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Abstract
Introduction Poststroke shoulder pain is a common complication that severely affects the recovery of upper limb motor function. Acupuncture has positive analgesic effects in treating poststroke shoulder pain, and studies have demonstrated the efficacy of transcranial direct current stimulation (tDCS) in treating patients with this pain. However, whether acupuncture combined with tDCS has a superior rehabilitation effect on poststroke shoulder pain is currently unknown. We aimed to observe the effect of the combined intervention on poststroke shoulder pain and explore its possible central analgesic mechanism.
Methods and analysis This study describes a randomised controlled trial using assessor blinding. A total of 135 poststroke patients with shoulder pain will be randomly assigned in a 1:1:1 ratio to the tDCS group, acupuncture group and combined group (acupuncture plus tDCS). All three groups will undergo conventional rehabilitation treatment. Participants in the tDCS group will receive tDCS stimulation on the M1 area for 20 min, while the acupuncture group will receive 20 min of acupuncture. The combined treatment group will receive both. All treatments will be performed five times per week for 4 weeks. The primary outcome indicator in this study is the Visual Analogue Scale pain score. Secondary outcome indicators include shoulder mobility, Shoulder Pain and Disability Index, Fugl–Meyer Motor Function Scale, Modified Barthel Index Scale, Self-Rating Anxiety and Depression Scale and functional MRI. All scale results will be assessed at baseline and at 2 weeks and 4 weeks, and during follow-up at 1 month, 3 months and 6 months postdischarge. A repeated analysis of variance will be conducted to observe the group×time interaction effects of the combined intervention. Moreover, functional MRI will be applied to explore the central analgesic mechanism.
Ethics and dissemination Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (2023KY-039–001). The results of the study will be published in a peer-reviewed journal and presented at scientific conferences.
Trial registration number ChiCTR2300078270.
- stroke
- shoulder
- randomised controlled trial
- acupuncture
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The intervention protocol used in this study will be evidence-based and rigorously developed based on evidence, recommendations, theories and practical criteria of systematic evaluation.
Sensitive, systematic and comprehensively valid evaluation results were selected, including subjective pain, psychological scales, objective functional assessment scales and functional MRI (fMRI) tests. Subjectivity and objectivity were combined to reduce the bias of confounding factors.
fMRI was used to reveal the possible central analgesic mechanism of transcranial direct current stimulation combined with acupuncture for treating poststroke shoulder pain, paving the way for subsequent in-depth mechanistic studies.
The source of case data was a single healthcare provider, and the lack of multicentre healthcare provider data affected the level of evidence for the study results.
Due to the visibility of the intervention, the design could not be blinded to participants and study researchers in the current study protocol.
Introduction
Stroke is the most common cerebrovascular disease in clinical practice, and survivors often suffer from varying degrees of functional impairment. Poststroke shoulder pain, occurring on the hemiplegic side of the patient, is a common complication after stroke. Epidemiological studies have reported that approximately 30%–65% of patients with stroke suffer from shoulder pain, and the main clinical presentations are shoulder pain and limited shoulder joint movement.1 2 Poststroke shoulder pain occurs in the chronic stage after stroke, usually 2–3 months thereafter. This pain can last for months or even years, is an important complaint of patients during medical consultations, and is the focus of attention of clinicians.3
Poststroke shoulder pain affects the recovery of upper limb motor function, thereby reducing shoulder mobility. The development of poststroke shoulder pain may affect recovery from other dysfunctions after stroke, leading to a lower level of daily living ability and limiting the return of patients to society and family life.4 Persistent pain not only affects the recovery of limb function but may also cause varying degrees of depression or anxiety, which will reduce quality of life, affect motivation to continue treatment, make withdrawal from the rehabilitation training programme easier, prolong rehabilitation treatment time, affect overall recovery and increase the burden on the patient and the community.5
To date, the exact pathogenesis of poststroke shoulder pain remains controversial due to the complex and multifactorial aetiology thereof, involving soft muscle tissue, motor control, neurological (peripheral and central nervous system) and psychological factors.6 Patients with poststroke shoulder pain reduce the activity of the affected limb due to muscle strength, tension, pain, spasm, dislocation and other reasons. This reduces stimulation of the brain by external factors, which is not conducive to the functional reorganisation of the brain, reducing upper limb function.7
Acupuncture, as a traditional therapy of Chinese medicine, has become an increasingly popular technique in recent years. It is widely used in treating various kinds of pain and is recognised as having efficacy in pain relief. Furthermore, clinical and basic research regarding acupuncture analgesia is a research hotspot.8–10 Additionally, acupuncture has also been applied in treating poststroke shoulder pain with clinical efficacy,11 12 to improve pain, upper limb motor function and daily living ability in these patients.13–15 A narrative review of clinical guideline recommendations for acupuncture as a treatment for poststroke dysfunction noted that the evidence for acupuncture for poststroke shoulder pain is increasing, with most evidence suggesting a positive analgesic effect.16
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation based on the principle of applying low-intensity electrical currents directly to the scalp, providing a safe stimulation technique to directly modulate neuronal activity and induce neuroplasticity changes. This is mainly manifested in the human motor cortex, such as the primary motor cortex (M1).17 18 tDCS can reduce pain in patients by altering the excitability of the cerebral cortex.19 Studies have demonstrated the safety and efficacy of tDCS in treating patients with post-stroke shoulder pain,20 and tDCS has been shown to reduce the magnitude and duration of pain and improve the quality of life of patients.21–23 tDCS is, therefore, a safe intervention to improve upper extremity pain and spasticity in stroke patients.24 25
Although a variety of rehabilitation therapies have been proposed for the treatment of poststroke shoulder pain, their therapeutic efficacy is inconsistent, and a single treatment may be insufficient. A combination of effective multidisciplinary interventions is required to further improve rehabilitation outcomes.26
Studies using functional MRI (fMRI) have shown that acupuncture can promote the recovery of cortical function by improving cognitive networks, which in turn relieves pain and improves limb motor function. Neuroplasticity and functional remodelling are potential rehabilitation mechanisms for acupuncture to improve shoulder pain after stroke, which has been confirmed by fMRI brain assessment techniques. Furthermore, repeated stimulation during acupuncture promotes the formation of functional neural pathways and activates the formation of new synapses. In other words, functional improvement and strengthening depend on cortical excitation and functional remodelling.27 28
From the perspective of neurorehabilitation, the combination of brain stimulation techniques and acupuncture may achieve a synergistic effect on functional rehabilitation, and the mutual combination may amplify neuroplasticity and functional remodelling. We hypothesised a synergistic effect of acupuncture combined with tDCS for the treatment of poststroke shoulder pain. However, it is unclear whether this combination will effectively improve this pain.
We, therefore, aimed to investigate whether the integration of tDCS and acupuncture has a synergistic effect on the improvement of shoulder pain after stroke. The randomised controlled trial (RCT) was designed with three groups, including a tDCS group, acupuncture group and tDCS combined with acupuncture group. It was hypothesised that these groups would show different improvements in primary and secondary outcomes. Our results may provide a further understanding of existing rehabilitation techniques and assist in the design of a more effective rehabilitation programme for poststroke shoulder pain.
Methods and analysis
Study design
This study will be a single-blind RCT consisting of a 4-week intervention and a 6-month follow-up. In total, 135 patients with poststroke shoulder pain were randomly divided into tDCS (control group A), acupuncture (control group B) and tDCS–acupuncture (intervention group C) groups in the ratio of 1:1:1. A brief flowchart of the study is shown in figure 1 and the schedule of activities is shown in table 1. The protocol was reported in accordance with the standard protocol items of randomised trials.29 The study protocol was approved by the Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (No. 2023KY-039–001) and registered in the China Clinical Trial Registry.
Schedule of enrolment, intervention and assessments
Study flow diagram. fMRI, functional MRI; tDCS, transcranial direct current stimulation.
Sample size calculation
The sample size was calculated by specifying an effect size based on minimal clinically important differences.30 Based on a previous two-way analysis of variance (ANOVA) F-test with a power of 0.80, an effect size of 0.25 and an alpha level of 0.05, it was estimated that 108 participants were needed for this study. Considering a dropout rate of approximately 20%, the final sample size will be 45 participants per group, for a total of 135 subjects.
Participants
Inclusion and exclusion criteria.
Inclusion criteria
(1) Clinical diagnosis of cerebral haemorrhage or cerebral infarction by CT/MRI; (2) age 18–85 years; (3) poststroke shoulder pain of ≥3 points in intensity (VAS ≥3/10) within the past 7 days; (4) >14 days after stroke; (5) mental health, the ability to answer questions, good communication skills and a Mini-Mental State Examination score ≥24.
Exclusion criteria
(1) Patients with craniocerebral trauma, thalamic disease or peripheral neuropathy; (2) there is a history of cervical spondylosis, shoulder periarthritis, shoulder fracture or trauma, osteoporosis, myocardial infarction, etc, which may cause shoulder pain; (3) patients with cerebral oedema or coma after stroke; (4) patients with serious infection or heart, liver or kidney disease; (5) those participating in other clinical trials that may affect the results of this study; (6) patients with severe cognitive deficits and aphasia.
Setting and recruitment
This study will be conducted at the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine. In this trial, participant recruitment will include advertising posters in the hospital (online WeChat and offline printed posters) and referrals from therapists or neurorehabilitation physicians. Details of the study will be communicated to potential participants. Patients will be invited to participate in this trial after voluntarily signing an informed consent form. Recruitment will begin from 1 December 2023 to 31 December 2026. All patients who meet the inclusion criteria and agree to participate will be asked to provide their written informed consent.
Randomisation, allocation concealment and blinding
Randomisation and allocation concealment will be provided by statistical analysts who are independent of the study team and are internationally accredited. Information (eg, demographic, clinical and outcome) on each participant who has signed the informed consent form and completed the preassessment will be uploaded to the online data management system. Participants will then be automatically randomly assigned to three groups in a 1:1:1 ratio according to the system’s built-in randomisation procedure. The acupuncturists at each centre would have been working at the hospital for at least 10 years, and acupuncturists and tDCS operators would receive uniform and standardised training.
Due to the visibility of the needling and tDCS interventions, blinding of study investigators and participants is not possible. Therefore, to avoid potential detection bias, blinding will only apply to the outcome assessor and statistician who will perform the final statistical analyses in this trial RCT. We will engage independent assessors who are not involved in the delivery of the intervention to ensure their impartiality. These assessors will be trained on the study protocol and blinded to the intervention status of the participants. The assessors will be responsible for data collection and analysis and will not be involved in the subject recruitment process. In the event that an assessor accidentally discovers the intervention group of a participant, we will immediately replace that assessor with an alternative blinded assessor. The success of the assessor blinding will be determined at the completion of the follow-up assessment for each participant by responding to the questions ‘Did you know which intervention group the participant was assigned to before the follow-up assessment was completed?’ and, ‘If “yes”, how did you find out?’
Intervention
The three groups will receive the same routine rehabilitation programme, including physiotherapy, occupational therapy and speech therapy. Rehabilitation interventions in all three groups will be for 5 days per week for 4 weeks (table 2).
Overview of intervention
tDCS group
The IS300 tDCS instrument (Sichuan Intelligent Electronics Industry, Chengdu, Sichuan, China) was used. The body surface was projected as the left and right hemispheric central areas, and the stimulation area was dominated by the side of stroke injury, such as the right side of the right hemisphere stroke stimulation of the right hemisphere central area, and the left hemisphere stroke stimulation of the left hemisphere central area. The cathode electrode sheet was placed in the contralateral supraorbital area of the patient; the stimulation current was 2 mA. The time of each stimulation was 20 min, five times per week and the treatment course was 4 weeks. The operation was performed by a physician qualified in neurophysiological training.
In the tDCS group, participants underwent treatment using the IS300 tDCS and a regular rehabilitation programme. Before performing the stimulation, the skin at the stimulated site was checked for wounds to avoid irritation of the damaged skin. In this study protocol, the tDCS instrument was used to stimulate the primary motor cortex, area M1 (C3 and C4), with the body surface projected as the central area of the left and right hemispheres.30 The stimulated area was mainly the side injured by stroke. For example, the central region of the right brain is stimulated in right stroke and the central region of the left brain is stimulated in left stroke. The cathode electrode was placed in the contralateral supraorbital region of the patient. The stimulation parameters were set to 2 mA dual head current with a relative current density of 0.057 mA/cm2 for 20 min, well within current safety limits.
Acupuncture group
Acupuncture points were selected for the treatment of shoulder pain from the ninth edition of the ‘Zhen Jiu Jia Yi Jing (Systematic Classic of Acupuncture and Moxibustion)’. The points were taken from the local shoulder joints, including shoulder Qian, Zhen, A Shi, Yanglingquan and Zhongping (one below Zusanli). At the same time, according to the pain location of the meridian differentiation of points, for Taiyin meridian syndrome, we added chi ze; Yin Lingquan; Yangming, Shaoyang classics, hand Sanli; Waiguan Sun classics, Houxi, Dashu and Kunlun; pain in Yangming, the sun plus mouth through Chengshan. Acupuncture techniques were used to supplement deficiency and reduce deficiency. Huatuo disposable acupuncture needles, 0.30 mm × 40 mm, were used for the acupuncture.
tDCS–acupuncture group
In the tDCS–acupuncture group, participants will receive a 20 min tDCS intervention, a 20 min acupuncture treatment and a conventional rehabilitation programme. tDCS and acupuncture interventions will be performed with stimulation modalities, sites, parameters and details as previously described.
Baseline characteristics of the participants
The demographics (eg, sex, age, marital status, accommodation address and telephone number) and clinical characteristics (eg, aetiology, clinical diagnosis, stroke type, stroke location and time since stroke onset) of the participants will be collected at baseline (T1).
Outcome measures
All outcome measures will be assessed by a research assistant who is a professional rehabilitation assessor and blinded to the RCT at baseline (T1), 2 weeks (T2) and 4 weeks (T3) during the intervention period and at 1 month (T4), 3 months (T5) and 6 months (T6) during the follow-up period (table 3). All outcome measures will be uploaded to the online data management system of the third-party data management organisation and will be kept in a secure and lock-protected location.
Outcome measures and tools
Shoulder pain
The VAS is used to assess pain in patients with poststroke shoulder pain. The VAS has been widely used in clinical pain assessment and has high reliability and validity. The minimum score is 0 and the maximum score is 10, and the scale consists of a 100 cm straight line. The VAS is simple, fast, accurate and easy to perform and determines the degree of pain relief. The scale is 10 cm long, labelled with 10 increments of 1 cm, with ‘0’ and ‘10’ at each end, with 0 indicating no pain, 10 indicating the most intolerable pain and the middle portion indicating different levels of pain. The patient is asked to mark the level of pain on the horizontal line according to subjective sensations.
Secondary outcome measures
Shoulder joint motion
Shoulder joint mobility was measured before and after treatment in all patients. This was performed in sitting or standing positions, with the long axis of the humerus as the mobile arm and shoulder flexion (with the acromion as the axis and the median line on the side of the body as the fixed arm) and abduction (with the acromion as the axis and the median line on the side of the body as the fixed arm) measured by a specialised practitioner using a general-purpose protractor.
Shoulder Pain and Disability Index
The Shoulder Pain and Disability Index is a method of assessing the degree of shoulder pain and dysfunction, including pain, activity function and other issues. The index is used to assess the severity of pain and the degree of difficulty in daily life. The total score is based on the total points of the pain and disability scale divided by the number of countable points out of a maximum of 100 points. The higher the score, the higher the degree of pain and dysfunction of the shoulder joint.
Motor function
The motor function of stroke patients was assessed using the Fugl–Meyer Assessment scale. The Fugl–Meyer Upper Limb Functional Assessment Scale is the most widely recognised and used assessment method in the field of hemiplegia in stroke and reflects the level of recovery of upper limb motor function after hemiplegia. The scale is comprehensive in its assessment, is highly sensitive and is often widely used in the evaluation of limb function in stroke patients, with a total score of 66. The score is positively correlated with the motor function of the upper limbs. The higher the score, the better the patient’s functional recovery.
Daily living ability
The Modified Barthel index (MBI) is a classic tool to assess a patient’s ability to perform activities of daily living and is widely used in clinical research. The index consists of 10 scores of daily living ability: eating, dressing, bathing, toileting, transferring to and from a chair, self-care in the toilet, non-self-care in the toilet, walking and walking up and down stairs. Each ability is scored with one point, with higher scores indicating better physical function. A score of 10 is given for complete self-care and 0 for complete lack of self-care. MBI has the advantages of being efficient, sensitive and reliable.
Depression level
The Self-rating Depression Scale (SDS) is a scale that provides an intuitive picture of the subjective feelings of depressed patients and how they change during treatment. The scale contains 20 items reflecting subjective feelings of depression, and each item is divided into four levels of scoring according to the frequency of symptoms. The normal upper limit of the SDS total score is 41, and the standard score is the integer part obtained by multiplying the total score by 1.25. The higher the score, the more serious the state of depression.
Anxiety level
The Self-rating Anxiety Scale is a self-rating scale used to assess an individual’s level of anxiety. The scale covers different aspects of anxiety, including subjective feelings, physical reactions and behavioural expressions. Each option is assigned a different score, which is calculated to give a total score, ranging from 20 to 80, with higher scores indicating more severe levels of anxiety.
Brain structure and function
3.0T functional MRI will be used to collect T1 structural images and resting state functional images of patients to evaluate and analyse the structural and functional plasticity of the brain. Functional nuclear magnetic resonance (NMR) data image acquisition was performed using a 3.0T Simens Prisma MRI scanner (Simens Prisma, Germany) with an eight-channel head coil. The data acquisition parameters of the T1 images are as follows: rapid gradient echo Magnetization-Prepared Rapid Gradient Echo sequence prepared by magnetisation (TR/TE/TI, 2000 ms/1.75 ms/450 ms; tilt angle, 15°; layer thickness, 1.0 mm) to obtain high-resolution T1-weighted anatomical images (Field of View=240×240×160 mm3; resolution matrix=256×256; voxel size=1×1×1 mm3). The resting state function NMR acquisition parameters are as follows: T2* weighted gradient echo plane imaging sequence to obtain 180 volumes (number of layers/TR/TE/rotation angle=32/2000 ms/30 ms/90°, matrix=64×64, FOV=230×230×128 mm3, voxel size=3.52×3.52×3.5 mm3). Scanning time is 6 min.
Patient safety and adherence
All adverse events (eg, pain and falls) that occur during the intervention and follow-up will be recorded on the case record form (CRF) via the way of the monitor and self-report and will be evaluated for relevance to the intervention. The occurrence rate of the adverse event was defined as the number of occurred participants divided by all participants (T1).
The following are some key strategies that can be used to improve adherence. (1) Education and communication: provide patients with clear, concise and comprehensive information about the intervention, its purpose, benefits and expected outcomes. (2) Support and motivation: provide emotional or financial support and encouragement to patients to maintain their motivation to adhere to the intervention; work with community organisations and social services to provide additional support. This research project will cover the cost of acupuncture, tDCS treatments and assessments performed during the participant’s participation in this study. Hence, this study can appropriately reduce the financial burden on participants. (3) Collaborative care: provide training and education for family members and caregivers to support patient adherence. Our group will invite a clinician who has been working for >10 years to give health education courses to the participants and caregivers once a month, either face-to-face or online.
Data management and monitoring
Two research assistants, who are unaware of the research process, will enter all data collected into the online data management system by double entry. Data checks (eg, CRF checks with raw data, double-checking) will be performed to ensure data accuracy before descriptive and statistical analyses are performed. Access to datasets will be limited to the Clinical Trial Management and Data Safety and Monitoring Committees.31 Storage and handling of hard copies of study data will be in strict accordance with the regulations and policies of the investigator’s institution and study site. In addition, serious adverse events will be reported to an independent Data Safety and Monitoring Committee, which will recommend whether to continue, modify or discontinue the intervention. During the study, datasets will be stored, analysed and archived under a pseudonym to protect the privacy of individuals.
Statistical analysis
All statistical analyses will be performed using IBM SPSS V.20.0. Outcome analyses are conducted on an intention-to-treat basis and missing data will be entered using multiple entry methods. Shapiro–Wilk tests will be used to test the normal distribution of continuous variables for demographic and outcome measures. Continuous variables will be described as mean±SD for normal distributions and median for non-normal distributions; categorical variables will be described as frequencies. χ2 tests or Fisher exact tests will be used to examine comparisons of categorical variables between the three groups. A two-way ANOVA with repeated measures will be used to examine the main effect of the group, the time factor and the group–time interaction effect. Simple effects post-hoc analyses will be conducted when time–group interactions are significant. The significance level for all statistical tests will be set at 0.05 and corrected for multiple comparisons using the Bonferroni correction method.
Patient and public involvement
The initial research idea was proposed by the research team. Patients with poststroke shoulder pain, physiotherapists and neurorehabilitation physicians were involved in the preparation of the proposal through face-to-face interviews. Additionally, the study protocol will be revised by the research team and all issues not addressed in the draft proposed at that time will be added based on their feedback to ensure the safety and applicability of the intervention.
Ethics and dissemination
All study procedures were in accordance with the current version of the Declaration of Helsinki (see www.wma.net for details) and relevant ethical guidelines. Ethical approval was obtained from the Research Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (No. 2023KY-039–001). The research team will communicate information about the study to recruited participants, including the purpose of the study, recruitment criteria, study protocol, potential risks and expected functional benefits. Informed consent will be obtained from patients who are eligible and choose to participate in the trial at a clinical research facility. Participants will be informed that they can withdraw from the study at any time without consequence. The results of the study will be published in peer-reviewed scientific journals and presented at conferences and seminars within 12 months of completion of the study.
Discussion
Poststroke shoulder pain and the resulting upper limb dysfunction remain a neglected problem, which can negatively affect clinical outcomes. Current evidence focuses on the use of a single approach to the treatment of poststroke shoulder pain, whereas, in actual clinical practice, multiple treatments are often chosen for simultaneous intervention with the expectation of improving patient outcomes. Therefore, research into combined therapeutic approaches for poststroke shoulder pain is urgent, and developing an ideal and effective rehabilitation programme is still ongoing.
This is the first clinical trial to study the combination of tDCS and acupuncture in treating patients with poststroke shoulder pain. The effectiveness of these interventions will be explored by designing a 4-week intervention and a 6-month follow-up. This research protocol will provide guidance on the importance of integrating existing and different rehabilitation techniques and designing more effective rehabilitation programmes.
The combination of tDCS enables patients with poststroke to maximise motor and functional recovery of the paralysed upper limbs and achieve independence in activities of daily living at an early stage, while also helping to maintain these results over time.32 33 The combined application of tDCS to patients with stroke not only accelerates functional recovery but also improves it, and the effects are maintained up to 1-year poststroke.34 It is unclear whether the combination of tDCS and acupuncture has a synergistic effect on improving poststroke shoulder pain, and the possible central mechanisms are unknown.
fMRI can objectively reflect cerebral nerve function, local blood flow status of the brain and brain tissue metabolism, reflecting the changes in cerebral neuroplasticity and has been widely used in recent years in the study of mechanisms of neurological diseases.35 36 Acupuncture stimulation of different regions can affect reflex circuits in the nervous system, establish new synaptic connections, promote neuronal synaptic regeneration and integrate central nervous system functions, thus improving the dysfunction of stroke patients. Acupuncture can induce a wide range of changes in brain activity, confirming the effects of acupuncture on the recovery of neurological function in stroke patients and that these changes in action are related to the neuroplasticity of acupuncture.28 37 The tDCS treatment of various chronic pain regulates cortical function by inducing cerebral neuroplasticity and affects the level of membrane potential and firing rates of target cortical neurons. tDCS changes, which are mainly manifested in the human motor cortex, such as the primary motor cortex (area M1), can alleviate the pain of the patients by altering the excitability of the cerebral cortex.38 39 Changes in neuroplasticity in the brain of patients with poststroke shoulder pain treated with tDCS combined with acupuncture have been observed by fMRI.
This study has a number of strengths. First, the intervention programme used in this study will be evidence-based and rigorously developed in accordance with the evidence, recommendations, theories and practice standards of systematic evaluation. Second, sensitive, systematic and comprehensive validated evaluation results were selected. These range from subjective pain and psychological scales to objective functional assessment scales and fMRI tests, combining subjectivity and objectivity to reduce the bias of confounding factors. Finally, fMRI was used to reveal the possible central mechanism of action in treating shoulder pain after stroke.
This research protocol may help to elucidate the interaction between tDCS and acupuncture. This new area of research may lead to the discovery of a central mechanism of action in the efficacy of tDCS and acupuncture in the treatment of poststroke shoulder pain, and potentially to the development of new therapeutic strategies aimed at improving the efficacy of treating poststroke shoulder pain. Therefore, this study will provide a more comprehensive and systematic protocol for further subsequent RCT studies.
This study protocol also has some limitations. Due to the visibility of the intervention, the design could not be blinded to participants and study researchers in the current study protocol. The source of data for the collection of cases was a single healthcare facility only, and there was a lack of multicentre healthcare facility data, which affected the level of evidence for the study findings. This study also lacks long-term follow-up and evaluation, and the long-term effects of the intervention are unknown. The shortcomings of acupuncture treatment are that it requires specialised doctors to administer the treatment and varies to some extent from doctor to doctor. There is also a lack of analysing the cost-effectiveness and cost-utility of tDCS combined with acupuncture for the treatment of poststroke shoulder pain. tDCS combined with acupuncture may increase the cost of treatment while improving clinical efficacy. We need to evaluate the cost inputs and health outputs of tDCS combined acupuncture from a health economics perspective in the future.
With this trial, we aim to test the hypothesis that tDCS combined with acupuncture treatment in patients with poststroke shoulder pain, when treated with conventional rehabilitation as a base treatment, not only improves pain and shoulder mobility in patients with poststroke shoulder pain but also improves the quality of daily life by improving the functional status of the upper limb. The positive results of this study will stimulate further large-sample-size, multicentre and even internationally collaborative RCTs that also include other types of dysfunction in stroke, potentially improving patient quality of life and expanding the number of patients who suffer from poststroke shoulder pain. In conclusion, the results of this study will demonstrate the effectiveness of tDCS combined with acupuncture treatment in patients with poststroke shoulder pain. More importantly, this study will investigate whether there is a synergistic enhancement of the effect of the combination of tDCS and acupuncture intervention and further explore its possible central mechanism of action.
Trial status
The trial is ongoing and recruiting participants. This study protocol is version 1 made on 28 September 2023. Recruitment commenced in December 2023 at the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine and is expected to be completed in December 2026.
Ethics statements
Patient consent for publication
Acknowledgments
This study was supported by the Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine, the Rehabilitation Technology Key Laboratory of Fujian Province and the College of Rehabilitation Medicine of Fujian University of Traditional Chinese Medicine. We thank all those who supported this research.
References
Footnotes
JC and Z-GL contributed equally.
Contributors SY, ZL, SC, JH, WL, ZL, YY TR and JC conceived and designed the study protocol and drafted the manuscript. JC, YY, RL and YJ wrote the manuscript. SY, ZL and JH are in charge of coordination and direct implementation. YY and ZL helped to develop the study measures and analyses. SY is the guarantor. SY and JC accepted full responsibility for the finished work and the conduct of the study, had access to the data, and controlled the decision to publish.
Funding This work was supported by the National Key Research and Development Program of China (Grant Nos: 2022YFC2009700), the National Natural Science Foundation of China (82074513), the Natural Science Foundation of Fujian Province (No: 2020J01760) and the Fujian Province University Industry University Cooperation Project (No: 2021Y4017).
Competing interests None declared.
Patient and public involvement Patients and/or the public were involved in the design, conduct, reporting or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.