Clinical Research Directory

Contextually Enriched Individualized Exercise Versus Contextually Fixed Exercise 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.

Supraspinatus Tendon Acute Effects After Two Exercise Exposures: a Crossover Randomized Trial.

The purpose of this study is to understand acute tendon changes after two exercise programs. We will invite individuals with and without shoulder pain to participate in this study. Every individual will participate in both exercise programs separated by up to 15 days. The researcher will evaluate the shoulder tendon using ultrasound before each exercise program and at 1 hour, 6 hours and 24 hours after each exercise program. The researcher will also evaluate self reported pain, pain sensitivity testing, and self reported questionnaires. We will compare the tendon changes after each exercise program, as well as between participants with and without shoulder pain.

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery

This study aimed to evaluate the effectiveness of serratus posterior superior intercostal plane (SPSIP) block in managing postoperative pain in patients undergoing arthroscopic shoulder surgery.

USG-Guided Shoulder Injections in Frozen Shoulder

Frozen shoulder (adhesive capsulitis) is characterized by pain and a progressive restriction of both active and passive shoulder range of motion, significantly impairing daily activities and quality of life. This study aims to evaluate the effectiveness of USG-guided shoulder injections, when added to a home-based exercise program, in the conservative management of patients with chronic, painful frozen shoulder. In this prospective randomized study, patients diagnosed with painful frozen shoulder will be included. In addition to a standardized home-based exercise program, patients will receive either USG-guided suprascapular nerve block alone or a combination of suprascapular nerve block and subacromial injection. The effects of these approaches on clinical outcomes will be assessed over a 20-week follow-up period. Primary outcome measures include pain intensity assessed by the Visual Analog Scale (VAS), functional status evaluated by the Shoulder Pain and Disability Index (SPADI), and shoulder range of motion. Secondary outcomes include depression level (Beck Depression Inventory), sleep quality, pain phenotype (nociplastic, neuropathic, or nociceptive), hand grip strength, ultrasonographic findings ( (coracohumeral ligament thickness, subacromial bursa thickness) , and patient satisfaction (subjective impression of improvement). The results of this study are expected to provide evidence on the comparative effectiveness and additional benefits of different shoulder injection approaches when combined with home-based exercise therapy in patients with chronic frozen shoulder.

Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis

Patients aged 18-75 years who present to a tertiary rehabilitation hospital with shoulder pain and restricted range of motion, and who consent to participate, will be included in the study. Eligibility will be determined based on predefined inclusion and exclusion criteria. Eligible patients will be randomly assigned to receive one of several nonsteroidal anti-inflammatory drugs (NSAIDs) with differing chemical properties (e.g., diclofenac, meloxicam, or indomethacin), in combination with a home-based exercise program for shoulder adhesive capsulitis. Patients' sociodemographic data, as well as detailed clinical and examination findings and baseline outcomes, will be recorded. Patients will be informed about their condition, and modifications to activities of daily living will be recommended.Patients' pain phenotypes (nociceptive, neuropathic, nociplastic) will be categorized based on clinical history and questionnaires, and it will be determined which pain types derive greater benefit from NSAIDs. Follow-up assessments will be conducted at the end of the first and second weeks. At the first-week follow-up, pain intensity will be evaluated using the Visual Analog Scale (VAS). If the treatment is deemed effective (defined as a ≥3-point reduction or ≥50% decrease in VAS), the same NSAID will be continued for an additional week; otherwise, it will be switched to an alternative NSAID with a different biochemical profile (group). The outcomes assessments will be performed by a blinded evaluator to minimize bias.

The Effect of Early-Phase Graded Motor Imagery Following Massive Rotator Cuff Repair.

Massive rotator cuff tears are associated with significant pain, functional limitations, and prolonged rehabilitation following surgical repair. In the early postoperative phase, rehabilitation protocols are often limited due to surgical protection requirements, which may delay the restoration of motor control and shoulder function. Graded motor imagery (GMI), a movement representation technique that includes laterality recognition, motor imagery, and mirror therapy, has been shown to modulate cortical processing and improve pain and motor function in various musculoskeletal and neurological conditions. However, its potential role in early postoperative shoulder rehabilitation has not been adequately investigated.

The Efficacy and Safety of Shoulder Motion Style Acupuncture Treatment (MSAT) on in Patients With Shoulder Pain Caused by Traffic Accidents

This study will test the effectiveness and safety of Motion Style Acupuncture Treatment (MSAT) for shoulder pain caused by traffic accidents. About 98 hospitalized patients with acute shoulder pain after a traffic accident will take part. Participants will be randomly assigned to one of two groups: MSAT + integrative Korean medicine group (acupuncture, herbal medicine, pharmacopuncture, Chuna therapy, plus MSAT), or Integrative Korean medicine only group (acupuncture, herbal medicine, pharmacopuncture, Chuna therapy). MSAT involves inserting needles into the shoulder area and gently moving the joint to improve pain relief and mobility. All treatments used in this study are standard care in Korean medicine. The main outcomes are pain reduction, shoulder movement, daily function, quality of life, and patient satisfaction. Safety will also be monitored by recording any side effects such as temporary soreness, bruising, or discomfort. Treatment will be provided during hospitalization (up to 5 days), and patients will be followed up by phone at 2 weeks and 1 month after enrollment. The results of this trial will help determine whether adding MSAT to standard integrative Korean medicine treatment provides greater benefit for patients with acute shoulder pain after traffic accidents.

Comparison of the Effectiveness of USG-Guided Interscalene Block Versus Combined Interscalen-Suprascapular Block for Arthroscopic Shoulder Surgery

This study aims to compare two commonly used regional anesthesia techniques for shoulder arthroscopy: the ultrasound-guided interscalene block and the combined interscalene-suprascapular nerve block. Both techniques are routinely performed to reduce pain during and after shoulder surgery. The purpose of this study is to determine which method provides better postoperative pain control, reduces the need for pain medication, and causes fewer side effects such as diaphragmatic dysfunction. Participants will receive one of the two nerve block techniques before surgery, and their pain scores, opioid consumption, and respiratory effects will be monitored during the first 24 hours after the operation.

Inspiratory Muscle Strength and Diaphragm Thickness in People With Shoulder Pain in Tennis Players

This observational case-control study will compare inspiratory muscle function and diaphragm morphology between individuals with shoulder pain and asymptomatic controls. Participants will be allocated into two groups according to the presence or absence of shoulder pain. Inspiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) using standardized procedures. Diaphragm thickness will be evaluated bilaterally using ultrasound imaging at the end of inspiration (Tins) and at the end of expiration (Texp). Pain intensity will be assessed using the Visual Analog Scale (VAS). Upper limb disability will be evaluated using the QuickDASH questionnaire, including the activities of daily living module and the optional sports module. All outcomes will be assessed in a single evaluation session. Between-group comparisons will be performed to analyze differences in inspiratory muscle strength, diaphragm thickness, pain intensity, and upper limb disability between participants with and without shoulder pain.

Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain

This study aims to compare the frequency of occurrence of ipsilateral shoulder pain in patients undergoing thoracotomy with ultrasound-guided interscalene block, anterior suprascapular block as adjunct to epidural and epidural block only.

OsseoFit Stemless Shoulder System (Anatomic)

The purpose of this clinical research protocol is to evaluate the safety, efficacy, and long-term outcomes of the OsseoFit Stemless Shoulder System (Anatomic) in patients with a primary diagnosis of osteoarthritis. The study aims to assess the intraoperative characteristics, postoperative complications, functional outcomes, and radiographic findings associated with the use of the stemless implant system. Ultimately, this research aims to improve patient outcomes, enhance surgical techniques, and inform clinical decision-making in the treatment of shoulder pathology.

HIIT for Inflammatory-driven Shoulder Pain.

This feasibility study investigates whether high-intensity interval training (HIIT) is feasible and acceptable for individuals with long-term shoulder pain where low-grade inflammation is suspected. Many patients do not recover fully with current local treatments, and systemic factors such as inflammation, and metabolic changes, additionally disturbances in the functioning of the nervous system often seem to play a role. HIIT is a time-efficient form of exercise that has been shown to improve inflammation and metabolic values and positively influence the balance of the nervous system. In this feasibility study, the investigators are enrolling 15 individuals with persistent shoulder pain (diagnosed with rotator cuff-related shoulder pain or frozen shoulder) with \>3 months of symptoms, and 15 individuals without shoulder complaints. All participants will undergo measurements of inflammatory levels, glycosylated hemoglobin (HbA1c), blood pressure, body composition, pain sensitivity tests, and complete questionnaires about autonomic complaints and quality of life. Participants with shoulder pain will also perform one personalized HIIT session on a cycle ergometer. The investigators will assess whether participants accept a systemic intervention for their shoulder pain, if they are cooperative, and how they feel about the session; additionally, any side effects will be recorded. The aim is to determine whether HIIT is practically feasible and safe for this group and whether there are indications that systemic factors such as inflammation and nervous system function are associated with persistent shoulder pain. The outcome will determine whether follow-up research with a larger study is worthwhile.

Bupivacaine With Epinephrine Over Diaphragm in Laparoscopy

Postoperative shoulder pain is often reported to be particularly bothersome after laparoscopy. The benefits of local anesthetic, such as bupivacaine, applied to subcutaneous tissue for general postoperative pain management after surgery is well established. However, there have been no studies on sprayed bupivacaine over the diaphragm to reduce shoulder pain in laparoscopic surgery. The purpose of the study is to evaluate if sprayed infra-diaphragmatic bupivacaine compared to placebo (saline) will improve postoperative shoulder pain in patients undergoing benign laparoscopic gynecologic surgery. The entire study will be conducted at Cedar Sinai Medical Center.

Opioid-Free Pain Protocol After Shoulder Arthroplasty

This randomized, single blinded, clinical trial aims to investigate the efficacy of a multimodal pain control regimen for shoulder arthroplasty. Patients who receive a multimodal pain control regimen alone (study group) will be compared to patients who receive a multimodal pain control regimen plus a standard prescription of an opioid containing medication (comparison group). The primary outcome is average daily Numerical Rating Scale (NRS) pain score in the first 10 days after surgery. We hypothesize that there will be no significant difference in the primary outcome between the two groups.

Embolization Treatment of Chronic Refractory Shoulder Tendinopathy

This is a randomized controlled trial in which patients with moderate to severe shoulder pain (Visual Analog Scale (VAS) \> 40), in the setting of rotator cuff tendinopathy refractory to conservative treatment, will be enrolled. The primary aim of the study is to estimate the effect of transcatheter arterial embolization (TAE) with physical therapy (PT) vs PT alone on the change in shoulder pain at 12-month follow up. Scientific objectives also include an assessment of safety of the intervention, assessment of changes in Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity score, Shoulder Pain and Disability Index (SPADI) scores, MRI Tendinopathy Score between the TAE + PT and PT groups.

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary total shoulder arthroplasty (implants and instrumentation) at a 1,2,3,5,7, and 10- year follow-up\* to meet EU Medical Device and other Regulatory Requirements for Post-Market Surveillance. Because Comprehensive Versa-Dial Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well to collect long-term data. \*The most recent available data will be used. If any of the listed time points are not available, data will be used from last available time point and follow-up will move forward at the closest available time point.

Virtual Reality-Supported Exercise for Chronic Musculoskeletal Shoulder Disorders: a Feasibility Study

People with long-term (chronic) shoulder disorders caused by injuries, overuse or conditions (such as arthritis) often need physiotherapy. This usually includes exercise therapy to help reduce pain, rebuild strength and make every day activities easier. However, it can be hard to stick to an exercise programme. People may stop due to pain, fear of making the symptoms worse or simply loosing motivation. Virtual Reality (VR) is a technology that may help people say engaged with their exercise programmes by making exercises more enjoyable and interactive. When using a headset (similar to goggles), people can see and interact with a 3D virtual world. Their movement, especially their hands and arms, are shown as an 'avatar' (a virtual character) in this virtual world. Exercise can feel more like playing a game or engaging with tasks/challenges, rather than performing repetitive movements. This shift might help reduce focus on pain and increase motivation. VR also provides real-time feedback, helping people track their progress and adjust their movements instantly. This might lead to more accurate and consistent exercise performance and better recovery outcomes. Before we can test whether VR exercise programmes are effective for people with chronic shoulder disorders, we firstly need to understand whether it is practical and acceptable for patients to use. This 'feasibility' study will therefore involve 20 patients with chronic shoulder disorders referred for physiotherapy at the Royal National Orthopaedic Hospital (RNOH) in Stanmore, United Kingdom. Participants will take part in three VR exercise sessions at the RNOH over a three-week period. Levels of pain, quality of life and sleep quality etc. will be measured before and after three weeks. Interviews will also be held up to two weeks after the final session to explore people's experiences and thoughts towards the VR exercise programme. The results will help us decide if a larger study should go ahead.

Effect of Adding Extracorporeal Shock Wave Therapy to Exercises in Rotator Cuff Tendinopathy

Rotator cuff tendinopathy (RCT) is one of the most common causes of shoulder pain, resulting in functional limitations and reduced quality of life. Exercise therapy is considered a first-line treatment; however, adjunct modalities such as extracorporeal shock wave therapy (ESWT) may enhance recovery. This study aims to evaluate the effect of adding ESWT to a rotator cuff and scapular stabilization exercise program in patients with rotator cuff tendinopathy.

How Dry Needling at the Neck Affects Shoulder Movement, Strength, Pain, and Shoulder Circulation

Segmental facilitation, originally proposed by Korr in the 1950s, suggests that certain spinal segments can become hyperexcitable, leading to chronic pain development. In a facilitated segment, neurons governing sensory, motor, and autonomic functions are in a state of heightened sensitivity, making them responsive to normally weak stimuli. Clinical signs include non-fatigable muscle weakness, brisk reflexes, muscle hypertonicity, tenderness upon palpation, and trophic changes like an orange-peel appearance in the affected segment's innervated areas. It's hypothesized that increased synaptic excitability in facilitated segments could cause vasoconstriction and reduced blood flow, contributing to trophic changes and muscle hypertonicity. Manual therapies like dry needling have been shown to alleviate muscle inhibition in the extremities. Previous studies have demonstrated that mobilization of the C5-6 joint can reduce non-fatigable weakness in shoulder external rotators primarily innervated by these segments. However, the neurophysiological effects of dry needling (DN) on muscle inhibition due to a facilitated segment remain unclear. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. While DN has been observed to increase local tissue blood flow, its potential to mitigate the clinical signs of segmental facilitation is uncertain. Therefore, this project aims to investigate whether DN applied at a facilitated segment could normalize blood flow to its associated muscles. Specifically, this study will explore whether DN at the C5-6 level improves blood flow in the infraspinatus muscle, enhances shoulder range of motion, and influences muscle strength over time. The secondary purpose is to determine whether C5-6 DN will reduce the number of tender points in the muscles supplied by C5-6.

Suprascapular Nerve Block to Improve Tolerance and Outcomes of Shoulder Hydrodistension in Adhesive Capsulitis

Adhesive capsulitis ("frozen shoulder") causes significant pain and loss of shoulder mobility. Shoulder hydrodistension is an established treatment that can improve movement and reduce symptoms, but the procedure itself may be painful and difficult for some patients to tolerate. This randomized clinical trial will evaluate whether performing a suprascapular nerve block with local anesthetic immediately before hydrodistension can reduce pain during the procedure, improve patient comfort, and potentially enhance clinical outcomes. Participants will be randomly assigned to one of two groups: hydrodistension alone, or suprascapular nerve block followed by hydrodistension. Pain, shoulder mobility, functional ability, psychological measures, and quality of life will be assessed at baseline, 1 month, and 3 months after the procedure. The study aims to determine whether adding a suprascapular nerve block provides better tolerability and improved recovery for patients with adhesive capsulitis.

Effect of Kinesio Taping After Rotator Cuff Surgery

The aim of this study is to evaluate whether postoperative kinesio taping provides additional benefits in pain reduction and functional recovery in patients who have undergone arthroscopic rotator cuff repair. Patients diagnosed with rotator cuff tear who have undergone surgical treatment will be randomly assigned into two groups. One group will receive standard postoperative rehabilitation together with kinesio taping applied for three weeks, while the control group will receive standard postoperative rehabilitation alone. Pain levels and shoulder function will be assessed during postoperative follow-up using commonly accepted clinical evaluation scales. The findings of this study are expected to contribute to a better understanding of the role of kinesio taping in the recovery process after rotator cuff surgery.

Shock Wave Therapy as a Treatment Intervention for Frozen Shoulder

Adhesive capsulitis (AC) is a debilitating condition that causes global restriction and pain at the glenohumeral joint. Physiotherapy treatment is often first line treatment management. Patients with failed conservative management are commonly referred to a specialist consultant for further treatment. Over the last 20 years, extracorporeal shock wave therapy (ESWT) has gained popularity as a treatment for various orthopaedic presentations, including chronic soft tissue conditions, being non-invasive, resulting in good outcomes with minimal side effects. There is a lack of evidence on the clinical effectiveness of ESWT for chronic AC following failed conservative treatments, with the available literature reporting positive outcomes, however, with heterogeneity in treatment protocols. This proposed study aims to explore the feasibility of a full trial of ESWT as a treatment for AC using a standardised treatment protocol, and clinical effects on outcomes of pain, function and shoulder joint range of movement in persons with chronic adhesive capsulitis. A Delphi study will first explore expert opinion for the optimum treatment protocol of ESWT as a treatment for chronic AC, followed by a mixed methods explanatory sequential study that includes a pilot trial with nested qualitative interviews. The Shoulder Pain and Disability Index, numerical pain rating scale, EuroQol-5D, and digital goniometer will be used to measure self-reported pain and function, pain, health-related quality of life, and shoulder joint range of movement, respectively. Quantitative data will be analysed by descriptive statistics. Qualitative data will be collected through semi-structured interviews. Interview data will be analysed using Braun and Clarke's inductive thematic analysis approach. The study will be conducted in an out-patient clinical setting in a community health hub facility, with patients recruited from an NHS Orthopaedics waitlist. Data collection is planned over a nine month period. This study is not affiliated with funding streams.

Mobile App-Assisted Home Exercise for Musculoskeletal Disorders

Overview This study evaluates the effectiveness of a dedicated mobile health (mHealth) application in supporting home exercise programs for patients with musculoskeletal disorders, such as neck, shoulder, back, or knee pain. The research aims to address the widespread challenge of low patient adherence to unsupervised home-based exercises. Study Design The project employs a dual-methodology approach: Clinical Trial: 30 participants presenting with neck, shoulder, back, or knee pain will be randomly assigned to either an app-assisted group or a traditional home exercise group. Both groups will undergo 4 weeks of physiotherapy. The study will compare pain intensity, physical function, and exercise adherence between the two cohorts. Retrospective Analysis: To complement the trial, the study will analyze a large-scale database containing approximately 700,000 anonymized real-world data entries. This analysis aims to observe real-time pain fluctuations before and after exercise sessions within routine clinical settings. Goal The primary objective is to determine if integrating mHealth technology into traditional rehabilitation can enhance clinical outcomes and improve patient adherence to home-based exercise routines.

Interscalene Block vs Serratus Posterior Superior Intercostal Plane Block

Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and a shorter hospital stay. Ultrasound (US)-guided brachial plexus blocks, such as interscalene and supraclavicular block, are usually performed. Interscalen brachial plexus block (ISCB) is one of the most preferred techniques among these. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked, and analgesia is provided. It has been reported that SPSIPB provides effective analgesia after shoulder surgery. The aim of this study is to compare the efficacy of the US-guided SPSIPB and ISCB for postoperative analgesia management after arthroscopic shoulder surgery.