Effectiveness of remote graded motor imagery therapy for patients with central sensitisation low back pain: study protocol for a randomised controlled trial

Abstract

Introduction

Chronic low back pain (CLBP) is a prevalent global condition that significantly impairs quality of life, reduces work productivity and imposes substantial healthcare burdens. Approximately 70% of adults worldwide experience at least one episode of low back pain during their lifetime. Central sensitisation, a common complexity of CLBP, involves heightened responsiveness of the central nervous system, resulting in amplified neural signalling and increased pain sensitivity. This phenomenon suggests that pain in CLBP extends beyond purely biomedical origins, involving multiple factors such as neural adaptation. Graded Motor Imagery (GMI) is a progressive, exercise-based therapeutic approach designed to retrain the brain’s representation of the body and has shown promise in managing pain associated with central sensitisation.

Methods and analysis

This randomised controlled trial aims to assess the efficacy of remote GMI therapy compared with conventional in-clinic therapy in CLBP patients exhibiting pain sensitisation. Adults aged 20–50 years with persistent low back pain for at least 6 months will be included. Exclusion criteria comprise significant spinal pathology, recent spinal surgery, severe mental disorders, other major chronic pain conditions, high baseline pain levels (Visual Analogue Scale, VAS >7), neurological motor disorders and pregnancy. Eligible participants will be randomised into either an online therapy group or a control group. The online therapy group will engage in GMI exercises using the ‘Recognise’ app, encompassing tasks such as left/right discrimination, explicit motor imagery and mirror therapy, performed twice daily for 10 min each. The control group will participate in equivalent exercises supervised by a physical therapist, employing physical aids for cognitive tasks and mirror therapy. Both groups will undergo an intensive 6-week therapy phase followed by a 6-month maintenance phase involving weekly sessions to reinforce progress and prevent relapse. Primary outcomes, including pain intensity (VAS) and functional disability (Oswestry Disability Index), alongside secondary measures of pain sensitivity and quality of life, will be assessed at baseline and at 3-month and 6-month follow-ups.

Ethics and dissemination

The study protocol has been approved by the Shanghai University of Sport Scientific Research Ethics Committee. Written informed consent will be obtained from all participants. Study results will be disseminated through publications in international peer-reviewed journals and presentations at academic conferences.

Trial registration number

ChiCTR2400084205.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The study is a randomised, controlled and single-blind trial, ensuring rigorous comparison between remote and in-clinic Graded Motor Imagery (GMI) therapy for chronic low back pain patients with central sensitisation.

• The protocol leverages the neuroplastic potential of GMI to retrain cortical representation, potentially offering a scalable, non-invasive and patient-centric solution for managing chronic pain.

• By including both remote and traditional treatment groups, the study addresses accessibility challenges in underserved areas, providing valuable insights into the practicality of telehealth interventions.

• The effectiveness of remote interventions relies heavily on participant adherence, and technological or cognitive barriers might affect compliance and study outcomes.

Introduction

Chronic low back pain (CLBP) is a highly prevalent musculoskeletal condition that significantly reduces quality of life, contributes to work absenteeism and imposes a substantial burden on healthcare systems worldwide.¹ It is estimated that approximately 70% of adults worldwide will experience back pain at least once in their lives, which contributes to an estimated annual healthcare cost of US$8.15 billion in high-income countries.² CLBP is typically defined as pain and functional impairment persisting for more than 12 weeks, with many individuals experiencing recurrent episodes over time.³

Central sensitisation—a condition in which the central nervous system amplifies neural signalling—has been increasingly recognised as a key mechanism underlying chronic pain in a subset of CLBP patients.⁴ For instance, patients may report intense pain from normally non-painful stimuli, such as light touch from clothing or shower water, even in areas beyond the original site of injury. This recognition has shifted the focus of treatment towards a comprehensive approach involving neurophysiological treatments, rather than focusing solely on biomechanical mechanisms. Central sensitisation in CLBP signifies a maladaptive response of the pain modulation system, where patients exhibit an exaggerated response to both painful and non-painful stimuli, a phenomenon not limited to the area of initial injury but often found across multiple body regions.⁴ A deeper understanding of central sensitisation in CLBP is essential for designing more targeted and effective therapeutic strategies.⁵

Graded Motor Imagery (GMI) is a progressive neurorehabilitation technique designed to retrain the brain’s representation of the body in order to alleviate pain associated with central sensitisation.⁶ It typically involves three sequential stages: laterality recognition, explicit motor imagery (EMI) and mirror therapy. The premise of this approach is that modifying cortical representation can alleviate pain by reducing perceived threat and restoring normal motor output.⁷ Through sequential activation of sensorimotor cortical areas, GMI aims to reverse the cortical reorganisation commonly seen in chronic pain states. In patients with central sensitisation, this reorganisation contributes to increased pain perception, body schema distortion and impaired motor planning.⁸ This neurophysiological mechanism aligns with the pathophysiology of central sensitisation, thereby supporting the rationale for applying GMI in relevant conditions.⁹ Evidence supporting the efficacy of GMI in conditions such as complex regional pain syndrome (CRPS) and phantom limb pain suggests its potential applicability in CLBP with central sensitisation.^{10 11} Additional benefits of GMI include improvements in grip strength and joint mobility, which further support its use in rehabilitation settings.¹²

Remote healthcare interventions—defined as the delivery of health-related services and information through telecommunication technologies—have demonstrated promising outcomes in managing chronic conditions, including persistent pain.¹³ Such interventions offer improved accessibility and cost-effectiveness for patients, particularly those with mobility or geographic limitations. Given that GMI relies heavily on visual and cognitive tasks rather than physical equipment, it is particularly well-suited for remote implementation. This advantage could benefit delivery of GMI therapy, enabling patients to receive guidance with convenience and relatively low cost.

Despite the theoretical advantages, there is a notable gap in the literature regarding the clinical efficacy of remote GMI interventions. To date, no randomised controlled trials (RCTs) have directly compared remote GMI with conventional delivery formats in CLBP patients with central sensitisation.¹⁴ The primary aim of this study is to evaluate the clinical efficacy of remote GMI therapy in comparison with conventional in-person GMI in CLBP patients with central sensitisation. We hypothesise that remote GMI will be non-inferior in improving pain and functional outcomes, while offering additional benefits in terms of accessibility and adherence.

Methods and analysis

Purpose of the study

This study aims to evaluate the clinical efficacy of remote GMI therapy compared with conventional in-person GMI therapy in patients with CLBP associated with central sensitisation. GMI is a progressive neurocognitive rehabilitation technique that incorporates laterality recognition, EMI and mirror therapy to retrain cortical representation and reduce maladaptive pain perception. The specific objectives of this study are as follows:

1. To assess whether remote GMI therapy effectively reduces pain intensity and improves functional outcomes in CLBP patients with central sensitisation.

2. To compare the clinical outcomes—including pain, disability and treatment adherence—between remote and in-person GMI interventions.

Study design

We will conduct a single-blind RCT to evaluate the efficacy of remote GMI in managing CLBP associated with central sensitisation (figure 1). The trial will recruit patients diagnosed with CLBP from Shanghai Shangti Orthopedic Hospital (Shanghai University of Sport Affiliated Hospital) in China and nearby communities.

Figure 1. Flow diagram of the study procedure.

The treatment period will span 6 months, beginning in December 2025 and concluding in June 2026. The first 3 months will constitute the active intervention phase, during which participants will receive structured rehabilitation therapy according to their assigned group. The subsequent 3 months will serve as a maintenance and follow-up phase, where no direct therapist supervision will be provided; participants will be encouraged to adjust their training plans based on individual needs.

Regardless of group allocation, all participants will attend scheduled in-person follow-up sessions during the final 3 months to ensure consistent clinical monitoring and data collection. Evaluations will be conducted at baseline, 6 weeks, 3 months (end of intervention) and 6 months (end of study). Each evaluation will include a combination of objective assessments, standardised questionnaires and measures of pain intensity, functional status and pain sensitivity.

General health condition, adverse events (AEs) and participants’ engagement with the training programme will also be monitored as secondary outcomes. All participants will be required to provide written informed consent prior to enrolment. The consent form, submitted as a supplementary file, includes detailed information on the study objectives, intervention procedures, potential risks and benefits, confidentiality assurances and participants’ rights, including the right to withdraw at any time. Ethical approval for this study has been obtained from the Institutional Review Board of Shanghai University of Sport (Approval number: 202405001).

Participants

Inclusion and exclusion criteria

To ensure that participants meet the study requirements, they must satisfy all of the following criteria: (1) Age range: 20–50 years; (2) Duration of symptoms: suffering from CLBP for more than 6 months; (3) Pain characteristics: the pain is not caused by recent acute trauma and is non-specific, primarily localised in the lumbar region; (4) Treatment history: poor response to conventional physical therapy and pain management within the past 6 months; (5) Cognitive and physical capabilities: sufficient cognitive and physical ability to adhere to the research protocol, including participation in remote therapy sessions; (6) Technological access and skills: capability to access necessary technology (such as a computer or tablet with internet connection) and possess basic operational skills to participate in remote therapy sessions and (7) Perceptual cognitive assessment: accuracy below 80% on a left/right discrimination test using the ‘Recognise’ application.¹⁵

Additionally, any of the following conditions will result in exclusion from the study: (1) Specific spinal pathology; (2) Recent imaging confirming specific lumbar spine pathologies such as herniated discs, spinal stenosis or spondylolisthesis; (3) Surgical history: history of spinal surgery within the past year; (4) Severe mental illness: diagnosed with severe depression, schizophrenia or other mental health conditions that may hinder participation in therapy; (5) Other significant pain disorders: diagnosed with fibromyalgia, CRPS or other chronic pain conditions that might interfere with treatment outcomes; (6) Current high pain level: a Visual Analogue Scale (VAS) score greater than 7, indicating a high baseline level of pain; (7) Neurological disorders: any condition affecting motor control or sensory perception, such as multiple sclerosis or Parkinson’s disease and (8) Pregnancy: current pregnancy, as it may affect pain perception and physical capabilities.

Withdrawal criteria and management

• Personal decision: Participants may withdraw from the study at any time based on their personal request.

• Adverse reactions: Occurrence of significant discomfort or illness.

Randomisation and blinding

Participants will be randomly assigned in a 1:1 ratio to either the online GMI therapy group or the control group receiving conventional clinic-based treatment. Randomisation will be conducted using a computer-generated random number sequence to ensure proper allocation concealment. An independent researcher not involved in the intervention or outcome evaluation will oversee the randomisation process. Group assignments will be sealed in opaque, sequentially numbered envelopes and opened only after participant enrolment.

This study will adopt a single-blind design, in which only the participants will be blinded to group allocation. Participants will be informed that they are receiving a validated form of GMI intervention, but they will not be made aware of whether their assigned therapy is part of the remote or in-person delivery model. Standardised instructions, identical session structures and uniform communication procedures will be used across both groups to minimise perception of group differences.

Blinding of outcome assessors and therapists is not feasible due to the operational demands of the study. Assessors are required to interact directly with participants during in-person follow-up visits, and therapists must administer interventions in distinctly different formats. As a result, both roles inherently involve awareness of group assignment. However, to reduce bias, assessors will follow standardised data collection protocols and will not be involved in intervention delivery. Any instance of unintentional unblinding among participants will be documented, and its potential impact will be addressed during sensitivity analyses.

Interventions

All participants will receive a comprehensive briefing on the study protocol, including personal background documentation and detailed instructions for the intervention. They will be required to complete standardised forms to record the frequency, duration and adherence to prescribed exercises. Participants will be instructed to maintain their usual daily routines and refrain from engaging in any additional physical therapy, rehabilitation training or pain-related interventions during the study period to avoid confounding effects. The entire intervention will span 6 months and will be divided into two distinct phases: an active training phase (weeks 1–12) and a maintenance phase (weeks 13–24).

During the active training phase, participants will engage in the full three-stage GMI programme 5 days per week (Monday–Friday), with weekends designated as rest days to prevent cognitive and physical fatigue. All exercises will be performed at home with remote therapist supervision via the telehealth platform. Participants will be encouraged to follow the prescribed schedule, and daily adherence will be recorded through an in-app digital logbook. During the maintenance phase, participants will continue training 3 days per week (eg, Monday, Wednesday, Friday), with each session consisting of a shortened version of the full GMI programme tailored to individual needs. Therapist support will be provided on a weekly basis to ensure consistency, modify protocols if needed and monitor pain levels or signs of overtraining.

Remote GMI therapy group

Phase 1: left/right discrimination

Participants will engage in left/right discrimination exercises using the ‘Recognise’ mobile application (developed by the Neuro Orthopaedic Institute Group). Each session will last 10 min, performed twice daily, with a 2 min rest after every 5 min to prevent cognitive overload.¹⁵ Participants will select either the ‘leg’ or ‘back’ module based on the pain location and will be shown a series of limb or spinal images. Using a touchscreen interface, they will identify whether each image depicts the left or right side of the body (figure 2). The image presentation speed will be adaptive, starting at 30 s per image and gradually decreasing to 15 s as accuracy improves. The app will automatically record the number of correct and incorrect responses, generating a performance log that will be reviewed weekly by therapists to track cognitive discrimination progress and adjust task difficulty accordingly (figure 3, figure 4). To avoid cognitive fatigue, it is recommended to take a 2 min rest after every 5 min of training.¹⁶

Figure 2. Online therapy using the Recognise application.

Figure 3. Training results based on the response time and accuracy of the subjects.

Figure 4. Cognitive exercises under a physical therapist’s guidance.

Phase 2: explicit motor imagery

In this stage, participants will engage in mental rehearsal of functional movements without actual physical execution. Each session will last 15 min, once per day and consist of imagining commonly performed daily activities (eg, walking, squatting, carrying household items or ascending stairs). Participants will be prompted to focus on the affected limb and visualise the movement from a first-person perspective, engaging not only visual imagery but also the sense of effort and body awareness. Each imagery set will last approximately 3–5 min, followed by a 1 min rest between sets. Progress will be assessed through weekly therapist check-ins and participant reports on imagery vividness and mental fatigue levels.

Phase 3: mirror therapy

Mirror therapy will be implemented using a standard household mirror, positioned vertically in front of the participant. Each session will be conducted once daily for 20 min, consisting of guided movements of the non-affected limb while observing the mirror reflection, which creates the illusion of symmetrical motion in the affected side.¹⁷ The therapy will begin with simple movements (eg, wrist extension, arm raising, leg tapping) and gradually progress to more complex and dynamic tasks (eg, bilateral reaching, multijoint coordination). Participants will take a 2 min rest after every 10 min to minimise visual and attentional fatigue. Therapists will provide real-time verbal or video-based guidance, and participants will be encouraged to offer subjective feedback on perceived movement synchrony and discomfort levels. The goal is to facilitate cortical reorganisation by reinforcing the brain’s perception of functional capability in the affected limb, thereby reducing pain and disability.

Control group

Participants in the control group will undergo the same three-phase GMI protocol as those in the online group, with identical frequency, duration and content. The only difference lies in the mode of delivery: all sessions will be conducted in person under the supervision of licensed physical therapists at the clinical site.

Phase 1: left/right discrimination

Participants will engage in left/right discrimination exercises for 10 min, twice daily, guided by a therapist. Instead of using digital tools, paper-based images and everyday objects (eg, sports magazines, yoga/dance visuals) will be used to stimulate recognition of limb laterality, focusing on the affected side (eg, left leg). This task is intended to re-establish spatial awareness and cortical representation of the painful body part. A 2 min rest will be incorporated after every 5 min of training to prevent mental fatigue.

Phase 2: explicit motor imagery

Under the guidance of a physical therapist, participants will perform 15 min EMI sessions once per day, using a combination of verbal instructions, physical prompts and visual aids (eg, demonstration videos, posture diagrams). Participants will be guided to mentally simulate pain-free movements of the lumbar spine and lower limbs. The training will progress from imagining third-person perspectives (eg, watching others perform tasks) to first-person self-imagery of daily pain-free activities. Brief rest periods (1 min) will follow each imagery sequence to optimise concentration and minimise mental strain.¹⁸

Phase 3: mirror Therapy

Participants will engage in 20 min mirror therapy sessions once per day, conducted in a clinical setting using a standardised mirror box. Under therapist supervision, they will observe the movement of the non-affected limb in the mirror and mentally project the same movement onto the affected limb. The exercise will begin with simple joint motions and progress to complex motor tasks over time. A 2 min rest will be incorporated after every 10 min to maintain visual and cognitive performance (figure 5).

Figure 5. Mirror therapy.

Both groups will receive weekly therapist follow-up sessions, either in person (control group) or via teleconsultation (intervention group), to review progress, manage potential barriers and adjust training intensity as needed. In addition, two groups will receive Pain Neuroscience Education sessions focused on explaining the biopsychosocial model of pain and strategies for reducing pain-related fear. Relaxation techniques such as diaphragmatic breathing, progressive muscle relaxation and guided imagery will also be taught to help manage pain-related stress and anxiety.^{19 20}

Outcome measures

Evaluations will occur at baseline, 6 weeks, 3 months (end of intervention) and 6 months (end of study). Each evaluation will include objective assessments, subjective questionnaires and validated tools to measure pain intensity, functional status and pain sensitivity. Secondary outcomes will include general health status, AEs and training adherence.

Primary outcome measurements

1. Visual Analogue Scale:

   The VAS was used in this study to evaluate the intensity of patients’ pain. The VAS typically consists of a 100 mm horizontal line, with pain severity ranging from 0 to 10, where ‘0’ represents the absence of pain and ‘10’ signifies intolerable pain. Patients articulate their pain levels and indicate the corresponding value on the line. VAS serves as an efficient and relatively accurate tool for pain assessment, validated for its reliability and effectiveness across numerous studies.²⁰

2. Oswestry Disability Index:

   The Oswestry Disability Index (ODI) is a specific questionnaire used to assess the level of functional impairment in patients with low back pain. It consists of 10 items, covering aspects such as pain intensity, personal care, lifting, walking, sitting, standing, sleep, social life, travelling and sexual activity. The total score on the ODI scale is 50, with higher scores indicating more severe functional impairment. This scale has been proven to have good reliability and validity, making it a common assessment tool in research related to nonspecific low back pain.²¹

3. Pain Sensitivity Questionnaire:

   The Pain Sensitivity Questionnaire (PSQ) is used to measure pain sensitivity, reflecting a patient’s perceptual sensitivity and threshold to pain. This questionnaire includes multiple items designed to evaluate the patient’s sensations to various pain stimuli. The PSQ has been used in multiple studies to determine the correlation between pain sensitivity and chronic pain states, proving its applicability and importance in the assessment of chronic pain.²²

Secondary outcome measurements

1. Short Form-36 Health Survey Health Survey Questionnaire:

   The SF-36 is a scale used to assess a wide range of health statuses, encompassing eight dimensions: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. This scale allows for the assessment of a patient’s quality of life from multiple perspectives. Each dimension’s raw score is initially converted to a scale from 0 to 100, where 0 represents the worst health status and 100 represents the best health status. Calculating the score for each dimension typically involves summing and standardising the responses to relevant questions, with scores below 40 potentially indicating poor health condition and functional impairment.²³

2. AEs in GMI Training:

   Any AEs occurring during GMI training will be documented.

3. Physical Interferences or Impacts on Online Group Training:

   Any physical interferences or impacts affecting the online group’s training will be recorded.

Data management and quality assurance

Data will be collected systematically at each scheduled time point, as detailed in table 1, using standardised case report forms for all participants. Patient-identifiable information will be securely stored, with access strictly limited to authorised personnel to maintain confidentiality. Two researchers will independently input data into a protected electronic database, with password security protocols updated regularly. Any inconsistencies between entries will be reviewed and resolved collaboratively to ensure accuracy. Only deidentified data sets will be accessible to the research team, and external access will require prior approval through formal agreements. A Data Monitoring Committee (DMC), consisting of experts in relevant disciplines such as clinical methodology, ethics and statistics, will oversee compliance with regulatory standards and ensure the integrity of the study. This committee will conduct regular reviews via scheduled meetings or remote consultations and hold the authority to suspend or terminate the trial in cases of significant safety concerns or AEs.

Table 1. Schedule of enrolment, interventions and assessments*.

	Enrolment	Allocation	Postallocation			Close-out
Time point	4 weeks prior	0	First session	6 weeks	3 months	6 months
Enrolment:
Eligibility screen	X
Informed consent	X
Allocation		X
Interventions：
Online therapy group
Control group
Assessments:
VAS		X		X	X	X
ODI		X		X	X	X
PSQ		X		X	X	X
SF-36 HSQ		X		X	X	X
Adverse events
Physical interferences or impacts

X, , All groups; , Online group.

^*The assessments evaluate pain intensity, functional disability, pain sensitivity and overall health quality. Examination also monitors adverse events and physical impacts associated with the intervention.

Events, Adverse Events in GMI Training; HSQ, Health Survey Questionnaire; ODI, Oswestry Disability Index; Physical Interferences or Impacts, Physical Interferences or Impacts on Online Group Training; PSQ, Pain Sensitivity Questionnaire; SF-36, Short Form-36; VAS, Visual Analogue Scale.

To enhance participant retention and ensure comprehensive follow-up, several strategies will be employed. Both groups will adhere to a schedule of regular in-person follow-up visits over the 6-month trial period, occurring at 6 weeks, 3 months and 6 months. Participants who discontinue or deviate from the intervention protocols will still be encouraged to attend these follow-up evaluations to collect essential outcome data, including VAS, functional recovery ODI and PSQ. To improve compliance, periodic reminders will be sent via email or phone, and follow-up appointments will be tailored to accommodate participants’ schedules. Additionally, those experiencing challenges with adherence will be offered personalised support, such as motivational guidance and assistance in addressing technical or logistical barriers. These measures aim to reduce dropout rates and ensure the collection of high-quality data for the study.

At the conclusion of the study, anonymised data may be shared with the academic community, contingent on obtaining participant consent and adhering to established data-sharing policies. Thorough documentation of the data management workflow will support transparency and facilitate reproducibility of the study outcomes.

Adverse events

Any AEs occurring during GMI training will be carefully documented, including their type, frequency, severity, duration and potential relationship to the intervention. Participants will be encouraged to report any discomfort or unexpected symptoms during or after the sessions. AEs may include, but are not limited to, increased pain, fatigue, dizziness or emotional distress related to the exercises. Each reported event will be assessed by the research team to determine its significance and potential impact on the participant’s safety and study outcomes. In the case of severe AEs, such as significant exacerbation of symptoms or other serious health complications, immediate medical attention will be provided, and the event will be reviewed by the DMC. The DMC will evaluate whether adjustments to the intervention protocol or study design are necessary to ensure participant safety. Comprehensive records will be maintained to uphold study transparency and regulatory compliance.

Sample size estimate

This study is a single-blind, RCT aimed at evaluating improvements in low back pain intensity using the VAS as the primary outcome measure. The sample size was calculated based on a two-sided α of 0.05 and a power of 90%, with the minimal clinically important difference in VAS for low back pain set at 1.5.^{24 25} Assuming an intragroup SD of 1.8, the required sample size was determined to be 87 participants per group. Accounting for an anticipated 10% dropout rate, the study will enrol at least 97 participants in each group, for a total of 194 participants.

Statistical analysis

Statistical analyses will be conducted using SPSS 26.0 and Microsoft Excel to ensure comprehensive data processing and analysis. Continuous variables will be presented as mean±SD, while categorical variables will be depicted as frequencies and percentages. A two-way analysis of variance for repeated measures will be employed to compare primary and secondary outcomes between the online GMI group and traditional clinical treatment group across different time points (baseline, 6 weeks, 3 months and 6 months). This analysis will facilitate the identification of time and treatment effects, as well as potential interactions between these factors. An intention-to-treat (ITT) analysis will be performed to preserve the benefits of randomisation and reduce potential bias arising from participant drop-out or non-compliance. All randomised participants will be included in the analysis based on their original group allocation, regardless of adherence to the intervention protocol or withdrawal. For handling missing data, we will apply a weighted last observation carried forward (WLOCF) approach, which considers the probability of missingness and minimises distortion of treatment effect estimates. This method ensures that the estimated effects reflect the treatment’s impact in a real-world clinical context, thereby enhancing the external validity of the findings. Baseline characteristics between groups will be compared using independent t-tests to ensure primary comparability. Paired t-tests (or Wilcoxon signed rank tests for non-normally distributed data) will be used to assess within-group changes in measures such as the VAS pain score and ODI. Statistical significance will be set at a p<0.05 for all tests, with all analyses conducted on a two-sided basis. Additionally, an effect size will be calculated for each primary and secondary outcome to ascertain the magnitude of change within and between groups, offering valuable clinical significance beyond the p values.

Ethics and dissemination

The study protocol has been reviewed and approved by the Scientific Research Ethics Committee at Shanghai University of Sport (Approval number: 202405001), and the trial has been registered with the Chinese Clinical Trial Registry (ChiCTR2400084205) on 13 May 2024. Participation in the study is entirely voluntary, and participants may withdraw at any time without penalty or impact on their medical care. The results of this study will be disseminated through presentations at academic conferences and publications in peer-reviewed scientific journals.

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.

Discussion

Expected outcomes and significance

This randomised controlled trial aims to investigate whether remote delivery of GMI therapy is as effective as traditional in-person methods for managing CLBP associated with central sensitisation. We hypothesise that remote GMI therapy will demonstrate non-inferiority in reducing pain intensity and improving functional outcomes, while also potentially showing superior adherence and accessibility. By leveraging the neuroplastic capabilities of GMI—specifically, cortical remapping and reduced pain-related threat perception—this study anticipates validating remote interventions as effective tools for managing complex chronic pain conditions. If the results align with our expectations, they will significantly support the theoretical foundations of GMI, underscoring its capacity to induce cortical reorganisation and reduce maladaptive pain responses.²⁶

Clinical implications and translation to practice

Integrating remote GMI into clinical practice can potentially expand the scope of chronic pain management beyond conventional pharmacological and in-clinic approaches. By employing a scalable telehealth model, clinicians could offer personalised neurorehabilitation therapies that are not confined by geographical or logistical constraints. This mode of delivery is especially significant for underserved communities, where traditional rehabilitation services might be limited or inaccessible.^{27 28}

The findings from this study could, therefore, serve as a critical step towards establishing remote GMI as a mainstream clinical option, providing healthcare professionals with a practical, cost-effective and patient-centred approach. Moreover, telehealth interventions may improve patient adherence by reducing travel burdens and providing greater flexibility, thereby enhancing treatment consistency and overall effectiveness.²⁹

Methodological considerations and strengths

This study’s methodological rigour, characterised by a randomised controlled design and ITT analysis, reinforces the validity of potential findings. Employing a single-blind approach, wherein only participants are blinded to group allocation, addresses practical constraints inherent in behavioural intervention trials. Although blinding therapists and outcome assessors was unfeasible due to the distinct delivery methods (remote vs in-person), the study incorporates comprehensive measures to minimise bias, such as standardised outcome collection protocols and detailed adherence monitoring. Also, the consistent frequency, intensity and content of interventions across both groups isolate the delivery method as the sole independent variable, thereby facilitating clear interpretation of results. The use of the WLOCF method for addressing missing data further supports the trial’s robustness and external validity, aligning closely with real-world clinical scenarios.

Impact on future research

The outcomes of this trial may open new avenues for investigating GMI across diverse chronic pain conditions where central sensitisation plays a critical role, such as neuropathic pain or fibromyalgia. Future research could explore integrated therapeutic models, combining GMI with psychological interventions, conventional physical therapy or pharmacological treatments, aiming to enhance overall patient outcomes. Additionally, the anticipated results may provide foundational evidence for the broader adoption of digital health platforms in chronic pain rehabilitation. Investigations into patient-specific factors influencing remote therapy adherence could further refine digital interventions, potentially incorporating artificial intelligence or personalised feedback mechanisms to optimise clinical effectiveness.

Limitations and future directions

Despite its methodological rigour, several limitations merit consideration. The study’s geographic concentration within Shanghai may limit the generalisability of findings across broader populations, highlighting the need for future research to recruit participants from more diverse geographical and demographic backgrounds to enhance external validity. Additionally, the 6-month follow-up duration, although substantial, may be insufficient to fully evaluate long-term therapeutic sustainability given the chronic and recurrent nature of CLBP. Future studies should incorporate extended follow-up periods of at least 1 year to better assess sustained treatment effectiveness and potential relapse prevention. Finally, the inherent reliance on patient adherence in remote interventions poses a challenge. While adherence-enhancing strategies have been implemented, further research into optimising patient engagement through interactive and motivational approaches is necessary to improve adherence and maximise therapeutic outcomes.

Trial status

The protocol version number for this clinical trial is ChiCTR2400084205, dated 13 May 2024. The current version is V.2.1. Participant recruitment is expected to take place in 2025.