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NCT07636941
This study aims to investigate the relationship between thoracic kyphosis angle, trunk rotation mobility, and balance performance in individuals with rotator cuff pathology. The rotator cuff, consisting of the supraspinatus, infraspinatus, teres minor, and subscapularis muscles, plays a crucial role in providing both static and dynamic stability to the shoulder joint. Rotator cuff pathologies are among the most common causes of shoulder pain and functional limitation, with their prevalence increasing with age. Although shoulder pain has traditionally been considered a localized musculoskeletal problem, recent biomechanical evidence highlights the importance of the kinetic chain concept, which emphasizes the interconnected function of the upper extremity with the lower extremity, thoracic spine, and postural control mechanisms. Within this framework, thoracic spine mobility and postural stability are considered key factors in preventing pathological loading on the rotator cuff tendons. The thoracic spine serves as a fundamental biomechanical platform for scapulothoracic joint function. Increased thoracic kyphosis has been shown to negatively affect scapular upward rotation and posterior tilt during humeral elevation, contributing to narrowing of the subacromial space and increased mechanical stress on the rotator cuff tendons. In addition, trunk rotation mobility plays an essential role in efficient energy transfer along the kinetic chain, particularly during functional movements such as reaching or throwing. Limitations in trunk rotation may disrupt this energy transfer, resulting in compensatory loading of the shoulder complex and increased injury risk. Furthermore, kinesiophobia associated with chronic pain may alter movement strategies, reduce physical activity levels, contribute to muscle atrophy, and indirectly impair postural control mechanisms. Balance performance is maintained through the integration of visual, vestibular, and somatosensory systems. In individuals with rotator cuff pathology, impaired proprioceptive input from the shoulder girdle and increased pain-related postural sway may lead to decreased performance in dynamic balance tasks such as the Y-Balance Test. In contrast, in healthy individuals, postural control strategies have been shown to correlate with self-perception and body awareness levels. Based on this theoretical framework, the primary aim of the present study is to compare thoracic kyphosis angle, trunk rotation mobility, static balance, and dynamic balance performance between individuals with rotator cuff pathology and healthy controls, and to examine the relationships between these variables. It is hypothesized that individuals with rotator cuff pathology will demonstrate significant differences in these parameters compared to healthy individuals. The study will be conducted at the Physical Therapy Unit of Iğdır State Hospital and will include individuals aged 18-65 years. Sample size calculation was performed using G\*Power software based on a previously reported effect size (Cohen's d = 0.63) for thoracic kyphosis. With an alpha level of 0.05 and statistical power of 80%, at least 36 participants per group were required. To account for potential dropouts, a total of 80 participants will be included, consisting of at least 40 individuals with rotator cuff pathology and 40 healthy controls. All participants will provide written informed consent, and sociodemographic and clinical information will be collected through face-to-face interviews. Thoracic kyphosis angle will be measured using a smartphone-based digital inclinometer by calculating the angular difference between T1-T2 and T12-L1 vertebral levels. Trunk rotation range of motion will be assessed using a digital goniometer. Static balance performance will be evaluated using the Single Leg Stance Test under eyes-open and eyes-closed conditions. Dynamic balance performance will be assessed using the Y-Balance Test protocol, in which reach distances in three directions are normalized according to leg length. These measurement tools have been reported to demonstrate high validity and reliability in clinical research. In conclusion, this study seeks to demonstrate that rotator cuff pathology should not be considered solely a localized shoulder disorder but rather a condition associated with impairments in the kinetic chain, including thoracic spine mobility and postural control mechanisms. The findings are expected to highlight the importance of assessing thoracic mobility and balance performance in shoulder rehabilitation programs.
NCT07555704
The aim of this study was to evaluate the effectiveness of a mobile application for telemedicine in patients recovering from arthroscopic rotator cuff tendon repair. Participants were randomly assigned to one of two groups: a test group using a mobile application for exercise guidance and monitoring, or a control group receiving standard paper-based exercise instructions. The study aimed to compare the effectiveness of rehabilitation, treatment adherence, cost savings, and patient satisfaction between the two methods over a 6-month follow-up period.
NCT06381791
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery. Participants will: * track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary. * Complete two short surveys. Once before surgery and once after. * Have bloodwork tested after surgery
NCT07501013
This observational study aims to evaluate the long-term recovery and clinical outcomes of patients undergoing minimally invasive (arthroscopic) surgeries for sports-related shoulder and knee injuries. Sports injuries, such as ligament tears, meniscus damage, and rotator cuff tears, are common and can significantly impact a person's daily life and ability to return to sports. While surgery is an effective treatment, the recovery process and final outcomes can vary greatly from person to person. Researchers will follow patients who are already scheduled for routine shoulder or knee surgery at the study center. By collecting detailed information about the patient's initial injury, the specific surgical techniques used by the doctor, and the patient's recovery progress over two years, the study hopes to identify which factors lead to the best healing and functional outcomes. Participants will be asked to complete standard questionnaires about their joint function and pain levels before their surgery, and again at 6 months, 1 year, and 2 years after surgery. The study is strictly observational; it will not change the standard medical care, surgical plan, or rehabilitation routine the patients receive.
NCT06505135
Treatment of rotator cuff tears with micro-fragmented adipose tissue is a minimal-invasive procedure with the potential to shorten and ease recovery, accelerate return to daily activity and work of thus with a potential capacity to improve the functional result compared to conventional surgery alone. The study will provide evidence whether the addition of micro-fragmented adipose tissue therapy can augment conventional rotator cuff tear treatment. The study will also reveal whether this treatment can be feasible for standard care of patients with rotator cuff tear as it will be simple to standardize. Moreover, besides providing a novel treatment for patients with rotator cuff tears, the project will based on data from muscle biopsies and scanning modalities, generate new knowledge, preparing for precision regenerative medicine in shoulder disease.
NCT06371872
The purpose of this study is to identify, at 5 years, the clinical and therapeutic factors associated with improvement in shoulder functionality and quality of life in patients with transfixing (total) rotator cuff injuries undergoing treatment.
NCT06851650
The study investigates the effect of accelerate rehabilitation protocol(adding scapular strengthen exercises (lower trapezius and serratus anterior) from week 1) after arthroscopic rotator cuff repair on scapular upward rotation during shoulder elevation.
NCT06318403
Rotator cuff tears in the shoulder are common causes of pain and disability, often fail to heal with surgery, and tears, worse outcomes after surgery, and failure of healing are associated with estradiol deficiency. In this study, post-menopausal women will be randomized to either estradiol patches or placebo patches after repair of the rotator cuff. The purpose of this study is to determine whether estradiol patches show promise in improving shoulder pain, strength, muscle volumes, and function when given with rotator cuff repair.
NCT04923477
Rotator cuff tendinopathy, one of the pathologies identified as part of the cluster of shoulder symptoms known as subacromial pain syndrome, is a common musculoskeletal shoulder condition. Resolution of pain and disability is poor despite treatment, with only about 50% reporting full recovery at 12 - 18 months. Prior studies suggest therapeutic exercise when used alone and with other interventions can have positive outcomes; however, not all patients with rotator cuff tendinopathy respond. Few studies have assessed the effects of exercise for individuals with chronic pain, especially brain driven mechanisms, thought to play a key role. In this study, we will use brain imaging to understand the mechanisms, identify predictors of a positive response to exercise, and the relationship to biomechanical and pain-related factors in patients with RC tendinopathy. The findings from this study will optimize the delivery and treatment response to exercise for individuals with shoulder pain.
NCT07372222
The goal of this clinical study is to learn if using a special pillow placed behind the shoulder can help to reduce pain and improve sleep for patients after surgery to repair a torn rotator cuff. The main questions it aims to answer are: * Do patients who choose to use the posterior shoulder pillow have lower pain levels after surgery? * Do these patients report better sleep quality during recovery? * How safe and comfortable is the pillow for patients to use? Researchers will compare patients who use the pillow to those who do not use it to see if there is a difference in their recovery. Participants will: * Be asked about their willingness to use the pillow. Their treatment and recovery plan will be decided together with their doctor. * Be asked to rate their pain and sleep quality several times after surgery: at 1 week, 2 weeks, 4 weeks, and 6 weeks. * Have their shoulder function assessed by a clinician at 2, 4, and 6 weeks after surgery. * Receive a standard MRI scan before and 6 weeks after surgery as part of their regular medical care to check on healing.
NCT05906004
This is a clinical investigation study. It will verify the long-term safety and performance of the Pitch-Patch when implanted to reinforce partially repairable rotator cuff tears and used as described by the manufacturer's instructions. The medical device in this study is already on the market and is manufactured by Xiros Ltd. The Pitch-Patch is a single-use polyester prosthesis available in two sizes (30x20mm and 35x25mm). It is reinforced around the perimeter and around each eyelet to provide strength and stability to the device and repair. The study will collect data on patients who meet the entry criteria and have received the device. This is a single-armed study, meaning all patients will have a Pitch-Patch. The total length of the is expected to be 3 years. A minimum of 37 patients will be enrolled into the study. Patients will be enrolled at a study specific follow up visit 2-2.5 years after implant, and data for baseline and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.
NCT05297305
The goal of this study is to compare the effect of different ways to place the component that goes at the top of the humerus (upper arm) in reverse total shoulder replacement. Some surgeons place the humeral tray component sitting on the bone while others place it in the bone. Changing the way that the humeral component is placed may change how much the arm can raise up or turn out/in after surgery for some patients. This study compares patients with inlay humeral component (tray sits in the upper arm bone) versus onlay humeral component (tray sits on top of the upper arm bone) to see if there are differences in range of motion or function after surgery.
NCT05444465
The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.
NCT07289893
Kettlebell exercises are seen as one of the approaches that can be used conservatively in individuals with shoulder pain. However, it is still unknown what results it has on its therapeutic effects. These findings highlight the need for higher quality studies evaluating the effects of kettlebell use and exercises for shoulder pain. Therefore, the purpose of this study was to investigate the effects of 8 weeks of kettlebell training on shoulder pain, function, and performance. The hypotheses of our study are as follows: * H1: In individuals with Rotator Cuff-Related Shoulder Pain, the improvement in shoulder-related pain perception is greater with Kettlebell training compared to the standard rehabilitation program. * H2: In individuals with Rotator Cuff Related Shoulder Pain, shoulder function improvement is greater with Kettlebell training compared to the standard rehabilitation program. * H3: In individuals with Rotator Cuff-Related Shoulder Pain, shoulder performance improvement is greater with Kettlebell training than with the standard rehabilitation program.
NCT06818708
Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia. This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approach and stimulation administration during the first 7 days following foot and shoulder surgery as well as training the clinical investigators.
NCT06664645
The increase of the population life expectancy and the active lifestyle adopted in recent years have contributed to the higher incidence of rotator cuff injuries. For large (\>3 cm) and extensive (\>5 cm) injuries of the rotator cuff, even after complete or partial repair, the chances of failure reach 94%. An alternative in rotator cuff injuries is the use of the long head of the biceps (LHB) as an autologous graft to increase the healing rate and the final outcomes. The primary objective is to compare the functional results, according to the ASES score, between patients who use or not the long head biceps brace for complete repairs of large and extensive rotator cuff tears. The secondary objectives are to compare the groups according to structural results by MRI and functional results by the UCLA score.
NCT04450342
The study is designed to assess the safety and efficacy of Arthroscopic rotator cuff repair (ARCR) augmented with REGENETEN in subjects requiring full-thickness rotator cuff tear repair or revision repair versus Arthroscopic rotator cuff repair alone.
NCT06669741
To assess the benefits of using the Incrediwear products for patients recovering from Arthroscopic Rotator Cuff Repair surgery for postoperative pain, range of motion, and swelling.
NCT05450510
Latissimus dorsi transfer is an established treatment option with favorable results in massive, irreparable rotator cuff tears, however, it is controversial if earlier motion is detrimental or beneficial to the postoperative goal of reduced pain and improved clinical outcomes. Therefore, the aim of this study is to compare the effects of slow and accelerated rehabilitation protocols after latissimus dorsi transfer in massive, irreparable rotator cuff tears.
NCT05975801
Shoulder pain is the most common musculoskeletal problem after spine and knee complaints. Rotator cuff injuries (RCI) are the most common cause of shoulder pain. RCI includes a wide spectrum from subacromial impingement syndrome (SIS) to chronic tendinopathy, partial and total ruptures of the rotator cuff. In recent years there has been a renewed interest in traditional and complementary medicine (TCM) for various musculoskeletal problems. Cupping therapy, which is one of the most commonly used TCM methods, is one of the oldest medical applications with thousands of years of history. Although it is thought to be effective in many diseases, there are not enough studies in the literature about its effectiveness and mechanism of action. Our aim in this study is to investigate the effects of moving dry cupping therapy on pain, range of motion (ROM), functionality and quality of life in RCI.