visible) to estimate the perceived distance. The absolute difference between the 120 mm reference distance and the subject’s estimated distance was calculated. This procedure was repeated three times, and the average value was taken.

Roland-Morris Disability Questionnaire (RMDQ)^{40 41}: The RMDQ is a 24-item self-report questionnaire that assesses functional disability in individuals with low back pain. Each item is rated as either present (1) or absent (0). The total score ranges from 0 to 24, with higher scores indicating greater disability. It focuses on activities of daily living and the impact of low back pain on physical functioning.

Oswestry Disability Index (ODI)^{42 43}: The ODI is a 10-item questionnaire designed to measure disability in individuals with low back pain. Each item is rated on a 6-point scale ranging from 0 (no disability) to 5 (maximum disability). The total score ranges from 0 to 50, with higher scores indicating greater disability. It assesses various aspects of daily living, such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, travelling and employment.

Five Facet Mindfulness Questionnaire (FFMQ)^{44 45}: The FFMQ is a 39-item self-report measure designed to assess individual levels of mindfulness across five dimensions: Observing, Describing, Acting with Awareness, Non-judging of Inner Experience and Non-reactivity to Inner Experience. Each item is rated on a 5-point Likert scale ranging from 1 (‘never or very rarely true’) to 5 (‘very often or always true’). Higher total scores indicate a greater level of dispositional mindfulness.

Depression Anxiety Stress Scales-21 (DASS-21)^{46 47}: The DASS-21 is a 21-item self-report instrument developed to measure the negative emotional states of depression, anxiety and stress. It comprises three subscales, each containing seven items. Respondents rate how much each statement applied to them over the past week using a 4-point scale (0=Did not apply to me at all, 3=Applied to me very much or most of the time). Higher scores indicate greater severity of the emotional state.

Regulatory Self-Efficacy Scale (RESE)^{48 49}: The RESE assesses individuals’ self-efficacy in regulating positive and negative affective states. It consists of 12 items rated on a 5-point Likert scale (1=Not well at all, 5=Very well). The scale includes two subdimensions: perceived ability to manage negative affect (eg, anxiety, irritability, sadness) and to express positive affect (eg, joy, enthusiasm). Higher scores indicate stronger emotional self-regulation efficacy.

BDI-II^{50 51}: The BDI-II is a 21-item self-report measure that assesses the presence and severity of depressive symptoms. Each item is rated on a 4-point scale ranging from 0 to 3, with higher scores indicating more severe depression. The total score ranges from 0 to 63. It covers cognitive, affective and somatic aspects of depression.

Beck Anxiety Inventory (BAI)^{52 53}: The BAI is a 21-item self-report questionnaire designed to measure the severity of anxiety symptoms. Each item is rated on a 4-point scale ranging from 0 (not at all) to 3 (severely). The total score ranges from 0 to 63, with higher scores indicating more severe anxiety. It assesses both physical and psychological symptoms of anxiety.

Fear-Avoidance Beliefs Questionnaire (FABQ)^{54 55}: The FABQ is a 16-item questionnaire that assesses fear-avoidance beliefs related to work and physical activity. It consists of two subscales: the Work subscale (seven items) and the Physical Activity subscale (nine items). Each item is rated on a 7-point scale ranging from 0 (strongly disagree) to 6 (strongly agree). Higher scores indicate stronger fear-avoidance beliefs.

Pain Catastrophizing Scale (PCS)^{56 57}: The PCS is a 13-item self-report questionnaire that measures the tendency to catastrophise pain. Each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (always). The total score ranges from 0 to 52, with higher scores indicating a greater tendency towards pain catastrophising. It assesses three subscales: Rumination, Magnification and Helplessness.

Pain Sensitivity Questionnaire (PSQ)^{58 59}: The PSQ consists of 17 items, each describing a specific aspect of daily life. Participants are required to indicate the level of pain associated with each situation using a numerical rating scale from 0 (no pain) to 10 (worst pain).

Pittsburgh Sleep Quality Index (PSQI)^{60 61}: The PSQI consists of 19 individual items, which are aggregated into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored on a 0–3 scale, yielding a global PSQI score ranging from 0 to 21, with higher scores indicating poorer sleep quality.

Patient safety

During the study, accidental injuries and sudden illnesses will be recorded as adverse events (AE), and classified as mild, moderate or severe. A serious AE (SAE) is defined as an event that results in death, is life-threatening, requires hospitalisation or causes persistent significant disability. SAEs and AEs will be reported to the ethics committee. Researchers will record the degree of symptoms, time of occurrence, duration and treatment measures in the case report form (CRF) and evaluate their correlation with intervention training.

Statistical analysis

This study employed SPSS 25.0 statistical software. The statistical analysis of each indicator was conducted by statisticians who were not informed of the experimental group allocation. All statistical tests are two-sided with a significance level of α= 0.05. A significance level of 95% (two-sided alpha, p<0.05) will be used.

Outcome analysis of all allocated participants will be performed on an intention-to-treat basis or per-protocol analysis, and missing data will be imputed using multiple imputation methods. SPSS 25.0 software will be used to conduct all statistical tests. Continuous variables will be described as mean and SD or median and IQR, and categorical variables will be described as frequencies and percentages (%).

The normality of data will be checked using the Kolmogorov-Smirnov test. Data will be analysed using analysis of variance (assuming normal distribution) or the Kruskal-Wallis test (non-parametric). Intragroup comparisons (changes in the VAS, SF-MPQ, RMDQ, ODI, FFMQ, DASS-21, RESE, TPD, PTP, TPE, BDI-II, BAI, FABQ, PCS, PSQ, PSQI scores at baseline and after treatment) will be performed using paired t-tests. A 2×2 factorial analysis of variance will evaluate the statistical significance of differences observed between groups. This test will examine the main and interaction effects of the two interventions (acupuncture and MBSR).

Patient and public involvement

No patients or public were involved in this study.

Trial status

The current research plan version is 4.0, which was registered on 21 March 2025. This research project will be conducted from January 2025 to December 2028. The participant recruitment plan will be carried out from April 2025 to March 2026.

Ethics and dissemination

All procedures will be performed in accordance with the Declaration of Helsinki. Ethical approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of FJTCM (2024KY-041-04).

All researchers in this study will receive anonymous copies of all data to disseminate the study results. The results will be disseminated through peer-reviewed publications and conferences.

Before being included in the study, all eligible participants will receive detailed oral and written explanations regarding the purpose of the study, the study procedures, potential risks and benefits, data confidentiality and the rights as a study participant. Before any procedures related to the study are carried out, all participants will be required to provide written informed consent. Participants will be clearly informed that their participation is entirely voluntary and that they can withdraw from the study at any time without any adverse impact on their future medical care or other rights. The template of the participant’s informed consent form is provided as online supplemental material 1.

The potential risks associated with the study interventions are considered minimal. Acupuncture may cause transient discomfort, minor pain, bruising or dizziness, while MBSR may occasionally lead to temporary emotional discomfort during practice. All adverse events will be monitored throughout the study, documented systematically and managed appropriately by qualified clinical staff when necessary.

The information of the participants will be strictly confidential. All collected data will be anonymised using a unique research identification code and securely stored on password-protected devices, accessible only to authorised members of the research team. Personal identification information will not be disclosed in any publications or presentations based on this study.

The results of this study will be disseminated through peer-reviewed journal publications and academic conferences.

Discussion

CNLBP is a complex disease influenced by multiple factors. It has a prolonged course, a high recurrence rate and strong disability, causing significant burdens on both individual health and the social economy. Traditional treatments mostly focus on drugs or physical means, which have limited therapeutic effects and are difficult to maintain in the long term. This study aims to evaluate the efficacy and potential interactions of acupuncture, MBSR and their combined intervention in patients with CNLBP through a 2×2 factorial randomised controlled trial. Taking VAS as the primary outcome and combining secondary outcome indicators such as dysfunction, emotional state and mindfulness level, the efficacy of acupuncture combined with MBSR in improving the symptoms and functions of CNLBP was explored.

This study adopted a 2×2 factorial randomised controlled design, which could simultaneously evaluate the main effects and their interactions of acupuncture and MBSR, thereby enhancing statistical power under a smaller sample size and providing a comparison of the relative and combined effects of the two interventions. Second, this study strictly implemented randomisation and blinding control. The allocation sequence was generated by independent statisticians and kept confidential. Both the result evaluators and the data analysts maintained blinding to reduce allocation and measurement bias. In addition, this study evaluated multidimensional outcome indicators including pain intensity, functional impairment and emotional state, which can comprehensively reflect the intervention effect.

Although this study has certain advantages, its limitations still need to be noted. First, due to the intervention characteristics of acupuncture and MBSR, it is difficult to implement blinding for the participants, which may introduce performance bias and reporting bias. Specifically, the participants’ expectations and personal preferences for acupuncture or mindfulness training may affect their subjective assessment, causing the scale results to deviate from the true therapeutic effect. It may also affect their subjective assessment of pain and function, causing the scale results to deviate from the true therapeutic effect. Moreover, the lack of participant blinding may also affect the behavioural performance during the trial. For example, participants with higher beliefs in MBSR may invest more effort in family mindfulness practice; some participants may also use additional self-management strategies or pain-relieving drugs during the study. At the same time, communication among participants may lead to some intervention-related information or behaviours being adopted in different study groups, thereby weakening the intervention differences between groups. The communication among participants may also lead to the dissemination of intervention information among different study groups, thereby potentially causing inter-group contamination.

To reduce the above-mentioned result deviations, this study has taken several measures. First, standardised information will be uniformly provided during the recruitment and screening of participants, emphasising that all intervention measures may have potential benefits, in order to minimise the impact of expectation differences. Second, the result evaluators and statisticians will maintain a blind status regarding the group allocation to reduce bias in the evaluation and analysis stages. Moreover, during the entire research process, the WeChat programme will be used to monitor and record the intervention compliance of participants. The statistical analysis will be based on the intention-to-treat principle and sensitivity analyses will be conducted in appropriate circumstances to assess the robustness of the results.

Even with the implementation of the aforementioned control measures, residual effects related to the participants’ expectations still cannot be completely avoided. Therefore, caution is necessary when interpreting the research results. Additionally, although the compliance of the intervention was monitored through the WeChat programme, there may still be individual differences in the intensity of family practice, which could affect the dose-response relationship of the intervention, especially in the case of MBSR. On the other hand, this study adopted a single-centre design and had a limited planned sample size, which to some extent may limit the generalisability of the results. It is still necessary to further verify the robustness of the study results in larger sample size, multicentre and longer follow-up time studies in the future.

The results of this study may have significant clinical significance. If the results show that both acupuncture and MBSR can effectively relieve pain and improve function, it will further verify the clinical value of multidimensional non-pharmaceutical intervention in the management of CNLBP. If the combination of the two interventions shows a superior effect than a single therapy, it can provide a basis for future combined treatment models. Correlation analysis among different outcome indicators may also reveal the potential mechanism relationship between pain relief and mood improvement, as well as attention regulation.

Future research should explore the long-term effects of the combined use of acupuncture and MBSR, including follow-up assessments after a 6-week intervention period. By studying the neurobiological mechanisms through advanced imaging techniques (such as MRI and Electroencephalogram), the ways in which these interventions regulate pain perception and emotional regulation can be further clarified. Additionally, multicentre trials targeting different populations will enhance the external validity of the research results and facilitate the translation of the research into clinical practice.