Do therapeutic exercises impact supraspinatus tendon thickness? Secondary analyses of the combined dataset from two randomised controlled trials in patients with rotator cuff-related shoulder pain.

BACKGROUND: The mechanistic response of rotator cuff tendons to exercises within the context of rotator cuff-related shoulder pain (RCRSP) remains a significant gap in current research. A greater understanding of this response can shed light on why individuals exhibit varying responses to exercise interventions. It can also provide information on the influence of certain types of exercise on tendons. The primary aim of this article is to explore if changes in supraspinatus tendon thickness (SSTT) ratio differ between exercise interventions (high load vs. low load). The secondary aims are to explore if changes in SSTT ratio differ between ultrasonographic tendinopathy subgroups (reactive vs. degenerative) and if there are associations between tendinopathy subgroups, changes in tendon thickness ratio, and clinical outcomes (disability). METHODS: This study comprises secondary analyses of the combined dataset from two randomized controlled trials that compared high and low-load exercises in patients with RCRSP. In those trials, different exercise interventions were compared: 1) progressive high-load strengthening exercises, and 2) low-load strengthening with or without motor control exercises. In one trial, there was also a third group that was not allocated to exercises (education only). Ultrasound-assessed SSTT ratio, derived from comparing symptomatic and asymptomatic sides, served as the primary measure in categorizing participants into tendinopathy subgroups (reactive, normal and degenerative) at baseline. RESULTS: Data from 159 participants were analyzed. Two-way repeated measures ANOVAs revealed significant Group (p<0.001) and Group X Time interaction (p<0.001) effects for the SSTT ratio in different tendinopathy subgroups, but no Time effect (p=0.63). Following the interventions, SSTT ratio increased in the "Degenerative" subgroup (0.14 [95% CI: 0.09 to 0.19]), decreased in the "Reactive" subgroup (-0.11 [95% CI: -0.16 to -0.06]), and remained unchanged in the "Normal" subgroup (-0.01 [95% CI: -0.04 to 0.02]). There was no Time (p=0.21), Group (p=0.61), or Group X Time interaction (p=0.66) effect for the SSTT ratio based on intervention allocation. Results of the linear regression did not highlight any significant association between the tendinopathy subgroup (p=0.25) or change in SSTT ratio (p=0.40) and change in disability score. CONCLUSION: Findings from this study suggest that, over time, SSTT in individuals with RCRSP tends to normalize, compared to the contralateral side, regardless of the exercise intervention. Different subgroups of symptomatic tendons behave differently, emphasizing the need to potentially consider tendinopathy subtypes in RCRSP research. Future adequately powered studies should investigate how those different tendinopathy subgroups may predict long-term clinical outcomes.

Patient and public involvement to inform the protocol of a clinical trial comparing total hip arthroplasty with exercise: an exploratory qualitative case study.

OBJECTIVE: To explore patient, clinician and decision-maker perceptions on a clinical trial evaluating the effectiveness of total hip arthroplasty (THA) compared with exercise to inform the trial protocol. DESIGN: This is an exploratory qualitative case study using a constructivist paradigm. SETTING AND PARTICIPANTS: Participants were enrolled into three key stakeholder groups: patients eligible for THA, clinicians, and decision makers. Focus group interviews were conducted in undisturbed conference rooms at two hospitals in Denmark, according to group status using semi-structured interview guides. ANALYSIS: Interviews were recorded, transcribed verbatim and thematic analysed using an inductive approach. RESULTS: We conducted 4 focus group interviews with 14 patients, 1 focus group interview with 4 clinicians (2 orthopaedic surgeons and 2 physiotherapists) and 1 focus group interview with 4 decision-makers. Two main themes were generated. 'Treatment expectations and beliefs impact management choices' covered three supporting codes: Treatment without surgery is unlikely to lead to recovery; Clinician authority impacts the management narrative; The 'surgery vs exercise' debate. 'Factors influencing clinical trial integrity and feasibility' highlighted three supporting codes: Who is considered eligible for surgery?; Facilitators and barriers for surgery and exercise in a clinical trial context; Improvements in hip pain and hip function are the most important outcomes. CONCLUSIONS: Based on key stakeholder treatment expectations and beliefs, we implemented three main strategies to improve the methodological rigorousness of our trial protocol. First, we added an observational study investigating the generalisability to address a potential low enrolment rate. Second, we developed an enrolment procedure using generic guidance and balanced narrative conveyed by an independent clinician to facilitate communication of clinical equipoise. Third, we adopted change in hip pain and function as the primary outcome. These findings highlight the value of patient and public involvement in the development of trial protocols to reduce bias in comparative clinical trials evaluating surgical and non-surgical management. TRIAL REGISTRATION NUMBER: NCT04070027 (pre-results).

Effectiveness of an expert assessment and individualised treatment compared with a minimal home-based exercise program in women with late-term shoulder impairments after primary breast cancer surgery: study protocol for a randomised controlled trial.

BACKGROUND: In breast cancer patients, late-term upper limb sequelae, such as shoulder pain and impaired shoulder function, remain common after primary breast cancer surgery. The aim of this trial is to evaluate whether an expert assessment of shoulder impairments, followed by an individualised treatment plan, is superior to a minimal physiotherapeutic rehabilitation program in reducing shoulder symptoms, among women with late-term shoulder impairments after primary breast cancer. METHODS/DESIGN: The study is designed as a stratified, parallel-group, assessor-blinded, randomised, controlled trial conducted in Denmark; 130 participants with late-term shoulder impairments 3-7 years after primary surgery for breast cancer will be recruited. Participants will be randomised (allocation 1:1) to either an expert assessment of shoulder impairments followed by an individualised treatment plan or to follow a minimal physiotherapeutic rehabilitation program delivered in a pamphlet. The primary outcome will be a change in shoulder pain and function from baseline to 12 weeks after initiating the treatment, as measured by the patient-reported outcome Shoulder Pain and Disability Index (SPADI) questionnaire. DISCUSSION: There has been an insufficient focus in research and clinical practice on late-term shoulder impairment in women following surgery for breast cancer. This trial will focus on interventions towards late-term shoulder impairments and is expected to provide evidence-based knowledge to physiotherapists and women about the management of shoulder pain and impaired shoulder function. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277909. Registered on 11 March 2022.

Total hip arthroplasty versus progressive resistance training in patients with severe hip osteoarthritis: protocol for a multicentre, parallel-group, randomised controlled superiority trial.

INTRODUCTION: Hip osteoarthritis (OA) is the leading cause for total hip arthroplasty (THA). Although, being considered as the surgery of the century up to 23% of the patients report long-term pain, and deficits in physical function and muscle strength may persist after THA. Progressive resistance training (PRT) appears to improve multiple outcomes moderately in patients with hip OA. Current treatment selection is based on low-level evidence as no randomised controlled trials have compared THA to non-surgical treatment. The primary aim of this trial is to investigate whether THA followed by standard care is superior to 12 weeks of supervised PRT followed by 12 weeks of optional unsupervised PRT for improving hip pain and function in patients with severe hip OA. METHODS AND ANALYSIS: This is a protocol for a multicentre, parallel-group, assessor-blinded, randomised controlled superiority trial conducted at four hospitals across three healthcare regions in Denmark. 120 patients aged ≥50 years with clinical and radiographic hip OA found eligible for THA by an orthopaedic surgeon will be randomised to THA followed by standard care, or 12 weeks of PRT (allocation 1:1). The primary outcome will be change in patient-reported hip pain and function, measured using the Oxford Hip Score, from baseline to 6 months after initiating the treatment. Key secondary outcomes will be change in the Hip disability and Osteoarthritis Outcome Score subscales, University of California Los Angeles Activity Score, 40 m fast-paced walk test, 30 s chair stand test and occurrence of serious adverse events. Patients declining participation in the trial will be invited into a prospective observational cohort study. ETHICS AND DISSEMINATION: The trial has been approved by The Regional Committees on Health Research Ethics for Southern Denmark (Project-ID: S-20180158). All results will be presented in peer-reviewed scientific journals and international conferences. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT04070027).

Cellulitis Is Associated with Severe Breast Cancer-Related Lymphedema: An Observational Study of Tissue Composition.

Cellulitis is a common complication in Breast Cancer-Related Lymphedema (BCRL). The excess amount of fat and lean mass in BCRL is a vital factor in patient stratification, prognosis, and treatments. However, it is not known whether cellulitis is associated with the excess fat and lean mass in BCRL. Therefore, this prospective observational study was designed to fundamentally understand the heterogonous biocomposition of BCRL. For this study, we consecutively enrolled 206 patients with unilateral BCRL between January 2019 and February 2020. All patients underwent Dual-Energy X-Ray Absorptiometry scans, bioimpedance spectroscopy, indocyanine green lymphangiography comprehensive history of potential risk factors, and a clinical exam. Multivariate linear and beta regression models were used to determine the strength of association and margins effect. Sixty-nine patients (33%) had at least one previous episode of cellulitis. Notably, a previous episode of cellulitis was associated with 20 percentage points more excess fat and 10 percentage points more excess lean mass compared to patients without cellulitis (p < 0.05). Moreover, each 1 increase in the patients BMI was associated with a 0.03 unit increase in the fat mass proportion of the lymphedema arm. Cellulitis was associated with more excess fat and lean arm mass in BCRL. In addition, patients BMI affect the proportion of fat mass in the arm.

Discriminative and convergent validity of strain elastography for detecting tendinopathy within the supraspinatus tendon: a cross-sectional study.

BACKGROUND: We aimed to explore the discriminative validity of ultrasound strain elastography (SEL) between patients with painful supraspinatus tendinopathy and healthy control shoulders, as well as the associations between SEL and magnetic resonance imaging (MRI), conventional ultrasound (tendon thickness), and the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). METHODS: Thirty patients with shoulder pain and MRI-verified supraspinatus tendinopathy and 30 healthy control shoulders (no pain) were examined using SEL, MRI, and conventional ultrasound of the supraspinatus tendon. SEL variables included raw data, ratios between the deltoid muscle and supraspinatus tendon (deltoid ratio), color rating, and presence of red/yellow lesions (middle, worst part, and total tendon). RESULTS: Statistically significant increases in odds ratios for being symptomatic (increased softening) were seen for all raw data variables, corresponding to 3.978 (95% confidence interval [CI], 1.414-11.197) for middle, 4.602 (95% CI, 1.536-13.788) for worst, and 4.865 (95% CI, 1.406-16.836) for total tendon, and 1.260 (95% CI, 1.027-1.545) for the deltoid ratio (worst), adjusted for sex and body mass index (BMI). Tendon thickness was not associated with SEL; however, significantly positive associations were found between raw data variables and MRI (ß ≥ 0.58, P < .01), and positive associations were found between raw data variables and the DASH score (ß = 0.01, P ≤ .04), adjusted for sex and BMI. CONCLUSIONS: Raw data variables and the deltoid ratio (worst) discriminated between patients with painful supraspinatus tendinopathy and healthy control shoulders when adjusted for sex and BMI. Associations were statistically significant for raw data variables and MRI or DASH score when adjusted for sex and BMI. Further studies are needed to understand SEL and the role of sex and BMI, including the responsiveness of SEL.

Strain Elastography and Tendon Response to an Exercise Program in Patients With Supraspinatus Tendinopathy: An Exploratory Study.

BACKGROUND: Shoulder pain is common, with a lifetime prevalence of up to 67%. Evidence is conflicting in relation to imaging findings and pain in the shoulder. Sonoelastography can be used to estimate tissue stiffness and may be a clinically relevant technique for diagnosing and monitoring tendon healing. PURPOSE: To evaluate changes in supraspinatus tendon stiffness using strain elastography (SEL) and associations with changes in patient-reported outcomes, supraspinatus tendon thickness, and grade of tendinopathy after 12 weeks of unilateral shoulder exercises in patients with supraspinatus tendinopathy. STUDY DESIGN: Controlled laboratory study. METHODS: A total of 23 patients with unilateral clinical supraspinatus tendinopathy performed 12 weeks of "standard care" exercises. At baseline and follow-up, supraspinatus tendon stiffness was measured bilaterally using SEL and compared with tendinopathy grading on magnetic resonance imaging scans and tendon thickness measured using conventional ultrasound. Patient-reported outcome measures included physical function and symptoms from the Disabilities of the Arm, Shoulder and Hand questionnaire and pain rating (visual analog scale). RESULTS: No significant changes in SEL within or between groups (asymptomatic vs symptomatic tendon) were seen. All patient-reported outcomes showed significant improvement from baseline to follow-up, but with no change in tendinopathy grading and tendon thickness. No significant differences in the proportion of patients changing above the minimal detectable change in SEL and PROM were seen, except for discomfort while sleeping. CONCLUSION: Despite no significant within-group or between-group changes in SEL, significant improvements were found in patient-reported outcomes. An acceptable agreement between patients changing above the minimal detectable change in SEL and patient-reported outcome measure was seen. Further studies should explore the use of SEL to detect changes after tendon repair and long-term training potentially in subgroups of different tendinopathy phases. CLINICAL RELEVANCE: In the short term, structural changes in supraspinatus tendons could not be visualized using SEL, indicating that a longer time span should be expected in order to observe structural changes, which should be considered before return to sports. Subgrouping based on stage of tendinopathy may also be important in order to evaluate changes over time with SEL among patients with supraspinatus tendinopathy. REGISTRATION: NCT03425357 (ClinicalTrials.gov identifier).

Effect of Psychomotricity in Combination With 3 Months of Active Shoulder Exercises in Individuals With Chronic Shoulder Pain: Primary Results From an Investigator-Blinded, Randomized, Controlled Trial.

OBJECTIVE: To evaluate whether psychomotor therapy (PMT) in combination with usual care active exercise (AE) rehabilitation for the shoulder is superior to merely AE. DESIGN: The trial was a single-center, stratified (by corticosteroid injection [yes or no]), randomized, and controlled superiority trial. SETTING: Shoulder unit of the orthopedic department at Hospital Lillebaelt, Vejle Hospital. PARTICIPANTS: Eligible participants (N=87) were adults aged 18-75 years with shoulder complaints lasting for at least 3 months, in addition to a score equal to or below 3 on the Multidimensional Assessment of Interoceptive Awareness score. Furthermore, patients had at least a visual analog scale pain score of 2 at rest, 3 at night, and 5 in activity (range: 0-10). INTERVENTIONS: Patients were randomized to 12 weeks of AE (control group) or in combination with 5 PMT sessions (intervention group). MAIN OUTCOME MEASURE: The primary outcome was the patient-reported outcome score Disability of the Arm, Shoulder and Hand questionnaire. The primary endpoint was 12 weeks after baseline. RESULTS: There was no between-group difference in function between the intervention group and control group. CONCLUSIONS: Our results showed no additional benefit on patient-reported function and pain from PMT over usual care in patients with long-lasting shoulder pain and low body awareness. This finding suggests that PMT adds no additional benefit to patients' recovery in relation to pain and active function in comparison to standard care.

Behavioural typologies of experienced benefit of psychomotor therapy in patients with chronic shoulder pain: A grounded theory approach.

In this study we aimed to develop a theoretical account of the experienced benefit of psychomotor therapy in addition to treatment as usual in patients with chronic shoulder pain. The qualitative study design was based on a grounded theory approach. Open-ended face-to-face interviews were conducted after treatment was completed. We generated data and performed analyses by constant comparative analysis and theoretical sampling that focused on the patients' behavioural characteristics related to the experienced benefit of psychomotor therapy. We conducted 12 interviews, eight of which were with men. "Regaining capability" emerged as representative of the pattern of behaviour. Through this pattern, the patients resolved concern about losing capability. Regaining capability involved three behavioural typologies: taking advice, minding the body, and encompassing life changes. The patients' behavioural typologies revealed different levels of life changes. Psychomotor therapy offered the patients in our study new and better ways of coping with their shoulder pain.

Intertester reliability of clinical shoulder instability and laxity tests in subjects with and without self-reported shoulder problems.

OBJECTIVE: First, to investigate the intertester reliability of clinical shoulder instability and laxity tests, and second, to describe the mutual dependency of each test evaluated by each tester for identifying self-reported shoulder instability and laxity. METHODS: A standardised protocol for conducting reliability studies was used to test the intertester reliability of the six clinical shoulder instability and laxity tests: apprehension, relocation, surprise, load-and-shift, sulcus sign and Gagey. Cohen's kappa (κ) with 95% CIs besides prevalence-adjusted and bias-adjusted kappa (PABAK), accounting for insufficient prevalence and bias, were computed to establish the intertester reliability and mutual dependency. RESULTS: Forty individuals (13 with self-reported shoulder instability and laxity-related shoulder problems and 27 normal shoulder individuals) aged 18-60 were included. Fair (relocation), moderate (load-and-shift, sulcus sign) and substantial (apprehension, surprise, Gagey) intertester reliability were observed across tests (κ 0.39-0.73; 95% CI 0.00 to 1.00). PABAK improved reliability across tests, resulting in substantial to almost perfect intertester reliability for the apprehension, surprise, load-and-shift and Gagey tests (κ 0.65-0.90). Mutual dependencies between each test and self-reported shoulder problem showed apprehension, relocation and surprise to be the most often used tests to characterise self-reported shoulder instability and laxity conditions. CONCLUSIONS: Four tests (apprehension, surprise, load-and-shift and Gagey) out of six were considered intertester reliable for clinical use, while relocation and sulcus sign tests need further standardisation before acceptable evidence. Furthermore, the validity of the tests for shoulder instability and laxity needs to be studied.

Three Months of Progressive High-Load Versus Traditional Low-Load Strength Training Among Patients With Rotator Cuff Tendinopathy: Primary Results From the Double-Blind Randomized Controlled RoCTEx Trial.

BACKGROUND: Progressive high-load exercise (PHLE) has led to positive clinical results in patients with patellar and Achilles tendinopathy. However, its effects on rotator cuff tendinopathy still need to be investigated. PURPOSE: To assess the clinical effects of PHLE versus low-load exercise (LLE) among patients with rotator cuff tendinopathy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: Patients with rotator cuff tendinopathy were recruited and randomized to 12 weeks of PHLE or LLE, stratified for concomitant administration of corticosteroid injection. The primary outcome measure was change from baseline to 12 weeks in the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, assessed in the intention-to-treat population. RESULTS: A total of 100 patients were randomized to PHLE (n = 49) or LLE (n = 51). Mean changes in the DASH questionnaire were 7.11 points (95% CI, 3.07-11.16) and 8.39 points (95% CI, 4.35-12.44) in the PHLE and LLE groups, respectively; this corresponded to a statistically nonsignificant adjusted mean group difference of -1.37 points (95% CI, -6.72 to 3.99; P = .61). Similar nonsignificant results were seen for pain, range of motion, and strength. However, a significant interaction effect was found between the 2 groups and concomitant corticosteroid use (P = .028), with the largest positive change in DASH in favor of PHLE for the group receiving concomitant corticosteroid. CONCLUSION: The study results showed no superior benefit from PHLE over traditional LLE among patients with rotator cuff tendinopathy. Further investigation of the possible interaction between exercise type and corticosteroid injection is needed to establish optimal and potentially synergistic combinations of these 2 factors. REGISTRATION: NCT01984203 (ClinicalTrials.gov identifier): Rotator Cuff Tendinopathy Exercise Trial (RoCTEx).

Ultrasound assessment for grading structural tendon changes in supraspinatus tendinopathy: an inter-rater reliability study.

AIM: To evaluate the inter-rater reliability of measuring structural changes in the tendon of patients, clinically diagnosed with supraspinatus tendinopathy (cases) and healthy participants (controls), on ultrasound (US) images captured by standardised procedures. METHODS: A total of 40 participants (24 patients) were included for assessing inter-rater reliability of measurements of fibrillar disruption, neovascularity, as well as the number and total length of calcifications and tendon thickness. Linear weighted κ, intraclass correlation (ICC), SEM, limits of agreement (LOA) and minimal detectable change (MDC) were used to evaluate reliability. RESULTS: 'Moderate-almost perfect' κ was found for grading fibrillar disruption, neovascularity and number of calcifications (k 0.60-0.96). For total length of calcifications and tendon thickness, ICC was 'excellent' (0.85-0.90), with SEM(Agreement) ranging from 0.63 to 2.94 mm and MDC(group) ranging from 0.28 to 1.29 mm. In general, SEM, LOA and MDC showed larger variation for calcifications than for tendon thickness. CONCLUSIONS: Inter-rater reliability was moderate to almost perfect when a standardised procedure was applied for measuring structural changes on captured US images and movie sequences of relevance for patients with supraspinatus tendinopathy. Future studies should test intra-rater and inter-rater reliability of the method in vivo for use in clinical practice, in addition to validation against a gold standard, such as MRI. TRIAL REGISTRATION NUMBER: NCT01984203; Pre-results.