Group‑delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia in primary care: study protocol for a pragmatic, multicentre randomized controlled trial

Background Insomnia is common in the general population and is a risk factor for ill-health, which highlights the importance of treating insomnia effectively and cost-efficiently. Cognitive-behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment due to its long-term effectiveness and few side-effects, but its availability is limited. The aim of this pragmatic, multicentre randomized controlled trial is to investigate the effectiveness of group-delivered CBT-I in primary care compared to a waiting-list control group. Methods A pragmatic multicentre randomized controlled trial will be conducted with about 300 participants recruited across 26 Healthy Life Centres in Norway. Participants will complete online screening and provide consent before enrolment. Those who meet the eligibility criteria will be randomized to a group-delivered CBT-I or to a waiting list according to a 2:1 ratio. The intervention consists of four two-hour sessions. Assessments will be performed at baseline, 4 weeks, 3- and 6 months post-intervention, respectively. The primary outcome is self-reported insomnia severity at 3 months post-intervention. Secondary outcomes include health-related quality of life, fatigue, mental distress, dysfunctional beliefs and attitudes about sleep, sleep reactivity, 7-day sleep diaries, and data obtained from national health registries (sick leave, use of relevant prescribed medications, healthcare utilization). Exploratory analyses will identify factors influencing treatment effectiveness, and we will conduct a mixed-method process evaluation to identify facilitators and barriers of participants’ treatment adherence. The study protocol was approved by the Regional Committee for Medical and Health Research ethics in Mid-Norway (ID 465241). Discussion This large-scale pragmatic trial will investigate the effectiveness of group-delivered cognitive behavioural therapy versus waiting list in the treatment of insomnia, generating findings that are generalizable to day-to-day treatment of insomnia in interdisciplinary primary care services. The trial will identify those who would benefit from the group-delivered therapy, and will investigate the rates of sick leave, medication use, and healthcare utilization among adults who undergo the group-delivered therapy.publishedVersio

SupportPrim—a computerized clinical decision support system for stratified care for patients with musculoskeletal pain complaints in general practice: study protocol for a randomized controlled trial

BackgroundMusculoskeletal disorders represented 149 million years lived with disability world-wide in 2019 and are the main cause of years lived with disability worldwide. Current treatment recommendations are based on “one-size fits all” principle, which does not take into account the large degree of biopsychosocial heterogeneity in this group of patients. To compensate for this, we developed a stratified care computerized clinical decision support system for general practice based on patient biopsychosocial phenotypes; furthermore, we added personalized treatment recommendations based on specific patient factors to the system. In this study protocol, we describe the randomized controlled trial for evaluating the effectiveness of computerized clinical decision support system for stratified care for patients with common musculoskeletal pain complaints in general practice. The aim of this study is to test the effect of a computerized clinical decision support system for stratified care in general practice on subjective patient outcome variables compared to current care.MethodsWe will perform a cluster-randomized controlled trial with 44 general practitioners including 748 patients seeking their general practitioner due to pain in the neck, back, shoulder, hip, knee, or multisite. The intervention group will use the computerized clinical decision support system, while the control group will provide current care for their patients. The primary outcomes assessed at 3 months are global perceived effect and clinically important improvement in function measured by the Patient-Specific Function Scale (PSFS), while secondary outcomes include change in pain intensity measured by the Numeric Rating Scale (0–10), health-related quality of life (EQ-5D), general musculoskeletal health (MSK-HQ), number of treatments, use of painkillers, sick-leave grading and duration, referral to secondary care, and use of imaging.DiscussionThe use of biopsychosocial profile to stratify patients and implement it in a computerized clinical decision support system for general practitioners is a novel method of providing decision support for this patient group. The study aim to recruit patients from May 2022 to March 2023, and the first results from the study will be available late 2023.Trial registrationThe trial is registered in ISRCTN 11th of May 2022: 14,067,965

Motion, Motor Control and Psychological Factors in Neck Pain

Bevegelse, motorisk kontroll og psykologiske faktorer ved nakkesmerte Sammendrag Hovedformålet med denne avhandlingen var å undersøke bevegelse og motorisk kontroll hos pasienter med nakkesmerte og om dette hadde sammenheng med faktorer som smerte, funksjon, frykt for bevegelse og selvopplevd bedring gjennom et behandlingsforløp. Nakkesmerte er globalt rangert som den fjerde viktigste årsaken for redusert funksjon. Effekten av ulike behandlinger er moderat med liten forskjell mellom ulike behandlingsmetoder. Pasienter med nakkesmerte utgjør ei heterogen gruppe, der årsaken til nakkesmerte oftest er ukjent. Tidligere studier viser at pasienter med nakkesmerte kan ha dårligere bevegelse og motorisk kontroll i nakken, men vi vet lite om hvorvidt dette har betydning for om de blir bedre eller ikke av behandling, eller om det er andre faktorer som virker inn. Noen studier har vist at tanker knyttet til frykt for bevegelse, katastrofetenkning og mestringstro kan virke inn på bevegelse av nakke/hodet, og om man blir bedre etter endt behandling. Men ingen studier har sett på forholdet mellom disse faktorene samlet gjennom et behandlingsforløp. Vi målte ulike aspekter av bevegelse og motorisk kontroll hos pasienter med uspesifikke nakkesmerter før oppstart av fysioterapibehandling, og etter 2 uker og 2 måneder. I tillegg brukte vi spørreskjema for å kartlegge smerte, funksjon, oppfatninger og tanker knyttet til frykt for bevegelse og mestringstro. Studie 1 og 2 viste at pasienter er preget av en generelt stivere bevegelse og kontroll av nakke sammenlignet med personer uten nakkesmerte. Studie 2 viste også at det stivere bevegelsesmønsteret befinner seg innenfor det man kan anta er styrt av viljemessige prosesser og ikke refleksstyrte. Frykt for bevegelse hadde liten eller ingen sammenheng med bevegelse av nakken i disse studiene. I løpet av 2 måneder med behandling fant vi kun små endringer på bevegelse og motorisk kontroll hos pasientene (studie 3). Økt bevegelsesutslag i nakken og forbedret finmotorisk kontroll viste seg å ha størst sammenheng med redusert smerte og forbedret funksjon. De samme aspektene av bevegelse og motorisk kontroll, i tillegg til smerteintensitet/-varighet og funksjon, predikerte pasientenes globale oppfatning av bedring etter 2 måneder. Oppfatninger og tanker ved oppstart av behandling, slik som frykt for bevegelse, katastrofetanker og mestringstro kunne ikke predikere bedring ved 2 måneder. Redusert frykt for bevegelse og katastrofetanker og økt mestringstro hadde derimot sammenheng med pasientenes opplevelse av global bedring, i tillegg til redusert smerte og økt funksjon (studie 4)

Rigid head-neck responses to unpredictable perturbations in patients with long standing neck pain does not change with treatment.

In a previous study we have shown that patients with long standing non-specific neck-pain display more rigid neck movement behavior than controls in response to unpredictable perturbations. In the present study we investigated head/neck motor control in patients with neck-pain during a course of physiotherapy intervention and the associations with pain, neck disability and kinesiophobia. In this longitudinal observational study, 72 patients with non-specific neck-pain were exposed to unpredictable horizontal rotations by means of an actuated chair in three conditions; with a visual reference, and without vision with and without a cognitive task before first consultation with physiotherapist, after 2 weeks and 2 months of intervention. The neck movements were analyzed in the frequency domain to cover voluntarily and reflex controlled responses. Questionnaires encompassed Neck Disability Index, Tampa Scale of Kinesiophobia, and the Numerical Rating Scale for current pain. The results showed that the response pattern for the amplitudes of movement between head and trunk across frequencies did not change over time, whereas some changes in timing were found for some frequencies. Pain, neck disability, and kinesiophobia improved after intervention, but were not significantly associated with neck movement responses to perturbations across time or condition. Although physiotherapy intervention improved self-reported function, the rigid responses to unpredictable perturbations remained unchanged. This indicates altered function in reflex mediated control mechanisms, i.e., the vestibulocollic and the cervicocollic reflex systems that control the head in space and on the trunk. Future research should further investigate pain related changes in reflex systems and whether alterations in these systems are modifiable

Associations between treatment goals, patient characteristics, and outcome measures for patients with musculoskeletal disorders in physiotherapy practice

Background Goal setting is linked to person-centred care and is a core component in physiotherapy, but the associations between goal classes, patient characteristics and outcome measures for musculoskeletal disorders has not been investigated. The study’s purpose was to examine 1) how goals used in clinical practice for patients with musculoskeletal disorders (MSD) are distributed in classes based on ICF, 2) if goal classes were associated with patient characteristics and 3) whether goal classes were associated with treatment outcome. Methods Data analysis from a longitudinal observational study (N = 2591). Goals were classified in symptom, function/structure, activity/participation and non-classifiable. Associations between patient characteristics and goal classes were examined using x2 and one-way ANOVA. Association between goal classes and outcomes were examined using multiple logistic and linear regression models. Outcomes are reported at 3 months or end of treatment if prior to 3 months. Results There was a high variability in goals used for patients with MSD. 17% had symptom goals, 32.3% function/structure, 43.4% activity/participation and 7.4% non-classifiable goals. We found significant associations between goal classes and age, gender, severity, region of pain/diagnosis and emotional distress (all p < .001). Activity/participation goals were associated with better outcomes on GPE (OR 1.80, 95% CI 1.23–2.66). Non-classifiable goal was associated with poorer outcomes on pain intensity (B .87, 95% CI .32–1.43). Conclusion There is an association between goal classes and patient characteristics. Including activity/participation in the main goal was associated with better outcomes for GPE and having a non-classifiable goal was associated with poorer outcomes for pain intensity. Trial registration The project is approved by the Regional committee for Medical and Health Research Ethics in Norway (REC no. 2013/2030). https://clinicaltrials.gov/ct2/show/NCT03626389

Associations between treatment goals, patient characteristics, and outcome measures for patients with musculoskeletal disorders in physiotherapy practice

Sammendrag Background Goal setting is linked to person-centred care and is a core component in physiotherapy, but the associations between goal classes, patient characteristics and outcome measures for musculoskeletal disorders has not been investigated. The study’s purpose was to examine 1) how goals used in clinical practice for patients with musculoskeletal disorders (MSD) are distributed in classes based on ICF, 2) if goal classes were associated with patient characteristics and 3) whether goal classes were associated with treatment outcome. Methods Data analysis from a longitudinal observational study (N = 2591). Goals were classified in symptom, function/structure, activity/participation and non-classifiable. Associations between patient characteristics and goal classes were examined using x2 and one-way ANOVA. Association between goal classes and outcomes were examined using multiple logistic and linear regression models. Outcomes are reported at 3 months or end of treatment if prior to 3 months. Results There was a high variability in goals used for patients with MSD. 17% had symptom goals, 32.3% function/structure, 43.4% activity/participation and 7.4% non-classifiable goals. We found significant associations between goal classes and age, gender, severity, region of pain/diagnosis and emotional distress (all p < .001). Activity/participation goals were associated with better outcomes on GPE (OR 1.80, 95% CI 1.23–2.66). Non-classifiable goal was associated with poorer outcomes on pain intensity (B .87, 95% CI .32–1.43). Conclusion There is an association between goal classes and patient characteristics. Including activity/participation in the main goal was associated with better outcomes for GPE and having a non-classifiable goal was associated with poorer outcomes for pain intensity. Trial registration The project is approved by the Regional committee for Medical and Health Research Ethics in Norway (REC no. 2013/2030). https://clinicaltrials.gov/ct2/show/NCT03626389

Mechanisms controlling human head stabilization during random rotational perturbations in the horizontal plane revisited

This study repeats the experimental protocol for investigation of head stabilization in healthy humans, described by Keshner and Peterson (1995) but with a modification of the analysis. Head movements were considered with respect to the room instead of relative to the trunk. The aim was to investigate the approximate contribution of reflex and voluntary control across perturbing frequencies and conditions with modulation of visual information and mental attention and discuss the resulting outcome while comparing methods. Seventeen healthy individuals were asked to keep the head steady in space while subjected to pseudorandom rotational perturbations in the horizontal plane, firmly seated on an actuated chair. Both methods confirmed the results for gain in previous studies showing fair ability to keep the head steady in space below 1 Hz with vision. Compensation deteriorated when vision was removed and worsened further with addition of a mental task. Between 1 and 2 Hz, unity gain occurred between head and trunk movements, whereas above 2 Hz the head moved more than the trunk. For phase angles, the original method demonstrated a phase split occurring from ~1 Hz, a purely mathematical artifact that caused subjects with virtually identical movements to appear as significantly different. This artifact was eliminated by analyzing the head-room relative to trunk-room rather than head–trunk relative to trunkroom angles, thus preventing potentially erroneous interpretations of the results

Frequency-dependent deficits in head steadiness in patients with nonspecific neck pain

Motor control impairments are reported in patients with nonspecific neck pain but the particular deficits in underlying regulatory systems are not known. Head steadiness is controlled both by voluntary and reflex systems that are predominantly effective within different frequency intervals. The aim of the present study was to investigate within which frequency range(s) potential motor control deficits may reside. The ability to keep the head stationary in space in response to unpredictable perturbations was tested in 71 patients with nonspecific neck pain and 17 healthy controls. Participants were exposed to pseudorandom horizontal rotations across 10 superimposed frequencies (0.185–4.115 Hz) by means of an actuated chair in three conditions; with a visual reference, and without vision with, and without a cognitive task. Below 1 Hz, patients kept the head less stable in space compared to healthy controls. Between 1 and 2 Hz, the head was stabilized on the trunk in both groups. Patients kept the head more stable relative to the trunk than relative to space compared to healthy controls. This was interpreted as higher general neck muscle co‐activation in patients, which may be explained by altered voluntary control, or/and upregulated gamma motor neuron activity which increases the contribution of reflex‐mediated muscle activation. Alternatively, increased muscle activity is secondary to vestibular deficits

Recovery trajectories in common musculoskeletal complaints by diagnosis contra prognostic phenotypes

Background There are large variations in symptoms and prognostic factors among patients sharing the same musculoskeletal (MSK) diagnosis, making traditional diagnostic labelling not very helpful in informing treatment or prognosis. Recently, we identified five MSK phenotypes across common MSK pain locations through latent class analysis (LCA). The aim of this study was to explore the one-year recovery trajectories for pain and functional limitations in the phenotypes and describe these in relation to the course of traditional diagnostic MSK groups. Methods We conducted a longitudinal observational study of 147 patients with neck, back, shoulder or complex pain in primary health care physiotherapy. Data on pain intensity and function were collected at baseline (week 0) and 1, 2, 3, 4, 6, 8, 12, 26 and 52 weeks of follow up using web-based questionnaires and mobile text messages. Recovery trajectories were described separately for the traditional diagnostic MSK groups based on pain location and the same patients categorized in phenotype groups based on prognostic factors shared among the MSK diagnostic groups. Results There was a general improvement in function throughout the year of follow-up for the MSK groups, while there was a more modest decrease for pain intensity. The MSK diagnoses were dispersed across all five phenotypes, where the phenotypes showed clearly different trajectories for recovery and course of symptoms over 12 months follow-up. This variation was not captured by the single trajectory for site specific MSK diagnoses. Conclusion Prognostic subgrouping revealed more diverse patterns in pain and function recovery over 1 year than observed in the same patients classified by traditional diagnostic groups and may better reflect the diversity in recovery of common MSK disorders

Profile of children referred to primary health care physiotherapy: a longitudinal observational study in Norway

Background Physiotherapy services are an important part of the primary health care services for children, serving a broad spectrum of children referred from different sources and for a variety of reasons. There is limited knowledge about their characteristics and outcome. The aim of this study was to describe the profile, i.e. referral patterns, baseline demographical and clinical characteristics, as well as treatment outcome at follow-up 6 months after baseline, of children receiving physiotherapy in primary health care. Methods Children referred to primary health care physiotherapy in a large municipality in Norway were invited to participate in this longitudinal observational study. The children’s demographics, referral sources, causes of referral, functional diagnoses, influence on their daily activities, main goals and planned treatments were registered at baseline. Goal attainment and treatment compliance were registered at follow-up maximum 6 months after baseline. Results The physiotherapists registered baseline characteristics for 148 children. Parent-reported data at baseline were available for 101 (68.2%) of these children. Children were mainly referred from child health care centres (n = 74; 50.0%), hospital (n = 25; 16.9%) and kindergarten (n = 22; 14.9%). The most frequent causes of referral were concerns for motor development (n = 50; 33.8%), asymmetry (n = 40; 27.0%) and orthopaedic conditions (n = 25; 16.9%). Eighty-one (54.7%) children were below the age of 1 year. There was partly agreement between causes of referral and the physiotherapists’ functional diagnoses. Parents of 69 (71.1%) children reported that their child’s daily activities were little to not at all affected by the problem or complaint for which they were referred. Follow-up data were registered for 64 children. The main treatment goal was achieved in 37 (57.8%) and partly achieved in 26 (40.6%) children and the treatment was carried out as planned in 55 (87.3%) children. Conclusions The large variation in the profile of children receiving physiotherapy in a primary health care setting in Norway shows how primary health care physiotherapists can contribute to fulfil the broad purpose of the primary health care services. Trial registration ClinicalTrials.gov Identifier: NCT03626389. Registered on August 13th 2018 (retrospectively registered)