Rotator cuff tear involves damage to the group of muscles and tendons stabilizing the shoulder joint. Clinical trials in this area explore a range of treatment evaluations including surgical techniques and non-surgical interventions such as physical ...
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Found 229 Actively Recruiting clinical trials
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Partial-thickness rotator cuff tear is a common shoulder condition where tears involve 50% or less of the tendon thickness. This trial evaluates the safety and effectiveness of an investigational treatment called TPX-115, which consists of allogeneic fibroblasts injected into the tendon. The study aims to improve tendon repair beyond standard conservative treatments by measuring shoulder function and pain scores over time. Participants are randomly assigned to receive either TPX-115 or a placebo injection guided by ultrasound directly into the tendon. The study is double-blinded, meaning neither participants nor researchers know which treatment is given. Assessments occur at 4, 12, 24, and 52 weeks after injection, with structural evaluations using MRI at 24 and 52 weeks to monitor tendon changes. During the study, participants will complete various shoulder function tests including the Constant Score, pain assessments using Visual Analogue Scale, and other shoulder-specific questionnaires. Range of motion and MRI scans will also be performed to observe physical and structural changes. The primary outcome is the change in Constant Score at 24 weeks, with ongoing safety and efficacy monitoring through one year of follow-up.
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This research aims to evaluate the therapeutic effectiveness of using an acellular dermal matrix derived from human skin combined with autologous orthobiologics for patients with large to massive rotator cuff tears. The study focuses on patients with tears involving the supraspinatus and infraspinatus tendons, addressing a significant surgical challenge. The trial is sponsored by Istituto Ortopedico Rizzoli and involves a randomized, double-blind design to compare treatment methods. Participants will be randomly assigned to one of two groups: one group will receive a suture-bridge surgical repair augmented with the acellular dermal matrix alone, while the other group will receive the same surgical technique combined with orthobiologic treatments, including humeral bone marrow concentrate and subacromial bursa tissue. The orthobiologics are harvested and prepared during surgery using an automatic concentrating system. Both treatments use standard arthroscopic procedures with dedicated sutures and anchors. Throughout the study, participants will undergo pre-operative magnetic resonance imaging and complete outcome assessments. Researchers will monitor the re-tear rate of the rotator cuff at 12 months after surgery as the primary outcome. Secondary outcomes include cell yield and subacromial bursa assessments at baseline. The trial requires participants to be able to understand and complete outcome scores and involves follow-up to evaluate the healing and effectiveness of the treatments over time.
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Researchers are investigating whether using a 10% benzoyl peroxide (BPO) acne cleanser before arthroscopic rotator cuff repair surgery can reduce contamination by Cutibacterium acnes, a common bacteria that can remain after standard sterilization. Although prior studies showed the bacteria can persist in up to 30% of cases despite cleaning, evidence specifically for rotator cuff surgery is limited. This study aims to provide clear guidance on improving preoperative skin preparation for this type of shoulder surgery. Participants will be randomly assigned to one of two groups. The control group will cleanse the surgical area with soap or body wash following current routine practices. The experimental group will receive a 10% BPO acne cleanser and instructions to use it on the shoulder and surrounding skin during bathing the day before surgery. After surgical disinfection, skin samples and segments of surgical sutures will be collected for bacterial culture to compare contamination rates between groups. During the study, patients will follow preoperative skin cleansing instructions according to their assigned group. Researchers will collect skin and suture samples right after surgery to assess bacterial presence. The primary measurement is the bacterial culture result from sutures immediately after surgery. This prospective randomized design will help determine if BPO cleansing effectively lowers contamination and may influence future surgical preparation practices. Participation lasts through surgery and immediate postoperative sampling.
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Researchers are investigating the role of acupuncture in managing pain and improving outcomes after total knee replacement surgery (TKA) for patients with primary osteoarthritis. This study aims to assess whether acupuncture can help control acute pain, prevent chronic pain, improve joint function, and increase patient satisfaction. The research also examines how acupuncture influences inflammation by measuring specific biomarkers, which may relate to recovery and long-term joint stiffness. Participants will receive standard anesthesiology care including sedation, regional nerve blocks, and pain medications. They will be randomly assigned to either a standard treatment group or an acupuncture group, which receives additional acupuncture and auriculotherapy sessions before and after surgery. The acupuncture treatment targets specific body and ear points over multiple sessions during the first three days post-surgery. Throughout the study, participants will be monitored regularly for pain levels, medication use, vital signs, joint mobility, and rehabilitation progress. Blood samples will be taken before surgery and at set intervals afterward to measure inflammation markers. Patient-reported outcomes and satisfaction will be collected up to one year post-surgery. Evaluations will be done in person or by phone if necessary, with the entire follow-up extending through one year after the operation.
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Researchers are studying patients with subacute stroke to evaluate the additional effects of kinesio taping combined with conventional physical therapy on upper limb function, range of motion, and spasticity. This randomized control trial aims to determine whether adding kinesio taping provides significant improvements compared to physical therapy alone. The study is conducted in rehabilitation settings and includes adults aged 40 to 65 years with a history of diagnosed stroke and moderate spasticity. Participants are divided into two groups. The experimental group receives kinesio taping three times per week along with physical therapy exercises including passive and active range of motion (ROM), PNF stretching, D1 flexion and extension movements, and resistance training with a medium resistance band from weeks 3 to 6. The control group receives the same physical therapy regimen but without kinesio taping. Treatments last 30 minutes on alternate days over six weeks. During the study, participants' upper limb spasticity and function are assessed at baseline, week 3, and week 6 using the Modified Ashworth Scale and the Wolf Motor Function Test. Range of motion is measured with a goniometer for shoulder, elbow, and wrist joints. Data collection includes demographic information and questionnaires. The study monitors outcomes throughout the six-week treatment period to analyze differences between groups.
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Researchers are evaluating the additional effects of combining mobilization with movement and upper quadrant core strengthening in people experiencing rotator cuff related shoulder pain. This randomized controlled trial aims to determine how these treatments impact pain, range of motion, proprioception, and fear of movement (kinesiophobia). Participants are randomly assigned to one of two groups. One group performs an upper quadrant core strengthening protocol over four weeks, including scapular postural correction, shoulder shrugging, and rotation exercises. The other group performs the same strengthening protocol combined with mobilization techniques involving acromioclavicular, scapular, and glenohumeral joint glides. During the study, participants will have their pain intensity, shoulder range of motion, proprioception, and kinesiophobia measured after four weeks. Data collection includes assessments before and after treatment, and participants provide informed consent before enrollment. The study runs from July 2024 to June 2025.
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Researchers are comparing three types of nerve blocks used for managing pain after shoulder arthroscopic surgeries. The study focuses on anterior glenoid nerve block, pericapsular nerve group (PENG) block, and interscalene brachial plexus (ISB) block. These blocks help reduce postoperative pain, improve patient comfort, speed up rehabilitation, and potentially shorten hospital stays. ISB blocks are well known as the standard method, while the PENG block is a newer technique that may provide pain relief with fewer side effects and quicker movement recovery. Participants will be randomly assigned to receive one of the three nerve blocks: the interscalene brachial plexus block, the anterior glenoid nerve block, or the pericapsular nerve group (PENG) block. All blocks are applied using ultrasound guidance during shoulder arthroscopic surgery. The study is double-blinded, meaning neither patients nor doctors know which block is given to ensure unbiased results. During the study, researchers will monitor the time until patients need their first rescue pain medication within 24 hours after surgery. They will also track total opioid use, pain levels, hospital stay duration, time to freely move the operated shoulder, and patient satisfaction. These measures help assess each block's effectiveness and safety. The entire study includes follow-up up to one week after surgery to observe recovery progress and potential complications.
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This research aims to analyze patients who come to the emergency department with anterior shoulder dislocation. The study focuses on documenting patient demographics, injury causes, orthopedic classifications, treatment methods, pain scores before and after procedures, and the time spent in the emergency department. The goal is to see if any current treatment approach leads to better emergency outcomes for these patients. Patients will be observed as they receive one of four types of analgesic treatments chosen by their doctors: ketamine, interscalene nerve block, suprascapular nerve block, or intraarticular lidocaine injection. The study will not change how treatments are given but will compare these groups based on pain management, time needed for shoulder reduction, patient comfort, and hospital stay length. Participants will be followed during their emergency department visit to collect data on treatments, pain levels, and outcomes such as discharge or admission to a ward. Researchers will review these details within 24 hours, focusing on the shoulder reduction process. The study includes monitoring patient outcomes related to their treatment and emergency stay duration without interfering in medical care.
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This research aims to explore the use of shock wave therapy combined with conventional rehabilitation training for patients diagnosed with rotator cuff tears who choose conservative treatment. The study is a single-center clinical trial enrolling about 22 patients from the Department of Sports Medicine and Rehabilitation at Beijing Third Hospital. It seeks to provide new treatment ideas to promote tendon healing, improve shoulder function, and help patients return to daily activities and exercise faster. Participants will receive either shock wave therapy along with functional exercise seven times a week or conventional conservative treatment paired with functional exercise. The study compares these two approaches to evaluate their clinical effects on rotator cuff tear recovery. This approach hopes to offer a theoretical basis for the wider clinical use of shock wave therapy. During the study, patients will be monitored at 6 weeks, 3 months, and 6 months after treatment using pain VAS scores, ASES scores, UCLA scores, and MRI evaluations to assess healing and shoulder function. Active shoulder range of motion will also be recorded at these times. Patients will complete exercise tests and questionnaires to track their progress. The total duration of follow-up is 6 months, with assessments focused on pain relief, function improvement, and tendon healing.
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This research aims to evaluate the safety of using allogeneic umbilical cord-derived mesenchymal stem cells in patients undergoing arthroscopic rotator cuff repair for large to massive rotator cuff tears. It focuses on adults aged 19 and older who have significant shoulder pain and full-thickness tears that have not improved with conventional treatments. The study is sponsored by Korea University Anam Hospital and is designed to assess pain and tissue healing over a year. Participants receive a single injection of allogeneic umbilical cord-derived mesenchymal stem cells during their rotator cuff repair surgery. Two dosing options are studied: a low dose of 2.5x10 cells in 0.5 mL and a high dose of 5x10 cells in 1 mL. The injection is performed into the lesion using ultrasound guidance by the investigator. This treatment is given only once during the study period. Throughout the 12 months following treatment, participants will be monitored for pain during movement using the Visual Analog Scale (VAS) and changes in the size of their rotator cuff tears through MRI scans. Adverse events will also be tracked to assess safety. Participants will complete questionnaires and attend regular follow-up visits during the study. The total duration of participation spans one year from the intervention.
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