Toward designing human intervention studies to prevent osteoarthritis after knee injury: A report from an interdisciplinary OARSI 2023 workshop

Objective: The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies. Design: An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward. Results: Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population. Conclusions: Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges

Establishing outcome measures in early knee osteoarthritis

The classification and monitoring of individuals with early knee osteoarthritis (OA) are important considerations for the design and evaluation of therapeutic interventions and require the identification of appropriate outcome measures. Potential outcome domains to assess for early OA include patient-reported outcomes (such as pain, function and quality of life), features of clinical examination (such as joint line tenderness and crepitus), objective measures of physical function, levels of physical activity, features of imaging modalities (such as of magnetic resonance imaging) and biochemical markers in body fluid. Patient characteristics such as adiposity and biomechanics of the knee could also have relevance to the assessment of early OA. Importantly, research is needed to enable the selection of outcome measures that are feasible, reliable and validated in individuals at risk of knee OA or with early knee OA. In this Perspectives article, potential outcome measures for early symptomatic knee OA are discussed, including those measures that could be of use in clinical practice and/or the research setting

Patient-reported outcome measures for hip-related pain: A review of the available evidence and a consensus statement from the International Hip-related Pain Research Network, Zurich 2018

Hip-related pain is a well-recognised complaint among active young and middle-aged active adults. People experiencing hip-related disorders commonly report pain and reduced functional capacity, including difficulties in executing activities of daily living. Patient-reported outcome measures (PROMs) are essential to accurately examine and compare the effects of different treatments on disability in those with hip pain. In November 2018, 38 researchers and clinicians working in the field of hip-related pain met in Zurich, Switzerland for the first International Hip-related Pain Research Network meeting. Prior to the meeting, evidence summaries were developed relating to four prioritised themes. This paper discusses the available evidence and consensus process from which recommendations were made regarding the appropriate use of PROMs to assess disability in young and middle-aged active adults with hip-related pain. Our process to gain consensus had five steps: (1) systematic review of systematic reviews; (2) preliminary discussion within the working group; (3) update of the more recent high-quality systematic review and examination of the psychometric properties of PROMs according to established guidelines; (4) formulation of the recommendations considering the limitations of the PROMs derived from the examination of their quality; and (5

Moderators of the effect of therapeutic exercise for knee and hip osteoarthritis: a systematic review and individual participant data meta-analysis

Background Many international clinical guidelines recommend therapeutic exercise as a core treatment for knee and hip osteoarthritis. We aimed to identify individual patient-level moderators of the effect of therapeutic exercise for reducing pain and improving physical function in people with knee osteoarthritis, hip osteoarthritis, or both. Methods We did a systematic review and individual participant data (IPD) meta-analysis of randomised controlled trials comparing therapeutic exercise with non-exercise controls in people with knee osteoathritis, hip osteoarthritis, or both. We searched ten databases from March 1, 2012, to Feb 25, 2019, for randomised controlled trials comparing the effects of exercise with non-exercise or other exercise controls on pain and physical function outcomes among people with knee osteoarthritis, hip osteoarthritis, or both. IPD were requested from leads of all eligible randomised controlled trials. 12 potential moderators of interest were explored to ascertain whether they were associated with short-term (12 weeks), medium-term (6 months), and long-term (12 months) effects of exercise on self-reported pain and physical function, in comparison with non-exercise controls. Overall intervention effects were also summarised. This study is prospectively registered on PROSPERO (CRD42017054049). Findings Of 91 eligible randomised controlled trials that compared exercise with non-exercise controls, IPD from 31 randomised controlled trials (n=4241 participants) were included in the meta-analysis. Randomised controlled trials included participants with knee osteoarthritis (18 [58%] of 31 trials), hip osteoarthritis (six [19%]), or both (seven [23%]) and tested heterogeneous exercise interventions versus heterogeneous non-exercise controls, with variable risk of bias. Summary meta-analysis results showed that, on average, compared with non-exercise controls, therapeutic exercise reduced pain on a standardised 0–100 scale (with 100 corresponding to worst pain), with a difference of –6·36 points (95% CI –8·45 to –4·27, borrowing of strength [BoS] 10·3%, between-study variance [τ2] 21·6) in the short term, –3·77 points (–5·97 to –1·57, BoS 30·0%, τ2 14·4) in the medium term, and –3·43 points (–5·18 to –1·69, BoS 31·7%, τ2 4·5) in the long term. Therapeutic exercise also improved physical function on a standardised 0–100 scale (with 100 corresponding to worst physical function), with a difference of –4·46 points in the short term (95% CI –5·95 to –2·98, BoS 10·5%, τ2 10·1), –2·71 points in the medium term (–4·63 to –0·78, BoS 33·6%, τ2 11·9), and –3·39 points in the long term (–4·97 to –1·81, BoS 34·1%, τ2 6·4). Baseline pain and physical function moderated the effect of exercise on pain and physical function outcomes. Those with higher self-reported pain and physical function scores at baseline (ie, poorer physical function) generally benefited more than those with lower self-reported pain and physical function scores at baseline, with the evidence most certain in the short term (12 weeks). Interpretation There was evidence of a small, positive overall effect of therapeutic exercise on pain and physical function compared with non-exercise controls. However, this effect is of questionable clinical importance, particularly in the medium and long term. As individuals with higher pain severity and poorer physical function at baseline benefited more than those with lower pain severity and better physical function at baseline, targeting individuals with higher levels of osteoarthritis-related pain and disability for therapeutic exercise might be of merit

COOP/WONCA-funksjonsskjema - Et nyttig og sensitivt evalueringsverktøy til bruk i fysioterapipraksis

The main objective of the present investigation was to determine whether the COOP/WONCA charts would prove a valid and responsive instrument for measuring functional impairment and clinical relevant changes in functional ability and health status accompanying physical therapy treatment. 163 patients with musculoskeletal disorders were recruited from eight physical therapy clinics. The mean age was 45.3 years (SD = 13.5, range = 16 -74) and 71 percent were women. The patients completed a self-administered questionnaire that included the COOP/WONCA charts and visual analogue scales (VAS) for pain and patient satisfaction. The questionnaires were filled in four times; at the initial examination, after four to six treatments, at discharge and at follow-up three months later. There was a significant improvement for most of the variables measured. The largest effect sizes were found between the initial examination and discharge. The positive effects were maintained at three months after the final treatment. The COOP/WONCA charts appeared to meet the criteria required to make them a useful tool for measuring change in the patient’s functional ability and health status during and after a physical therapy intervention

Performance-based functional outcome for children 12 years or younger following anterior cruciate ligament injury : a two to nine-year follow-up study.

There is limited scientific knowledge on ACL injuries in children 12 years or younger. Substantial controversy exists on treatment algorithms and there are no published data on performance based functional outcome. Classification of adult ACL injured subjects as copers and non-copers is common, but no study has classified knee function in children using performance based functional test after ACL injury. The aim of the present study was to evaluate the long term functional outcome among children with ACL injury, and to classify them as copers and non-copers. Children 12 years or younger who were referred to our institution from 1996 to 2004 with an ACL injury were included. Twenty non-operated subjects (21 knees) and six ACL reconstructed subjects (7 knees) were examined at a minimum of two years after ACL injury or reconstruction. Four single legged hop tests, isokinetic muscle strength measurements, and three functional questionnaires (IKDC 2000, KOS-ADLS and Lysholm) were used as outcome measurements. Children who had resumed their pre-injury activity level and performed above 90% on all hop tests were classified as copers following non-operative treatment and ACL reconstruction. The 26 children were on average 10.1 years at time of injury. Sixty-five percent of the nonoperated children had returned to pre-injury activity level, and 50% were classified as copers. Copers scored significantly better than non-copers on single hop for distance, IKDC 2000, and Lysholm score. Nine and a half percent of the non-operated children had suffered a secondary meniscus injury. Sixty-seven percent of the ACL reconstructed subjects were classified as copers at follow-up. Non-operated ACL-deficient children demonstrated excellent knee function on performance based single legged hop tests and 65% had returned to pre-injury activity level. Delayed ACL reconstruction resulted in success for a majority of the ACL reconstructed children. Treatment algorithms for ACL injured children are discussed