Tuina on knee pain and functional decline of lower limbs for patients with mild-to-moderate knee osteoarthritis in Shanghai: protocol for a multicentre, assessor-blinded, randomised controlled trial

Introduction

As one of the most common musculoskeletal diseases worldwide,1 about 30% of people over the age of 45 have radiographic evidence of knee osteoarthritis (KOA), with approximately half experiencing obvious discomfort symptoms.2 In China, through the large sample research statistics and previous research, the cumulative incidence of KOA is estimated to be 8.7%, and the prevalence of symptomatic KOA in women (10.3%) is higher than that in men (5.7%). The prevalence of KOA escalates with advancing age, indicating a progressively increasing disease burden and demand for elderly care within the Chinese population.3 4 Shanghai, being the largest city in eastern China, bears a substantial population burden and consequently experiences significant demands for medical services.5 Previous epidemiological studies have demonstrated that the prevalence of symptomatic KOA in this region reaches up to 3.4%, with higher rates of tibiofemoral joint OA observed among urban populations compared with Caucasians.6 7 As urbanisation expands and the population ages, the healthcare strain and socioeconomic burden associated with KOA will become more severe, necessitating urgent exploration of cost-effective treatment.8

Strong evidence indicates that KOA could be affected by a variety of risk factors including sex, obesity and previous knee injury,9 and it is characterised by intermittent or sustained chronic knee pain, brief morning stiffness and functional limitations related to muscle weakness.10 11 The most prevalent issue among patients is knee pain, which could lead to restricted lower limb movement and abnormal gait due to the onset and exacerbation of pain.12–14 Therefore, numerous therapeutic interventions are focused on alleviating knee pain, which leads to enhancing patients’ quality of life and promoting their physical and mental well-being through effective medical management.15–17 According to the guidelines, oral non-steroidal anti-inflammatory drugs have been recommended to mitigate pain.18 19 Among them, celecoxib, the frequently prescribed medication in clinical practice, demonstrates substantial efficacy in alleviating pain and inflammation based on ample evidence.20–22 Although previous studies have demonstrated comparable cardiovascular safety to ibuprofen or naproxen,23 24 its use is not recommended for individuals with cardiovascular or gastrointestinal comorbidities in the context of KOA.25 Consequently, the potential variation in side effects associated with drug therapy restricts its application.

Currently, several trials exhibit sufficient evidence that exercise therapy has significant benefits for patients with lower extremity OA in terms of pain relief and improving limitation in function.26 However, with regard to the age of OA patients in China and the level of basic medical condition,4 the need to develop a personalised, standardised and high-quality exercise training programme for the large population of patients could be hard to achieve. Furthermore, considering concomitant factors such as excess obesity, the obvious effect of exercise therapy may take a relatively high cost of time. As symptoms worsen, surgical treatment including total knee arthroplasty could be considered to bring greater pain relief and functional improvement,27 but it may also be accompanied by a higher cost of treatment and an increased risk of adverse events which can raise the burden of living.28 Thus, considering both cost and the applicable population, an effective and safe intervention for KOA is urgently needed.

Tuina, a non-invasive physical therapy based on the meridian theory of traditional Chinese medicine (TCM), is a general term for various massage techniques.29 The feature of this manipulation lies in the use of different forms, strengths and actions of the palm or fingers. When treating diseases in different parts of the body, Tuina physicians employ distinct areas of both hands, such as the palm, dorsal side of the hand or thumb, to perform specific manipulative techniques (including but not limited to compression, percussion, friction, oscillation and joint mobilisation, etc) on the surface of the patient. The efficacy of Tuina on pain relief of different diseases has been proven, such as non-specific chronic neck pain,30 tension-type headache,31 as well as chronic fatigue syndrome,32 and this therapeutic manual therapy is also helpful for the relief of anxiety and depression.33 34 In addition, owing to the low requirements for equipment, the process and duration of Tuina are flexible and adjustable, which to some extent reduces the potential risk of therapeutic damage brought by other physical therapies. In previous randomised controlled trials (RCTs), the incidence of adverse events in Tuina therapy is generally low,35 36 which is due to the timely communication between therapists and patients during the treatment. Unlike physical therapy, Tuina therapy is a passive manual therapy that does not require extra effort from patients. During the treatment process, patients maintain a comfortable sitting or lying position while being in a relaxed state.29 Tuina therapy caters to a wide range of age groups. If the criteria for treatment are met, designated Tuina treatments can be performed for children or elderly individuals recovering from stroke.37–39 Furthermore, compared with high cost of surgery, the cost of non-surgical therapies such as Tuina is lower and does not increase the medical burden of OA patients.40 41 The efficacy of Tuina in treating KOA has been supported by several studies.42 43 However, there remains a dearth of sufficient evidence regarding its impact on physical function improvement, and the evaluation of this complementary therapy’s effectiveness still lacks credible high-quality evidence.

Building on the findings of our previous studies,43 44 we developed the multicentre, large-sample RCT with the aim of implementing this effective complementary intervention for treating knee pain and lower limb dysfunction in diverse community settings in Shanghai. Evidence on the effectiveness and safety of Tuina in reducing pain in patients with KOA will be collected. This study’s findings could contribute to validating Tuina’s use as a complementary therapy for KOA.

Methods and analysis

Hypothesis

We will conduct this RCT to hypothesise that the application of Tuina as a complementary therapy would reduce pain levels, improve the quality of life and enhance physical function in patients with KOA. The objectives of this study are to validate the efficacy of Tuina in relieving pain and improving physical function in individuals with mild-to-moderate KOA compared with celecoxib.

Study design and settings

This study is a 12-week, multicentre RCT conducted in eight public hospitals at various levels (Shanghai Municipal Hospital of TCM, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai General Hospital, Shanghai Jing’an District Hospital of TCM, Shanghai Jiading District Hospital of TCM, Shanghai Qingpu District Hospital of TCM, Shanghai Jing’an District Central Hospital, Shanghai Jiangning community health service centre) from February 2023 to December 2025.

Patients who meet the inclusion criteria will be recruited and randomly assigned equally into one of two groups: the Tuina group (TG) or the celecoxib Group (CG). Participants in TG will receive Tuina treatment two times a week for 4 weeks, each treatment lasts for 30 min. In CG, participants will be required to take 200 mg of celecoxib orally daily for 4 weeks. At the end of the intervention, an 8-week follow-up will be conducted, and relevant outcome measures will be assessed at 8, 12 weeks of the follow-up phase. All participants will complete the assessments by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 36-item Short-Form Health Survey (SF-36), Timed Up and Go test (TUG), Short Physical Performance Battery (SPPB) and Gait analysis (detailed trial process seen in figure 1 and table 1). All patients will be completely informed of the potential benefits, potential risks and responsibilities, those who will sign the informed consents once they are included. Participants will receive brief reports at the end of the study, which demonstrate the changes before and after the intervention.

Figure 1
Figure 1

Study flow chart. SF-36, 36-item Short-Form Health Survey; SPPB, Short Physical Performance Battery; TUG, Timed Up and Go test; WOMAC, Western Ontario and McMaster Universities Osteoarthritis Index.

Table 1

Schedule of recruitment, interventions and assessments

Participants

The trial will recruit patients who had symptomatic, radiologically confirmed KOA according to criteria from the American College of Rheumatology.45 To precisely screen the target patients, the following criteria were developed for this clinical trial.

Inclusion criteria

All patients with mild-to-moderate KOA will be assessed to see if they meet the following inclusion criteria:

  1. Men or non-pregnant women.

  2. Aged ≥40 years and ≤70 years.

  3. Meeting the diagnostic criteria for OA of the knee.45

  4. Mild-to-moderate radiographic tibiofemoral OA (Kellgren and Lawrence grades I–II) in at least one knee.46 47

  5. WOMAC pain subscore ≥3 on at least one of five questions.48

  6. Unilateral knee involvement.

  7. Understand Chinese and speak Mandarin Chinese.

  8. No previous knee surgery and no accompanying other knee problems.

  9. Volunteer to participate in this study and provide written informed consent.

Exclusion criteria

Participants who meet any of the following criteria will be excluded from this trial:

  1. History of trauma and surgery on knee.

  2. History of other treatment in last 6 months.

  3. Have tumours, tuberculosis, osteomyelitis and other diseases in the knee.

  4. Have severe liver and kidney dysfunction, severe cardiovascular disease, diabetes mellitus and mental illness.

  5. Suffer physical pain caused by other diseases.

  6. Non-steroidal drug allergy.

  7. Alcohol and drug abuse.

  8. Voluntary withdrawal.

  9. Current participation in another study.

Recruitment

We will recruit participants from eight public hospitals by recruitment posters. Patients with KOA who show interest in this trial could make a call or scan the QR code on the poster to get in touch with our trial contact person and will be informed to have a face-to-face interview in any of eight public hospitals. On meeting, the inclusion criteria and expressing their willingness to participate in this study, participants will be requested to provide written informed consent and undergo a comprehensive baseline assessment. Patients who have previously participated in trial design consultations will not be recruited as study participants.

Sample size calculation

The calculation of sample size was based on the hypothetical changes in the outcome measurement, WOMAC pain subscale, at week 4. According to our previous clinical trial,43 we formulate expected effects with WOMAC pain subscale as the primary outcome. We hypothesised that a 2-point improvement in WOMAC pain subscale occurred in the TG. Group sample sizes of 142 achieve 90% power to detect non-inferiority using a one-sided, two-sample t-test with the significance level (alpha) of the test is 0.025 through PASS software (V.15.0.5).49 According to the conservative principle and the ability of each centre to enrol patients, considering a drop-out rate of about 20%, the study will require 360 patients in total.

Randomisation and blinding

This trial adopts stratified block randomisation and will be completed by an independent statistical expert team. Eligible patients will be randomly allocated on a 1:1 basis to either TG or CG by a computer-generated random sequence in R (R Project for Statistical Computing, cloud.r-project.org). Randomisation will be stratified among the eight public hospitals and the random block design will be adopted in which the block sizes will be changed randomly. Random allocation hiding will be implemented through random envelopes. Two copies of the random envelope will be given to researchers and each hospital. The randomised envelope of group information stored with the study researchers shall not be opened during the duration of the study.

Due to significant differences in intervention, this trial will be an open one in that researchers and participants will not implement the blind method. However, group concealment can still be implemented through blinding outcome evaluators, data monitors and statistical analysts. Data monitors who will perform data entry, query and data management and statistical analysts will be blinded as to the allocated intervention until all statistical analyses are completed. Each part of this trial will remain separate and independent.

Intervention

Before the trial officially starts, all the physicians and therapists involved in this study will be trained in a standardised operating procedure to acquire a full understanding of this trial. We do not recommend that patients continue to receive additional interventions during this trial. Medications will be permitted if necessary, and the type and dosage of medications will be recorded timely. Participants will not bear the treatment costs during this study.

Celecoxib group

Participants in CG will take 200 mg of oral celecoxib (Pfizer, USA.) daily for 4 weeks. After randomisation, the patients will be required to make weekly visits to the hospital in order to collect their medications for the upcoming week and will be reminded to take their medications by daily text message or email. The whole process will be carried out under the guidance of physicians and medication records will be completed by regular telemonitoring.

Tuina group

Tuina treatment will be performed in the outpatient department of each pilot. The Tuina doctors involved in this study must hold the Chinese medicine practitioner licence from the Ministry of Health of the People’s Republic of China. To minimise the gap of the manipulation caused by the different doctors, we will select those who have more than 5 years of experience for clinical experience and familiarise them with the treatment process. They will be required to strictly adhere to established procedures. Participants in TG will receive 30 min Tuina treatment two times a week for 4 weeks. The interval between treatments should be at least 24 hours. The Tuina treatment procedure comprises three steps, which involve manipulative techniques through massages on both sides of the lower limbs and passive knee joints mobilisation. Details of the Tuina process are depicted and explained in figure 2.

Figure 2
Figure 2

Process and details of Tuina therapy for the knee: Step 1: (A): Roll* back and forth (the forearm rotates to roll the back of the hand) on the posterior thigh, popliteal fossa and posterior leg with the back of the hand for 5 min. (B): Knead and Press* on Weizhong (BL40)** and Chengshan (BL57) for 30 s each. Step 2: (C): Roll back and forth on the anterior thigh with the back of the hand for 5 min. (D): Knead and Press on Heding (EX-LE2), Neixiyan (EX-LE4), Dubi (ST35), Yanglingquan (GB34), Yinlingquan (SP9) and Xuehai (SP10) for 30 s each. Step 3: (E, F): Press the knee joint with one hand and hold the ankle joint with the other hand to passively flex and extend the lower limbs for 1 min. *Frequency: Rolling 80–120 times/min; Kneading and Pressing 60–80 times/min. **All selected acupoints are present on both sides.

Outcome measurements

Based on the study schedule, all outcome measurements will be collected at different time points as the trial progresses.

Primary outcome

The primary outcome of this study is the change in WOMAC pain subscale (standardised range, 0–10 cm; 0 cm=asymptomatic, 10 cm=extreme symptoms) from week 4 to baseline. WOMAC pain subscale will be measured at baseline, 4 weeks of treatment, 8, 12 weeks of follow-up. WOMAC is a self-reported Visual Analogue Scale specifically designed to assess OA symptoms, knee pain in five states will be assessed through five items. Participants will rate these five items according to their actual situation and will get a total score to reflect the pain level of the knee joint. The higher the score, the worse the knee pain and the worse the physical condition.50

Secondary outcomes

  1. WOMAC total score and WOMAC stiffness and function subscale

    • WOMAC stiffness subscale which contains 2 items will be used to measure the stiffness of the patient’s knee joint and the WOMAC function subscale also contains 17 items to assess knee joint physical function. The scores of each item in both scales are from 0 to 10 and will be assessed at baseline, 4 weeks of treatment, 8, 12 weeks of follow-up. WOMAC total score ranges between 0 and 240 (higher scores indicate more severe symptoms). The reliability, validity and sensitivity of the knee joint assessment will be evaluated objectively through these scores.

  2. SF-36

    • SF-36 covers eight health concepts in separate scales: physical functioning, role limitations due to physical functioning, bodily pain, role limitations due to physical health problems, general mental health, role limitations due to personal or emotional problems, social functioning, energy/fatigue or vitality and general health perceptions. The eight scales are also scored to produce two summary component measures of physical and mental health and will be assessed at baseline, 4 weeks of treatment, 8, 12 weeks of follow-up.51–53

  3. TUG test

    • The functional status of the knee joint will be measured at the end of the 4-week intervention through the TUG test. The test is performed so that the patient is properly positioned on the test stand. The patient sits in a steady chair, and after declaring readiness, the task is to get up, cover a distance of 3 m and return to the chair. The tests were performed in triplicate and the mean value was calculated. The normal value for a healthy adult is 10 s or less.

  4. SPPB

    • The SPPB is a performance-based test that includes three components: walking velocity, time for five repeated chair stands and a balance test. A score of 0–4 points is assigned to each test (4=best), and scores are summed to yield an overall score ranging from 0 to 12 (12=best). This test is used to evaluate lower extremity function and will be measured after 4 weeks of treatment.

  5. Gait analysis

    • Gait analysis parameters are associated with increased odds of KOA onset and progression.54 In this trial, 28 retroreflective markers will be affixed to the pelvis and bilateral lower extremities. Kinematic and kinetic data will be captured with a 16-camera motion analysis system (Vicon Vero V.2.2, Vicon, UK, 100 Hz) as participants walked over an embedded 6- m pressure distribution measurement platform (FDM-3, Zebris, Germany). Participants will complete overground gait analysis and these data will be recorded and held consistent within individuals across trials. Ten non-invasive wireless EMG electrodes (Noraxon Ultium, Noraxon, USA) will be used to collect sEMG data from five muscles, including rectus femoris, vastus medialis, vastus lateralis, biceps femoris and gastrocnemius in both lower limbs of participants.55–57 Additionally, three-dimensional (3D) kinematic and kinetic gait data will be calculated. Ground reaction force data will be tested by four-channel force plates (AMTI BP400600, AMTI, USA, 1000 Hz). Maximal knee compressive force, external knee adduction moment, AP shear force, vertical ground reaction forces, 3D moments and forces of hip, knee and ankle joints will all be collected and analysed at the same time. Moreover, gait kinematics of the lower limbs also include total time of one gait cycle (s), velocity (cm/s), step length (cm), knee joint angles (°) during walking. All data will be processed using Visual 3D, and gait analysis will provide us with functional descriptions of knee joints by comparing the objective differences in gait data before and after the 4-week intervention.

Drop-outs and adverse events

Considering the age of patients with KOA, it is possible that they have other chronic diseases. We will truthfully record the standard medication content of relevant diseases instead of discontinuing the drug medication during the course of the trial. Participants in all groups will continue taking their individual routine dosage from baseline to follow-up. If their conditions change during the study, they will be free to consult our therapist from eight hospitals to make adjustments based on actual conditions. For better implementation of standard medical therapy, researchers will try to carry out proper health education for all patients and supervise them in recording their daily medication dosage.

Any adverse events including unfavourable or unintended signs, symptoms or diseases due to oral administration of celecoxib need to be reported by participants and will be recorded during this trial. Participants who refuse to continue taking celecoxib medication could be considered a drop-out in the study.

Tuina therapy is a non-invasive, safe, manual treatment and does not rely on other equipment, but we will not completely rule out the occurrence of adverse events. Common adverse events were skin breakage, bruising due to local subcutaneous haemorrhage and soft tissue injury. The therapists must promptly report any adverse events, which will then be recorded.

Statistical analysis

The data will be analysed by professional statisticians who are blinded to group assignment and patients’ basic information. The principles of intention-to-treat analysis will be used. A full analysis set will include all qualified participants who have received at least one intervention and at least one outcome measurement. A per-protocol set will also be used to analyse those who completed the study without major protocol violations as an auxiliary set. Missing data will be completed with the last data recorded for each of these variables through last-observation-carried-forward.

To examine the baseline characteristics of the sample, a descriptive analysis will be conducted. The Kolmogorov-Smirnov test with Lilliefors corrections will be used to determine if quantitative variables follow a normal distribution. Initial homogeneity between groups will be assessed using analysis of variance or Kruskal-Wallis test based on data distribution normality. Continuous data will be presented as mean±SDs for normally distributed data or median and IQR for skewed data.

Changes in repeat outcomes over time will be compared by generalised estimated equation. The outcomes measured at baseline and after the 4-week intervention will be compared using a t-test or Mann-Whitney U non-parametric test, depending on whether they follow a normal distribution. The association between changes in WOMAC scale scores and physical parameters (TUG, SPPB, Gait data) will be examined through correlation analysis using Spearman or Pearson correlation coefficients for two continuous variables to help identify the uniformity between patient self-report and changes in objective measures.

All data will be analysed by using the statistical software SPSS (V.24.0). Values of p<0.05 (two sided) are considered to have statistical significance. Data analysis will start after the completion of the follow-up of the last participant.

Data management

The raw data will be captured using case report forms (CRFs, paper) at the designated time. Two data administrators, who are not affiliated with the research team and blinded to group allocation, will independently receive the completed CRFs and enter the raw data into an Excel database (Microsoft, Redmond, Washington, USA). Simultaneously, they will input real-time data into China Clinical Trial Registry (http://www.chictr.org.cn). Both administrators must undergo comprehensive training in data monitoring. To enhance data authenticity, we have established an independent data safety monitoring board (DSMB) responsible for reviewing and monitoring trial data. The DSMB comprises experts in Tuina therapy, orthopaedics, methodology and statistics who ensure the overall quality and completeness of the collected information. Committee members will conduct spot checks on raw data during meetings with evaluators to ensure adherence to protocol guidelines. They possess authority to terminate the study prematurely if necessary. On completion of the study period, all collected data will be locked and researchers will not have access to modify it thereafter. All CRFs will be securely preserved for a minimum of 5 years following article publication. In case reviewers have any concerns regarding our trial’s validity or reliability, they can contact the corresponding author for access to raw data.

Quality control

To ensure consistent procedures at all the hospitals before the official start of the trial, a trial kick-off meeting was scheduled, and all staff (except statisticians) were trained on the participants and content of the trial, patient recruitment, treatment scheduling, the precautions of patient–physician communication and outcome assessment. Uniform and standardised operating procedures are developed and provided to all hospital staff. After undergoing centralised training, the Tuina doctors in each subcentre will undergo assessment and be required to strictly adhere to the established Tuina process and time. Additionally, they are expected to provide appropriate knee joint health guidance verbally during treatment sessions. Dedicated personnel will be stationed at the subcentre hospitals to establish regular contact with the participants via telephone or email, ensuring timely medication intake, providing health guidance and maintaining accurate records of all medications and dosages administered throughout the study period. If the patient proactively discontinues medication due to significant symptom improvement, they will provide feedback to the attending physician through the dedicated personnel, signifying the completion of intervention. The established plan will be used to evaluate primary and secondary outcomes, record relevant data and proceed to the follow-up phase. Comprehensive review of completed cases and clinical procedures by independent monitors was required. Once they find problems or serious adverse events during the intervention, they can raise direct objections and even discontinue this trial.

Patient and public involvement

Prior to the design, the principal investigators consulted with patients who had KOA in clinical departments. The number and duration of treatments were designed from clinical experience and patient feedback.

Ethics and dissemination

This study protocol has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2023SHL-KY-16-01, 2023SHL-KY-16-02), and any revisions or corrections of this protocol will be discussed by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine. Changes of detailed information will be kept. The trial will not officially begin until written informed consent has been collected from all patients. After the study completed and the data analysed, results of this trial will be presented as articles in peer-reviewed journals or at academic conferences.

Discussion

In China, Tuina, as a complementary and traditional therapy, has been used since ancient times. Drawing on the principles of TCM, Tuina stimulates specific acupoints and surface muscles to promote optimal circulation of Qi and Blood around the affected joints, reaching a state of Qi and Blood flow while enhancing joint mobility. It involves external physical manipulation that enhances muscle compliance and range of motion around the knee joint in the lower limbs.58–60 This approach effectively reduces both passive and active stiffness of the knee joint, improves lower limb movement function, which leads to alleviating pain.61 Increasing evidence supports the efficacy and safety of non-pharmacological therapies which are readily accepted by patients.62 It is reasonable for us to speculate that Tuina could play a role in pain relief and the functional limitation of KOA.

The selection of pressure points of Tuina treatment is mainly proximal acupoints in previous studies.63 We referred to the results of data mining and selected the acupoints including Liangqiu (ST34), Neixiyan (EX–LE4), Dubi (ST35) and Xuehai (SP10) on the front of the thigh and Weizhong (BL40) on the back side which appeared at a high frequency in the treatment of KOA.64 These points in TCM theory are interpreted as tonifying Qi and Blood, promoting the circulation of meridian channels and collaterals, leading to facilitating joint function recovery. Previous RCTs have also confirmed that acupoint stimulation around the knee joint has a significant effect on KOA and improves patients’ pressure-pain threshold,63 65 which was consistent with the findings of our previous study.43

This multicentre pilot study expands patient recruitment beyond a single hospital setting to minimise regional differences that may exist. Additionally, we adjusted our sample size based on previous findings to reduce individual treatment variations and potential bias risks. Based on our prior study design, objective outcomes were supplemented to effectively assess changes in physical function and biomechanics of the lower limbs before and after treatment.

In general, there may exist potential safety concerns during the trial implementation, including the inherent risk of untimely or missed drug administration and loss to follow-up. Participants might inadvertently forget to adhere to their prescribed celecoxib regimen due to temporary symptom improvement or pain reduction, or they may opt for alternative treatments due to a perceived lack of efficacy. To mitigate these risks, we proactively addressed these issues in the early stages of trial design. First, by carefully selecting patients who are theoretically suitable candidates, we will emphasise the importance and safety of regular medication intake while excluding individuals resistant to oral celecoxib therapy. Second, scheduled telemonitoring and regular reminders via SMS or email will be employed to minimise loss to follow-up; additionally, our contact information will be provided for participants in case of incomplete data due to attrition. Lastly, regardless of group assignment (TG or CG), if a patient’s symptoms worsen significantly and become unbearable, intervention or follow-up will be interrupted promptly with data recorded prior to withdrawal. Direct access to medical attention can be requested through multiple channels aiming at reducing barriers for patients and ensuring timely healthcare access. The fidelity of the whole intervention must be upheld while reducing the risk of bias.

To alleviate the increasing burden of chronic joint disease, pertinent guidelines and studies have proposed a stepped treatment strategy for KOA, excluding surgical intervention for end-stage or severe cases, non-surgical treatments are recommended to use based on varying stages and severity levels of KOA and the optimal timing of the various treatment options is to be discussed.66 67 Among them, physical therapy or non-pharmacological interventions are recommended for patients in the early stage or when symptoms are mild. In China, one major challenge faced by KOA patients is the selection of appropriate treatment options. Numerous individuals are concerned about potential side effects and safety risks associated with drugs, leading them to avoid or reject this approach. Additionally, various constraints make it difficult for these patients to engage in personalised self-management or regular exercise. As a result, they tend to rely on short-term interventions provided by hospitals at different levels in order to obtain symptom relief.

The findings will provide valuable references and examples for urban residents’ clinical treatment and community health management related to KOA, aiming at effectively alleviating knee pain and improving lower limb function. It is anticipated that implementing this multicentre study in Shanghai will offer vital insights for Tuina doctors across TCM hospitals at different levels and expand treatment options available for patients with mild-to-moderate KOA in the region while ensuring reasonable costs within the comprehensive national healthcare system.

Trial status

At the time of submission, recruitment for the trial has been started. The first participant was included on 5 August 2023. The study is scheduled to end in December 2025.

This post was originally published on https://bmjopen.bmj.com