Clinical Research Directory

Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery

Shoulder surgery often causes severe pain after the operation. To control this pain, doctors commonly perform a nerve block (interscalene brachial plexus block), which numbs the shoulder area. However, when the effect of a single-injection nerve block wears off, many patients experience sudden, intense pain known as "rebound pain". One way to prevent rebound pain is to place a thin catheter near the nerves so that local anesthetic can be given continuously for a longer period (continuous nerve block). However, this method is technically demanding and can cause problems such as catheter dislodgement, infection, and inconvenience for patients. Another simpler option is to give a single-injection nerve block together with an intravenous (IV) injection of dexamethasone, a steroid medication known to prolong the effect of nerve blocks and reduce rebound pain. The purpose of this study is to determine whether a single-injection nerve block combined with IV dexamethasone (5 mg) is not inferior to a continuous nerve block in preventing rebound pain after shoulder surgery. A total of 92 adult patients scheduled for elective shoulder surgery will be randomly assigned to one of the two groups. The main outcome is the rebound pain score, defined as the difference between the last pain score recorded in the recovery room (while the nerve block is still working) and the highest pain score reported within the first 24 hours after the nerve block. The investigators expect that the simpler single-injection method with IV dexamethasone will provide comparable pain control while avoiding the complications and inconvenience of catheter-based continuous nerve blocks.

Rotator Cuff Repairs With or Without BioEnthesis™ Augmentation

Rotator cuff (RC) injuries are particularly prevalent, difficult to repair, and attachment between the bone and tendon is notoriously difficult to achieve. The most common method and current standard of care (SOC) for reattaching connective tissues (e.g., ligaments, tendons) to bone typically involves suture anchor-based techniques, but this is fraught with problems. More specifically, re-tearing of the connective tissue after this procedure occurs in 30-60% of cases, and can be even higher in patients who engage in smoking, have a diagnosis of diabetes, etc. To address these clinical challenges, Sparta Biopharma Inc. (Sparta) developed a unique technology, called BioEnthesis, to improve the connection between the tendon and bone. Pre-clinical in vivo studies demonstrated that the biphasic bovine cancellous matrix regenerated at the bone-soft tissue interface-thereby leading to high structural integrity and will likely lead to reduced re-tear rates over time. The investigators hypothesize that patients in this interventional cohort will experience enhanced mobility, reduced pain, and less re-tears after RC procedures versus a standard suture anchor-based repair.

Mulligan and Proprioceptive Neuromuscular Facilitation Techniques in Individuals With Rotator Cuff Lesions

This study aims to compare the effects of Mulligan mobilization with movement (MWM) and Proprioceptive Neuromuscular Facilitation (PNF) techniques on pain, functionality, proprioception, and quality of life in individuals diagnosed with rotator cuff lesions. A total of 45 participants aged 30-70 years with partial supraspinatus tears confirmed by clinical and radiological assessment will be randomly assigned to three groups: conventional physiotherapy, Mulligan + conventional physiotherapy, and PNF + conventional physiotherapy. All groups will receive a standardized three-week physiotherapy program, while the Mulligan and PNF groups will additionally undergo their respective manual therapy interventions. Outcome measures will include pain intensity (VAS), shoulder range of motion, functional disability (DASH), joint position sense, and rotator cuff-specific quality of life (RC-QoL). The study seeks to determine which manual therapy approach (Mulligan or PNF) provides superior improvements in clinical outcomes compared with conventional treatment alone.

Subscap Reverse Shoulder Arthroplasty

The subscapularis is part of the rotator cuff and is release as part of a reverse shoulder replacement. The decision to repair this tendon is controversial. This research is being done to help determine if rotator cuff repair improves or hinders shoulder replacement. A worrisome but rare complication after shoulder replacement is dislocation. Rotator cuff repair may help reduce this risk. The repair may hinder some of the range of motion afterwards or could help with internal rotation strength. There is a chance that the repair doesn't matter at all. The goal of this study is to delineate outcomes after reverse shoulder arthroplasty with the respect to management of the subscapularis tendon. Further information about rotator cuff repair after reverse shoulder replacement can help define complications, potentially decrease OR time, and improve functional outcomes. A total of 148 patients will be enrolled and the duration of the study will be 5 years. All patients will be required to follow-up at 2¬-week, 6-week, 3-month, 6-month, 1-year, and 2-year post-operative marks. Any time information is collected for a study there is a small risk of breach of confidentiality. There are no monetary costs or payments associated with this study. You may or may not benefit by taking part in this study. There is no guarantee that you will receive direct benefit from your participation in this study. To be clear, participation in this study is completely voluntary.

Contextually Enhanced Exercise Programs for Rotator Cuff-Related Shoulder Pain

The goal of this clinical trial is to learn whether adding personalized contextual factors to an exercise program can improve pain and function in people with rotator cuff-related shoulder pain. This condition is a common cause of shoulder pain and can limit daily activities. The main questions this study aims to answer are: 1. Does a contextually enriched and individualized exercise program lead to greater improvement in upper-limb disability (measured by the QuickDASH questionnaire) compared with a contextually fixed program? 2. Does it lead to greater reductions in pain intensity (measured by the Numeric Pain Rating Scale) and greater improvements in autonomic nervous system regulation (measured by heart rate variability)? 3. Does it result in more favorable changes in psychosocial outcomes, exercise adherence, and therapeutic alliance? Researchers will compare two exercise programs to determine whether adding personalized contextual features enhances treatment effectiveness. One group will receive a standardized, evidence-based exercise program delivered in a fixed and neutral manner. The other group will receive the same exercise program with added personalized contextual elements, such as: * Preferred music and lighting * Choice between equivalent exercises (without changing exercise type or dosage) * Motivational feedback and supportive communication * Personalized progress tracking Both groups will: * Attend supervised exercise sessions twice per week for 12 weeks * Follow a structured home exercise program * Complete questionnaires assessing pain, function, and psychological factors * Undergo heart rate variability assessment to evaluate autonomic regulation * Be followed for 12 months after treatment The researchers expect that integrating personalized contextual elements into exercise therapy may enhance recovery, increase motivation, and improve long-term outcomes.

Effectiveness of Non-surgical Management in Rotator Cuff Calcific Tendinopathy (THE EFFECT TRIAL)

The aim of this study will be to compare the effectiveness of an exercise therapy program with extracorporeal shockwave therapy, ultrasound-guided percutaneous irrigation and a wait and see approach in people with rotator cuff calcific tendinopathy.

The Role of Pectoralis Minor Tightness in the Development of Rotator Cuff Tears

This study investigates whether tightness of a small chest muscle called the pectoralis minor is associated with the development of partial rotator cuff tears in the shoulder. Using a propensity score matched case-control design, the study compares patients with rotator cuff tears (case group, n=45) to patients with intact rotator cuffs (control group, n=45). Adults aged 18-55 with shoulder pain who are evaluated by MRI and/or shoulder arthroscopy at Gazi University Hospital may be invited. The case group includes patients found to have partial rotator cuff tears during arthroscopy. The control group includes patients whose rotator cuff was documented as intact by MRI. Groups are matched 1:1 on age, sex, BMI, and dominant side. Before surgery, two trained clinician measures shoulder posture and pectoralis minor length using simple external tools (a digital caliper and ruler-like square). For arthroscopy patients, the surgeon records general arthroscopic findings. No extra procedures are added for research. We expect to include 90 participants total. The primary hypothesis is that pectoralis minor tightness is more prevalent in patients with rotator cuff tears compared to controls. A secondary hypothesis is that tears in patients with pectoralis minor tightness more often partial-thickness bursal side rotator cuff tear. Results may help clinicians understand shoulder mechanics and improve prevention or rehabilitation strategies.

Comparison of Two General Anesthesia Maintenance Strategies on Intraoperative Visibility During Arthroscopic Rotator Cuff Surgery: A Randomized Trial

Shoulder arthroscopy is one of the most common orthopedic procedures, and the quality of the surgeon's view inside the joint is critical to its safety and success. Unlike limb surgery, no tourniquet can be applied to the shoulder, so surgical visibility depends almost entirely on how much bleeding occurs within the joint - which is itself influenced by the anesthetic drugs used to keep the patient asleep. Two standard techniques exist for maintaining general anesthesia: inhaled anesthesia (sevoflurane) and total intravenous anesthesia (TIVA, using propofol). Evidence from other types of keyhole surgery (nasal, ear) suggests that propofol may produce better surgical visibility, possibly because sevoflurane causes slightly greater dilation of the smallest blood vessels in tissue, leading to more bleeding into the joint. However, in shoulder arthroscopy specifically, the data are scarce and contradictory. CLEAR-SHOULDER is a randomized, single-blind trial designed to determine whether propofol-based intravenous anesthesia provides superior intraoperative visibility compared to sevoflurane-based inhaled anesthesia during arthroscopic rotator cuff repair. Surgical visibility will be assessed from blinded video recordings of each procedure using the validated modified Fromme-Boezaart score. An exploratory artificial intelligence analysis of the arthroscopic videos will also be conducted. Secondary outcomes include operating time, irrigation fluid consumption, hemodynamic stability, vasopressor requirements, surgeon satisfaction, postoperative recovery, and environmental impact of each anesthetic strategy.

Evaluation of Thoracic Kyphosis, Trunk Rotation, and Balance in Rotator Cuff Pathology

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.

Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant

This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients who are undergoing rotator cuff repair using the REGENETEN◊ Bioinductive Implant System. The Registry will include up to 50 centers in the United Kingdom (UK), Europe, Australia, and up to 400 patients for the initial evaluation. Patients will be treated and evaluated according to standard medical care. Outcome data is collected up to 2 years post-surgery.

Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff

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 study 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, procedure, and other time points prior to 2 years (3month, 6month, and 1 year post surgery) will be collected retrospectively from medical records if available.

Concentric vs Eccentric Full Can Exercise in Partial Rotator Cuff Tears

This study aims to compare the effects of concentric and eccentric full can exercises on supraspinatus muscle architecture in individuals with partial rotator cuff tears. Rotator cuff tears are a common cause of shoulder pain and functional limitation. The supraspinatus muscle plays a key role in shoulder movement and stability, and its structure may be affected in individuals with partial tears. Exercise-based rehabilitation is widely used in the conservative management of these conditions. The full can exercise is commonly prescribed to selectively activate the supraspinatus muscle. However, the effects of different contraction types, specifically concentric and eccentric exercises, on muscle structure and clinical outcomes are not fully understood. In this study, participants will be randomly assigned to either a concentric or eccentric full can exercise group. Both groups will receive a standard physiotherapy program, including therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS), in addition to the assigned exercise protocol. The intervention will last for 6 weeks, with sessions performed three times per week. Outcomes will be assessed before and after the intervention. The primary outcome is the change in supraspinatus muscle pennation angle measured by ultrasound imaging. Secondary outcomes include muscle architecture parameters, pain intensity, range of motion, muscle strength, functional status, and kinesiophobia. The findings of this study may help improve exercise selection in the rehabilitation of individuals with rotator cuff tears.

Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty

The current prospective single-center study is designed to examine an approach that utilizes both high-resolution CT and MRI scans, coupled with customized finite element modelling to analyze the stress placed on the acromion of patients who have undergone RSA surgery. The degree of rotator cuff deficiency will be assessed using Goutallier classification and quantified as Cuff Deficiency Index (CDI), which directly provides biomechanical information for calculating deltoid forces used in finite element analysis. Von Mises stresses will then be analyzed in anatomically defined acromial zones (Levy zones I-III).

CBD for Pain Following Orthopedic Shoulder Surgery

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

Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries

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.

Stem Cell Treatment for Regeneration of the Rotator Cuff (Lipo-Cuff Study)

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.

Shoulder RFA Pilot Study

Through this prospective, single-arm cohort pilot study, we plan to explore the safety and effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears.

Estradiol Supplementation and Rotator Cuff Repair

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.

Telerehabilitation for Shoulder Surgery Recovery

This study aims to evaluate the effectiveness of a telerehabilitation protocol utilizing the Band Connect platform in patient recovery following rotator cuff repair surgery. This will be a randomized control trial with patients assigned into a traditional rehabilitation or a telerehabilitation protocol.

Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome - Outcomes and Mechanisms

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.

Effect of a Posterior Shoulder Pillow on Pain and Sleep Quality After Rotator Cuff Repair

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.

Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair

Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.

Safety and Efficacy of Platelet-Rich Plasma Combined With Compound Betamethasone in Arthroscopic Surgery for Rotator Cuff Injury With Shoulder Adhesion: A Prospective, Multicenter, Randomized Controlled Trial

Background: Patients undergoing arthroscopic surgery for rotator cuff tears with shoulder adhesion often experience significant postoperative pain and stiffness. This study investigates whether adding a long-acting local anesthetic (Liposomal Bupivacaine) to a standard anti-inflammatory steroid injection (Compound Betamethasone) during surgery can improve outcomes. Methods: This is a prospective, randomized, double-blind, controlled trial. Approximately 70 eligible adult patients will be randomly assigned to one of two groups: (1) the Combination Group, receiving an intra-articular injection of Liposomal Bupivacaine plus Compound Betamethasone after surgery, or (2) the Control Group, receiving Compound Betamethasone alone. Patients and outcome assessors will not know the group assignment. What participants will do: All participants will receive standard arthroscopic rotator cuff repair and adhesion release. They will be followed for 12 months after surgery, with assessments at multiple time points (from hours to months post-op) to measure pain levels, shoulder function, range of motion, and tendon healing via MRI. Main Goals: The primary goal is to compare the improvement in UCLA shoulder scores between the two groups at 12 months. Secondary goals include comparing pain scores, other functional scores (Constant-Murley), joint mobility, MRI findings, and safety (complication rates).

Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

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.