Clinical trials

Objectives： This study aims to compare the efficacy of transcatheter arterial microembolization (TAME) and corticosteroid injection for treatment of frozen shoulder. Background： Frozen shoulder (adhesive capsulitis) is a common condition that leads to significant functional impairment and reduced quality of life. Current treatment options are diverse, including pharmacological therapy, physical rehabilitation, corticosteroid injection, hydrodilatation, and the more recently developed transcatheter arterial microembolization (TAME). Corticosteroid injection, due to its anti-inflammatory effects, has been shown in numerous clinical studies to provide short-term pain relief and improved range of motion; however, its benefits are often limited to several weeks or months, and some patients continue to experience persistent symptoms. In contrast, TAME has emerged as a novel treatment for musculoskeletal disorders by targeting abnormal neovascularization and inflammatory processes in the affected tissues, there by achieving pain reduction. Multiple studies from both international and domestic medical centers have demonstrated its safety and efficacy, though most reports focus on case reports or case series observational outcomes. To date, there is a lack of clinical trials directly comparing the therapeutic outcomes of TAME versus corticosteroid injection in patients with frozen shoulder. Study Design： This study is a single-center, prospective, randomized controlled trial (RCT). Methods： A total of 94 patients diagnosed with frozen shoulder in the freeing stage will be recruited from the Department of Physical Medicine and Rehabilitation at Shin Kong Hospital. Eligible patients will be randomly assigned to either the transcatheter arterial microembolization (TAME) group and the corticosteroid injection (CS) group. The arterial microvascular embolization group will receive one treatment, while the corticosteroid injection group will receive two corticosteroid injections into the shoulder joint and subacromial bursa, with a two-week interval between the two injections. Additionally, all patients in both groups will undergo 4 weeks of physical therapy. Clinical assessments will be conducted at baseline and at 1, 2, 4, and 6 months after initiation of treatment, including Shoulder Pain and Disability Index (SPADI), the Visual Analogue Scale (VAS) for pain, Shoulder Disability Questionnaire (SDQ), active and passive range of motion (ROM), Short Form-36 (SF-36) for quality of life, and patient-reported global efficacy. Patients will be followed for 6 months after completion of treatment, and statistical analyses will be performed to evaluate the therapeutic outcomes. Effect： Efficacy comparison: Both the TAME and corticosteroid injection are expected to effectively improve pain, function, and quality of life. However, the TAME group is anticipated to demonstrate greater pain relief and better recovery of shoulder function compared with the corticosteroid injection group, with longer-lasting therapeutic effects. Safety: Both treatments are considered safe. TAME may lead to temporary local pain, transient radial artery spasm, or low-grade fever, all of which are self-limiting or manageable with supportive care. Corticosteroid injection may be associated with transient hyperglycemia, local injection site pain, or, rarely, infection. No permanent or severe adverse events are expected. Exploration of prognostic factors: By comparing treatment responses between the two groups and incorporating clinical characteristics, imaging findings, and treatment outcomes, this study aims to identify potential prognostic factors that may predict therapeutic response, thereby guiding future clinical decision-making. Intermediate follow-up results: At 1 to 3 months post-treatment, both groups are expected to show improvement in the clinical outcomes, but the TAME group is expected to demonstrate superior effect compared with that of the corticosteroid injection group.

The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.

The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight hyaluronic acid injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.

Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb. It is often treated with endovascular therapy (EVT), a minimally invasive procedure that opens the blocked artery, but the artery frequently narrows or closes again afterward. These procedures are usually guided by X-ray pictures taken with dye (angiography). Intravascular ultrasound (IVUS) is an imaging tool that uses a small catheter inside the artery to give a more detailed view of the vessel, which may help doctors open it more completely. It is not yet clear whether adding IVUS improves results below the knee. This study is testing whether guiding treatment with IVUS plus angiography keeps the artery open better than angiography alone. Adults aged 18 or older with CLTI who are having endovascular therapy for a blocked artery below the knee may take part. Participants are assigned by chance to be treated with either both imaging methods or angiography alone, and are followed for 12 months. The main question is how well the treated artery stays open at 6 months; researchers will also compare repeat procedures, amputation, complications, wound healing, survival, and quality of life.

Chronic limb-threatening ischemia (CLTI) is the most severe form of peripheral artery disease, a condition in which narrowed or blocked arteries reduce blood flow to the legs. People with CLTI may have severe leg pain at rest, non-healing wounds, or gangrene, and face a high risk of leg amputation and death. Even after successful procedures to restore blood flow to the leg (called revascularization), many patients still experience serious complications. Inflammation in the blood vessels is believed to play an important role in these poor outcomes. Colchicine is an anti-inflammatory medication that has been used safely for decades to treat gout and other inflammatory conditions. Recent large clinical trials have shown that a low dose of colchicine (0.5 mg per day) can reduce heart attacks and strokes in patients with coronary artery disease. However, it has not been studied in patients with CLTI. The CIRCLE-Asia trial (Colchicine in Chronic Limb-Threatening Ischemia for Reduction of Complications and Limb Events in Asia) is a pilot study designed to evaluate whether colchicine can improve outcomes in patients with CLTI who have recently undergone a successful procedure to restore blood flow to their leg. Treatment begins within 7 days of the procedure. This is a randomized, double-blind, placebo-controlled, multicenter trial conducted at five hospitals in Taiwan. A total of 200 adult patients with CLTI who have undergone successful revascularization will be randomly assigned in a 1:1 ratio to receive either colchicine 0.5 mg once daily or a matching placebo pill, in addition to their usual medications, for 12 months. Neither the patients nor the study doctors will know which treatment each patient receives. The main outcome of interest is amputation-free survival, defined as the time until major amputation of the affected leg (above the ankle) or death from any cause, over 12 months of follow-up. The study will also assess other important outcomes including major limb complications, heart attacks, strokes, wound healing, changes in blood flow measurements, inflammatory blood markers, quality of life, and medication safety. This pilot trial will provide the first randomized evidence on the potential benefits and safety of colchicine in CLTI patients and will help inform the design of a larger definitive trial.

Frozen shoulder, or adhesive capsulitis of the shoulder, is a common clinical problem characterized by pain, loss of both passive and active range of motion (ROM) of glenohumeral joint (GHJ), leads to functional limitation, and reduces quality of life. Primary frozen shoulder occurs without any obvious connection to any other condition, and secondary frozen shoulder is related to some medical problems, such as an injury, inflammatory, immunological, and endocrine conditions, or surgery of the shoulder. The prevalence of frozen shoulder is 2%-5% in general population, usually between 40 to 60 years old, and more in female. Diabetes patients have more chance of developing frozen shoulder than general population and the prevalence was 13.4%. Frozen shoulder is clinically divided into 3 overlapping phases. The painful freezing phase has a duration of 10 to 36 weeks and is characterized by pain and stiffness around the shoulder, which may worsen at night. The frozen phase is characterized by restricted ROM with a gradual relief of pain, which occurs at 4 to 12 months. The thawing phase with spontaneous improvement in the ROM takes 12 to 42 months. .Although frozen shoulder is a self-limited condition, the recovery may be slow and incomplete. Treatment of frozen shoulder consists of physiotherapy, oral medication (nonsteroidal anti-inflammatory drugs or corticosteroid), intra-articular corticosteroid injection, hydrodilatation, suprascapular nerve block, mobilization, manipulation under anesthesia, and operative intervention (arthroscopic release or open release). Because of the uncertainty of the efficacy and risk of surgical treatment, nonsurgical treatments are more likely chosen by patients. Among them, intra-articular steroid injection and physical therapy are commonly used nonsurgical treatments and have shown some benefits. .Because the clinical picture of frozen shoulder may be similar to, or combining with chronic subacromial bursitis, especially in the freezing stage, concomitant subacromial/subdeltoid (SASD) bursa injection may be needed for treatment of frozen shoulder. In addition, the 3 stages of frozen shoulder often overlap and the clinical symptoms of patients are complex, adjuvant therapy is often needed throughout the course of treatment. Even after physical therapy (PT) and corticosteroid injection, mild to moderate contracture, especially external rotation, abduction, and internal rotation may still be present. Over the past few years new evidence has emerged on the effectiveness of extracorporeal shock wave therapy (ESWT) in the treatment of many musculoskeletal disorders. Briefly, ESWT has been shown to promote neovasculization, amplify growth factor and protein synthesis, increase of pain inhibiting substance, alteration of pain receptor neurotransmission, and intensification of tissue regeneration. Furthermore, ESWT can produce a cavitation effect between tissues, cause intertissue release, promote the separation of adhesion, and release the adhesive tissue. Because of its analgesic, anti-fibrotic, and anti-inflammatory effect, application of ESWT as main treatment or an adjunct to other interventions has been tried. Knoblock et al found that focused ESWT can reduce pain in painful nodules in Dupuytren's disease; in a randomized controlled trial Chen et al showed focused ESWT was superior to oral corticosteroid for frozen shoulder, although oral corticosteroid is not commonly prescribed for patients with frozen shoulder. Vahdatpour compared ESWT with sham ESWT on treatment of frozen shoulder after 40mg triamcinolone intra-articular injection, and found that ESWT group seemed to have positive effects on treatment, and quicker return to daily life. Another two studies investigating application of radial shock wave to patients with frozen shoulder showed improvement of ROM, even for diabetic patients. A systemic review and meta-analysis also showed ESWT seems beneficial to patients with frozen shoulder and could be used as an adjunct therapy to routine treatments. However, the authors mentioned that the quality of the included randomized controlled trials were hampered by significant heterogeneity regarding long-term analgesia and joint ROM. Because the effect of ESWT against frozen shoulder has not been well established, we aim to investigate whether adding ESWT to corticosteroid injection and routine PT beneficial for patients with frozen shoulder? We hypothesize that ESWT would be a positive adjunctive therapy in the treatment of frozen shoulder.

Cervical radiculopathy (CR) is a painful condition caused by irritation of the cervical nerve roots, often leading to neck, shoulder, and arm pain, sometimes with numbness or weakness. These symptoms can reduce quality of life and place a burden on healthcare systems. Current treatments, such as physical therapy, cervical traction, and medication, are often not fully effective. Pulsed radiofrequency (PRF) has shown benefits for nerve-related pain, but because it requires an invasive procedure, its use is limited. Transcutaneous pulsed radiofrequency (TCPRF) is a non-invasive version of PRF. It has shown promising results in animal studies and in clinical research for knee and shoulder conditions, but has not been tested for CR. Recent improvements in ultrasound allow more precise targeting of cervical nerve roots, making ultrasound-guided TCPRF a potentially safe and accessible treatment option. This pilot study will evaluate the efficacy and safety of ultrasound-guided TCPRF in patients with CR compared to a sham treatment. A total of 32 participants with CR lasting more than six weeks will be randomly assigned to either TCPRF or sham treatment. Both groups will receive 12 treatment sessions over four weeks, combined with a standard rehabilitation program. The main outcome is pain intensity measured by the Numeric Rating Scale (NRS). Secondary outcomes include neck-related disability, medication use, and any side effects.

Carpal tunnel syndrome (CTS) is a common musculoskeletal disorder, which is caused by compression of the median nerve as it travels through the wrist. There are several treatments for CTS, including conservative and surgical options. Though local corticosteroid injection has been considered more effective than physical therapy for treatment of CTS and has significant short-term benefits, long term benefits are not evidenced. Several studies in recent years reported significantly superior longer-term benefit of D5W and PRP compared with corticosteroid injections and other conservative managements. In addition, percutaneous release of the transverse carpal ligament (TCL) was developed to treat CTS in recent years. Because the effectiveness of the recently developed techniques in treating CTS has not been well established, the investigators aim to investigate whether combining US-guided partial release of the transverse carpal ligament with a needle plus D5W hydrodissection is more beneficial for CTS comparing to either treatment alone.

Osteoarthritis (OA) is a serious worldwide public health concern, causing increased disability-adjusted life years (DALY), the reasons of which include rising prevalence of obesity and increasing older populations. The knee is one of the most easily injured joint in the body, and knee OA can become a chronic and disabling condition that pose a threat to not only the patient but also his or her caretakers and healthcare resources. The prevalence of knee OA is 5% - 15% in men over 60 years, and 10% - 25% in women aged more than 60. Knee OA can result from injuries, diseases, or wear and tear from overuse. It refers to structural changes that affect subchondral bone, articular cartilage, menisci, ligaments, synovium, and other joint structures. Currently, there are several conservative management of knee OA, including physiotherapy (therapeutic exercise, diathermy, electrotherapy), oral or topical medications, intra-articular and extra-articular injections, and radiofrequency. There are various substances used in injections for knee OA, among which are corticosteroid, platelet-rich plasma (PRP), AmnioFix, exosome, dextrose, and hyaluronic acid (HA). Compared with PRP, AmnioFix, exosome, and HA, which are not covered by the health insurance system, dextrose is a readily available and cost-effective substance. The principle of hypertonic dextrose injection, "prolotherapy", is injection of small volumes of the irritant solution at or around the lesion in order to stimulate fibroblast and vascular proliferation, local tissue healing, reduction of joint instability, thus resulting in pain relief. Previous studies have demonstrated that prolotherapy resulted in clinically meaningful sustained improvement of function and pain in knee OA, and there were no severe adverse events related to hypertonic dextrose injection. A study in 2023 showed that among various dextrose concentrations, higher concentrations demonstrated greater improvement of knee OA, thus 20% dextrose is recommended. Regarding the site of dextrose injection in knee OA, previous studies demonstrated comparable effects of intra-articular and extra-articular injections. The periarticular injections include points around the knee where periarticular nerves exit the joint capsule, and acupuncture points at upper medial and lateral parts of knee joint. A study in 2024 revealed that prolotherapy combining intra-articular with peri-articular perineural injection resulted in better pain alleviation and improvement in knee joint function in knee OA. There are several choices of imaging modality for recognizing the sites of lesion in knee OA, such as X-ray, ultrasound (US), and magnetic resonance imaging (MRI). Radiography is used to assess osteophytes, joint space narrowing, and subchondral sclerosis, but it has limited ability to detect synovial inflammation, joint effusion, soft tissue abnormalities, and early cartilage damage. US can be used to evaluate synovial fluid and cartilage thickness, but not deep structures (e.g. subchondral bone change, meniscus tear, and ACL tear, etc.). On the other hand, MRI is an optimal and accurate imaging choice for visualizing soft tissue as well as deep structures (e.g. ACL, meniscus, etc) in knee OA. The MRI findings of knee OA includes cartilage damage, meniscus tear, bone marrow lesions, synovitis, ligamentous laxity, and osteophytes. The detection of bony lesions can aid intraosseous Infiltrations, and signs of ligamentous laxity also provides target for ligaments injection. However, there is no current evidence on the effectiveness of prolotherapy targeting knee OA lesion sites according to MRI findings. Because the effectiveness of prolotherapy targeting lesion sites according to MRI findings has not been well established, the investigators aim to investigate whether injecting dextrose into MRI-positive lesion sites is more beneficial for knee OA comparing to intra-articular injections. The investigators hypothesize that MRI could be a good choice for the guidance of prolotherapy targets.

Efficacy of transcutaneous acupoint pulsed radiofrequency with rehabilitation for knee osteoarthritis.

This clinical trial aims to evaluate whether continuous passive motion (CPM) can prevent ankle joint contracture and muscle atrophy in critically ill patients receiving mechanical ventilation in the ICU. The study will also assess the feasibility and safety of implementing CPM therapy in this population. The primary objectives are: To determine whether CPM preserves ankle dorsiflexion range of motion during ICU immobilization. To assess whether ultrasound can detect changes in tibialis anterior muscle morphology in response to CPM. In this within-subject design, each participant will receive CPM therapy on one ankle while the contralateral ankle serves as the control. Outcomes related to joint mobility and muscle condition will be compared between the two sides. Participants will: Receive CPM treatment on one ankle for 30 minutes, twice daily, for up to 7 days or until ICU discharge. Undergo goniometric and ultrasound assessments at baseline and after the intervention. Continue to receive standard ICU care throughout the study period.

The study employs a double-blind, randomized clinical trial design with 60 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the experimental group receives combined hyaluronic acid and Triamcinolone Acetonide injections, while the control group receives hyaluronic acid alone injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.

Currently, the literature regarding the relationship between Pulse Wave Velocity (PWV) and functional recovery, particularly of upper limb function, in patients with subacute stroke is still limited. Therefore, the aim of the study is to evaluate the changes in baPWV after four weeks of intensive rehabilitation therapy, and the correlation between these changes and functional recovery.