Effects of manual lymphatic drainage combined with Kinesio taping on post-stroke shoulder-hand syndrome: a study protocol for a randomized controlled trial in the Southwest China region

Abstract

Background

Shoulder-hand syndrome (SHS) is a common upper limb complication following stroke. It is associated with poor functional recovery of the upper limb and reduced mobility. Both kinesiology tape (KT) and manual lymphatic drainage (MLD) are considered effective interventions for treating pain and swelling associated with SHS. However, there is currently no research examining the limitations and safety profile of combining K-tape with MLD for SHS management. This study aims to investigate the efficacy of KT combined with MLD in patients with post-stroke shoulder-hand syndrome.

Methods

This study will be a prospective, single-center, randomized, factorial, controlled clinical trial. This exploratory randomized controlled trial aimed to investigate the efficacy of MLD combined with KT for post-stroke SHS. This study used a blinded design. Ninety-six patients with post-stroke SHS are randomly divided into four groups: (n = 24 per group): Experimental Group 1: Conventional Rehabilitation (CR) + KT, Experimental Group 2: Conventional Rehabilitation (CR) + MLD, Experimental Group 3 (EG3): KT + MLD, Control Group: CR alone. All participants will receive CR as the baseline intervention. All subjects are first‑ever stroke patients diagnosed with unilateral limb paralysis by CT and/or MRI and meet the diagnostic criteria for SHS.

The informed consent process is carried out by a trained researcher not involved in the patients’ clinical care in a private room. Therapists participating in this study must hold a rehabilitation therapist qualification. Unified training will be provided to the treating therapists on MLD, KT, and conventional rehabilitation techniques. This study is conducted at the Army Specialized Medical Center. The Army Specialized Medical Center is a tertiary Grade A hospital located in Southwest China. In China’s hierarchical medical system, tertiary Grade A hospitals represent the highest level in the hospital classification system. Outcome measures will be assessed at four time points: baseline (T0), 4 weeks after initiating the intervention (T1), 3 months post-treatment (T2), 6-month follow-up (T3). The primary endpoints will be as follows: pain intensity measured by the Visual Analogue Scale (VAS) at T1, volume difference between the affected and unaffected upper limbs at T1. Secondary endpoints will include the following: upper limb motor function assessed by the Fugl-Meyer assessment for upper extremity (FMA-UE), activities of daily living evaluated using the modified Barthel index (MBI), joint range of motion (ROM) measurements, quality of life measured by the Stroke-specific quality of life scale (SS-QOL). Safety is assessed by monitoring vital signs (blood pressure and heart rate) before and after treatment, examining skin integrity at the tape application site for any adverse reactions (e.g., redness, rash), and recording any patient-reported increases in pain or other unexpected discomfort potentially related to the intervention.

Discussion

The efficacy of personalized rehabilitation therapy prescription interventions will be assessed through changes in primary and secondary outcome measures at the 4-week intervention point and during the 12-week follow-up period. To analyze whether MLD combined with KT for post-stroke shoulder-hand syndrome is superior to conventional rehabilitation in terms of pain, swelling, and motor function.

Trial registration

Clinical Trial Registry-China ChiCTR2300074140. https://www.chictr.org.cn/. First submitted on 31 July 2023.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-026-09728-x.

Introduction

Background

Stroke stands as the primary global cause of death and disability [1], characterized by five hallmark features: high incidence, disability rate, mortality rate, recurrence rate, and substantial economic burden [2]. Shoulder-hand syndrome (SHS), the third most prevalent complication following stroke, affects 12.5%–70% of stroke survivors according to epidemiological studies [3–6], with symptom onset typically occurring 1 to 3 months post-stroke [7]. Shoulder-hand syndrome, also known as reflex sympathetic dystrophy, is now classified as complex regional pain syndrome type I [8, 9]. Research suggests that SHS occurs because changes in the cranial vasomotor center following stroke cause vascular spasms. These spasms result in either increased sympathetic nervous system excitability or abnormal reflex sympathetic innervation of the limb [10]. Patients with SHS typically present with painful hand swelling that becomes particularly evident during wrist extension. SHS typically develops 1–3 months post-stroke [10]. In advanced stages, patients may develop muscular atrophy along with contractures and deformities of the finger joints [11, 12]. SHS represents one of the primary factors impeding upper limb motor function recovery in stroke survivors. Without timely intervention, progression to advanced stages may result in hand joint contractures and muscular atrophy. These sequelae can culminate in permanent hand disuse, significantly compromising patients’ quality of life (QoL) [13]. Clinically, SHS typically manifests with ipsilateral shoulder pain, edema, restricted mobility, sensory abnormalities, and trophic changes [14]. The pathogenesis of SHS remains incompletely understood and is associated with a poor prognosis. Current therapeutic approaches primarily rely on pharmacological interventions, which often entail substantial adverse effects while yielding insufficient efficacy. Beyond pharmacological interventions, physical therapy represents a common treatment approach for SHS. Physical therapy primarily comprises physical agent therapy and therapeutic exercise [15]. Despite the availability of multimodal therapeutic approaches—including pharmacological, physical, and exercise-based interventions—clinical outcomes remain suboptimal [16]. Consequently, identifying novel therapeutic approaches and determining optimal intervention strategies for post-stroke SHS rehabilitation have become imperative. The primary therapeutic objectives for SHS involve facilitating neuromuscular functional recovery, alleviating limb pain and edema, and restoring functional capacity of the affected limb. Manual lymphatic drainage (MLD) and kinesiology taping represent non-invasive therapeutic modalities characterized by high feasibility and low-risk profiles. Furthermore, studies have demonstrated that both MLD and KT effectively alleviate limb edema and pain [17–19]. However, other studies have found that manual lymphatic drainage (MLD) combined with exercise therapy failed to demonstrate efficacy in alleviating short-term pain in patients with complex regional pain syndrome type I (CRPS-I) [20]. In a study investigating combined manual lymphatic drainage (MLD) and repetitive transcranial magnetic stimulation (rTMS) therapy for post-stroke complex regional pain syndrome type I (CRPS-I), the combined treatment group demonstrated statistically significant improvements post-intervention [21]. Li Kunpeng et al. conducted a study in which the observation group received conventional comprehensive rehabilitation combined with manual lymphatic drainage. Before treatment and at 4weeks after treatment, hand edema, pain intensity in the affected limb, and motor function were assessed using the circumference method, the Visual Analogue Scale (VAS), and the simplified Fugl-Meyer Assessment (FMA), respectively. At baseline, there were no significant differences in VAS or FMA scores between the two groups (P = 0.75 and P = 0.78, respectively). At 4 weeks after treatment, the observation group showed significant improvements in edema (P = 0.02); VAS score (2.12 ± 0.39, mean ± SD); and FMA score (17.3 ± 2.9, mean ± SD), with all differences being statistically significant (P < 0.001) [22].

KT is primarily composed of a water-resistant elastic tape containing no pharmaceutical agents, medical-grade acrylic adhesive, and a release liner. The adhesive surface features a “fingerprint” or “water ripple” pattern resembling a sinusoidal waveform. Compared to traditional rigid athletic tape (white tape), KT possesses elastic properties. It exerts its therapeutic effects through the application of varying degrees of tension. After the externally applied tension is released from the skin, the tape generates a recoil force due to its inherent elasticity [23]. This mechanical action induces deformation of the skin and underlying tissues, thereby increasing the subcutaneous space. This mechanism contributes to multiple therapeutic effects, including enhanced sensory input, alleviation of pain, and improved circulatory function [24]. Wu Qiong et al. found that myofascial release technique significantly improved the FMA and modified MBI scores in stroke patients with SHS after treatment (P = 0.031, P < 0.001) [25]. Owing to its advantages of cost-effectiveness, ease of application, non-invasiveness, and diverse therapeutic effects, KT has been increasingly utilized in the field of rehabilitation medicine in recent years [26, 27]. MLD and kinesiology taping represent non-invasive therapeutic modalities characterized by high feasibility and low-risk profiles. Previous investigations have demonstrated the efficacy of both interventions in managing limb edema and pain through non-invasive mechanisms [19, 28]. Consequently, this study integrates these complementary techniques to evaluate their combined clinical efficacy and biomechanical impact on SHS. Although MLD and KT exhibit synergistic potential and share similarities in their underlying therapeutic mechanisms, there is a paucity of clinical research reporting on their combined application for SHS [29]. Furthermore, previous studies on this topic have been characterized by limitations, including small sample sizes, a lack of multi-group randomized controlled trials (RCTs), and insufficient long-term efficacy follow-up.Therefore, we conducted a RCT aiming to evaluate the clinical efficacy of combining MLD with KT for the treatment of SHS following stroke.

Methods

Study design

This study was a single-center, randomized, controlled, parallel-group trial conducted to evaluate the clinical efficacy of combining MLD with KT for the treatment of SHS following stroke. It also aims to establish standardized protocols and treatment regimens for this combined MLD and KT intervention. The trial was designed as a superiority trial to test the hypothesis that manual lymphatic drainage combined with Kinesio taping is superior to conventional rehabilitation alone in improving outcomes for patients with post-stroke SHS. Eligible participants were randomly assigned to either the observation group or the control group in a 1:1:1:1 allocation ratio. After enrollment, all baseline measurements were collected prior to randomization. These included demographic data (age, gender, disease duration) and clinical outcome measures. Following the baseline assessment, patients were randomly assigned in a 1:1:1:1 ratio to either the observation group or the control group. A total of 96 patients with post-stroke SHS were enrolled and randomly allocated to four groups (n = 24 per group): Experimental Group 1: Conventional Rehabilitation (CR) + KT, Experimental Group 2: Conventional Rehabilitation (CR) + MLD, Experimental Group 3 (EG3): KT + MLD, Control Group: CR alone. The interventions were administered five times per week for 4 weeks. Outcome measures were assessed at four time points: T₀: baseline (pre-treatment); T₁: 4 weeks post-treatment initiation; T₂: 3 months post-treatment completion; T₃: follow-up (6 months post-baseline*). The study flowchart is presented in Fig. 1. The study design, including intervention groups and time points for rehabilitation assessment, is presented in Figs. 2 and 3.

Fig. 1.

The flowchart of the research design. SHS, shoulder-hand syndrome; CR, conventional rehabilitation therapy; KT, Kinesio taping; MLD, manual lymphatic drainage

Fig. 2.

Experimental interventions and rehabilitation assessments, SHS, shoulder-hand syndrome; CR, conventional rehabilitation therapy; KT, Kinesio taping; MLD, manual lymphatic drainage. Visual Analogue Scale, VAS; modified Barthel index, MBI; joint range of motion, ROM; Stroke-specific quality of life scale, SS-QOL

Fig. 3.

SPIRIT figure displaying the schedule of enrolment, interventions, and assessments

Recruitment and informed consent

Patients meeting the diagnostic criteria for post-stroke SHS and receiving conventional rehabilitation therapy at the Department of Rehabilitation Medicine, Army Medical Center of PLA will undergo screening for enrollment. The Army Specialized Medical Center is a tertiary Grade A hospital located in Southwest China. In China’s hierarchical medical system, tertiary Grade A hospitals represent the highest level in the hospital classification system.

Recruitment of participants for this randomized controlled trial (RCT) is being conducted at the Army Medical Center of PLA from February 2024 to 2026. Participants will receive professional rehabilitation assessment, MLD, and KT at no cost. The informed consent form will explicitly state the specific intervention protocol, potential trial risks, and contact information. The informed consent process is carried out by a trained researcher not involved in the patients’ clinical care in a private room. The trained researcher explained the study’s purpose, procedures, potential benefits, and possible risks in detail. Patients are informed that their participation is entirely voluntary and that they could withdraw from the study at any time without any consequences for their routine medical care. Participants (or their legal guardians) may directly contact the project leader directly. Patients who agree to participate will sign the written informed consent form and undergo randomized allocation. Upon hospital admission, baseline data will be recorded, including patient demographics (e.g., age, gender), medical history, and baseline assessment scores of rating scales. To promote participant retention and complete follow-up, the following strategies will be used:

Participants will be offered flexible scheduling for assessment visits, and reminder calls will be made 24–48 h before scheduled appointments. For participants who discontinue the intervention, efforts will be made to complete all scheduled outcome assessments unless the participant explicitly withdraws consent for all data collection. For participants who deviate from the intervention protocol or discontinue early, all available outcome data will still be collected at scheduled time points whenever possible, and these participants will be included in the intention-to-treat analysis.

Inclusion criteria

Patients must meet all of the following criteria to be eligible for enrollment: ① patients with first-ever stroke (cerebral infarction or intracerebral hemorrhage) resulting in unilateral hemiplegia, diagnosed per the 4th Chinese Stroke Association Academic Conference criteria, radiologically confirmed by CT and/or MRI; ② diagnosed per SHS criteria; ③ alert and oriented, with intact cognitive function enabling compliance with assessment and therapy; ④ aged < 80 years with voluntarily signed informed consent forms; ⑤ clinically stable with non-progressing neurological symptoms; ⑥ absence of critical systemic illnesses including severe cardiac disease, renal impairment, or malignancies.

Exclusion criteria

Subjects meeting any of the following criteria will be excluded from this study: ① deterioration in clinical condition or occurrence of new infarction or hemorrhage; ② subjects presenting with concurrent active infections, erysipelas, deep vein thrombosis (DVT), or other contraindications to MLD will be excluded; ③ subjects failing to adhere to the treatment protocol will be excluded; ④ subjects with compromised skin integrity of the upper limbs contraindicating KT will be excluded; ⑤ subjects with pain attributable to underlying pathologies such as frozen shoulder, cervical spondylosis, or myocardial infarction) will be excluded; ⑥ subjects with underlying conditions such as hepatic or renal impairment, malignancy, congestive heart failure (CHF), or multi-organ failure (MOF)) will be excluded; ⑦ subjects currently enrolled in other clinical trials, or who have received edema- or pain-related treatments prior to enrollment, will be excluded.

Randomization and blinding design

1. Random allocation and concealment: The random allocation sequence was generated using Excel software via the random number table method with 1:1:1:1 allocation ratio. The resulting sequence and grouping methodology were sealed in sequentially numbered, opaque envelopes, entrusted to a trial-independent third party, and maintained confidential with allocation scheme concealed until trial completion.

2. Random group assignment: During the trial, sequentially numbered envelopes were opened in ascending order according to patients’ enrollment sequence. The allocation sequence was retrieved, and eligible patients were randomly assigned to either the control or test group based on instructions within the envelopes.

3. Blinding procedure: Due to the physical nature of the interventions, blinding of patients and therapists is not possible. To reduce measurement bias, the outcome assessors are kept blinded to group assignment. All baseline and post-treatment evaluations are conducted by independent evaluators who are not involved in the intervention implementation, with the same evaluator assessing each patient at both time points. During the assessment process, the evaluators are prohibited from inquiring about the patients’ treatment experiences, and the patients are instructed not to disclose their group allocation. The statistical analysis is performed by personnel who are blinded to group assignments. Unblinding of outcome assessors is not anticipated to be necessary, as assessors are not involved in participant care.

4. Sample size estimation: The sample size for this study was calculated using G*Power software (version 3.1.9.7). A repeated measures analysis of variance (ANOVA) was used to detect differences among the four groups across four time points. According to the study by Ou Jianlin et al. [30], the effect size was estimated at f = 0.20. With a two-tailed significance level of α = 0.05 and a desired power (1 – β) of 0.80, the required sample size was calculated to be 76 participants. To account for an anticipated dropout rate of 20%, the sample size was inflated to 96 participants, resulting in 24 participants per group.

Intervention

Manual lymphatic drainage therapy

The patient is positioned supine. The physiotherapist stands laterally beside the patient and first applies gentle manual pressure toward the drainage direction. During MLD, therapist hand contact must be made directly with the patient’s skin. The treatment sequence begins by clearing lymph nodes bilaterally. Before addressing the edematous area, MLD initiates in the proximal contralateral quadrant(s) closest to the swelling. Subsequently, the therapist moves across the lymphatic watershed, overriding its natural drainage patterns. Finally, lymph fluid is directed from the ipsilateral (affected) quadrant(s) towards the contralateral quadrant(s). Lymph nodes serve as convergence points for numerous afferent and efferent lymphatic vessels. Therefore, during MLD, therapists must repeatedly clear these lymph nodes. To clear lymph nodes, therapists apply gentle pressure using two or three fingers in a pumping motion. This technique anchors the skin without sliding, while slowly applying downward pressure. Additionally, within superficial lymphatic territories, therapists exclusively employ gentle gliding strokes using the palmar surface. This technique redirects lymph fluid toward cleared lymph nodes. Given the extreme fragility of lymphatic vessels, MLD application requires minimal pressure—merely sufficient to create subtle skin traction. Axillary region technique: the PT performs stationary circles over the axillary lymph nodes. Medial upper arm technique: using both hands, the PT executes stationary circles on the medial upper arm (specifically over the biceps brachii in the mid-arm region), applying pressure toward the axilla. Deltoid region technique: the PT performs stationary circles over the deltoid muscle, applying pressure toward the axillary lymph nodes. Lateral upper arm technique: pump pressure is applied to the lateral and anterior aspects of the upper arm. Elbow region technique: the PT performs stationary circles over the medial and lateral epicondyles, applying pressure proximally. The PT applies stationary circles to the cubital region (cubital lymph nodes) while concurrently performing passive flexion and extension of the elbow joint. Forearm region technique: the PT applies: scoop technique to the forearm (flexor and extensor aspects) stationary circles OR pump pressure as indicated. Hand dorsum and digits technique: stationary circles over the dorsal wrist. Stationary circles on the hand dorsum. Stationary circles or thumb flattening to fingers and thumb Palmar region technique: lymphatic drainage from the palmar surface (excluding central zone) flows:

dorsally → proximally. Central palmar lymph drains laterally toward the central forearm drainage area. The PT administers MLD at a frequency of once daily (1 ×/d), with each session lasting 20 min. Treatments are delivered 5 sessions per week over 4 consecutive weeks.

Kinesio taping therapy

Researchers applied 5-cm-wide KT. Prior to treatment, all participants underwent hypersensitivity testing. Individuals demonstrating KT hypersensitivity are excluded from the study. KT Application Protocol for Shoulder Pain Relief: Therapist applies an X-shaped KT strip with natural tension. Position the patient in seated posture with the affected shoulder in neutral position, elbow flexed to 90°, and forearm pronated. The central anchor is centered over the painful point in the shoulder region, with the tails extending bilaterally. Therapist applies an I-shaped KT strip with 15–25% applied tension. Position the patient in seated posture with the shoulder abducted to 45° and elbow flexed to 90°. The anchor is fixed medial to the superior angle of the scapula, with the tail directed over the greater tubercle of the humerus toward the deltoid tuberosity. To reduce hand edema and facilitate contraction of the wrist extensors apply claw taping using natural tension. Patient positioning: supine or seated, with the arm pronated and resting on the treatment table. Maintain the wrist in a natural flexed position. For this claw taping application: anchor placement: position the anchor over the lateral epicondyle of the humerus. Tape path: extend the tape distally along the path of the wrist extensors. Tails: split the tape distally, extending the tails over the dorsum of the hand and continuing over the dorsal aspects of the fingers towards the interphalangeal joints. The kinesiology tape application remains in place for 2 days per session. Each application is followed by a 1-day (1d) rest period. This treatment cycle is repeated for a total duration of 4 weeks.

Conventional rehabilitation therapy

All patients in this trial will receive a 4-week course of conventional rehabilitation therapy conducted on weekdays. The therapy regimen comprises the following:

• (1) physical therapy (PT), including sit-to-stand training (STT), trunk control training, balance training, and gait training; (2) occupational therapy (OT), consisting of upper limb stretching, passive/active-assisted range of motion (P/AAROM) training, and object transfer training; (3) Traditional Chinese Medicine (TCM) rehabilitation therapy, involving moxibustion and acupuncture treatment. The conventional rehabilitation therapy will be delivered by two specially trained and blinded therapists.

Outcome measures

Primary outcome measures

Pain assessment

Measurement variable

Pain intensity is assessed using the Visual Analogue Scale (VAS). This scale consists of a 100-mm line ranging from 0 (no pain) to 10 (worst imaginable pain). Patients rate their pain on a scale of 0 to 10, with higher scores indicating greater pain severity.

Analysis metric

The change in VAS score from baseline to week 4.

Method of aggregation

Mean and standard deviation (x̄ ± s) are calculated for each group.

Time points

Baseline and 4 weeks post-treatment.

Clinical significance

Pain is the most distressing symptom for patients with shoulder-hand syndrome; its relief directly reflects the clinical benefit of the intervention and represents the treatment outcome most valued by patients.

Volume difference between the affected and unaffected upper limbs

The volume of the affected upper limb is assessed using the perimeter measurement method. Arm circumferences are measured at five levels: the ulnar styloid process, and 10 cm, 20 cm, 30 cm, and 40 cm above it. The volume of each segment is calculated using the formula V = h(C₁² + C₂² + C₁C₂)/12π, where C₁ and C₂ represent the circumferences (in cm) at the proximal and distal ends of the segment, respectively, and h is the segment length (10 cm). The total limb volume is the sum of the segmental volumes. The volume difference between the two limbs is calculated as follows: healthy side volume − affected side volume. The unit for measuring the volume of the upper limbs is milliliters.

Analysis metric

The change in the volume difference between the two sides from baseline to week 4.

Method of aggregation

Mean and standard deviation (x̄ ± s) are calculated for each group.

Time points

Baseline and 4 weeks post-treatment.

Clinical significance

Upper limb edema is a core clinical manifestation of shoulder-hand syndrome; changes in the volume difference objectively reflect the degree of edema improvement.

Secondary outcome measures

Upper limb motor function assessment

Motor impairment of the upper limb will be assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE). The FMA-UE is a well-established and widely used measure for this purpose. The upper limb section comprises 33 items. Performance on each item is scored on a 3-point ordinal scale: 0, 1, or 2. A score of 0 indicates the inability to perform the movement. A score of 1 indicates partial completion of the movement. A score of 2 indicates full completion of the movement. The total score ranges from 0 to 66, with higher scores indicating better motor function. The main analysis assesses the changes in FMA-UE scores from baseline to each follow-up time point.

Activities of daily living (ADL)

Functional independence in ADL will be assessed using the modified Barthel index (MBI). The MBI evaluates performance across 10 domains: fecal continence; urinary continence; grooming; toilet use; feeding; chair/bed transfers; ambulation; dressing; stair climbing; and bathing. Each item is rated on a 5-point ordinal scale based on the level of assistance required: total dependence; maximal assistance; moderate assistance; minimal assistance; or complete independence. The total score ranges from 0 to 100 points, with higher scores indicating greater functional independence. The Barthel index scoring system classifies ADL function based on the total score: 0–20 points indicate total functional dependence; 25–45 points indicate severe functional impairment; 50–70 points indicate moderate functional impairment; 75–95 points indicate mild functional impairment; and 100 points indicate functional independence. For each group, the mean and standard deviation (x̄ ± s) are calculated.

Joint range of motion (ROM) measurement

Active and passive ROM will be measured using a universal goniometer. The goniometer will be positioned on the lateral aspect of the target joint. During measurement, the axis of the goniometer will be aligned with the joint’s axis of rotation. The stationary arm will be positioned parallel to the longitudinal axis of the proximal bone segment, while the moving arm will be aligned parallel to the longitudinal axis of the distal bone segment. Active and passive ROM measurements will be performed and recorded for the following joints in standardized positions: shoulder: flexion/extension, abduction/adduction, external rotation/internal rotation. Elbow: flexion/extension. Wrist: flexion/extension, ulnar deviation/radial deviation. Digits (fingers): flexion/extension. The unit of measurement for joint range of motion is degrees.

Quality of life (QOL) assessment

Quality of life will be assessed using the Stroke-specific quality of life scale (SS-QOL). The SS-QOL is a patient-centered, stroke-specific instrument designed to measure health-related quality of life. It comprises 12 domains: energy; family roles; language; mobility; mood; personality; self-care; social roles; thinking; upper extremity function; vision; and work/productivity. these domains encompass a total of 49 items. Each item is rated on a 5-point Likert scale (ranging from 1 to 5 points). Higher scores on the scale indicate better perceived health status.

Safety outcomes

Measurement variable

All adverse events occurring during the study period are documented, including but not limited to skin irritation/allergic reactions, increased pain, falls, and deep vein thrombosis.

Analysis metric

Incidence rate of adverse events.

Method of aggregation

The number and percentage (n, %) of patients experiencing adverse events are calculated for each group.

Time point

Throughout the entire study period.

Clinical significance

Monitoring adverse events is essential for evaluating the safety of the intervention and provides evidence to support its clinical application.

Statistical analysis

All data in this study will be statistically analyzed using SPSS software, version 17.0 (IBM Corp., Armonk, NY, USA). Descriptive statistics for continuous variables: continuous variables will be expressed as mean ± standard deviation (SD) if normally distributed; otherwise, they will be reported as median and interquartile range (IQR) (median (IQR)). Descriptive statistics for categorical variables: categorical variables will be presented as frequency counts and percentages (n (%)). For normally distributed continuous variables, between-group comparisons will be performed using analysis of variance (ANOVA); for non-normally distributed variables, the Kruskal–Wallis test will be employed. The chi-square (χ²) test will be used for comparisons involving categorical variables. For within-group or between-group comparisons of normally distributed continuous variables, the assumptions of homogeneity of variance and sphericity will be assessed. When these assumptions are satisfied, repeated-measures analysis of variance (RM-ANOVA) will be employed. For continuous variables not normally distributed or with unequal variance, nonparametric rank-sum tests will be used for between-group comparisons (Mann–Whitney U test for two groups; Kruskal–Wallis test for three or more groups). For ordinal categorical data, ordinal logistic regression (OLR) will be performed. For all outcomes, treatment effects are presented as mean differences with 95% confidence intervals (CIs), in addition to P values. A two-tailed P value < 0.05 was considered statistically significant [31]. Primary and secondary outcome analyses were performed on the intention-to-treat (ITT) population, defined as all patients who were randomized, regardless of whether they completed the full intervention protocol or withdrew from the study. To handle missing data, we will use mixed-effects models for repeated measures (MMRM) as the primary analytic approach. MMRM is widely used in clinical trials for analyzing longitudinal continuous outcomes [32] and uses all available observed data under the missing at random (MAR) assumption, thereby avoiding biases associated with single imputation methods such as last observation carried forward (LOCF) [33]. Baseline demographic and clinical characteristics are summarized descriptively to describe the study population. Continuous variables are presented as mean ± standard deviation (x̄ ± s) and categorical variables as frequencies and percentages (n, %). Because participants were randomly assigned to groups, formal statistical comparisons of baseline variables were not performed [34]. These continuous outcomes were measured at four time points (baseline, 4 weeks, 3 months, and 6 months post‑treatment). A two‑way repeated‑measures ANOVA was conducted to assess the effects of group (four groups), time (four time points), and their interaction (group × time) on these outcomes. If the assumption of sphericity was violated, the Greenhouse–Geisser correction was applied. In the case of a significant interaction effect, pairwise comparisons among groups at each time point were performed with Bonferroni correction to adjust for multiple comparisons. Upper limb motor function (FMA‑UE), activities of daily living (MBI), joint range of motion, and quality of life (SS‑QOL): These continuous outcomes were also measured at four time points. The same two‑way repeated‑measures ANOVA model described above was used to analyze these outcomes, followed by Bonferroni‑corrected pairwise comparisons when appropriate. Although multiple secondary outcomes were analyzed, the primary outcome was prespecified as the main focus of the study. This randomized controlled trial was conducted and reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement [35].

Discussion

To the best of our knowledge, no studies have yet been conducted to investigate the safety and clinical efficacy of combined MLD and KT for post-stroke SHS. This prospective, single-center, randomized, factorial-designed, controlled clinical trial, employing a protocol of a 4-week intervention with a 6-month follow-up, was designed to validate the safety and efficacy of this combination therapy. The lymphatic system (LS) is a crucial component of the human immune defense system and constitutes a major part of the vascular system. Lymph fluid returns protein molecules from the interstitial fluid to the bloodstream. Additionally, the LS effectively filters out red blood cells (RBCs) and pathological macromolecules that cannot be reabsorbed. (RBCs) and large molecules that cannot be reabsorbed by blood capillaries from the bloodstream [36]. The driving force for interstitial fluid entry into the initial lymphatics is the pressure gradient between the interstitial fluid and the lymph within these vessels. Elevated interstitial fluid pressure enhances lymph formation. MLD is recognized as a manual technique that stimulates the LS, thereby enhancing lymphatic pump function and promoting lymph fluid clearance from peripheral tissues. Gentle massage and compression applied via MLD stimulate the LS. This stimulation enhances lymphatic pumping action, which constitutes one of the primary driving forces for interstitial fluid (IF) entry into the initial lymphatics. Valves within lymphatic vessels prevent lymph backflow [13]. The walls of collecting lymphatics contain contractile smooth muscle. The coordinated activity of these valves and smooth muscle constitutes the “lymphatic pump,” propelling lymph fluid flow. This enhanced pumping increases lymphatic transport capacity and lymph node (LN) reabsorption function, improves microcirculatory dynamics, facilitates interstitial fluid (IF) uptake into initial lymphatics and subsequent lymph return, ultimately achieving edema reduction [37, 38]. MLD targets the subcutaneous initial lymph vessels. Based on the anatomical location of the lymphotomes, this technique employs a gentle massage modality. MLD activates collateral lymphatic vessels, enhancing lymphatic diversion. This process redirects lymph fluid from edematous areas to adjacent, functional lymphotomes. Research has demonstrated that MLD can rapidly and effectively reduce lymphedema by enhancing lymph node (LN) reabsorption and facilitating lymph return [39–41]. Research has also found that both Conventional Rehabilitation (CR) alone and CR combined with MLD are effective in reducing pain and edema in the affected upper limb of hemiplegic patients. However, patients receiving the combined CR and MLD treatment demonstrated significantly greater reductions in both pain and edema severity compared to those receiving CRT alone [42]. A possible mechanism is that MLD techniques exert tugging forces on subcutaneous anchoring filaments. This filament movement stimulates initial lymphatic endothelial cells, thereby activating the lymphatic system to enhance the return of peripheral lymph and IF. This enhanced fluid return further improves microcirculatory dynamics, ultimately reducing edema severity and pain in the affected limb [43]. Additionally, when KT adheres to the skin, it creates convolutions that elevate the cutaneous layer. This lifting effect facilitates the movement of IF and lymph. Through careful placement of the tape’s Anchor and Tail segments, practitioners establish a directional pathway, guiding the flow of IF and lymph toward the closest lymph nodes (LNs), thereby promoting drainage into the lymphatic system. Research indicates that KT increases interstitial space beneath the skin and reduces interstitial pressure resulting from postoperative swelling. This effect also facilitates lymphatic drainage pathways, thereby enhancing its efficacy in reducing edema and improving microcirculation [44].

Compared to traditional non-elastic bandages, KT provides structural support without restricting joint mobility. A constant shear force can be maintained on the skin for several days. Due to these properties, KT is clinically used to: stabilize joints, manage muscle spasticity, enhance muscle function through increased mechanical stimulation of cutaneous mechanoreceptors, and reduce pain and inflammation by improving lymphatic and microcirculatory dynamics [24]. Study has found that KT application is superior to placebo/sham taping or no intervention in reducing pain among stroke patients, regardless of whether they are in the acute, subacute, or chronic phase [45]. Huang et al. implemented an intervention combining the muscle inhibition technique with space correction taping in patients with hemiplegic shoulder pain. After 3weeks of intervention, significant improvements were observed in the patients’ Shoulder Pain and Disability Index (SPADI) scores and shoulder ROM, specifically in flexion, external rotation, and internal rotation. These improvements suggest that KT may serve as a viable therapeutic alternative for managing hemiplegic shoulder pain [46]. Research has indicated that KT application may offer beneficial effects in the management of various inflammatory joint conditions, including but not limited to reducing swelling and alleviating pain [47]. KT application inherently possesses proposed mechanisms for myofascial adjustment. However, when used as a standalone intervention, its efficacy in pain alleviation remains inconsistent [14]. Some researchers propose that the mechanism underlying KT analgesic effect involves its generated mechanical stimulation. This stimulation is hypothesized to inhibit pain transmission at the spinal cord level via the gate control mechanism, while concurrently enhancing local blood and lymphatic circulation [14]. According to the Gate Control Theory (GCT), the application of KT to the skin stimulates large-diameter sensory nerve fibers (Aβ fibers). This stimulation generates afferent signals that travel to the central nervous system, where they inhibit the transmission of nociceptive (pain) signals, thereby alleviating symptoms [48, 49]. Prior research has demonstrated that pain can alter the central nervous system (CNS). This alteration consequently modifies the transmission of reflexive neural messages, thus changing motor output. In their study, Le Pera et al. delivered transcranial magnetic stimulation (TMS) over the primary motor cortex (M1). This stimulation was applied under both painful and non-painful conditions. The researchers then recorded motor evoked potentials (MEPs) via electromyography (EMG) to assess muscle contraction responses [50–52]. They found that during painful stimulation, the amplitude of muscle contraction responses decreased. Mellor et al. found that individuals with symptomatic patellofemoral pain (PFP) exhibited reduced motor unit synchronization in the vastus medialis obliquus (VMO) muscle during maximum isometric knee contraction compared to asymptomatic individuals with PFP [53]. Additionally, KT enhances muscle contraction. This facilitates more effective contraction of lymphatic vessels, thereby promoting lymph flow. Furthermore, the slight tension exerted by KT stimulates lymphatic vessels. This stimulation facilitates the movement of lymph from high-pressure regions to low-pressure regions. Specifically, K-tape can be applied using targeted techniques to direct lymph flow toward healthy lymph nodes, thereby enhancing drainage. Several studies indicate that KTcan reduce limb swelling, increase limb ROM, and alleviate pain and discomfort in patients with lymphedema following breast cancer surgery or head and neck cancer treatment. However, variations exist in the quality and sample sizes of these studies. Additionally, higher-quality randomized controlled trials (RCTs) are required to further elucidate K-tape’s mechanisms of action on lymphedema, establish optimal application techniques, and confirm long-term efficacy [54–56].

This study combined MLD and KT therapy. The synergistic approach leverages MLD as the foundational technique, while KT application provides directional facilitation and creates tissue pathways. This combined modality enhances the efficiency of interstitial fluid and lymphatic fluid drainage towards the terminal reservoir, ultimately improving limb edema. Furthermore, the tactile input provided by the application of MLD and KT to the skin may effectively alleviate or eliminate pain associated with SHS [57].Through this randomized controlled trial (RCT), we aim to provide preliminary evidence regarding whether the combined application of MLD and KT ameliorates symptoms of SHS following stroke. Should the findings of this study confirm the efficacy of the combined MLD and KT protocol, we will then conduct a large-scale, multicenter randomized RCT to validate its therapeutic effectiveness and clinical applicability.

Trial status

Recruitment of participants started in February 2024. The trial is currently underway and expected to be completed by the end of 2026.This trial started later than the scheduled time in the contract because the principal investigator made partial revisions to the detailed content of the trial. All revisions made to the trial are classified as minor revisions. Since the revisions are minor and do not involve changes to key ethical content, they are within the scope of the initial ethical approval. The protocol version number is 2022MSXM035.

Authors' contributions

C- YG. Protocol conception: C- YG, H- JC, HS-G. Protocol design: L-Y L, LY. Ethical review: Y- SL, YZ,CY-Y. Ethical approval: LYL, YZ. Statistical analysis: LY. Establishment of study database: YT. Clinical population recruitment and assignment: YT. Manuscript drafting: L- YL, LY. All authors approved the final version of this manuscript.

Funding

This study is being supported by grants from the Chongqing Municipal Association of Science and Technology and Medical Association Joint Medical Research Project (2022MSXM035), the National Natural Science Foundation of China (NSFC, Grant No. 82572945) and the Chongqing Medical Scientific Research Project (2025ZDXM039).

Data availability

The datasets used and/or analyzed during the current study are available from the study management team on reasonable request.

Declarations

Ethics approval and consent to participate

This study has been approved by the Ethical Review Opinion on Biomedical Research Involving Humans by the Ethics Committee of the Chinese People’s Liberation Army Medical Center (2023) No. 149 All methods will be conducted in accordance with the ethical standards of the Declaration of Helsinki. Informed consent will be obtained from all subjects.

Consent for publication

Consent for publication is not required as there are no details on individuals reported within the manuscript.

Competing interests

The authors declare that they have no competing interests.