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70 active trials for Shoulder Pain

A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.

Start: October 2019

Biopsychosocial Influence on Shoulder Pain

Chronic shoulder pain is a common, costly, and disabling problem for society. The identification of factors predictive of the development of chronic shoulder pain is necessary to develop innovative and effective treatments to reduce the societal impact of shoulder disorders. In previous work the investigators identified a genetic and psychological subgroup that robustly predicted heightened shoulder pain responses in a pre-clinical cohort and poor 12 month shoulder pain recovery rates in a clinical surgical cohort. In this follow-up study the investigator proposes to test how interventions tailored to the high risk subgroup affect pain responses in a pre-clinical cohort. The optimal theorized match for the identified high-risk subgroup is a combination of personalized pharmaceutical and education interventions. This combined personalized intervention versus a placebo pharmaceutical and general education intervention group is the primary comparison of interest. Also, an evaluation of the individual effect of personalized pharmaceutical and educational interventions will be part of the study. Such comparisons will provide important information on what the active portion of the combined personalized intervention may be.

Start: January 2016

Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.

Start: August 2021

Virtual Reality in Reeducation : Application to Shoulder Affections

The objective of this study is to assess the interest and the efficiency of virtual reality in functional rehabilitation of shoulder pain and shoulder injuries. Participants will follow a 12-week rehabilitation program based either on exercises or on a program integrating virtual reality. Results obtained with classical rehabilitation will be compared with the one obtained virtual reality.

Start: February 2019

Simple and Evidence-based Examination and Treatment of Shoulder Pain in General Practice

Previous research suggests that general practitioners find handling patients with shoulder pain difficult and that the current care for shoulder pain is not in line with the best available evidence (1).This project aims to assess the effectiveness, costs and implementation of an evidence-based guideline for shoulder pain in general practice.

Start: March 2021

Post-Operative Pain Control Following Shoulder Surgery

This study will evaluate overall opioid and non-narcotic analgesic use following surgical treatment for shoulder pathology, and recommend evidence based guidelines for standardized postoperative pain management.

Start: December 2020

Proprioceptive Neuromuscular Facilitation Techniques in Patients With Adhesive Capsulitis

Adhesive capsulitis is a condition that causes limitation of function and movement in the shoulder joint and affects many activities of daily life. The clinical indicators of adhesive capsulitis; shoulder pain and progressive global stiffness of the glenohumeral joint, night pains and accompanying sleep disturbances, joint capsule contracture, decrease in synovial fluid, abnormal changes in scapular position, functional limitation and consequently decreased quality of life. When we look at the literature, it is seen that traditional rehabilitation practices aim to improve range of motion and reduce pain caused by capsular contracture. In this context, classical therapeutic exercises consisting of stretching and strengthening, joint mobilization methods, proprioceptive neuromuscular facilitation methods are applied. However, there are limited number of studies investigating the effects of PNF techniques on pain, function and activity limitation. Therefore, within the scope of the research, it is planned to apply a traditional rehabilitation program prepared in accordance with the guidelines for one group, and PNF approaches for the upper extremity and scapula in the other group. Thus, it is aimed to examine the effects of the use of upper extremity and scapula PNF techniques on pain, function, range of motion, proprioception, quality of life, sleep and patient satisfaction compared to traditional exercises in adhesive capsulitis rehabilitation. Exercises will be applied 3 days a week for 4 weeks. Each training session will last 45 minutes. Pain, function, range of motion, proprioception, quality of life and sleep quality evaluations will be performed at the beginning of the study and at the end of 4 weeks.

Start: February 2021

ASHCOM Shoulder System and Its Related Instruments

The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.

Start: December 2019

Mitigating the Impact of Shoulder Movement Dysfunction; a Randomized Controlled Trial

The purpose of the proposed work is to screen the effectiveness of an evidence-based, targeted, treatment intervention versus a non-specific, generalized, treatment intervention to treat symptomatic shoulder instability in collegiate swimmers. The results of the study will allow direct observation of treatment effects designed to mitigate the effects of symptomatic shoulder instability. These results will facilitate the optimization of future treatments and interventions.

Start: August 2021

Effect of Intravenous Dexmedetomidine on Patient Discomfort in Laparoscopic Cholecystectomy Under Spinal Anesthesia.

Laparoscopic cholecystectomy (LC) has been routinely performed under general anesthesia despite the several disadvantages of general anesthesia compared to regional anesthesia. There are multiple reports that have been published regarding the feasibility of spinal anesthesia for LC associated with many problems such as referred shoulder pain secondary to intra-abdominal pneumoperitoneum; patient anxiety, pain, and discomfort; and inadequate sedation.The aim of our study is to prospectively observe the feasibility of using intravenous dexmedetomidine to abolish patient discomfort and shoulder pain, thus making the patient more comfortable without causing excessive sedation and respiratory depression.

Start: November 2019

The Effectiveness of Therapeutic Ultrasound in the Treatment of Calcific Tendinitis of the Shoulder

Rotator cuff tendinitis (RCT) has a prevalence between 2.7 and 22%, and predominantly affects middle-aged women. The pathophysiology has not been fully elucidated to date. RCT is characterized by hydroxyapatite crystal deposition in the rotator cuff tendons. Approximately half of the patients with RCT have pain with acute or chronic shoulder mobility limitation. In some patients, RCT shows a tendency for spontaneous and rapid regression. Diagnostic ultrasound (D-US) is a non-invasive, non-ionizing, and relatively inexpensive diagnostic imaging method that is safe and reliable in assessing rotator cuff pathology. It is very sensitive in the identification of calcifications that are shown in grayscale (B-mode) as hyperechoic structures with or without acoustic shadow. Based on ultrasound findings, Chiou HJ et al. have classified calcifications into 4 types: type I are arcuate, type II are fragmented or punctiform, type III are nodular, and type IV are cystic. Spontaneous resorption may occur with type III and IV calcifications. A positive Doppler signal (PD) surrounding the calcification is highly correlated with pain intensity. According to the European Union of Medical Specialists-Physical and Rehabilitation Medicine (UEMS-PRM) guidelines, the basis of RCT therapy is individual medical gymnastics (IMG). It includes exercises aimed to restore full shoulder mobility, and improve rotator cuff and scapular stabilizer muscles strength. Other passive procedures are elective in the choice of treatment. Ultrasound therapy is often used in the treatment of musculoskeletal shoulder pathology due to its thermal and non-thermal effects. It is considered that tissue heating stimulates healing (vasodilation, acceleration of the metabolism, and improvement of the viscoelastic properties of the connective tissue). The frequency of ultrasound therapy is selected depending on the desired depth of action (3 MHz for surface structures up to 2.5 cm depth, and 1 MHz for deeper structures, up to 5 cm depth). Pulse mode is commonly used in acute, while continuous in chronic conditions. To date, only a few studies have evaluated the reduction in calcification size after ultrasound therapy. Although ultrasound therapy is routinely used in the treatment of painful shoulder, reviewing the results of research published so far, we can say that current knowledge about the effectiveness of ultrasound therapy in RCT is inconsistent (only several studies with a small number of subjects, different parameters of applied ultrasound therapy in terms of penetration depth, applied energy and duration of treatment). This indicates the need for further research.

Start: April 2021

MDR SureLock All-Suture Anchor

To report the outcomes of a series of patients with recurrent anterior and/or posterior shoulder instability who underwent surgical repair of the affected labrum using the SureLock all-suture anchor.

Start: November 2019

"Shoulder Musculoskeletal Disorders in Type 2 Diabetes Mellitus: Contributing Factors and Rehabilitation Protocol"

Goals: to compare the effects of two distinct rehabilitation protocols (conventional shoulder musculoskeletal rehabilitation combined with aerobic exercises versus solely conventional shoulder musculoskeletal rehabilitation) on shoulder pain, function, strength, kinematics and tendon thickness in patients with type 2 DM after 12 weeks of intervention and a subsequent follow up of 8 weeks. The secondary objective of this study will be to evaluate the association between AGEs accumulation and shoulder pain, function, strength, kinematics and tendon thickness in individuals with type 2 DM. Methodology: is a single-blinded randomized controlled trial, in which all subjects with a clinical diagnosis of type 2 DM (with at least 1 year of diagnosis), of both sexes, between 40 and 70 years, presenting shoulder pain (uni or bilateral) for at least 3 months with a pain intensity score from 3 points on a numerical rating scale for pain intensity, will be invited to participate. The main outcomes of this study will include the AGEs accumulation through skin autofluorescence measurement; shoulder pain through NRS scales; shoulder function through SPADI questionnaire and range of motion measurement; isometric shoulder muscles strength through manual muscle dynamometer measurement; shoulder kinematics through three dimensional inertial units measurements; supraspinatus tendon thickness through ultrasound measurement. All these outcomes will be measured before and after the rehabilitation protocols. Participants will be randomly assigned to one of the two rehabilitation groups: specific shoulder rehabilitation protocol group (SRG); or 2) specific protocol of shoulder rehabilitation plus aerobic exercise group (ARG). All individuals will be evaluated before starting the rehabilitation protocol (baseline) and at the end of rehabilitation (post 12 weeks) and 8 weeks after the end of the rehabilitation (follow up). For the statistical analysis, to verify the effectiveness of protocols over time, a variance analysis (ANOVA) of mixed model with Bonferroni adjustment will be performed for pairwise comparisons. Variables that do not meet the ANOVA assumptions will be analyzed by the Mann-Whitney and Wilcoxon tests with Bonferroni correction a priori. In order to assess the secondary objective of the study, correlation tests depending on data distribution will be performed (Pearson or Spearman correlation tests). A simple linear regression analysis will also be performed in order to analyze how much the AGEs accumulation can explain the alterations in the musculoskeletal and biomechanical variables. The significance level will be set at 5%.

Start: November 2021

Nordic Throwing Shoulder Project (NTS - Project)

As a part of the Olympic program and with 150 countries in the international Handball Federation team handball has become a worldwide popular sport. Unfortunately, a large number of different types injuries have been reported among team handball players, and shoulder pain has some of the biggest incidence. In handball 44-75% of the athletes had a history of shoulder pain and a weekly prevalence of shoulder problems in 28% of the athletes. Shoulder pain has been reported to have an impact on the athletes' training activities, performance, and daily life. Several studies have established risk factors for shoulder injuries among overhead athletes, with a focus on the range of motion in glenohumeral joint (ROM), shoulder strength and scapula control. Injury occurrence results from a combination of possessing these different risk and the amount of throwing. Thereby training overhead sports must be considered a primary risk factor for shoulder injury. However, several studies have performed kinematics analysis of different throws techniques commonly used in team handball. But no studies havn't investigated kinematics and kinetics of different throwing techniques in relation to team handball players and the development of shoulder pain, and if a throwing technique or a wrong throwing technique stresses the shoulder joint more than other throwing techniques. In baseball it was found that youth pitchers throwing with a curveball was associated with a 52% increased risk of shoulder pain and the slider was associated with an 86% increased risk of elbow pain, and there was a significant association between number of throws and rate of shoulder pain. Two types of wind-ups are used in handball, and those different wind-ups also changed the throwing kinematics and throwing performance. Investigators found that the pelvis rotation was more important in the throw with the circular wind-up than in the whip-like wind up. In addition, the total throwing time was longer with the circular wind up. This could result in less stress and forces on the shoulder joint when compared with the whip like to reach the same performances. The questions arises whether the used throwing techniques of the handball players during training and matches are a risk factor for shoulder pain and if some throwing techniques cause bigger risk than other throwing techniques as the players could put more force on the shoulder and elbow joint.

Start: February 2020

Does The Type of Exercise Influence Outcome in Rotator Cuff Related Shoulder Pain

Rotator cuff related shoulder pain (RCRSP) is the most common shoulder disorder and its chronicization leads to multiple consequences such as early retirement, absenteeism from work, decreased participation and quality of life and expensive yearly healthcare costs (128 739 687 $ according to CNESST). Even though scientific evidence has shown that prioritising physiotherapy exercises over surgery for the initial management of RCRSP is a great way to save on healthcare costs without compromising quality, it does not always result in a resolution of symptoms and patients' quality of life can still be affected thereafter: up to 30% of people with RCRSP remain symptomatic despite rehabilitation interventions. This lack of therapeutic success could be explained by a multitude of factors, but a central issue that can explain a lack of improvement is an inappropriate dosage or choice of exercises prescribed. The purpose of this study is to compare the effectiveness of 3 non-operative methods of delivering shoulder management (2 types of exercises and an advice and education only group) on symptoms and functional limitations for people with RCRSP. Results from this project should help us further our knowledge on which non-operative treatment to promote with patients presenting with RCRSP, thus decreasing the proportion of individuals experiencing pain even after going through a rehabilitation program.

Start: May 2019

MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere

The objective of this retrospective/prospective consecutive 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, fractures and revision 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 Reverse Ti Glenospheres have only been on the market since 2009, a prospective aspect to the study will be utilized as well in order to collect long-term data.

Start: October 2019

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

Start: December 2019

Effects of Dry Needling in Teres Major in Patients With Shoulder Pain

The aim of the study is to investigate the effects of the dry needling technique in teres major muscles on pain, range of motion, strength and extensibility of the posterior part of the tissues of the shoulder in athletes with shoulder pain.

Start: February 2021

Metabolic Syndrome and Persistent Shoulder Pain 1 Year After Primary Diagnosis

In a longitudinal cohort project, the objective is to evaluate general prognostic and individual risk factors for long lasting shoulder pain, with a specific focus on evaluation of the association between metabolic syndrome and tendinopathy, while simultaneous adjusting for other potential prognostic candidate variables (PROGRESS Theme I-II).

Start: January 2021

Ultrasound-guided Percutaneous Neuromodulation Versus Dry Needling in Shoulder Pain Treatment

Background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. Ultrasound-guided Percutaneous Neuromodulation (US-guided PNM) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance. Objectives: the primary aim is to determine changes in strength after US-guided PNM or Ultrasound-guided Dry Needling (US-guided DN) intervention in the Suprascapular Nerve (SN) as well as its effectiveness in changes of muscle function, pain and disability. Methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: US-guided PNM or US-guided DN. It will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.

Start: September 2020