Elbow Tendinopathy Research Articles

Effect of premodulated interferential current versus diadynamic current on the management of lateral elbow tendinopathy

Abstract Study aim: To compare the effect of premodulated interferential current (PREMOD IFC) and diadynamic current (DD) with exercise training on the management of lateral elbow tendinopathy (LET). Material and methods: One hundred and four patients with unilateral LET from both genders (55 females and 49 males) were randomly allocated into two groups. Group A received PREMOD IFC in addition to the exercises, and group B received DD with the same exercises. The outcomes were maximum grip strength assessed by the hand dynamometer, the pinch strength assessed by the pinch gauge dynamometer, and pain and functional disability of the forearm assessed by a patient-rated tennis elbow evaluation (PRTEE) questionnaire. All participants received electrical stimulation, consisting of three sessions per week for six weeks. Results: The mean PRTEE score, and grip strength were significantly improved after six weeks in favour of group A, while there was no significant difference between the two groups in pinch strength. (p < 0.05). Conclusion: The results revealed that the combination of PREMOD IFC with exercises could improve pain, functional disability, and grip strength compared to DD with exercises in LET patients without a significant difference between the two groups in pinch strength.

The Effectiveness of Electrophysical Agents in the Management of Lateral Elbow Tendinopathy (LET)

The Effectiveness of Electrophysical Agents in the Management of Lateral Elbow Tendinopathy (LET)

Physical Therapy for People with Lateral Elbow Tendinopathy: Using the Evidence to Guide Musculoskeletal Rehabilitation Clinical Practice.

Lateral elbow tendinopathy (LET) is an overuse injury of the common extensor tendon that occurs in active people. Modifiable risk factors include repetitive movements of the elbow, forearm, and hand, and tasks like handling heavy tools, which may overload the tendon. The clinical course of LET varies considerably. Some people experience a single, brief episode of symptoms, whereas others have persistent or recurring episodes of LET. J Orthop Sports Phys Ther 2023;53(1):5-6. doi:10.2519/jospt.2023.0501.

The Best Arm Position for Therapeutic Ultrasound Application in Lateral Elbow Tendinopathy Patients

Objectives: To determine which is the best arm position for Therapeutic Ultrasound (TUS) application in Lateral Elbow Tendinopathy (LET) patients. Patients and Methods: A randomized clinical trial was carried out with 33 patients who had Let in a research center. They were randomly allocated to three groups. Group A (n=11) was treated with were treated with an exercise program and application of TUS with the wrist in full flexion. An exercise program and application of TUS with the wrist in mid position between flexion and extension was given to group B (n=11). Group C (n=11) received an exercise program and application of TUS with the wrist in full extension. All patients received three treatments per week for six weeks. The pain was evaluated using a visual analogue scale and function using a visual analogue scale and pain-free grip strength at the end of the four-week course of treatment (week 4) and one month (week 8) after the end of treatment. Results: The application of TUS with the wrist in full extension produced the largest effect in the reduction of pain and in the improvement of function at the end of the treatment (P<0.05) and at any of the follow-up time points (P<0.05). Conclusion: The application of TUS with the wrist in full extension was the most effective treatment. Future well-designed studies are needed to confirm the results of the present trial.

Isometric Exercise for the Management of Lateral Elbow Tendinopathy

The most common tendinopathy in the elbow area and one of the two most common tendinopathies in the upper limb is Lateral Elbow Tendinopathy (LET) [...].

Effect of Supervised over Self-Performed Eccentric Exercise on Lateral Elbow Tendinopathy: A Pilot Study.

The efficacy of eccentric exercise self-performed by the patient has not been proved in the treatment of lateral elbow tendinopathy (LET). The aim of this study was to compare the effects of a programme of eccentric exercises applied by a physiotherapist to patients with LET through a structured manual programme compared to its self-performance, guided by an illustrated brochure. A single-blind, pilot, randomised, controlled trial was conducted. Twenty patients were randomised. The intervention group carried out eccentric exercises applied directly by a physiotherapist (10 sessions). The control group carried out eccentric exercises that were self-performed by the patient (10 sessions). Both groups received simulated ultrasounds. Pain (visual analogue scale (VAS)), function (DASH questionnaire) and satisfaction (with a Likert scale) were measured at the beginning of the intervention, immediately after the intervention and 3 months after the intervention. The mean age was 53.17 and 54.25 years old. The experimental group presented a greater tendency to improve function (DASH -15.91) and reduce pain (VAS -2.88) compared to the control group, although these differences were not significant (p > 0.05). Eccentric exercise, both performed by the physiotherapist and self-performed by the patient, improved function and pain in the patients with LET.

Shoulder & Elbow

The December 2022 Shoulder & Elbow Roundup360 looks at: Biceps tenotomy versus soft-tissue tenodesis in females aged 60 years and older with rotator cuff tears; Resistance training combined with corticosteroid injections or tendon needling in patients with lateral elbow tendinopathy; Two-year functional outcomes of completely displaced midshaft clavicle fractures in adolescents; Patients who undergo rotator cuff repair can safely return to driving at two weeks postoperatively; Are two plates better than one? A systematic review of dual plating for acute midshaft clavicle fractures; Treatment of acute distal biceps tendon ruptures; Rotator cuff tendinopathy: disability associated with depression rather than pathology severity; Coonrad-Morrey total elbow arthroplasty implications in young patients with post-traumatic sequelae.

Lateral Elbow Pain and Muscle Function Impairments.

Although often described as a self-limiting condition and likely to resolve on its own, high recurrence rates and extended sick leave frame a need for effective non-surgical treatment for people with lateral elbow tendinopathy. The interrelationship of histological and structural changes to the tendon, the associated impairments in motor control, and potential changes in pain processing may all drive symptoms. This clinical practice guideline covers the epidemiology, functional anatomy and pathophysiology, risk factors, clinical course, prognosis, differential diagnosis, tests and measures, and interventions for managing lateral elbow tendinopathy in the physical therapy clinic. J Orthop Sports Phys Ther 2022;52(12):CPG1-CPG111. doi:10.2519/jospt.2022.0302.

A New Test for the Advanced Diagnosis of Lateral Elbow Tendinopathy with Concomitant Intrasubstance Tear: Failure to Resist Extension Effort (the Free Test).

Lateral elbow tendinopathy (LET) is one of the most common causes of musculoskeletal pain. The diagnosis is based on the clinical history and different physical maneuvers. Ultrasound (US) is a complementary diagnostic method to detect degenerative tendon changes and intrasubstance tears (IST). To date, there is no available physical maneuver to identify an IST in patients with LET. To evaluate the diagnostic accuracy of an index test to detect an IST confirmed by ultrasound in patients with LET. A diagnostic retrospective study was performed. Patients who presented medical records with LET were recruited. Two orthopaedic surgeons developed the physical maneuver. The index test was considered positive when the position failed to resist the wrist extension maximum effort. Clinical findings were associated with confirmation of IST by US. Data were calculated using diagnostic accuracy, sensitivity, and specificity with 95% confidence intervals. Thirty-nine patients (39 elbows) were analyzed, 25 (64%) women and 14 (36%) men, with an average age of 47.7 years. The index test's sensitivity was 0.86 (95% CI, 0.67-0.96). Accuracy was 0.79 (95% CI, 0.64-0.91), and the specificity was 0.64 (95% CI, 0.31-0.89). The index test presented very good sensitivity and good accuracy in patients with LET with US diagnostic confirmation of IST. Diagnostic study, Level III.

Physical therapy intervention versus corticosteroid injection for lateral elbow tendinopathy. Does slow and steady win the race? - A systematic review.

Lateral elbow tendinopathy is one of the most common chronic and degenerative diseases which significantly affects quality of life and the activities of daily living of a person. The following is a systematic review reporting a comparison between physical therapy intervention and corticosteroid injection for the treatment of lateral elbow tendinopathy. PubMed, Web of Science, and Embase were searched using headings related to treatment options for Lateral elbow tendinopathy. The following keywords were used: lateral epicondylitis, physical therapy, and corticosteroid injection. We descriptively analyzed and reviewed a total of 12 studies including a total of 1253 patients for lateral elbow tendinopathy. The physical therapy intervention included interventions like electrotherapy, manual therapy, and exercise. The studies included had an overall low to unknown risk of bias. Our review suggests corticosteroid injection provides beneficial short-term effects and physical therapy interventions provide intermediate to long-term effects, less additional treatment and low recurrence rate in patients with lateral elbow tendinopathy. Although high-quality randomized control trials are required in order to have a better understanding of both intervention types.

Managing work-related lateral elbow tendinopathy: Australian hand therapist's experiences with workplace-based interventions.

Lateral elbow tendinopathy (LET) is one of the most prevalent work-related musculoskeletal conditions. Current treatments for LET focus mainly on the physiological symptoms of pain, grip strength, and function. Recently, a novel workplace-based hand therapy educational intervention, Working Hands-ED, was developed based on the Person-Environment-Occupation- Performance model, International Classification of Functioning, Disability and Health framework and the Australian Clinical Framework for the Delivery of Health Services. Combining a hand therapist's specialised knowledge and skills in upper limb rehabilitation with an approach that considers injured workers' occupations and work environments may provide a more holistic approach to managing work-related LET. To the best of our knowledge, no previous studies have investigated the experiences of hand therapists who perform workplace-based educational interventions for the management of LET. An exploratory, descriptive qualitative design using semi-structured interviews was used with hand therapists who delivered the novel hand therapy intervention Working Hands-ED. Ten occupational therapists working in hand therapy were interviewed. Three main themes and eight subthemes were identified from interview data: Person-centred approach, opportunity for therapists to provide enhanced service, and improved stakeholder engagement in the return-to-work process. Logistical challenges such as the costs and time spent away from the clinical setting were identified. All hand therapists reported delivering Working Hands-ED when managing work-related LET was a positive experience for them. They believed that the novel intervention could provide a more holistic approach to care that added value to their service delivery; however, there were some logistical factors to consider including the additional time and costs associated with the intervention.

Where does pain present during clinical tests for lateral elbow tendinopathy? - a pilot study of pain mapping

Introduction: Lateral elbow pain is common with prevalence up to 14% and incidence up to 50% in racquet-sports. The term covers various presentations including tendinopathy, typified by focal pain. Lack of consensus on treatment may be due to participant heterogeneity in research studies. Elbow tendinopathy clinical tests may lack specificity and pain-spread during testing has not been described. Participants with focal pain may have different pain responses to those with diffuse pain that may indicate hyperalgesia.

Adherence to therapeutic exercise for lateral elbow tendinopathy – A scoping review

Introduction: Exercise is effective in improving pain and function in lateral elbow tendinopathy (LET). One factor that may affect the efficacy of exercise is adherence to the prescribed exercise program. However, consensus around measurement and reporting of adherence in exercise trials for LET has not been formally addressed. This study aimed to discover gaps in the reporting of adherence to direct future research targeted at enhancing the way therapeutic exercise adherence is measured, reported, influenced, and evaluated in published studies of individuals with LET. Methods: We searched the PubMed, Proquest, Web of Science, PEDRO, Embase and Cochrane Library databases from inception to 02 February 2021 to identify randomized controlled studies (RCT) written in English featuring therapeutic exercises for LET in adults. Titles, abstracts and full texts were screened independently by two authors and any disagreements resolved through discussion with all authors. Eligible studies were searched for the term adherence or related terms. The quality of reporting of adherence was rated using criteria specifically developed for this review. Information on the definition, measurement, results and analysis of adherence, as well as the factors that affect adherence were collated and summarized according to the Multidimensional Adherence Model. Results: 60 studies were identified and 19 (32%) of those reported adherence. The overall quality of reporting of adherence was low (average 1.6 out of 4 constructs being adequately described). All studies defined adherence by the frequency of exercise sessions and most measured it using self-reported diaries. Five (26%) studies provided quantitative data, with adherence ranging from 38% to 100%. Only 2 studies statistically analyzed the relationships between adherence and clinical outcomes or other condition-related factors. Another, two studies provided anecdotal information about the impact of pain on exercise adherence. There was limited information on psychological or healthcare system factors affecting adherence according to MAM. Discussion: This scoping review identified that two thirds of published RCTs investigating therapeutic exercise for treatment of LET did not report any information on adherence to exercise, impacting the ability to estimate the true effects of exercise. The other one third demonstrated a series of limitations in the quality of reporting. Variation in the definitions and methods of measuring adherence hampers the ability to compare adherence rates across studies. Finally, there is insufficient information to conclude whether patient, condition, therapy or healthcare system related factors affect adherence to therapeutic exercises for LET. Future research is needed to evaluate whether pain provocation during exercise influences adherence to an exercise program. Impact and application to the field: This scoping review provides recommendations to improve the standard of reporting of adherence to therapeutic exercises for LET. This information will enable future clinical trials to be assessed rigorously in order to determine exercise effectiveness more precisely, therefore leading to improved rehabilitation strategies for LET. Statement of Disclosure: My co-authors and I acknowledge that we have no conflict of interest of relevance to the submissions of this abstract

Effects of multidirectional elastic tape on forearm muscle activity and wrist extension during submaximal gripping in individuals with lateral elbow tendinopathy: A randomised crossover trial

BackgroundLateral elbow tendinopathy is associated with changes to forearm muscle activity and wrist posture during gripping. Multidirectional elastic tape is thought to exert a deloading effect on underlying musculotendinous structures, which could potentially alter muscle activity or wrist posture. MethodsThis single-blinded randomised crossover trial compared the immediate effects of tensioned multidirectional elastic tape, untensioned control tape, and no tape, in individuals with lateral elbow tendinopathy. Muscle activity of extensor carpi radialis longus and brevis, extensor carpi ulnaris, and extensor digitorum and wrist extension angle were recorded during a submaximal gripping task. Muscle activity was normalised to the maximum amplitude recorded during maximal grip. Change scores were calculated (post-condition minus baseline). Repeated-measure analyses of variance were used to examine between-condition differences. Findings27 participants (16 males, mean age (SD): 48.6 (11.9) years) underwent all conditions. Extensor digitorum muscle activity was reduced during the multidirectional elastic tape, compared to control tape and no tape (MD −5.6% [95%CI: −9.9 to −1.3], MD −5.8% [95%CI: −10.2 to −1.4], respectively). Extensor carpi ulnaris muscle activity was reduced during the multidirectional elastic tape, compared to the control tape (mean difference [MD] −3.2% [95%CI: −5.3 to −1.1]), but increased during the control tape, compared to the no tape (MD 2.9% [95%CI: 0.8 to 5.0]). No differences were observed in extensor carpi radialis brevis or longus muscle activity, or extension wrist angle between conditions. InterpretationA decreased in extensor carpi ulnaris and extensor digitorum muscle activity during multidirectional elastic tape may be evidence of a deloading effect during submaximal gripping.

Responsiveness and Minimally Important Changes for Persian-version of Patient-Rated Tennis Elbow Evaluation Questionnaire in Patients with Lateral Elbow Tendinopathy Following Physiotherapy Intervention.

Evaluating responsiveness and calculating minimally important change (MIC) for the Persian-version of the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire following physiotherapy in patients with lateral elbow tendinopathy (LET). We enrolled 82 patients with LET to complete the PRTEE. After completing four weeks of physiotherapy, all patients were reevaluated by the PRTEE. The patients also rated their changes on a 7-point global rating of change scale (GRoC). The receiver operating characteristic (ROC) curve and correlation analysis were used for evaluating the responsiveness. The MIC was determined by determining a desirable cutoff on the ROC curve. The results showed a moderate relationship (Spearman's correlation coefficient= 0.43-0.56) of total PRTEE, pain subscale, and function subscale with the GRoC scale. The total PRTEE, pain subscale, and function subscale revealed an area under the curve of 0.87, 0.82, and 0.83, respectively. We found the MICs 31.33, 14.5, and 15.5 points for total PRTEE, pain subscale, and function subscale, respectively. The Persian-version of the PRTEE questionnaire has acceptable responsiveness and can measure changes in patients with LET following physiotherapy. We advocate using the PRTEE questionnaire in both clinical settings and research.

Lateral elbow tendinopathy and artificial intelligence: Binary and multilabel findings detection using machine learning algorithms.

BackgroundUltrasound (US) is a valuable technique to detect degenerative findings and intrasubstance tears in lateral elbow tendinopathy (LET). Machine learning methods allow supporting this radiological diagnosis.AimTo assess multilabel classification models using machine learning models to detect degenerative findings and intrasubstance tears in US images with LET diagnosis.Materials and methodsA retrospective study was performed. US images and medical records from patients with LET diagnosis from January 1st, 2017, to December 30th, 2018, were selected. Datasets were built for training and testing models. For image analysis, features extraction, texture characteristics, intensity distribution, pixel-pixel co-occurrence patterns, and scales granularity were implemented. Six different supervised learning models were implemented for binary and multilabel classification. All models were trained to classify four tendon findings (hypoechogenicity, neovascularity, enthesopathy, and intrasubstance tear). Accuracy indicators and their confidence intervals (CI) were obtained for all models following a K-fold-repeated-cross-validation method. To measure multilabel prediction, multilabel accuracy, sensitivity, specificity, and receiver operating characteristic (ROC) with 95% CI were used.ResultsA total of 30,007 US images (4,324 exams, 2,917 patients) were included in the analysis. The RF model presented the highest mean values in the area under the curve (AUC), sensitivity, and also specificity by each degenerative finding in the binary classification. The AUC and sensitivity showed the best performance in intrasubstance tear with 0.991 [95% CI, 099, 0.99], and 0.775 [95% CI, 0.77, 0.77], respectively. Instead, specificity showed upper values in hypoechogenicity with 0.821 [95% CI, 0.82, −0.82]. In the multilabel classifier, RF also presented the highest performance. The accuracy was 0.772 [95% CI, 0.771, 0.773], a great macro of 0.948 [95% CI, 0.94, 0.94], and a micro of 0.962 [95% CI, 0.96, 0.96] AUC scores were detected. Diagnostic accuracy, sensitivity, and specificity with 95% CI were calculated.ConclusionMachine learning algorithms based on US images with LET presented high diagnosis accuracy. Mainly the random forest model shows the best performance in binary and multilabel classifiers, particularly for intrasubstance tears.

Effectiveness of High-Intensity Laser Therapy Plus Ultrasound-Guided Peritendinous Hyaluronic Acid Compared to Therapeutic Exercise for Patients with Lateral Elbow Tendinopathy.

Lateral elbow tendinopathy (LET) is a common painful musculoskeletal disorder. Several treatments have been proposed to provide pain reduction and functional recovery, including laser therapy, hyaluronic acid peritendinous injection (Hy-A), and therapeutic exercise (TE). Our study aims to assess the effectiveness of a combined approach with high-intensity laser therapy (HILT) and Hy-A injections compared to TE on pain, muscle strength, and disability in patients with painful LET. A retrospective longitudinal study was carried out by consulting the medical records of patients with a diagnosis of painful LET formulated by clinical and instrumental findings that received functional evaluations, including the Patient-Rated Tennis Elbow Evaluation (PRTEE) and muscle strength measurement at least four times: T0 (“baseline”), 1-month (T1), 3-month (T2), and 6-month follow-ups (T3). Medical records of 80 patients were analyzed. In the HILT + HyA group, the Peak-strength (p < 0.001) and mean strength (p < 0.001) significantly increased compared to the TE group between study times. For the PRTEE-total-score as for the subscales, the HILT + HyA group reported statistically significant reductions only for the comparisons of baseline versus T1 and baseline versus T2. No serious adverse events occurred. Our findings suggest that Hy-A associated with HILT might be more effective than TE for people with LET in the short–medium term.

Efficacy of Osteopathic Manipulative Treatment (OMT) Vs Physiotherapy in Chronic Lateral Epicondylitis

Background: Several rehabilitative treatments have been proposed for Lateral Elbow Tendinopathy (LET). Therapeutic exercise showed the greatest beneficial effects together with patient education, and multimodal treatment subject specific. In recent years, osteopathic manipulative treatment (OMT) has been proposed as treatment for LET. The aim of the study was to focus on this emerging approach by comparing it to more traditional physiotherapy. Methods: Thirty-two patients with a diagnosis of LET were enrolled and randomly assigned to two groups: the OMT group and the physiotherapy group. In the former, patients underwent OMT according to the common techniques. In the latter, patients underwent a physiotherapy protocol consisting in stretching and strengthening exercises, and laser therapy. Outcome measures included the Patient-Rated Tennis Elbow Evaluation (PRTEE), the Mayo Elbow Performance, and VAS for pain. Assessment was carried out at baseline (T0), after 1 (T1) and 3 (T2) months. In addition, an ultrasound assessment of the elbow common extensor tendon was performed at T0 and T2. Results: Both the OMT and the Physiotherapy group showed a statistically significant improvement along the follow-up for VAS for pain and PRTEE score. No significant difference was found for the Mayo Score in the Physiotherapy group. Ultrasound assessment confirmed the presence of abnormalities of vascularization, echogenicity, and thickness of the tendon at T0, partially reduced at T2. Conclusion: OMT and physiotherapy resulted both effective in the treatment of LET, offering a significant clinical improvement which helped patients recovering their functional activities in the short-term follow-up.

Validation of a novel magnetic resonance imaging classification and recommended treatment for lateral elbow tendinopathy

BackgroundLateral epicondylitis is one of the most common upper extremity problems presented to orthopedic surgeons. Despite a rapid and accurate arrival at a diagnosis by clinical examination, there exists no consensus classification for this condition, which hampers clinical approaches for treatment of the disease based on its severity. Thus, the aim of this study was to propose and valiadate a new magnetic resonance imaging (MRI) classification of lateral epicondylitis, staging by tendinosis, the degree of thickness tears of the common extensor tendon (CET) and bone bruise lesion.MethodMRI assessment of the elbow of 75 patients (57 women and 18 men; mean age:51.4 years (range,34–73) from Jan 2014 to Jan 2021 who were diagnosed with lateral epicondylitis were included in the study. MR images were reviewed retrospectively by two independent upper extremities orthopedists and one musculoskeletal radiologist. Inter- and intra-observer reliabilities for the classification were calculated using kappa statistics for the analysis of interrater agreement. Correlation between the stage of the disease and the duration of symptom before MRI was calculated using Kruskal–wallis test.ResultsVarious degrees of CET lesions were demonstrated in this population (Stage I-17, IIA-7, IIB-22 and III-29). Intra-observer agreements of MRI staging were substantial to satisfactory. Inter-observer agreements were moderate to substantial. There was no significant correlation between the disease stage and the patient age or the duration of symptom before MRI.ConclusionOur MRI classification has emerged as one of the most reliable methods to define stages of chronic lateral epicondylitis. At the end, we have suggeted a clearer direction for understanding the disease pathology as well as an appropriate management protocol for each stage of the disease in line with the recent body of literature.

Effects of Heavy Slow Resistance Training Combined With Corticosteroid Injections or Tendon Needling in Patients With Lateral Elbow Tendinopathy: A 3-Arm Randomized Double-Blinded Placebo-Controlled Study

Background: Lateral elbow tendinopathy is a disabling tendon overuse injury. It remains unknown if a corticosteroid injection (CSI) or tendon needling (TN) combined with heavy slow resistance (HSR) training is superior to HSR alone in treating lateral elbow tendinopathy. Purpose/Hypothesis: The purpose was to investigate the effects of HSR combined with either (1) a CSI, (2) TN, or (3) placebo needling (PN) as treatment for lateral elbow tendinopathy. We hypothesized that 12 weeks of HSR in combination with a CSI or TN would have superior effects compared with PN at 12, 26, and 52 (primary endpoint) weeks’ follow-up on primary (Disabilities of the Arm, Shoulder and Hand [DASH] score) and secondary outcomes in patients with chronic unilateral lateral elbow tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 60 patients with chronic unilateral lateral elbow tendinopathy were randomized to perform 12 weeks of home-based HSR with elastic band exercises combined with either (1) a CSI, (2) TN, or (3) PN, and at 12, 26, and 52 weeks, we assessed the primary outcome, the DASH score, and secondary outcomes: shortened version of the DASH (QuickDASH) score, pain (numerical rating scale [NRS] score), pain-free grip strength, and hypervascularization (power Doppler area). Results: A CSI, TN, and PN improved patient outcomes equally based on the DASH (Δ20 points), QuickDASH (Δ21 points), and NRS (Δ2.5 points) scores after 12 weeks. Further, after 12 weeks, a CSI also resulted in decreased hypervascularization (power Doppler area) compared with PN (Δ–2251 pixels, P = .0418). Except for the QuickDASH score (CSI increased score by Δ15 points compared with PN; P = .0427), there were no differences between the groups after 52 weeks. Conclusion: These results suggest that 12 weeks of HSR improved symptoms in both the short and the long term and that a CSI or TN did not amplify this effect. In addition, a CSI seemed to impair patient-reported outcomes compared with HSR alone at long-term follow-up. Registration: NCT02521298 (ClinicalTrials.gov identifier).