Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial.

Importance: Moderate-grade adolescent idiopathic scoliosis (AIS) may be treated with full-time bracing. For patients who reject full-time bracing, the effects of alternative, conservative interventions are unknown. Objective: To determine whether self-mediated physical activity combined with either nighttime bracing (NB) or scoliosis-specific exercise (SSE) is superior to a control of physical activity alone (PA) in preventing Cobb angle progression in moderate-grade AIS. Design, Setting, and Participants: The Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) randomized clinical trial was conducted from January 10, 2013, through October 23, 2018, in 6 public hospitals across Sweden. Male and female children and adolescents aged 9 to 17 years with an AIS primary curve Cobb angle of 25° to 40°, apex T7 or caudal, and skeletal immaturity based on estimated remaining growth of at least 1 year were included in the study. Dates of analysis were from October 25, 2021, to January 28, 2023. Interventions: Interventions included self-mediated physical activity in combination with either NB or SSE or PA (control). Patients with treatment failure were given the option to transition to a full-time brace until skeletal maturity. Main Outcomes and Measures: The primary outcome was curve progression of 6° or less (treatment success) or curve progression of more than 6° (treatment failure) seen on 2 consecutive posteroanterior standing radiographs compared with the inclusion radiograph before skeletal maturity. A secondary outcome of curve progression was the number of patients undergoing surgery up until 2 years after the primary outcome. Results: The CONTRAIS study included 135 patients (45 in each of the 3 groups) with a mean (SD) age of 12.7 (1.4) years; 111 (82%) were female. Treatment success was seen in 34 of 45 patients (76%) in the NB group and in 24 of 45 patients (53%) in the PA group (odds ratio [OR], 2.7; 95% CI, 1.1-6.6). The number needed to treat to prevent curve progression with NB was 4.5 (95% CI, 2.4-33.5). Treatment success occurred in 26 of 45 patients (58%) in the SSE group (OR for SE vs PA, 1.2; 95% CI, 0.5-2.8). Up to 2 years after the primary outcome time point, 9 patients in each of the 3 groups underwent surgery. Conclusions and Relevance: In this randomized clinical trial, treatment with NB prevented curve progression of more than 6° to a significantly higher extent than did PA, while SSE did not; in addition, allowing transition to full-time bracing after treatment failure resulted in similar surgical frequencies independent of initial treatment. These results suggest that NB may be an effective alternative intervention in patients rejecting full-time bracing. Trial Registration: ClinicalTrials.gov Identifier: NCT01761305.

Physiotherapists' experiences of implementation of the BetterBack model of care for low back pain in primary care - a focus group interview study.

INTRODUCTION: The BetterBack model of care (MoC), a best practice physiotherapy MoC for low back pain (LBP), was implemented in Swedish primary care to improve management of patients with LBP and provide patients with support tools to better self-manage episodes of LBP. PURPOSE: The objective was to describe how physiotherapists in primary care experienced the implementation of the BetterBack MoC for LBP. METHODS: Focus group interviews were conducted with physiotherapists in 2018-2019, 14-18 months after the introduction of the BetterBack MoC. Data were analyzed using qualitative content analysis. RESULTS: Five focus group interviews with 23 (15 female and 8 male) physiotherapists, age range 24-61 years were analyzed. A supportive organization and adaptation to the local culture, combined with health care professionals' attitudes and collaboration between physiotherapists emerged as important factors for a successful implementation and for long-term sustainability of the MoC. Physiotherapists had differing opinions if the implementation led to change in clinical practice. Improved confidence in how to manage patients with LBP was expressed by physiotherapists. CONCLUSIONS: Several barriers and facilitators influence the implementation of a best practice physiotherapy MoC for LBP in primary care, which need to be considered in future implementation and sustainability processes.

The effect of neck-specific exercise and prescribed physical activity on headache and dizziness in individuals with cervical radiculopathy: Further analyses of a randomized study with a 1-year follow-up.

OBJECTIVE: To evaluate the effect of neck-specific exercise (NSE) compared to prescribed physical activity (PPA) on headache and dizziness in individuals with cervical radiculopathy (CR). Also, to investigate associations between headache or dizziness and pain, neck muscle endurance (NME), neck mobility, physical activity, and fear avoidance beliefs. METHODS: Individuals randomized to either NSE or PPA were selected to a headache subgroup (n = 59) and/or a dizziness subgroup (n = 73). Data were evaluated, according to headache and/or dizziness outcomes at baseline and at 3, 6, and 12-month follow-ups. RESULTS: No significant between-group differences were found between NSE and PPA in either subgroup. In the headache subgroup, significant within-group improvements were seen at all follow-ups for NSE (p < .001) and from baseline to 3 (p = .037) and 12 (p = .003) months for PPA. For dizziness, significant within-group improvements were seen from baseline to 3 months for NSE (p = .021) and from baseline to 3 (p = .001) and 6 (p = .044) months for PPA. Multiple regression models showed significant associations at baseline between headache intensity and neck pain (adjusted R-square = 0.35, p < .001), and for dizziness with neck pain and dorsal NME (adjusted R-square = 0.34, p < .001). CONCLUSION: NSE and PPA show similar improvements in headache intensity and dizziness in individuals with CR. Headache intensity is associated with neck pain, and dizziness with neck pain and dorsal NME, highlighting the importance of these factors when evaluating headache and dizziness.

Correction: Dufvenberg et al. Six-Month Results on Treatment Adherence, Physical Activity, Spinal Appearance, Spinal Deformity, and Quality of Life in an Ongoing Randomised Trial on Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS). J. Clin. Med. 2021, 10, 4967.

In the original publication [...].

Measuring the determinants of implementation behavior in multiprofessional rehabilitation.

BACKGROUND: The Determinants of Implementation Behavior Questionnaire (DIBQ) measures facilitators or barriers of healthcare professionals' implementation behaviors based on the current implementation research on practice and policy. The DIBQ covers 18 domains of the Theoretical Domains Framework and consists of 93 items. A previously tailored version (DIBQ-t) covering 10 domains and 28 items focuses on implementing best-practice low back pain care. AIM: To tailor a shortened version of DIBQ to multiprofessional rehabilitation context with cross-cultural adaptation to Finnish language. DESIGN: A two-round Delphi study. SETTING: National-level online survey. POPULATION: Purposively recruited experts in multiprofessional rehabilitation (N.=25). METHODS: Cross-cultural translation of DIBQ to Finnish was followed by a two-round Delphi survey involving diverse experts in rehabilitation (physicians, physiotherapists, occupational therapists, psychologists, nursing scientists, social scientists). In total, 25 experts in Round 1, and 21 in Round 2 evaluated the importance of DIBQ items in changing professionals' implementation behavior by rating on a 5-point Likert Scale (1 = Strongly Disagree, 5 = Strongly Agree) of including each item in the final scale. Consensus to include an item was defined as a mean score of ≥4 by ≥75% of Delphi participants. Open comments were analyzed using inductive content analysis. Items with agreement of ≤74% were either directly excluded or reconsidered and modified depending on qualitative judgements, amended with experts' suggestions. After completing an analogous second-round, a comparison with DIBQ-t was performed. Lastly, the relevance of each item was indexed using content validity index on item-level (I-CVI) and scale-level (S-CVI/Ave). RESULTS: After Round 1, 17 items were included and 48 excluded by consensus whereas 28 items were reconsidered, and 20 items added for Round 2. The open comments were categorized as: 1) "modifying"; 2) "supportive"; and 3) "critical". After Round 2, consensus was reached regarding all items, to include 21 items. After comparison with DIBQ-t, the final multiprofessional DIBQ (DIBQ-mp) covers 11 TDF domains and 21 items with I-CVIs of ≥0.78 and S-CVI/Ave of 0.93. CONCLUSIONS: A Delphi study condensed a DIBQ-mp with excellent content validity for multiprofessional rehabilitation context. CLINICAL REHABILITATION IMPACT: A potential tool for evaluating determinants in implementing evidence-based multiprofessional rehabilitation interventions.

PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): A protocol for a randomized controlled trial comparing scoliosis-specific exercises with observation in mild idiopathic scoliosis.

BACKGROUND: Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Mild scoliosis is in many cases observed or, in some cases, treated with scoliosis-specific exercises. More severe curves are treated mainly with a brace. The aim of this study is to investigate the effectiveness of scoliosis-specific exercises compared to observation in adolescents with mild idiopathic scoliosis. METHODS: Subjects. Previously untreated and skeletally immature children aged 9-15 years of age with idiopathic scoliosis (curve magnitude Cobb 15-24 degrees) will be included. A total of 90 subjects will be included to receive one of two possible interventions. Interventions. Both groups will receive a physical activity prescription according to the World Health Organization recommendations. The intervention group will receive an additional active self-correction treatment strategy for curve correction and will have outpatient sessions once every two weeks for the first three months. They will be prescribed to do the exercises at least three times per week. The intervention will be performed until skeletal maturity or progression of the curve. Outcome. The subjects will participate in the study until curve progression or until skeletal maturity (defined as less than 1 cm growth for six months). The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees on two consecutive x-rays compared to the baseline x-ray. Secondary outcome measures include patient-reported outcomes, clinical characteristics (i.e. angle of trunk rotation and trunk asymmetry) and number requiring brace treatment. Clinical follow-ups will be performed every six months and radiographs will be taken annually. DISCUSSION: This study will compare effectiveness of an active self-corrective exercise strategy in mild idiopathic scoliosis with observation in terms of halting curve progression.

Are illness perceptions and patient self-care enablement mediators of treatment effect in best practice physiotherapy low back pain care? Secondary mediation analyses in the BetterBack trial.

INTRODUCTION: A best practice physiotherapy model of care (BetterBack MoC) for low back pain (LBP) aimed to improve patients' illness perceptions and self-care enablement, according to the Common-Sense Model of Self-Regulation (CSM). OBJECTIVE: To confirm if illness perceptions and patient self-care enablement, in line with the CSM, are mediators of treatment effects on disability and pain of the BetterBack MoC for patients with LBP compared to routine primary care. A secondary aim was to explore if illness perceptions and patient self-care enablement are mediators of guideline adherent care. METHODS: Pre-planned single mediation analyses tested whether hypothesized mediators at 3 months mediated the treatment effect of the MoC (n = 264) compared to routine care (n = 203) on disability and pain at 6 months. Secondary mediation analyses compared guideline adherent care with non-adherent care. RESULTS: No indirect effects were identified. The BetterBack intervention did not have superior effects over routine care on the hypothesized mediators. Illness perceptions and self-care enablement were significantly associated with disability and pain at 6 months. Secondary analyses showed significant indirect effects of guideline adherent care through tested mediators. CONCLUSION: Despite no indirect effects, patients' illness perceptions and self-care enablement were associated with disability and back pain intensity outcomes and are potentially relevant treatment targets.

Improved adherence to clinical guidelines for low back pain after implementation of the BetterBack model of care: A stepped cluster randomized controlled trial within a hybrid type 2 trial.

BACKGROUND: The BetterBack model of care (MoC) for low back pain (LBP) was recently developed in Swedish physiotherapy (PT) primary care. OBJECTIVE: To evaluate if PTs' adherence to LBP clinical practice guidelines (CPGs) improves after implementation of the BetterBack MoC (intervention). METHODS: This was a stepped, single-blinded cluster randomized controlled trial. Patients nested in the three clusters were allocated to routine care (n = 222) or intervention (n = 278). The primary outcome was referral to specialist consultation. This was among five best practice recommendations divided into an assessment quality index (no referral to specialist consultation and no medical imaging) and a treatment quality index (use of educational interventions; use of exercise interventions; no use of non-evidence-based physiotherapy). For overall adherence, patients had to be treated with all five recommendations fulfilled. Logistic regression was used for between-group comparisons. RESULTS: The proportion of patients receiving referral to specialist consultation during the PT treatment period was low in both groups with no between-group differences. However, patients in the intervention group showed significantly higher assessment quality index, treatment quality index and overall adherence compared to routine care. Adherence to the separate recommendations showed improved stratified number of visits, use of exercise was maintained high, patient educational intervention increased and use of non-evidence-based physiotherapy decreased. A reduction of medical imaging during the physiotherapy treatment period was also observed. CONCLUSIONS: The adoption of CPGs could be substantially improved by introducing a MoC through PT training and supportive materials.

Learning from the past to plan for the future: A scoping review of musculoskeletal clinical research in Sweden 2010-2020.

Background: The aims of this study are to 1) determine the scope of musculoskeletal (MSK)-related clinical research in Sweden; 2) collate the amount of first-tier funding received; 3) discuss strategies and infrastructure supporting future MSK clinical trials in Sweden. Methods: A systematic scoping review protocol was applied in PubMed, Scopus, and SweCRIS databases. The articles were examined, and data were extracted in multiple stages by three blinded authors. Results: The search strategy resulted in 3,025 publications from 479 Swedish-affiliated authors. Primary health care was the basis for 14% of the publications, 84% from secondary health care, and 2% from occupational health care with a similar proportional distribution of first-tier research grant financing. Approximately one in six publications were randomized controlled trials (RCTs), while the majority were of observational cohort design. The majority of publications in primary and occupational health care were related to pain disorders (51 and 67%, respectively), especially diagnosis, prognosis, and healthcare organizational-related interventions (34%) and rehabilitation (15%) with similar proportional distribution of first-tier research grant financing. In secondary health care, rheumatic inflammatory disorder-related publications were most prevalent (30%), most frequently concerning diagnosis, prognosis, and healthcare organizational-related interventions (20%), attracting approximately half of all first-tier funding. Publications related to degenerative joint disorders (25%), fractures (16%), and joint, tendon, and muscle injuries (13%) frequently concerned surgical and other orthopedic-related interventions (16, 6, and 8%, respectively). Pain disorder-related publications (10%) as well as bone health and osteoporosis-related publications (4%) most frequently concerned diagnosis, prognosis, and healthcare organizational-related interventions (5 and 3%, respectively). Conclusions: Swedish-affiliated MSK disorder research 2010-2020 was predominantly observational cohort rather than RCT based. There was skewed first-tier funding allocation considering prevalence/incidence and burden of disease. Use of infrastructure supporting register-based RCTs, placebo-controlled RCTs, and hybrid effectiveness-implementation studies on prevention and clinical intervention is important strategies for the future in all healthcare sectors.

Digitally Delivered Exercise and Education Treatment Program for Low Back Pain: Longitudinal Observational Cohort Study.

BACKGROUND: Exercise and education is recommended as first-line treatment by evidence-based, international guidelines for low back pain (LBP). Despite consensus regarding the treatment, there is a gap between guidelines and what is offered to patients. Digital LBP treatments are an emerging way of delivering first-line treatment. OBJECTIVE: The aim of this study is to evaluate outcomes after participation in a 3-month digitally delivered treatment program for individuals with subacute or chronic LBP. METHODS: We analyzed data from 2593 consecutively recruited participants in a digitally delivered treatment program, available via the national health care system in Sweden. The program consists of video-instructed and progressive adaptable exercises, education through text lessons, and a chat and video function connecting participants with a personal physiotherapist. The primary outcome was mean change and proportion reaching a minimal clinically important change (MCIC) for LBP (2 points or 30% decrease) assessed with the numerical rating scale (average pain during the past week, discrete boxes, 0-10, best to worst). Secondary outcomes were mean change and proportion reaching MCIC (10 points or 30%) in disability, assessed with the Oswestry Disability Index (ODI; 0-100, best to worst) and a question on patient acceptable symptom state (PASS). RESULTS: The mean participant age was 63 years, 73.85% (1915/2593) were female, 54.72% (1419/2593) had higher education, 50.56% (1311/2593) were retired, and the mean BMI was 26.5 kg/m2. Participants completed on average 84% of the prescribed exercises and lessons, with an adherence of ≥80% in 69.26% (1796/2593) and ≥90% in 50.13% (1300/2593) of the participants. Mean reduction in pain from baseline to 3 months was 1.7 (95% CI -1.8 to -1.6), corresponding to a 35% relative change. MCIC was reached by 58.50% (1517/2593) of participants. ODI decreased 4 points (95% CI -4.5 to -3.7), and 36.48% (946/2593) reached an MCIC. A change from no to yes in PASS was seen in 30.35% (787/2593) of participants. Multivariable analysis showed positive associations between reaching an MCIC in pain and high baseline pain (odds ratio [OR] 1.9, 95% CI 1.6-2.1), adherence (OR 1.5, 95% CI 1.3-1.8), and motivation (OR 1.2, 95% CI 1.0-1.5), while we found negative associations for wish for surgery (OR 0.6, 95% CI 0.5-0.9) and pain in other joints (OR 0.9, 95% CI 0.7-0.9). We found no associations between sociodemographic characteristics and pain reduction. CONCLUSIONS: Participants in this digitally delivered treatment for LBP had reduced pain at 3-month follow-up, and 58.50% (1517/2593) reported an MCIC in pain. Our findings suggest that digital treatment programs can reduce pain at clinically important levels for people with high adherence to treatment but that those with such severe LBP problems that they wish to undergo surgery may benefit from additional support. TRIAL REGISTRATION: ClinicalTrials.gov NCT05226156; https://clinicaltrials.gov/ct2/show/NCT05226156.

The association between patients' illness perceptions and longitudinal clinical outcome in patients with low back pain.

Introduction: Illness perception is suggested to influence outcome in patients with low back pain (LBP). It is unknown if specific illness perceptions are of more importance for longitudinal outcomes, including development of self-management strategies. Objectives: This study explores whether patients' initial illness perceptions were associated with disability, pain, health-related quality of life, and self-care enablement outcomes in patients with LBP after 3 and 12 months. Methods: Four hundred sixty-seven consecutive patients seeking physiotherapeutic primary care for LBP were eligible to participate in this prospective cohort study, providing data at baseline and after 3 and 12 months (mean age 45 years, 56% women). Multiple linear regression analysis was used to explore whether patients' illness perceptions at baseline were associated with outcome in the Oswestry Disability Index (ODI), Numeric Rating Scale-LBP (NRS-LBP), EuroQol Five Dimensions, and Patient Enablement Instrument (PEI). Results: Stronger beliefs that the back problem will last a long time at baseline were associated with worse outcome in ODI, NRS-LBP, and PEI at 3 and 12 months and in EuroQol Five Dimensions at 12 months. Negative beliefs regarding treatment's ability to improve LBP were associated with worse outcome in NRS-LBP and PEI at 3 and 12 months and in ODI at 12 months. Conclusions: Illness perceptions regarding prognosis and treatment's ability to improve symptoms were the most prominent perceptions explaining several longitudinal clinical outcomes. These expectations should be addressed in an early stage in the delivery of interventions for LBP. These expectations were also important for patients' development of coping and self-management strategies.

Analgesic prescriptions received by patients before commencing the BOA model of care for osteoarthritis: a Swedish national registry study with matched reference and clinical guideline benchmarking.

Background and purpose - Swedish clinical guidelines for osteoarthritis (OA) prioritize patient education, exercise, and-if necessary-weight reduction before considering adjunct pharmacological intervention. Contrariwise, we investigated the proportion and type of dispensed analgesic prescriptions in Sweden received by patients during 3 years before commencing non-pharmacological primary care interventions for OA (2008-2016) compared with the general population. Furthermore, we analyzed the proportion of analgesic prescriptions dispensed before (2008-2012) compared with after (2012-2016) guideline publication in terms of concordance with clinical guideline recommendations. Patients and methods - Patients with hip or knee OA (n = 72,069) from the Better Management of OA national quality register receiving non-pharmacological interventions in primary care between 2008 and 2016 were included (OA cohort). An age, sex, and residence matched reference cohort (n = 216,207) was formed from the Swedish Total Population Register. Based on a period 3 years prior to inclusion in the OA cohort, Swedish Prescribed Drug Register data was linked to both the OA and reference cohorts. Results - Compared with the reference cohort, a distinctly larger proportion of the OA cohort had dispensed prescriptions for most types of analgesics, increasing exponentially each year prior to commencing non-pharmacological intervention. Since guideline publication, the proportion of the OA cohort having no dispensed prescription analgesics prior to non-pharmacological primary care intervention concordantly increased by 5.0% (95% CI 4.2-5.9). Furthermore, dispensed prescriptions concordantly decreased for non-selective NSAIDs -8.6% (CI -9.6 to -7.6), weak opioids -6.8% (CI -7.7 to -5.9), glucosamine -9.5% (CI -9.8 to -8.8). and hyaluronic acid -1.6% (CI -1.8 to -1.5) but discordantly increased for strong opioids 2.8% (CI 2.1-3.4) and glucocorticoid intra-articular injection for hip OA 2.1% (CI 1.0-3.1). Interpretation - In Sweden, dispensed prescription of analgesics commonly occurred before initiating non-pharmacological primary care interventions for OA but reduced modestly after guideline publication, which prioritizes nonpharmacological before pharmacological interventions. Additional modest improvements occurred in the steppedcare prioritization of analgesic prescription types. However, future strategies are required to curb an increase of strong opioids prescription for OA and glucocorticoid intra-articular injection for hip OA.

Six-Month Results on Treatment Adherence, Physical Activity, Spinal Appearance, Spinal Deformity, and Quality of Life in an Ongoing Randomised Trial on Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS).

Adolescents with idiopathic scoliosis (AIS) often receive conservative treatments aiming to prevent progression of the spinal deformity during puberty. This study aimed to explore patient adherence and secondary outcomes during the first 6 months in an ongoing randomised controlled trial of three treatment interventions. Interventions consisted of physical activity combined with either hypercorrective Boston brace night shift (NB), scoliosis-specific exercise (SSE), or physical activity alone (PA). Measures at baseline and 6 months included angle of trunk rotation (ATR), Cobb angle, International Physical Activity Questionnaire short form (IPAQ-SF), pictorial Spinal Appearance Questionnaire (pSAQ), Scoliosis Research Society (SRS-22r), EuroQol 5-Dimensions Youth (EQ-5D-Y) and Visual Analogue Scale (EQ-VAS). Patient adherence, motivation, and capability in performing the intervention were reported at 6 months. The study included 135 patients (111 females) with AIS and >1-year estimated remaining growth, mean age 12.7 (1.4) years, and mean Cobb angle 31 (±5.3). At 6 months, the proportion of patients in the groups reporting high to very high adherence ranged between 72 and 95%, while motivation ranged between 65 and 92%, with the highest proportion seen in the NB group (p = 0.014, p= 0.002). IPAQ-SF displayed significant between group main effects regarding moderate activity (F = 5.7; p = 0.004; ηp2 = 0.10), with a medium-sized increase favouring the SSE group compared to NB. Walking showed significant between group main effects, as did metabolic equivalent (MET-min/week), with medium (F = 6.8, p = 0.002; ηp2 = 0.11, and large (F = 8.3, p = < 0.001, ηp2 = 0.14) increases, respectively, for the SSE and PA groups compared to NB. From baseline to 6 months, ATR showed significant between group medium-sized main effects (F = 1.2, p = 0.019, ηp2 = 0.007) favouring the NB group compared to PA, but not reaching a clinically relevant level. In conclusion, patients reported high adherence and motivation to treatment, especially in the NB group. Patients in the SSE and PA groups increased their physical activity levels without other clinically relevant differences between groups in other clinical measures or patient-reported outcomes. The results suggest that the prescribed treatments are viable first-step options during the first 6 months.

PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace.

INTRODUCTION: Idiopathic scoliosis is the most common spinal deformity in children. Treatment strategies aim to halt progression of the curve. Patients are treated mainly with thoracolumbosacral orthosis (TLSO) if indicated. This form of brace treatment has been shown to be cumbersome and tough on growing individuals. However, computer aided design and manufactured (CAD/CAM) braces might increase comfortability and ultimately outcome if compliance is improved. In a multicenter, randomized controlled trial, we aim to compare CAD/CAM designed Boston 3D-brace to standard Boston brace. METHODS: Subjects: 170 previously untreated and skeletally immature children diagnosed with idiopathic scoliosis, aged 9-17 years of age (curve magnitude Cobb 25-40 degrees) will be included. Interventions: Both groups will receive a physical activity prescription according to the World Health Organization recommendations. Randomization will be performed 1:1 to a 3D CAD/CAM designed Boston 3D-brace or a standard Boston brace, both with prescribed daily wear time of 20 hours. Outcome: The subjects will participate in the study until curve progression or until skeletal maturity. The primary outcome variable is failure of treatment, defined as progression of the Cobb angle more than 6 degrees compared to the baseline x-ray. The progression is confirmed if seen on two consecutive standing spinal x-rays. Radiographs will be taken at each six-month follow-up. Secondary outcome measures include patient and clinical reported outcomes, including number of individuals requiring surgical intervention. DISCUSSION: This study will show if efficacy in brace treatment can be improved with new brace designs. TRIAL REGISTRATION: The protocol has been registered on ClinicalTrials.gov, identifier: NCT04805437.

[Swedish osteoarthritis treatment at the forefront]. / Svensk artrosbehandling är i framkant men underutnyttjad.

Osteoarthritis (OA) is a highly prevalent group of disorders and among the most common causes of chronic pain and disability globally. First-line evidence-based treatments for hip and knee OA, two of the most common variants, are available in Sweden with the potential for wide national reach through face-to-face and digital platforms. Research results suggest important reductions in symptoms in patients with knee or hip OA. Despite evidence, availability and low cost, first-line evidence-based treatments are not utilized to the full extent to reduce the burden of OA.

Adapting the determinants of implementation behavior questionnaire to evaluate implementation of a structured low back pain programme using mixed-methods.

BACKGROUND AND AIMS: Best-practice low back pain (LBP) primary care programmes have been developed based on evidence-based clinical guidelines and implemented in Sweden and Denmark. The theoretical domains framework (TDF) was utilized in the design of the implementation strategy. Based on the TDF domains, the Determinants of Implementation Behavior Questionnaire (DIBQ) has been developed to evaluate implementation determinants, but its feasibility and validity need to be tested and adapted to study specific contexts. This study aimed to tailor the DIBQ for evaluation of implementation for LBP primary care programmes. The objectives were to (a) translate the DIBQ into Swedish and Danish, (b) adapt the DIBQ into DIBQ-tailored (DIBQ-t) to study content validity, (c) test the DIBQ-t for feasibility, and (d) perform validity testing of DIBQ-t. METHODS: We used a mixed-methods design. First, forward translation of the DIBQ, then adaptation into DIBQ-t using qualitative face validity and quantitative content validity was done. Finally, to determine feasibility and construct validity using confirmatory factor analyses, we used data from DIBQ-t collected after the programmes' 2-day course. RESULTS: The final DIBQ-t included 28 items describing 10 of the original 18 DIBQ domains and was considered feasible. A total of 598 clinicians out of 609 responded to the DIBQ-t, with only 2‰ of the items missing. The confirmatory factor analyses showed a good fit after removing two items with the lowest domain loading. The DIBQ-t maintained linkage to all domains within the Behavioral Change Wheel. The clinicians' expectations, according to the DIBQ-t, indicate facilitating determinants outweighing barriers at the initiation of implementation processes. CONCLUSIONS: The study resulted in a feasible and valid version of a questionnaire for evaluating clinicians' expectations regarding implementation determinants of best-practice LBP primary care programmes.

Effectiveness and Quality of Implementing a Best Practice Model of Care for Low Back Pain (BetterBack) Compared with Routine Care in Physiotherapy: A Hybrid Type 2 Trial.

Low back pain (LBP) occurs in all ages and first-line treatment by physiotherapists is common. The main aim of the current study was to evaluate the effectiveness of implementing a best practice model of care for LBP (intervention group-BetterBack☺ MoC) compared to routine physiotherapy care (control group) regarding longitudinal patient reported outcomes. The BetterBack☺ MoC contains clinical guideline recommendations and support tools to facilitate clinician adherence to guidelines. A secondary exploratory aim was to compare patient outcomes based on the fidelity of fulfilling a clinical practice quality index regarding physiotherapist care. A stepped cluster randomized design nested patients with LBP in the three clusters which were allocated to control (n = 203) or intervention (n = 264). Patient reported measures were collected at baseline, 3, 6 and 12 months and analyzed with mixed model regression. The primary outcome was between-group changes from baseline to 3 months for pain intensity and disability. Implementation of the BetterBack☺ MoC did not show any between-group differences in the primary outcomes compared with routine care. However, the intervention group showed significantly higher satisfaction at 3 months and clinically meaningful greater improvement in LBP illness perception at 3 months and quality of life at 3 and 6 months but not in patient enablement and global impression of change compared with the control group. Physiotherapists' care that adhered to all clinical practice quality indices resulted in an improvement of most patient reported outcomes with a clinically meaningful greater improved LBP illness perception at 3 months and quality of life at 3 and 6 months, significantly greater improvement in LBP illness perception, pain and satisfaction at 3 and 6 months and significantly better enablement at all time points as well as better global improvement outcomes at 3 months compared with non-adherent care. This highlights the importance of clinical guideline based primary care for improving patient reported LBP outcomes.

Evaluation of training in guideline-oriented biopsychosocial management of low back pain in occupational health services: Protocol of a cluster randomized trial.

BACKGROUND: To prevent low back pain (LBP) from developing into a prolonged disabling condition, clinical guidelines advocate early stage assessment, risk-screening, and tailored interventions. Occupational health services recommend guideline-oriented biopsychosocial screening and individualized assessment and management. However, it is not known whether training a limited number of health care professionals improves the management process. The primary objective of this study is to investigate whether training in the biopsychosocial practice model is effective in reducing disability. Furthermore, we aim to evaluate health-economic impacts of the training intervention in comparison to usual medical care. METHODS: The occupational health service units will be allocated into a training or control arm in a two-arm cluster randomized controlled design. The training of occupational physiotherapists and physicians will include the assessment of pain-related psychosocial factors using the STarT Back Tool and the short version of the Örebro Musculoskeletal Pain Screening Questionnaire, the use of an evidence-based patient education booklet as part of the management of LBP, and tailored individualized management of LBP according to risk stratification. The control units will receive no training. The study population will include patients aged 18-65 with nonspecific LBP. The primary outcome is a patient-reported Oswestry Disability Index from baseline to 12 months. By estimating group differences over time, we aim to evaluate the effectiveness of the training intervention in comparison to usual medical care, and to undertake an economic evaluation using individual patients' health care records (participant-level data) and the participating units' registries (cluster-level data). In addition, through interviews and questionnaires, we will explore the health care professionals' conceptions of the adoption of, the barriers to, and the facilitators of the implementation of the practice model. DISCUSSION: The evaluation of training in the guideline-oriented biopsychosocial management of LBP in occupational health services is justified because LBP represents an enormous burden in terms of work disability.

Patients' experiences of the BetterBack model of care for low back pain in primary care - a qualitative interview study.

Purpose: The aim of this study was to describe patient experiences of received primary care for low back pain (LBP) according to the BetterBack Model of Care (MoC) with a focus on illness beliefs and self-management enablement. Methods: Individual interviews were conducted with 15 adults 4-14 months after receiving treatment according to the BetterBack MoC for LBP in primary care in Sweden. Data were analysed using content analysis. Results: When analysing the data, the following theme emerged; "Participant understanding of their treatment for low back pain and self-management strategies-a matter of support systems", comprising the following categories: "Knowledge translation", "Interaction and dialogue", "The health care professional support" and "Form organization". Participants experienced that they had better knowledge about their LBP and received tools to better manage their health condition. The participants expressed good communication with the treating physiotherapist and provided suggestions to further improve the treatment of LBP. Conclusions: Participants experienced that they had gained new knowledge about their health problems and after the treatment they had the tools to handle their back problems. This suggests that the BetterBack MoC may be used as a basis for a support system to provide valuable tools for self-management for patients with low back pain.

What Mediates Treatment Effects in a Presurgery Physiotherapy Treatment in Surgical Candidates With Degenerative Lumbar Spine Disorders? A Mediation and Conditional Process Analysis of the PREPARE Randomized Controlled Trial.

OBJECTIVES: Treatment guidelines recommend targeting both physical and psychological factors in interventions for degenerative lumbar spine disorders. Studying the treatment mechanisms gives information on key factors explaining the outcome improvement that can refine treatments. This study explores treatment mediators in a physiotherapy treatment on disability, pain intensity, and health-related quality of life in surgical candidates with degenerative lumbar spine disorders compared with waiting-list controls. An additional aim was to evaluate patients' expectation as a moderator of treatment outcome. MATERIALS AND METHODS: Data collected from 197 patients in a single-blinded randomized controlled trial comparing 9 weeks of multifaceted physiotherapy with waiting-list controls were used in this conditional process analysis. Analysis was carried out on group differences for change in Oswestry Disability Index, Pain Visual Analog Scale (VAS) back pain, EuroQol-5D, and EuroQol-VAS. The putative moderation role of expectations and mediation role of change in physical variables and psychosocial variables were tested. RESULTS: Change in self-efficacy mediated improvement in all outcomes. Improvement in Oswestry Disability Index was also mediated by change in depression; VAS was mediated by change in fear-avoidance beliefs; and EuroQol-VAS was mediated by change in activity level and fear avoidance beliefs. Improvements were moderated by patients' treatment expectations. DISCUSSION: Self-efficacy, fear-avoidance beliefs, physical activity level, and patients' treatment expectations were found to be important factors explaining treatment effects. Self-efficacy was the consistent mediator for effects of the presurgical physiotherapy on disability, back pain intensity, and health-related quality of life.