Development of an internet-delivered cognitive behavioral therapy program for use in combination with exercise therapy and education by patients at increased risk of chronic pain following total knee arthroplasty.

BACKGROUND: Approximately 20% of patients experience chronic pain after total knee arthroplasty (TKA). Due to the growing number of TKA procedures, this will affect an increasing number of people worldwide. Catastrophic thinking, dysfunctional illness perception, poor mental health, anxiety and depression characterize these non-improvers, and indicate that these patients may need individualized treatment using a treatment approach based on the bio-psycho-social health model. The present study developed an internet-delivered cognitive behavioral therapy (iCBT) program to be combined with exercise therapy and education for patients with knee osteoarthritis (OA) at increased risk of chronic pain after TKA. METHODS: The development process followed the first two phases of the UK Medical Research Council framework for complex interventions. In the development phase, the first prototype of the iCBT program was developed based on literature review, established iCBT programs and multidisciplinary workshops. The feasibility phase consisted of testing the program, interviewing users, condensing the program, and tailoring it to the patient group. A physiotherapist manual was developed and adapted to physiotherapists who will serve as mentors. RESULTS: The development process resulted in an iCBT program consisting of 10 modules with educational texts, videos and exercises related to relevant topics such as goalsetting, stress and pain, lifestyle, automatic thoughts, mindfulness, selective attention, worry and rumination. A physiotherapist manual was developed to guide the physiotherapists in supporting the patients through the program and to optimize adherence to the program. CONCLUSIONS: The iCBT program is tailored to patients at risk of chronic pain following TKA, and may be useful as a supplement to surgery and/or exercise therapy. A multicentre RCT will evaluate the iCBT program in combination with an exercise therapy and education program. This novel intervention may be a valuable contribution to the treatment of OA patients at risk of chronic pain after TKA. TRIAL REGISTRATION: The RCT is pre-registered at ClinicalTrials.gov: NCT03771430 11/12/2018.

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.

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.

[Pain and functional ability in patients with total disc replacement in the lumbar spine]. / Smerte- og funksjonsforløp hos pasienter med lumbal skiveprotese.

BACKGROUND: Total disc replacement in the lumbar spine is offered to patients with long-lasting localized low back pain secondary to degenerative disc disease, where non-operative treatment has failed. The aim of the study was to evaluate the outcome in patients offered operation with disc replacement using Prodisc II. MATERIAL AND METHODS: All patients that had gone through disc replacement with Prodisc II at Kysthospitalet in Hagevik during the autumn of 2003 (n = 14) were included in a time-series designed study, with repeated measures 3 times preoperative and 5 times postoperative. The last measurement was done 2 years after the operation. Questionnaires and physical performance tests were used to measure differences in function, pain, psychological factors, fear of physical activity and dynamic flexibility of the back. RESULTS AND INTERPRETATION: Preoperative measures showed reduction in pain, depression and somatisation. The other variables were rather stable before the operation. All the variables showed significant improvement 6 months after operation. While pain and perceived functional ability improved substantially after 3 months, physical performance did not show clinically important changes until 6 months after operation. The Oswestry Disability Index (ODI) showed a 29-point mean decrease after 2 years. 11 patients demonstrated a clinically significant improvement (ODI < or =10 points) after 2 years. The effect of this operative treatment should be assessed in randomised controlled trials with a longer follow-up.

Effect of a brief cognitive training programme in patients with long-lasting back pain evaluated as unfit for surgery.

The aim of the study was to evaluate the effect of cognitive intervention (information and physical exercise), on patients with long-lasting back pain referred for surgical evaluation at an orthopaedic hospital, but evaluated as unfit for surgery. One hundred and fifty-two patients were randomized to a five days intervention or control. The intervention had no significant effects on pain. At three-month follow-up, the patients in the intervention group used significantly more active strategies to cope with the back pain compared to the control group. This effect seemed to increase over time, being more pronounced at one-year follow-up evaluation.

Criteria of gait asymmetry in patients with hip osteoarthritis.

Gait symmetry is often a goal for physiotherapy in patients with hip osteoarthritis and after total hip replacement. However, there is no agreement on criteria for pathological gait asymmetry. In this study we investigated discriminative abilities of trunk and footfall gait symmetry measures, and thereafter assessed whether a 10% cutoff value is valid as a general criterion of pathological gait asymmetry across measures. Anteroposterior, vertical, and mediolateral trunk symmetry, single support, and step length symmetry were obtained simultaneously by trunk accelerometry and an electronic walkway in 37 patients with end-stage hip osteoarthritis and 56 controls. Subjects walked six times along a 7-meter walkway at slow, preferred, and fast speed, before data were normalized for gait velocity. Anteroposterior, vertical, and single support symmetry measures showed best discriminating abilities. The general 10% criterion of gait asymmetry and optimal cutoff criteria calculated for each symmetry measure showed approximately equal total classification ability. However, the optimal cutoff criteria classified a high number of controls as having pathological gait asymmetry. The general criterion of 10% is valid with high total classification ability, does not classify asymmetry in able-bodied subjects as pathological, and is feasible for use on individual patients in the clinic as well as in research.

Changes in gait symmetry, gait velocity and self-reported function following total hip replacement.

OBJECTIVE: To investigate the magnitude of change at different time points in measures of gait symmetry, gait velocity and self-reported function following total hip replacement. DESIGN: Longitudinal with test occasions pre-surgery and 3, 6 and 12 months post-surgery. SUBJECTS: Thirty-four patients with hip osteoarthritis (mean age 63 years, standard deviation 11 years). METHODS: Subjects walked back and forth along a 7-m walkway at slow, preferred and fast speed. Anteroposterior, vertical and mediolateral trunk symmetry was assessed by accelerometry, while single support symmetry, step-length symmetry and gait velocity was simultaneously assessed by an electronic walkway. Self-reported function was assessed by Hip disability and Osteoarthritis Outcome Score. Gait symmetry data were normalized for gait velocity. Changes between test occasions were reported as effect size. RESULTS: All measures showed effect sizes > 0.30 from pre-operative to 12-months postoperative assessments, and improvements were significant (p < 0.05) in all measures, except mediolateral symmetry. In general, gait symmetry and gait velocity improved most 6 and 12 months postoperatively, while self-reported function improved most 3 months postoperatively. CONCLUSION: Early improvements were seen in self-reported function, suggesting immediate relief from stiffness and pain, while gait symmetry and velocity improved later postoperatively, suggesting that gait quality and performance require prolonged rehabilitation with postoperative guidance, muscular strengthening and motor relearning.