Exercise therapy, education, and cognitive behavioral therapy alone, or in combination with total knee arthroplasty, in patients with knee osteoarthritis: a randomized feasibility study.

BACKGROUND: One in five patients experience chronic pain 1 year after total knee arthroplasty (TKA), highlighting the need for enhanced treatment strategies to improve outcomes. This feasibility trial aimed to optimize the content and delivery of a complex intervention tailored to osteoarthritis (OA) patients at risk of poor outcome after TKA and assess the feasibility of initiating a full-scale multicenter randomized controlled trial (RCT). METHODS: Patients scheduled for TKA were included between August 2019 and June 2020 and block-randomized into one of three groups: (a) 12-week exercise therapy and education (ExE) and 10-module internet-delivered cognitive behavioral therapy (iCBT), (b) TKA followed by ExE and iCBT and (c) TKA and standard postoperative care. Outcomes were (i) recruitment and retention rate, (ii) compliance to the intervention and follow-up, (iii) crossover, and (iv) adverse events, reported by descriptive statistics. RESULTS: Fifteen patients were included in the study. Only 1 out of 146 patients screened for eligibility was included during the first 4 months. During the next 3 months, 117 patients were not included since they lived too far from the hospital. To increase the recruitment rate, we made three amendments to the inclusion criteria; (1) at-risk screening of poor TKA outcome was removed as an eligibility criterion, (2) patients across the country could be included in the study and (3) physiotherapists without specific certification were included, receiving thorough information and support. No patients withdrew from the study or crossed over to surgery during the first year. Nine out of 10 patients completed the ExE program and six out of 10 completed the iCBT program. Fourteen out of 15 patients completed the 1-year follow-up. One minor adverse event was registered. CONCLUSIONS: Except for recruitment and compliance to iCBT, feasibility was demonstrated. The initial recruitment process was challenging, and necessary changes were made to increase the recruitment rate. The findings informed how a definitive RCT should be undertaken to test the effectiveness of the complex intervention. TRIAL REGISTRATION: The MultiKnee RCT, including the feasibility study, is pre-registered at ClinicalTrials.gov: NCT03771430 11/12/2018.

Early Surgery Versus Exercise Therapy and Patient Education for Traumatic and Nontraumatic Meniscal Tears in Young Adults-An Exploratory Analysis From the DREAM Trial.

OBJECTIVE: To compare the effect of early meniscal surgery versus exercise and education with the option of later surgery on pain, function, and quality of life in young patients with a meniscal tear, taking symptom onset into account. DESIGN: Randomized controlled trial. METHODS: In a randomized controlled trial (the "Danish RCT on Exercise versus Arthroscopic Meniscal surgery for young adults" [DREAM] trial), 121 patients aged 18-40 years with a magnetic resonance imaging-verified meniscal tear were randomized to surgery or 12 weeks of supervised exercise and patient education. For this exploratory study, the analyses were stratified by symptom onset (traumatic/nontraumatic). The main outcome was the difference in change after 12 months in the mean score of 4 Knee injury and Osteoarthritis Outcome Score subscales (KOOS4) covering pain, symptoms, function in sport and recreation, and quality of life. RESULTS: Forty-two patients (69%) in the exercise therapy group and 47 (78%) in the surgery group were categorized as having a traumatic tear. We observed no difference in change in the KOOS4 after 12 months between the 2 treatment groups for either traumatic tears (18.8 versus 16.0 in the surgery versus exercise therapy groups; adjusted mean difference, 4.8 [95% confidence interval, -1.7 to 11.2]) or nontraumatic tears (20.6 versus 17.3 in the surgery versus exercise therapy groups; adjusted mean difference, 7.0 [95% confidence interval, -3.7 to 17.7]). CONCLUSION: In patients with traumatic and nontraumatic meniscus tears, early meniscal surgery did not appear superior to exercise and education in improving pain, function, and quality of life after 12 months. Further research is needed to confirm the clinical applicability of these findings. J Orthop Sports Phys Ther 2024;54(5):1-10. Epub 22 February 2024. doi:10.2519/jospt.2024.12245.

Are Outcomes From an Exercise Therapy and Patient Education Program for Osteoarthritis Associated With Hip and Knee Replacement Within Two Years? A Register-Based Study of 9,339 Patients With Osteoarthritis.

OBJECTIVE: The objective of this study was to determine whether short-term outcomes from exercise therapy and patient education for osteoarthritis (OA) are associated with hip or knee replacement within two years. METHODS: Individual-level data from the Good Life with osteoArthritis in Denmark (GLA:D) Registry were linked to the Danish National Patient Registry and other national registries. Cox proportional hazards models were used to investigate associations between program outcomes (baseline to three-month changes) and time to primary hip or knee replacement. Patients who did not receive joint replacement were censored at two years, time of death, or emigration. RESULTS: A total of 2,304 and 7,035 patients with clinically diagnosed hip and knee OA, respectively, were included. Of these, 30% with hip OA and 10% with knee OA had joint replacement within two years. Postprogram improvements in hip-related quality of life and arthritis self-efficacy (pain subscale) were associated with a reduced hazard of hip replacement (adjusted hazard ratios [HRs] for a 10-unit improvement: 0.74 [95% confidence interval (CI) 0.69-0.80] and 0.90 [95% CI 0.85-0.96], respectively). Improvements in knee pain, knee-related quality of life, and arthritis self-efficacy (pain subscale) were associated with a lower hazard of knee replacement (adjusted HRs for 10-unit improvement: 0.81 [95% CI 0.76-0.86] to 0.90 [95% CI 0.86-0.95], 0.70 [95% CI 0.63-0.78] to 0.79 [95% CI 0.72-0.86], and 0.89 [95% CI 0.83-0.94], respectively). CONCLUSION: The magnitude of improvement in key measures after exercise therapy and education was significantly associated with the likelihood of surgery. Progression to hip replacement was three times higher than progression to knee replacement. This information can guide patient-clinician conversations around anticipated program outcomes.

Mapping interventional components and behavior change techniques used to promote self-management in people with multimorbidity: a scoping review.

Ageing populations and improved survival, have contributed to a rise in the number of people living with multimorbidity, raising issues related to polypharmacy, treatment burden, competing priorities and poor coordination of care. Self-management programs are increasingly included as an essential component of interventions to improve outcomes in this population. However, an overview of how interventions supporting self-management in patients with multimorbidity is missing. This scoping review focused on mapping the literature on patient-centered interventions for people living with multimorbidity. We searched several databases, clinical registries, and grey literature for RCTs published between 1990-2019 describing interventions that supported self-management in people with multimorbidity. We included 72 studies that were found to be very heterogeneous when it comes to the population, delivery modes and modalities, intervention elements and facilitators. The results pointed to an extensive use of cognitive behavioral therapy as a basis for interventions, as well as behavior change theories and disease management frameworks. The most coded behavior change techniques stemmed from the categories Social Support, Feedback and monitoring and Goals and Planning. To allow for implementation of effective interventions in clinical practice, improved reporting of intervention mechanisms in RCTs is warranted.

Nurse navigation, symptom monitoring and exercise in vulnerable patients with lung cancer: feasibility of the NAVIGATE intervention.

We developed the Navigate intervention to improve survival among vulnerable lung cancer patients. In this intervention-only study, we examined feasibility in terms of recruitment, retention, attendance, adherence, and acceptability to specify adjustments to study procedures and intervention components prior to a randomized trial. The Navigate intervention includes nurse navigation, patient-reported outcomes, and physical exercise. Patients ≥ 18 years old, diagnosed with non-small cell lung cancer at any stage, with performance status ≤ 2, eligible for cancer treatment and vulnerable according to a screening instrument were included. The recruitment goal of eligible patients was 40% while the retention goal was 85%. The predefined cut-offs for sufficient attendance and adherence were ≥ 75%. Acceptability was evaluated by semi-structured interviews with participants, nurse navigators, and physiotherapists. Seventeen (56%) out of 30 screened patients were considered vulnerable and eligible for the study, 14 (82%) accepted participation, and 3 (21%) were subsequently excluded due to ineligibility, leaving 11 patients. Four patients dropped out (36%) and four patients died (36%) during follow-up and 3 (27%) were retained. All 11 patients participated in nurse sessions (mean 16, range 1-36) with 88% attendance and dialogue tools being applied in 68% of sessions. Ninety-one percent of patients responded to PROs (mean of 9 PROs, range 1-24) with 76% of the PRO questionnaires used (attendance) and 100% adherence (completion of all questions in PRO questionnaires), and 55% participated in exercise sessions with 58% attendance and 85% adherence. We identified important barriers primarily related to transportation, but overall acceptability was high. The Navigate intervention was feasible with high participation, acceptability and satisfactory adherence. Retention and exercise attendance were low, which resulted in adjustments.Trial registration: The feasibility study was initiated prior to the multicenter randomized controlled trial registered by ClinicalTrials.gov (number: NCT05053997; date 23/09/2021).

Two-year MRI-defined structural damage and patient-reported outcomes following surgery or exercise for meniscal tears in young adults.

OBJECTIVE: To investigate potential differences in structural knee joint damage assessed by MRI and patient-reported outcomes (PROMs) at 2-year follow-up between young adults randomised to early surgery or exercise and education with optional delayed surgery for a meniscal tear. METHODS: A secondary analysis of a multicentre randomised controlled trial including 121 patients (18-40 years) with an MRI-verified meniscal tear. For this study, only patients with 2-year follow-up were included. The main outcomes were the difference in worsening of structural knee damage, assessed by MRI using the Anterior Cruciate Ligament OsteoArthrits Score, and the difference in change in the mean score of four Knee Injury and Osteoarthritis Outcome Score (KOOS4) subscales covering pain, symptoms, function in sport and recreation, and quality of life, from baseline to 2 years. RESULTS: In total, 82/121 (68%) patients completed the 2-year follow-up (39 from the surgical group and 43 from the exercise group). MRI-defined cartilage damage had developed or progressed in seven (9.1%) patients and osteophytes developed in two (2.6%) patients. The worsening of structural damage from baseline to 2-year follow-up was similar between groups. The mean (95% CI) adjusted differences in change in KOOS4 between intervention groups from baseline to 2 years was -1.4 (-9.1, 6.2) points. The mean improvement in KOOS4 was 16.4 (10.4, 22.4) in the surgical group and 21.5 (15.0, 28.0) in the exercise group. No between group differences in improvement were found in the KOOS subscales. CONCLUSIONS: The 2-year worsening of MRI-defined structural damage was limited and similar in young adult patients with a meniscal tear treated with surgery or exercise with optional delayed surgery. Both groups had similar clinically relevant improvements in KOOS4, suggesting the choice of treatment strategy does not impact 2-year structural knee damage or PROMs. TRIAL REGISTRATION NUMBER: NCT02995551.

Prognostic factors of knee pain and function 12 months after total knee arthroplasty: A prospective cohort study of 798 patients.

BACKGROUND: Approximately 20% of patients undergoing total knee arthroplasty (TKA) do not experience long-term improvements. Our aim was to identify prognostic factors of knee pain and function 12 months after TKA. METHODS: In a prospective cohort study, 1026 patients underwent primary TKA between 2018 and 2020. Main outcome was measured by the Oxford Knee Score (OKS) categorized in five categories (0-9, 10-19, 20-29, 30-39 and 40-48). Potential prognostic factors obtained at baseline included sex, age, baseline OKS, pain catastrophizing scale, EuroQol 5 dimensions, previous surgery, BMI, ASA classification, opioid consumption, living and employment conditions as well as educational level. Ordinal logistic regression analysis was used to identify prognostic factors of OKS. RESULTS: A total of 915 patients completed follow up (89%), and patients with complete data were included (n = 798). Patients with a baseline OKS between 10-19 and 20-29 had 2.5 (CI 1.6;4.0) and 1.6 (CI 1.1;2.4) higher odds, respectively, of no improvement or deterioration to a lower post-operative OKS category, compared with patients with a baseline score between 30 and 39. Female patients had 1.5 (CI 1.1;2.0) and patients receiving social benefits compared with retired patients had 2.0 (CI 1.1;3.5) higher odds of no improvement or deterioration to a lower OKS category. CONCLUSION: Baseline level of pain and function, sex and employment status were significant prognostic factors of OKS 12 months after TKA. Overall, the regression analysis only explained 4% of the outcome, indicating that it is difficult to predict 12-month TKA outcome prior to surgery.

Neo-train: study protocol and feasibility results for a two-arm randomized controlled trial investigating the effect of supervised exercise during neoadjuvant chemotherapy on tumour response in patients with breast cancer.

BACKGROUND: Prehabilitation with exercise interventions during neoadjuvant chemotherapy (NACT) is effective in reducing physical and psychosocial chemotherapy-related adverse events in patients with cancer. In preclinical studies, data also support a growth inhibitory effect of aerobic exercise on the tumour microenvironment with possible improved chemotherapy delivery but evidence in human patients is limited. The aim of the study here described is to investigate if supervised exercise with high-intensity aerobic and resistance training during NACT can improve tumour reduction in patients with breast cancer. METHODS: This parallel two-armed randomized controlled trial is planned to include 120 women aged ≥ 18 years with newly diagnosed breast cancer starting standard NACT at a university hospital in Denmark (a total of 90 participants needed according to the power calculation and allowing 25% (n = 30) dropout). The participants will be randomized to usual care or supervised exercise consisting of high-intensity interval training on a stationary exercise bike and machine-based progressive resistance training offered three times a week for 24 weeks during NACT, and screening-based advice to seek counselling in case of moderate-severe psychological distress (Neo-Train program). The primary outcome is tumour size change (maximum diameter of the largest lesion in millimetre) measured by magnetic resonance imaging prior to surgery. Secondary outcomes include clinical/pathological, physical and patient-reported measures such as relative dose intensity of NACT, hospital admissions, body composition, physical fitness, muscle strength, health-related quality of life, general anxiety, depression, and biological measures such as intratumoural vascularity, tumour infiltrating lymphocytes, circulating tumour DNA and blood chemistry. Outcomes will be measured at baseline (one week before to 1-2 weeks after starting NACT), during NACT (approximately week 7, 13 and 19), pre-surgery (approximately week 21-29), at surgery (approximately week 21-30) and 3 months post-surgery (approximately 33-42 weeks from baseline). DISCUSSION: This study will provide novel and important data on the potential benefits of supervised aerobic and resistance exercise concomitant to NACT on tumour response and the tumour microenvironment in patients with breast cancer, with potential importance for survival and risk of recurrence. If effective, our study may help increase focus of exercise as an active part of the neoadjuvant treatment strategy. TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT04623554) on November 10, 2020.

Effect of exercise therapy versus surgery on mechanical symptoms in young patients with a meniscal tear: a secondary analysis of the DREAM trial.

OBJECTIVE: To compare the effect of early surgery versus exercise and education on mechanical symptoms and other patient-reported outcomes in patients aged 18-40 years with a meniscal tear and self-reported mechanical knee symptoms. METHODS: In a randomised controlled trial, 121 patients aged 18-40 years with a MRI-verified meniscal tear were randomised to surgery or 12-week supervised exercise and education. For this study, 63 patients (33 and 30 patients in the surgery and in the exercise group, respectively) reporting baseline mechanical symptoms were included. The main outcome was self-reported mechanical symptoms (yes/no) at 3, 6 and 12 months assessed using a single item from the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes were KOOS4 and the 5 KOOS-subscales and the Western Ontario Meniscal Evaluation Tool (WOMET). RESULTS: In total, 55/63 patients completed the 12-month follow-up. At 12 months, 9/26 (35%) in the surgery group and 20/29 (69%) in the exercise group reported mechanical symptoms. The risk difference and relative risk at any time point was 28.7% (95% CI 8.6% to 48.8%) and 1.83 (95% CI 0.98 to 2.70) of reporting mechanical symptoms in the exercise group compared with the surgery group. We did not detect any between-group differences in the secondary outcomes. CONCLUSION: The results from this secondary analysis suggest that early surgery is more effective than exercise and education for relieving self-reported mechanical knee symptoms, but not for improving pain, function and quality of life in young patients with a meniscal tear and mechanical symptoms. TRIAL REGISTRATION NUMBER: NCT02995551.

Influence of Self-Reported Knee Instability on Outcomes Following Education and Exercise: A Cohort Study of 2,466 Patients With Knee Osteoarthritis.

OBJECTIVE: To study the influence of self-reported knee instability on changes in knee pain and gait speed following patient education and supervised exercise therapy in patients with knee osteoarthritis (OA). METHODS: We included patients enrolled in the Good Life With Osteoarthritis in Denmark (GLA:D) program, an 8-week education and supervised neuromuscular exercise program. Patients were classified into 4 groups according to their level of self-reported knee instability (never; rarely; sometimes; most of the time or all the time). Knee pain intensity was evaluated on a 0-100 mm scale and gait speed from the 4 × 10 meters fast-paced walk test at baseline and after the program. Using linear regression, we examined the association between knee instability and the change in pain and gait speed, respectively. Sex, age, body mass index, physical activity level, and previous knee surgery were covariates in adjusted models. RESULTS: Among 2,466 patients with knee OA, mean baseline pain and gait speed varied between 38-59 mm and 1.39-1.56 meters/second in patients experiencing no instability and patients experiencing instability most or all the time, respectively. All instability groups improved in pain and gait speed. Compared to the no instability group, patients reporting instability most or all the time experienced larger improvements in pain (4.3 mm [95% confidence interval 1.2, 7.5]), while no difference between instability groups was found for gait speed. CONCLUSION: Knee OA patients with self-reported instability seem to benefit even more from a patient education and supervised exercise therapy program than OA patients without instability.

Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial.

OBJECTIVES: The main objective was to investigate 5-year outcomes in patients with knee osteoarthritis, randomised to one of two non-surgical treatments. SETTING: Two outpatient clinics. PARTICIPANTS: At baseline, 100 patients with radiographic and symptomatic knee osteoarthritis not found eligible for knee replacement (KR) were included. Main exclusion criteria were average score above 75 of the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales pain, symptoms, function of daily living and quality of life; KOOS4 and average knee pain the previous week greater than 60 mm on a 100 mm visual analogue scale. INTERVENTIONS: Patients were randomised to supervised non-surgical treatment consisting of patient education, supervised exercise, weight loss, insoles, and pain medication (the MEDIC treatment) or written advice. The 12-week MEDIC treatment included patient education, neuromuscular exercise, insoles and a dietary weight loss programme and/or pain medication if needed and written advice consisted of two leaflets. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome was 5-year mean change for KOOS4. Secondary outcomes included KOOS subscales, self-reported health, usage of pain medication and self-reported physical activity. RESULTS: Thirty-nine (78%) and 36 (72%) from the MEDIC and written advice groups responded at 5 years. There were no between-group differences in KOOS4 (difference 5.3 (95% CI -1.5 to 12.1) or any secondary outcomes. However, the 95% CI included the minimal clinically important difference for the main outcome.Seventy-six percent of the MEDIC group and 66% of the written advice group experienced clinically important improvements in KOOS4.Fifteen patients (30%) from the MEDIC group and 17 (34%) from the written advice group received KR in the index knee. Undergoing KR did not result in a statistically significant greater improvement in KOOS4 (difference 6.1 (95% CI -1.1 to 13.4). CONCLUSIONS: No statistically significant differences between supervised non-surgical treatment and written advice were demonstrated at 5 years. Most patients experienced clinically important improvements, irrespective of initial treatment strategy or KR. TRIAL REGISTRATION NUMBER: NCT01535001; ClinicalTrials.gov.

Changes in systemic inflammation after pulmonary rehabilitation in patients with COPD and severe physical inactivity - an exploratory study.

BACKGROUND: Severe physical inactivity (SPI) in patients with COPD is associated with a poor prognosis. It is unknown whether there is a link between SPI and systemic inflammation, and if systemic inflammation in SPI changes following pulmonary rehabilitation (PR). METHODS: A prospective, observational study of patients referred for at least 7 weeks of PR comprising 2 h of exercise therapy and education twice weekly. At baseline and after PR, daily physical activity level (PAL) was measured with a validated activity monitor, SenseWear® as well as systemic inflammation: b-eosinophils, p-fibrinogen, p-CRP, s-IL-6 and s-CD 163. SPI was defined as PAL <1.4. RESULTS: At baseline, SPI was present in 31 of the 57 patients included, and 23% (7/31) improved to non-SPI after PR. We observed no differences between patients with SPI and non-SPI, except baseline plasma fibrinogen level was slightly yet significantly higher in patients with SPI (median 13.3 [6.2-23.6] vs 11.2 [6.5-16.7] µmol/l) but change in fibrinogen levels differed insignificantly between patients who improved to non-SPI at follow-up compared to patients with persistent SPI (-0.6 [-16.9-9.9] vs -0.4 [-11.2-1.2] µmol/l). CONCLUSION: SPI in COPD appears not to be associated with a distinct inflammatory profile compared to less sedentary COPD patients attending pulmonary rehabilitation. Currently biomarkers have no role in the detection of SPI in COPD.

The Effect of Occupational Engagement on Lifestyle in Adults Living with Chronic Pain: A Systematic Review and Meta-analysis.

Background: Healthy lifestyle is important to decrease health risks in individuals living with chronic pain. From an occupational therapy perspective, human health and lifestyle are linked to occupational engagement in meaningful everyday activities. This study is aimed at investigating the effect of including occupational engagement in chronic pain interventions on lifestyle. Methods: In this systematic review (PROSPERO reg. CRD42020159279), we included randomized controlled trials (RCTs) on interventions involving occupational engagement (i.e., occupational performance based on involvement, choice, positive meaning, and commitment) and assessing modifiable lifestyle factors: physical activity, body anthropometrics, alcohol consumption, smoking, stress, and sleep. We sought the databases Ovid MEDLINE, Embase, PsycINFO, CINAHL, Cochrane, Scopus, Web of Science, OTseeker, ClinicalTrials.gov, OpenGrey, and the web engine Google Scholar and citations and references of relevant publications. We evaluated methodological quality with the Cochrane risk-of-bias tool 2.0, determined the overall evidence certainty using the GRADE methodology, and performed meta-analysis when two or more trials reported on the outcomes. Results: Of the 9526 items identified, 286 were full text screened. We included twelve articles with eleven RCTs comprising 995 adults and assessing physical activity, sleep quality, stress, and Body Mass Index. Sufficient data for meta-analysis was only available for physical activity and sleep quality. The meta-analysis suggested a moderate increase in physical activity after behavioral interventions for fibromyalgia and musculoskeletal pain (SMD = 0.69 (0.29; 1.09)) and a small increase in sleep quality up to 6 months after multidisciplinary self-management of fibromyalgia (SMD = 0.35 (95% CI 0.08; 0.61)). The overall certainty of the evidence was deemed low. Conclusion: Including occupational engagement in chronic pain interventions may increase short-term physical activity and long-term sleep quality. Due to the few available RCTs including occupational engagement in chronic pain treatment for adults living with chronic pain, further high-quality RCTs are needed and will likely change the conclusion.

Benefits and Harms of Interventions With Surgery Compared to Interventions Without Surgery for Musculoskeletal Conditions: A Systematic Review With Meta-analysis.

OBJECTIVE: To estimate the benefits and harms of interventions with and without surgery for musculoskeletal (MSK) conditions. DESIGN: Intervention systematic review with meta-analysis of randomized controlled trials (RCTs). LITERATURE SEARCH: MEDLINE, EMBASE, CINAHL, Web of Science, and CENTRAL, all up to January 7, 2021. STUDY SELECTION CRITERIA: RCTs (English, German, Danish, Swedish, and Norwegian) of interventions with and without surgery conducted in any setting for any non-fracture MSK condition in adults (mean age: 18+ years) evaluating the outcomes on a continuous (benefits) or count (harms) scale. Outcomes were pain, self-reported physical function, quality of life, serious adverse events (SAEs), and death at 1 year. DATA SYNTHESIS: Random-effects metaanalyses for MSK conditions where there were data from at least 2 trials. RESULTS: One hundred RCTs (n = 12 645 patients) across 28 different conditions at 9 body sites were included. For 9 out of 13 conditions with data on pain (exceptions include some spine conditions), 11 out of 11 for function, and 9 out of 9 for quality of life, there were no clinically relevant differences (standardized mean difference of 0.50 or above) between interventions with and without surgery. For 13 out of 16 conditions with data on SAEs and 16 out of 16 for death, there were no differences in harms. Only 6 trials were at low risk of bias. CONCLUSION: The low certainty of evidence does not support recommending surgery over nonsurgical alternatives for most MSK conditions with available RCTs. Further high-quality RCTs may change this conclusion. J Orthop Sports Phys Ther 2022;52(6):312-344. doi:10.2519/jospt.2022.11075.

Feasibility, safety, and patient-reported outcomes 90 days after same-day total knee arthroplasty: a matched cohort study.

BACKGROUND AND PURPOSE: Despite increased attention to and acceptance of fast-track procedures, there is a lack of studies concerning discharge on the day of surgery (DOS) following total knee arthroplasty (SD-TKA). We evaluated the feasibility of SD-TKA, and compared safety and patient-reported outcomes (PROs) between patients undergoing SD-TKA and patients undergoing standard TKA. PATIENTS AND METHODS: A SD-TKA group (n = 101) was matched 1:1 to a standard TKA group (n = 101) on age, sex, and ASA score. Feasibility (being discharged on DOS), safety (unplanned contacts and complications evaluated by telephone calls (2 weeks), outpatient visits (2 weeks), and readmission (90 days)) were assessed. Further, Oxford Knee Score (OKS) and Visual Analogue Scale (VAS) (pain at rest and activity) were reported (90 days). RESULTS: 89 of 101 SD-TKA patients were discharged on DOS. The number of telephone calls (≤ 83) and outpatient visits (12) were similar in the 2 groups. The number of readmissions was ≤ 3 in both groups, and only 1 of the readmissions was related to TKA surgery. No differences were found at 90-day follow-up in terms of OKS (34 in both groups) or VAS (rest: SD-TKA = 7 and standard TKA = 8; activity: SD-TKA = 17 and standard TKA = 15). INTERPRETATION: SD-TKA is feasible in a selected group of patients, and safety and PROs are comparable to patients undergoing standard TKA.

Clinical Characteristics of 100 Patients With Hypermobility Spectrum Disorders and Shoulder Complaints With or Without Mechanical Symptoms: A Cross-sectional Study.

OBJECTIVE: To describe the clinical characteristics of patients with hypermobility spectrum disorders (HSD) and shoulder complaints with or without mechanical symptoms, and to compare characteristics between these groups. DESIGN: A cross-sectional study. SETTING: Primary care. PARTICIPANTS: One-hundred patients with HSD and shoulder complaints for at least 3 months were included from primary care (N=100). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Medical history, self-reported (shoulder pain and function, discomfort due to other symptoms, fatigue, fear of movement, quality of life) and objective (strength, range of motion, proprioception) characteristics were collected by physiotherapists. Mechanical symptoms (yes/no) were defined as self-reported shoulder instability, subluxation, and/or laxity. RESULTS: Sixty-seven reported mechanical symptoms. Patients in both groups reported impairments related to shoulder pain, function, fatigue, fear of movement, and quality of life. Patients with mechanical symptoms were younger (mean, 35.1 years [95% CI, 32.3-37.9 years] vs 43.3 years [95% CI, 38.4-48.1 years]), had longer symptom duration (median, 46 months [95% CI, 36-66 months] vs 24 months [95% CI, 9-56 months]), reported a previous shoulder dislocation (25% [95% CI, 16-37] vs 3% [95% CI, 0-16]), experienced that their shoulder was loose (64% [95% CI, 52-76] vs 15% [95% CI, 5-32]), and reported discomfort due to other symptoms (odds ratio, 1.48 [95% CI, 1.17-1.87]). Furthermore, a larger proportion had received supplemental treatment (analgesic medication, steroid injection/surgery). CONCLUSIONS: Both groups with HSD and shoulder complaints presented with substantial shoulder-related impairments. Two-thirds reported mechanical symptoms, were younger, and more severely impaired than those without mechanical symptoms. These findings highlight the importance of managing mechanical shoulder symptoms to fully address the patients' impairments.

Associations of health-related quality of life with sociodemographic characteristics, health, pain, and lifestyle factors, and motivation for changing lifestyle in adults living with chronic pain: a cross-sectional exploratory study.

OBJECTIVES: We investigated the associations between health-related quality of life (HRQoL) and health, pain and lifestyle factors, as well as motivation for lifestyle changes, in adults living with chronic pain referred to a Danish pain centre. METHODS: A total of 144 outpatients completed a questionnaire on HRQoL (EQ-5D-5L), health, pain, lifestyle factors (Body Mass Index [BMI], physical activity, smoking, alcohol, physical fitness, eating, sleep and stress) and motivation for lifestyle changes. We used multiple linear regression analyses to assess associations between HRQoL and the independent variables. RESULTS: The participants (age mean 50 years, 81% females) had ≥2 body pain sites (93%), BMI≥25 (64%), sedentary lifestyle (43%) and multiple (n≥2) elevated metabolic risk factors (58%). Most considered lifestyle important for HRQoL (72%) and expressed moderate to very high motivation for changing lifestyle (92%). Poorer HRQoL in the study population was significantly associated with higher pain intensity in the most painful body site (ß=-0.316, p=0.001) and very poor sleep quality (ß=-0.410, p=0.024). Serious-to-extreme problems in usual activities were associated with significantly poorer health (ß=-0.328, p=0.030). CONCLUSIONS: Adults living with chronic pain participating in this survey had significantly lower self-evaluated HRQoL than the general population. Lower HRQoL was significantly associated with greater pain intensity and poor sleep quality. Serious-to-extreme problems in usual activities, such as work, study, housework, family and leisure, were associated with poorer self-evaluated health. We observed high frequencies of overweight, obesity, sedentary lifestyle, pain in multiple body sites and multiple lifestyle-related risk factors in the study population. Most participants felt motivated for changing lifestyle. Further interventions addressing pain alleviation, sleep quality, prevention of problems in usual activities and promotion of healthy lifestyle, e.g. physical activity and healthy eating, are needed to estimate the effect of a lifestyle-oriented approach on health and quality of life in people living with chronic pain. The results of this study will inform the research project reg. SJ-703, the Danish the Research Ethics Committee for Region Zealand, Denmark.

Prognostic Factors for Health Outcomes After Exercise Therapy and Education in Individuals With Knee and Hip Osteoarthritis With or Without Comorbidities: A Study of 37,576 Patients Treated in Primary Care.

OBJECTIVE: To identify prognostic factors for health outcomes following an 8-week supervised exercise therapy and education program for individuals with knee and hip osteoarthritis (OA) alone or with concomitant hypertension, heart or respiratory disease, diabetes mellitus, or depression. METHODS: We included individuals with knee and/or hip OA from the Good Life With OsteoArthritis in Denmark (GLA:D) program. GLA:D consists of 2 patient education sessions and 12 supervised exercise therapy sessions. Before GLA:D, participants self-reported any comorbidities and were categorized into 8 comorbidity groups. Twenty-one potential prognostic factors (demographic information, clinical data, and performance-based physical function) gathered from participants and clinicians before the program were included. Outcomes were physical function using the 40-meter Fast-Paced Walk Test (FPWT), health-related quality of life using the 5-level EuroQol 5-domain (EQ-5D-5L) index score, and pain intensity using a visual analog scale (VAS; range 0-100) assessed before and immediately after the GLA:D program. Within each comorbidity group, associations of prognostic factors with outcomes were estimated using multivariable linear regression. RESULTS: Data from 35,496 (40-meter FPWT) and 37,576 (EQ-5D-5L and VAS) participants were included in the analyses. Clinically relevant associations were demonstrated between age, self-efficacy, self-rated health, and pain intensity and change in 40-meter FPWT, EQ-5D-5L, or VAS scores across comorbidity groups. Furthermore, anxiety, education, physical function, and smoking were associated with outcomes among subgroups having depression or diabetes mellitus in addition to OA. CONCLUSION: Age, self-efficacy, self-rated health, and pain intensity may be prognostic of change in health outcomes following an 8-week exercise therapy and patient education program for individuals with OA, irrespective of comorbidities.

Early Surgery or Exercise and Education for Meniscal Tears in Young Adults.

BACKGROUND: Surgery is commonly used to treat meniscal tears; however, to our knowledge, no randomized controlled trials (RCTs) have compared surgery with nonsurgical alternatives in young adults. We hypothesized that early meniscal surgery would be superior to a strategy of exercise and education with the option of surgery later if needed. METHODS: In this pragmatic parallel-group RCT, we enrolled young adults (18-40 years of age) with magnetic resonance imaging­verified meniscal tears eligible for surgery from seven Danish hospitals. Patients were randomly assigned (1:1) to surgery (partial meniscectomy or meniscal repair) or 12-week supervised exercise therapy and education with the option of surgery later if needed. The primary outcome was the difference in change from baseline to 12 months in the mean score of four Knee Injury and Osteoarthritis Outcome Score (KOOS4) subscales covering pain, symptoms, function in sport and recreation, and quality of life, ranging from 0 (worst) to 100 (best). RESULTS: We enrolled 121 young adults (mean age, 29.7 years; 28% were female). In total, 107 participants (88%) completed the 12-month follow-up; 16 participants (26%) from the exercise group crossed over to surgery, while 8 (13%) from the surgery group did not undergo surgery. Intention-to-treat analysis showed no statistically significant difference in change between groups from baseline to 12 months in KOOS4 scores (19.2 vs. 16.4 in the surgery vs. exercise groups; adjusted mean difference, 5.4 [95% confidence interval, −0.7 to 11.4]). No difference in serious adverse events was observed (four vs. seven in the surgery and exercise groups, respectively; P=0.40). Per-protocol and as-treated analyses yielded similar results. CONCLUSIONS: Our results suggest that among young, active adults with meniscal tears, a strategy of early meniscal surgery is not superior to a strategy of exercise and education with the option of later surgery. Both groups experienced clinically relevant improvements in pain, function, and quality of life at 12 months, and one of four from the exercise group eventually had surgery. (Funded by the Danish Council for Independent Research, IMK Almene Fond, Lundbeck Foundation, Spar Nord Foundation, Danish Rheumatism Association, Association of Danish Physiotherapists Research Fund, Research Council at Næstved-Slagelse-Ringsted Hospitals, and Region Zealand; ClinicalTrials.gov number, NCT02995551.)

The effectiveness of exercise therapy and education plus cognitive behavioral therapy, alone or in combination with total knee arthroplasty in patients with knee osteoarthritis - study protocol for the MultiKnee trial.

BACKGROUND: One in five patients report chronic pain following total knee arthroplasty (TKA) and are considered non-improvers. Psychological interventions such as cognitive behavioral therapy (CBT), combined with exercise therapy and education may contribute to reduced pain an improved function both for patients with OA or after TKA surgery, but the evidence for the effectiveness of such interventions is scarce. This randomized controlled trial with three arms will compare the clinical effectiveness of patient education and exercise therapy combined with internet-delivered CBT (iCBT), evaluated either as a non-surgical treatment choice or in combination with TKA, in comparison to usual treatment with TKA in patients with knee OA who are considered candidates for TKA surgery. METHODS: The study, conducted in three orthopaedic centers in Norway will include 282 patients between ages 18 and 80, eligible for TKA. Patients will be randomized to receive the exercise therapy + iCBT, either alone or in combination with TKA, or to a control group who will undergo conventional TKA and usual care physiotherapy following surgery. The exercise therapy will include 24 one hour sessions over 12 weeks led by a physiotherapist. The iCBT program will be delivered in ten modules. The physiotherapists will receive theoretical and practical training to advise and mentor the patients during the iCBT program. The primary outcome will be change from baseline to 12 months on the pain sub-scale from the Knee Injury and Osteoarthritis Outcome Score (KOOS). Secondary outcomes include the remaining 4 sub-scales from the KOOS (symptoms, function in daily living, function in sports and recreation, and knee-related quality of life), EQ-5D-5L, the Pain Catastrophizing Scale, the 30-s sit-to-stand test, 40-m walking test and ActiGraph activity measures. A cost-utility analysis will be performed using QALYs derived from the EQ-5D-5L and registry data. DISCUSSION: This is the first randomized controlled trial to investigate the effectiveness of exercise therapy and iCBT with or without TKA, to optimize outcomes for TKA patients. Findings from this trial will contribute to evidence-based personalized treatment recommendations for a large proportion of OA patients who currently lack an effective treatment option. TRIAL REGISTRATION: Clinicaltrials.gov : NCT03771430 . Registered: Dec 11, 2018.