Development of a core outcome set for lateral elbow tendinopathy (COS-LET) using best available evidence and an international consensus process.

OBJECTIVES: To develop a core outcome set for lateral elbow tendinopathy (COS-LET) and to provide guidance for outcome evaluation in future studies. METHODS: We implemented a multi-stage mixed-methods design combining two systematic reviews, domain mapping of outcome measurement instruments to the core domains of tendinopathy, psychometric analysis of instruments, two patient focus groups and a Delphi study incorporating two surveys and an international consensus meeting. Following the OMERACT guidelines, we used a 70% threshold for consensus. RESULTS: 38 clinicians/researchers and 9 patients participated. 60 instruments were assessed for inclusion. The only instrument that was recommended for the COS-LET was Patient Rated Tennis Elbow Evaluation (PRTEE) for the disability domain. Interim recommendations were made to use: the PRTEE function subscale for the function domain; PRTEE pain subscale items 1, 4 and 5 for the pain over a specified time domain; pain-free grip strength for the physical function capacity domain; a Numerical Rating Scale measuring pain on gripping for the pain on activity/loading domain; and time off work for the participation in life activities domain. No recommendations could be made for the quality-of-life, patient rating of condition and psychological factors domains. CONCLUSIONS: The COS-LET comprises the PRTEE for the disability domain. Interim-use recommendations included PRTEE subscales, time off work, pain-free grip strength and a Numerical Rating Scale measuring pain on gripping. Further work is required to validate these interim measures and develop suitable measures to capture the other domains.

Patellar and Achilles tendinopathies are predominantly peripheral pain states: a blinded case control study of somatosensory and psychological profiles.

STUDY DESIGN: Case-control design. BACKGROUND: Tendinopathy is characterised by pain on tendon loading. In persistent cases of upper limb tendinopathy, it is frequently associated with central nervous system sensitisation, whereas less commonly linked in the case of persistent lower limb tendinopathies. OBJECTIVES: Compare somatosensory and psychological profiles of participants with persistent patellar (PT) and Achilles tendinopathies (AT) with pain-free controls. METHODS: A comprehensive battery of Quantitative Sensory Testing (QST) was assessed at standardised sites of the affected tendon and remotely (lateral elbow) by a blinded assessor. Participants completed the Victorian Institute of Sports Assessment, a health-related quality of life questionnaire, the Hospital Anxiety and Depression Scale and the Active Australia Questionnaire. Independent t-test and analysis of covariance (sex-adjusted and age-adjusted) were performed to compare groups. RESULTS: Participants with PT and AT did not exhibit differences from controls for the QST at the remote site, but there were differences at the affected tendon site. Compared with controls, participants with PT displayed significantly lower pressure pain threshold locally at the tendon (p=0.012) and fewer single limb decline squats before pain onset, whereas participants with AT only displayed fewer single heel raises before pain onset, but this pain was of a higher intensity. CONCLUSION: PT and AT appear to be predominantly local not widespread pain states related to loading of tendons without significant features of central sensitisation. LEVEL OF EVIDENCE: Level 4.

A combined program of education plus exercise versus general advice for ankle osteoarthritis: A feasibility randomised controlled trial.

BACKGROUND: Unlike hip and knee OA, there is little evidence to guide the management of ankle osteoarthritis (OA) and there are no clinical guidelines for ankle OA. Regardless of the body region, guidelines for treating OA typically include education, weight loss and exercise as the key components of management. Such an intervention has not been investigated in people with ankle OA. OBJECTIVES: To determine the feasibility of conducting a randomised controlled trial (RCT) that compares physiotherapist-delivered education plus exercise to physiotherapist-delivered general advice for people with ankle OA. Secondarily, to inform planning for future RCTs. DESIGN: A randomised parallel-group feasibility trial. METHOD: Study participants were recruited, assessed for eligibility, and randomised using 1:1 concealed allocation to receive either physiotherapist-delivered education plus exercise, or physiotherapist-delivered general advice. Primary feasibility outcomes were evaluated based on predetermined feasibility criteria. Secondary participant-reported and physical outcomes were collected to inform the design of future RCTs. RESULTS: Thirty participants (67% (n = 20) women, mean (standard deviation) age: 66.1 (11.5) years) were randomised. Data for key feasibility outcomes met a priori feasibility criteria: consent rate (97%), participant adherence with their allocated intervention arm (71%), fidelity of the intervention (94%) and rate of completion of outcome measures at 3 months (87%). CONCLUSIONS: This study demonstrates that it is feasible to run an adequately powered RCT comparing physiotherapist-delivered education plus exercise versus physiotherapist-delivered general advice for people with ankle OA. Study data will inform the planning of a full-scale RCT.

Implementing good life with osteoArthritis from Denmark (GLA:D®) in Australian public hospitals. Part 2: Service providers' perceptions.

BACKGROUND: Previous literature has reported the successful implementation of the Good Life with osteoArthritis in Denmark (GLA:D®) program into predominantly private practice settings. There may be unique challenges present within the public hospital setting that influence GLA:D® implementation in public health. OBJECTIVE: Explore the attitudes and experiences of service providers directly involved in implementing GLA:D® in Australian public tertiary hospitals. DESIGN: Qualitative descriptive study design. METHOD: Service providers (n = 14) from three participating hospitals took part in semi-structured focus groups at the completion of the 6-month implementation period. Inductive thematic analysis was employed to identify primary domains across all facilities. RESULTS: Four broad domains were identified. Factors that influenced uptake included GLA:D® being a recognisable, evidence-based product requiring minimal development or adaptation. The fidelity of the GLA:D® Australia program was challenged by referral of patients with multiple/complex medical comorbidities, and patient preference to complete registry data via paper rather than online. Several operational considerations are required when delivering GLA:D® in a public hospital setting, including adequate numbers of GLA:D®-trained staff, additional screening requirements, obtaining appropriate clinical space, and persisting patient barriers to attending the service. GLA:D® provided benefits beyond improvement in pain and function, including social interactivity, high attendance and promotion of long-term self-management, while also maximising service efficiencies. CONCLUSIONS: Implementing GLA:D® in Australian public hospitals was supported by service providers. Specific operational and administrative factors, including staff training, patient complexity, and registry requirements should be considered when attempting to embed and sustain GLA:D® in large Australian public tertiary hospitals.

Implementing good life with osteoArthritis from Denmark (GLA:D®) in australian public hospitals. Part 1: Feasibility.

BACKGROUND: Literature reporting positive outcomes from the Good Life with osteoArthritis in Denmark (GLA:D®) program in Australia mainly involves patients attending private physiotherapy services. OBJECTIVE: Evaluate the feasibility of implementing GLA:D® in Australian public hospitals. DESIGN: Implementation study in three metropolitan tertiary public hospitals over six months. METHOD: Patients aged ≥18 years with knee or hip joint-related problems deemed appropriate for non-surgical care were invited to participate in GLA:D®. Feasibility was evaluated using RE-AIM framework components (Implementation, Effectiveness, Maintenance) using service-level metrics, patient-level data, and program fidelity assessment. Findings of qualitative interviews with service providers are presented in Part 2. RESULTS: Implementation: 70 patients (69 with knee osteoarthritis) participated (13 cohorts). 55 (79%) patients attended both education sessions, and 49 patients (70%) attended 10-12 exercises sessions. Fidelity was met based on environmental, therapist, participant- and program-related criteria. EFFECTIVENESS: At 3 months, patients reported lower average pain (visual analogue scale [0-100 mm]: effect size -0.56, 95% CI -0.88 to -0.23) and disability (HOOS/KOOS-12 [100-0]: 0.67, 0.28 to 1.05), and improved quality of life (EQ-5D overall score: 0.46, 0.11 to 0.80). No adverse events were reported. All patients who completed 3-month assessment (n = 52) would recommend GLA:D®. Maintenance: All participating services elected to continue delivering GLA:D® beyond the study. CONCLUSIONS: Implementing GLA:D® in Australian public hospitals is feasible, safe, and acceptable to patients with knee osteoarthritis. Public hospital patients with knee osteoarthritis reported improvements in pain, disability, and quality of life similar to previous GLA:D® cohorts.

Protocol for a randomised feasibility trial comparing a combined program of education and exercise versus general advice for ankle osteoarthritis.

BACKGROUND: Ankle osteoarthritis (OA) is a serious problem with high associated pain and disability. While education and exercise are recommended for the initial management of OA, this has not been investigated in ankle OA. The primary aim of this study is to establish the feasibility of running a full-scale randomised controlled trial (RCT) investigating a combined education and exercise program compared to a general advice program for people with ankle OA. The secondary aims are to collect preliminary data which will inform sample size calculations, and understand the perspectives of people with ankle OA on their participation in the trial. METHODS: Thirty individuals aged 35 years or older with symptomatic radiographic ankle OA will be recruited from the community and randomised to receive either a combined education and exercise program or a general advice program, both of which will be delivered by a physiotherapist in a group setting. Primary outcomes of feasibility include responses to study advertisements, number of eligible participants, recruitment rate, adherence with the intervention, fidelity of the intervention, adverse events, drop-out rate, and credibility and expectancy of the intervention. Secondary participant-reported outcomes will include global rating of change, patient acceptable symptom state, severity of ankle pain and stiffness, self-reported function, quality of life, satisfaction with treatment, and use of co-interventions. Follow up will be at 8 weeks and 3 months. Physical measures of 40 m walking speed, timed stairs descent, heel raise endurance and ankle dorsiflexion range of motion will be collected at baseline and 8 weeks. Primary feasibility outcomes will be reported descriptively, and estimates of the variability of secondary participant-reported and physical outcomes will be calculated. Semi-structured interviews will be conducted with participants to understand perspectives about the intervention and participation in the trial, with data analyzed thematically. DISCUSSION: Study findings will establish the feasibility of running a full-scale RCT to investigate a combined education and exercise program compared to a general advice program for people with ankle OA. This study is a necessary first step to advance the international research agenda of evaluating the efficacy of exercise in the management of ankle OA. TRIAL REGISTRATION: ACTRN12623000017628. Registered 10 January 2023, https://www.anzctr.org.au/ACTRN12623000017628.aspx .

Pain-related cognitions and emotional distress are not associated with conditioned pain modulation: an explorative analysis of 1142 participants with acute, subacute, and chronic pain.

ABSTRACT: Reduced conditioned pain modulation (CPM) and psychological distress co-occur frequently in many pain conditions. This study explored whether common negative pain cognitions and emotional factors were related to lower CPM in individuals across the spectrum from acute to chronic pain. Previously collected data on the CPM effect, pain-related cognitions (fear of movement, pain catastrophizing), and emotional distress (depression, anxiety) through questionnaires from 1142 individuals with acute, subacute, or chronic pain were used. The presence of negative psychological factors was dichotomized according to cutoff values for questionnaires. Associations between the presence of each negative psychological factor and the amplitude of pain reduction in the CPM paradigm was explored with Generalized Linear Models adjusted for sex, age, body mass index, and pain duration. A secondary analysis explored the cumulative effect of psychological factors on CPM. When dichotomized according to cutoff scores, 20% of participants were classified with anxiety, 19% with depression, 36% with pain catastrophizing, and 48% with fear of movement. The presence of any negative psychological factor or the cumulative sum of negative psychological factors was associated with lower CPM (individual factor: ß between -0.15 and 0.11, P ≥ 0.08; total: ß between -0.27 and -0.12, P ≥ 0.06). Despite the common observation of psychological factors and reduced CPM in musculoskeletal pain, these data challenge the assumption of a linear relationship between these variables across individuals with acute, subacute, and chronic pain. Arguably, there was a nonsignificant tendency for associations in nonexpected directions, which should be studied in a more homogenous population.

The first year of private practice - new graduate physiotherapists are highly engaged and satisfied but edging toward burnout.

BACKGROUND: A greater understanding of physiotherapists' work-life during their first year of work in private practice, and whether their experiences are mediated by personal traits, may provide valuable information to support their transition and retention. OBJECTIVES: Describe the first year of practice for graduate physiotherapists in terms of employee engagement, job satisfaction, performance, and burnout, and evaluate the relationship between these measures and personal traits (resilience, grit, mind-set). DESIGN: One-year longitudinal mixed-methods study. METHODS: Twenty new graduate physiotherapists completed questionnaires evaluating resilience, grit, and mind-set within 1-week of commencing employment. Engagement and job satisfaction were evaluated at 3, 6 and 12-months, and burnout evaluated at 12-months. Performance data (number of patients seen, revenue) were collected throughout the year. Individual semi-structured interviews were conducted at baseline, 3, 9 and 12-months. RESULTS: Engagement and satisfaction were high at all time points. At 12-months, burnout was at a medium level. Resilience was positively associated with job satisfaction at 6 (ρ = 0.56, p = .019) and 12-months (ρ = 0.54, p = .027). Engagement (ρ = -0.57, p = .04) and job satisfaction (ρ = -0.56, p = .03) were negatively associated with burnout at 12-months. All participants remained passionate about their work although increasing administrative burden and patient complexity contributed to feelings of burnout. CONCLUSIONS: Resilience was positively associated with job satisfaction suggesting those with capacity to 'bounce back' were more satisfied and engaged with their job. Although moderate levels of burnout were reported at 12-months, those with higher job satisfaction and employee engagement had lower levels of burnout. Participants proposed practical strategies to help mitigate burnout.

ICON 2020-International Scientific Tendinopathy Symposium Consensus: A Scoping Review of Psychological and Psychosocial Constructs and Outcome Measures Reported in Tendinopathy Clinical Trials.

OBJECTIVE: To identify and describe the psychological and psychosocial constructs and outcome measures used in tendinopathy research. DESIGN: Scoping review. LITERATURE SEARCH: We searched the PubMed, EMBASE, Scopus, Web of Science, PEDro, CINAHL, and APA PsychNet databases on July 10, 2021, for all published studies of tendinopathy populations measuring psychological and psychosocial factors. STUDY SELECTION: Studies using a clinical diagnosis of tendinopathy or synonyms (eg, jumper's knee or subacromial impingement) with or without imaging confirmation. DATA SYNTHESIS: We described the volume, nature, distribution, and characteristics of psychological and psychosocial outcomes reported in the tendinopathy field. RESULTS: Twenty-nine constructs were identified, including 16 psychological and 13 psychosocial constructs. The most frequently-reported constructs were work-related outcomes (32%), quality of life (31%), depression (30%), anxiety (18%), and fear (14%). Outcome measures consisted of validated and nonvalidated questionnaires and 1-item custom questions (including demographics). The number of different outcome measures used to assess an individual construct ranged between 1 (emotional distress) and 11 (quality of life) per construct. CONCLUSION: There was a large variability in constructs and outcome measures reported in tendinopathy research, which limits conclusions about the relationship between psychological and psychosocial constructs, outcome measures, and tendinopathies. Given the wide range of psychological and psychosocial constructs reported, there is an urgent need to develop a core outcome set in tendinopathy. J Orthop Sports Phys Ther 2022;52(6):375-388. doi:10.2519/jospt.2022.11005.

Protocol for the development of a core outcome set for lateral elbow tendinopathy (COS-LET).

BACKGROUND: Lateral elbow tendinopathy (LET) is a common condition that can cause significant disability and associated socioeconomic cost. Although it has been widely researched, outcome measures are highly variable which restricts evidence synthesis across studies. In 2019, a working group of international experts, health care professionals and patients, in the field of tendinopathy (International Scientific Tendinopathy Symposium Consensus (ICON) Group), published the results of a consensus exercise defining the nine core domains that should be measured in tendinopathy research. The aim of this study is to develop a core outcome set (COS) for LET mapping to these core domains. The primary output will provide a template for future outcome evaluation of LET. In this protocol, we detail the methodological approach to the COS-LET development. METHODS: This study will employ a three-phase approach. (1) A systematic review of studies investigating LET will produce a comprehensive list of all instruments currently employed to quantify the treatment effect or outcome. (2) Instruments will be matched to the list of nine core tendinopathy outcome domains by a Steering Committee of clinicians and researchers with a specialist interest in LET resulting in a set of candidate instruments. (3) An international three-stage Delphi study will be conducted involving experienced clinicians, researchers and patients. Within this Delphi study, candidate instruments will be selected based upon screening using the Outcome Measures in Rheumatology (OMERACT) truth, feasibility and discrimination filters with a threshold of 70% agreement set for consensus. CONCLUSIONS: There is currently no COS for the measurement or monitoring of LET in trials or clinical practice. The output from this project will be a minimum COS recommended for use in all future English language studies related to LET. The findings will be published in a high-quality journal and disseminated widely using professional networks, social media and via presentation at international conferences. TRIAL REGISTRATION: Registered with the Core Outcome Measures in Effectiveness Trials (COMET) database, November 2019. https://www.comet-initiative.org/Studies/Details/1497 .

Local hyperalgesia, normal endogenous modulation with pain report beyond its origin: a pilot study prompting further exploration into plantar fasciopathy.

Background and aims Persistent tendinopathies were previously considered solely as peripheral conditions affecting the local tendinous tissue until quantitative sensory testing identified involvement of altered pain processing. In similar fashion, pain in patients with persistent plantar fasciopathy may also involve more than local tissue. The aim of this pilot study was to investigate potential differences in conditioned pain modulation and pressure and thermal pain thresholds, between individuals with PF and healthy pain-free controls, as a precursor to a larger-scale study. Methods We assessed 16 individuals with plantar fasciopathy and 11 pain-free controls. Plantar fasciopathy diagnosis was: palpation pain of the medial calcaneal tubercle or the proximal plantar fascia, duration ≥3 months, pain intensity ≥2/10, and ultrasound-measured plantar fascia thickness ≥4 mm. Quantitative sensory tests were performed locally at the plantar heel and remotely on the ipsilateral elbow. Assessments included pain thresholds for pressure, heat and cold, and conditioned pain modulation measured as change in local resting pressure pain threshold with cold water hand immersion. Participants rated pain intensity at pain threshold. Additionally, the area and distribution of plantar fasciopathy pain was drawn on a digital body chart of the lower limbs. Descriptive analyses were performed and between-group differences/effects expressed as standardised mean differences (d). Results There was no conditioned pain modulation difference between participants with plantar fasciopathy and controls (d = 0.1). Largest effects were on local pressure pain threshold and reported pain intensity on pressure pain threshold (d > 1.8) followed by pain intensity for heat and cold pain thresholds (d = 0.3-1.5). According to the digital body chart, pain area extended beyond the plantar heel. Conclusions The unlikelihood of a difference in conditioned pain modulation yet a pain area extending beyond the plantar heel provide a basis for exploring altered pain processing in a larger-scale study. Implications This was the first study to investigate the presence of altered pain processing in individuals with plantar fasciopathy using a conditioned pain modulation paradigm and thermal pain thresholds. We found no indication of an altered pain processing based on these measures, however, patients rated pain higher on thresholds compared to controls which may be important to clinical practice and warrants further exploration in the future.

Unsupervised Isometric Exercise versus Wait-and-See for Lateral Elbow Tendinopathy.

PURPOSE: This study aimed to investigate the effect of unsupervised isometric exercise compared with a wait-and-see approach on pain, disability, global improvement, and pain-free grip strength in individuals with lateral elbow tendinopathy. METHODS: Forty participants with unilateral lateral elbow tendinopathy of at least 6 wk duration were randomized to either wait-and-see (n = 19) or a single supervised instruction session by a physiotherapist, followed by an 8-wk unsupervised daily program of progressive isometric exercise (n = 21). Primary outcomes were Patient-Rated Tennis Elbow Evaluation, global rating of change on a six-point scale (dichotomized to success and no success) and pain-free grip strength at 8 wk. Secondary outcomes were resting and worst pain on an 11-point numerical rating scale, and thermal and pressure pain thresholds as a measure of pain sensitivity. RESULTS: Thirty-nine (98%) participants completed 8-wk measurements. The exercise group had lower Patient-Rated Tennis Elbow Evaluation scores compared with wait-and-see at 8 wk (standardized mean difference [SMD], -0.92; 95% confidence interval [CI], -1.58 to -0.26). No group differences were found for success on global rating of change (29% exercise vs 26% wait-and-see (risk difference, 2.3%; 95% CI, -24.5 to 29.1)), or pain-free grip strength (SMD, -0.33; 95% CI, -0.97 to 0.30). No differences were observed for all secondary outcomes except for worst pain, which was moderately lower in the exercise group (SMD, -0.80; 95% CI, -1.45 to -0.14). CONCLUSIONS: Unsupervised isometric exercise was effective in improving pain and disability, but not perceived rating of change and pain-free grip strength when compared with wait-and-see at 8 wk. With only one of the three primary outcomes being significantly different after isometric exercises, it is doubtful if this form of exercise is efficacious as a sole treatment.

Cervical lateral glide increases nociceptive flexion reflex threshold but not pressure or thermal pain thresholds in chronic whiplash associated disorders: A pilot randomised controlled trial.

Sensory hypersensitivity indicative of augmented central pain processing is a feature of chronic whiplash associated disorders (WAD). This study investigated the immediate effects of a cervical spine manual therapy (SMT) technique on measures of central hyperexcitability. In a randomised, single blind, clinical trial, 39 participants with chronic WAD were randomly assigned to a cervical SMT (lateral glide) or manual contact intervention. The Neck Disability Index (NDI) and GHQ-28 were administered at baseline. Pressure pain thresholds (PPTs), thermal pain thresholds (TPTs) and Nociceptive Flexion Reflex (NFR) responses (threshold and VAS of pain) were measured pre and post intervention. There was a significantly greater increase in NFR threshold following SMT compared to the manual contact intervention (p = 0.04). PPTs at the cervical spine increased following both SMT (mean +/- SE: 24.1 +/- 7.3%) and manual contact (21 +/- 8.4%) with no difference between interventions. There was no difference between interventions for pain ratings with the NFR test, PPTs at the Median Nerve or Tibialis Anterior, heat or cold TPT. SMT may be effective in reducing spinal hyperexcitability in chronic WAD.