Effectiveness of adding motivational interviewing or a stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders: the MI-NAV randomised controlled trial.

OBJECTIVES: To evaluate if adding motivational interviewing (MI) or a stratified vocational advice intervention (SVAI) to usual case management (UC), reduced sickness absence over 6 months for workers on sick leave due to musculoskeletal disorders. METHODS: We conducted a three-arm parallel pragmatic randomised controlled trial including 514 employed workers (57% women, median age 49 (range 24-66)), on sick leave for at least 50% of their contracted work hours for ≥7 weeks. All participants received UC. In addition, those randomised to UC+MI were offered two MI sessions from social insurance caseworkers and those randomised to UC+SVAI were offered vocational advice from physiotherapists (participants with low/medium-risk for long-term sickness absence were offered one to two sessions, and those with high-risk were offered three to four sessions). RESULTS: Median sickness absence was 62 days, (95% CI 52 to 71) in the UC arm (n=171), 56 days (95% CI 43 to 70) in the UC+MI arm (n=169) and 49 days (95% CI 38 to 60) in the UC+SVAI arm (n=169). After adjusting for predefined potential confounding factors, the results showed seven fewer days in the UC+MI arm (95% CI -15 to 2) and the UC+SVAI arm (95% CI -16 to 1), compared with the UC arm. The adjusted differences were not statistically significant. CONCLUSIONS: The MI-NAV trial did not show effect on return to work of adding MI or SVAI to UC. The reduction in sickness absence over 6 months was smaller than anticipated, and uncertain due to wide CIs. TRIAL REGISTRATION NUMBER: NCT03871712.

Implementing a Stratified Vocational Advice Intervention for People on Sick Leave with Musculoskeletal Disorders: A Multimethod Process Evaluation.

Purpose To perform a process evaluation of a stratified vocational advice intervention (SVAI), delivered by physiotherapists in primary care, for people on sick leave with musculoskeletal disorders participating in a randomised controlled trial. The research questions concerned how the SVAI was delivered, the content of the SVAI and the physiotherapists' experiences from delivering the SVAI. Methods We used qualitative and quantitative data from 148 intervention logs documenting the follow-up provided to each participant, recordings of 18 intervention sessions and minutes from 20 meetings with the physiotherapists. The log data were analysed with descriptive statistics. A qualitative content analysis was performed of the recordings, and we identified facilitators and barriers for implementation from the minutes. Results Of 170 participants randomised to the SVAI 152 (89%) received the intervention and 148 logs were completed. According to the logs, 131 participants received the correct number of sessions (all by telephone) and 146 action plans were developed. The physiotherapists did not attend any workplace meetings but contacted stakeholders in 37 cases. The main themes from the recorded sessions were: 'symptom burden', 'managing symptoms', 'relations with the workplace' and 'fear of not being able to manage work'. The physiotherapists felt they were able to build rapport with most participants. However, case management was hindered by the restricted number of sessions permitted according to the protocol. Conclusion Overall, the SVAI was delivered in accordance with the protocol and is therefore likely to be implementable in primary care if it is effective in reducing sick leave.

Fidelity of a Motivational Interviewing Intervention for Improving Return to Work for People with Musculoskeletal Disorders.

The objective of this study was to conduct a fidelity evaluation of a motivational interviewing (MI) intervention delivered by social insurance caseworkers, in a three-arm randomized controlled trial (RCT) for improving return to work for people on sick leave with musculoskeletal disorders. The caseworkers received six days of MI training, including an intervention manual prior to the trial onset, as well as supervision throughout the trial. The caseworkers recorded 21 MI sessions at regular intervals during the trial. An independent MI analysis center scored the recordings using the MI treatment integrity code (MITI 4). In addition, three experienced MI trainers assessed the adherence to the MI intervention manual on a 1-4 Likert scale and MI competence. Total MITI 4 mean scores were at beginning proficiency levels for two components (global technical, mean 3.0; SD 0.6 and the reflections/questions ratio, mean 1.1; SD 0.2) and under beginning proficiency for two components (global relational, mean 3.2; SD 0.7 and complex question, mean 34.0; SD 21.2). The MI trainers' assessment showed similar results. The mean adherence score for the MI sessions was 2.96 (SD 0.9). Despite delivering a thorough course and supervision package, most of the caseworkers did not reach proficiency levels of good MI competence during the study. The fidelity evaluation showed that a large amount of training, supervision and practice is needed for caseworkers to become competent MI providers. When planning to implement MI, it is important that thorough consideration is given regarding the resources and the time needed to train caseworkers to provide MI in a social insurance setting.

Barriers and Facilitators for Implementing Motivational Interviewing as a Return to Work Intervention in a Norwegian Social Insurance Setting: A Mixed Methods Process Evaluation.

Purpose The aim of this study was to evaluate potential barriers and facilitators for implementing motivational interviewing (MI) as a return to work (RTW) intervention in a Norwegian social insurance setting. Methods A mixed-methods process evaluation was conducted alongside a randomized controlled trial involving MI sessions delivered by social insurance caseworkers. The study was guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework using focus groups with the caseworkers. MI fidelity was evaluated through audio-recordings of MI sessions and questionnaires to sick-listed participants. Results Lack of co-worker and managerial support, time and place for practicing to further develop MI skills, and a high workload made the MI intervention challenging for the caseworkers. The MI method was experienced as useful, but difficult to master. MI fidelity results showed technical global scores over the threshold for "beginning proficiency" whereas the relational global score was under the threshold. The sick-listed workers reported being satisfied with the MI sessions. Conclusions Despite caseworker motivation for learning and using MI in early follow-up sessions, MI was hard to master and use in practice. Several barriers and facilitators were identified; these should be addressed before implementing MI in a social insurance setting.Trial registration ClinicalTrials.gov: NCT03212118 (registered July 11, 2017).

Use of Dietary Supplements and Perceived Knowledge among Adults Living with Fibromyalgia in Norway: A Cross-Sectional Study.

Fibromyalgia syndrome (FMS) is a complex medical condition characterized by widespread musculoskeletal pain. To date, no gold standard treatment has been developed, and persons with FMS often seek alternative methods to control their symptoms, such as dietary supplements (DS). This study aimed to describe the use of DS in persons living with FMS and examine the associations between the use of DS and its potential predictors. We recruited a convenience sample of 504 participants (≥18 years) living with FMS. The main outcome variables included estimated expenditure on DS in the last 12 months in Norwegian kroner (NOK) and the differences between the groups of users and non-users of DS. Of the 504 participants, 430 reported having used DS, and the mean amount of money spent in the previous year was determined to be NOK 2300. The most common DS reported were vitamin D, magnesium, and omega-3 fatty acids. The predictors of being a DS user were high education, high self-reported knowledge of DS but low overall knowledge of health claims. Users of DS marketed for muscles/joints appear to spend more money on DS. The increasing availability of DS and aggressive advertising in the media through health claims stipulate the need for interventions that lead to informed decisions about DS.

Motivational Interviewing and Return to Work for People with Musculoskeletal Disorders: A Systematic Mapping Review.

Purpose There is limited knowledge about motivational interviewing (MI) for people on sick leave with musculoskeletal disorders. Hence, our objective was to investigate what research on MI as a method to facilitate return to work for individuals who are on sick leave due to musculoskeletal disorders exists, and what are the results of the research? Methods We systematically searched MEDLINE, PsycINFO, EMBASE, Cochrane Library, CINAHL, Web of Science, Sociological Abstracts, Epistemonikos, SveMed + and DARE & HTA (covering 1983 to August 2019). We also searched the MINT bulletin and relevant web pages. Eligibility criteria: empirical studies investigating MI and return to work for people with musculoskeletal disorders. Two authors independently screened the records, critically appraised the studies and charted the data using a data extraction form. Results The searches identified 1264 records of which two studies were included. One randomized controlled trial (RCT) found no effect of MI on return to work for disability pensioner with back pain (n = 89, high risk of bias), while a cluster RCT found that MI increased return to work for claimants with chronic musculoskeletal disorders (n = 728, low risk of bias). Conclusions This mapping review identified a huge gap in research on MI to increase return to work for individuals with musculoskeletal disorders. Registration Current Research Information System in Norway, project id: 635823 ( https://app.cristin.no/projects/show.jsf?id=635823 ).

Study protocol for a randomized controlled trial of the effectiveness of adding motivational interviewing or stratified vocational advice intervention to usual case management on return to work for people with musculoskeletal disorders. The MI-NAV study.

BACKGROUND: Little research exists on the effectiveness of motivational interviewing (MI) on return to work (RTW) in workers on long term sick leave. The objectives of this study protocol is to describe a randomized controlled trial (RCT) with the objectives to compare the effectiveness and cost-effectiveness of usual case management alone with usual case management plus MI or usual case management plus stratified vocational advice intervention (SVAI), on RTW among people on sick leave due to musculoskeletal (MSK) disorders. METHODS: A multi-arm RCT with economic evaluation will be conducted in Norway with recruitment of 450 participants aged 18-67 years on 50-100% sick leave for > 7 weeks due to MSK disorders. Participants will be randomized to either usual case management by the Norwegian Labour and Welfare Administration (NAV) alone, usual case management by NAV plus MI, or usual case management by NAV plus SVAI. Trained caseworkers in NAV will give two MI sessions, and physiotherapists will give 1-4 SVAI sessions depending upon risk of long-term sick leave. The primary outcome is the number of sick leave days from randomization to 6 months follow-up. Secondary outcomes are number of sick leave days at 12 months follow-up, time until sustainable RTW (≥4 weeks of at least 50% of their usual working hours) at 12 months, proportions of participants receiving sick leave benefits during 12 months of follow-up, and MSK symptoms influencing health at 12 months. Cost-utility evaluated by the EuroQoL 5D-5L and cost-benefit analyses will be performed. Fidelity of the interventions will be assessed through audio-recordings of approximately 10% of the intervention sessions. DISCUSSION: The results from this RCT will inform stakeholders involved in supporting RTW due to MSK disorders such as staff within NAV and primary health care. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03871712 registered March 12th 2020.

A focus group study to understand biases and confounders in a cluster randomized controlled trial on low back pain in primary care in Norway.

BACKGROUND: Cluster randomized controlled trials are often used in research in primary care but creates challenges regarding biases and confounders. We recently presented a study on low back pain from primary care in Norway with equal effects in the intervention and the control group. In order to understand the specific mechanisms that may produce biases in a cluster randomized trial we conducted a focus group study among the participating health care providers. The aim of this study was to understand how the participating providers themselves influenced on the study and thereby possibly on the results of the cluster randomized controlled trial. METHODS: The providers were invited to share their experiences from their participation in the COPE study, from recruitment of patients to accomplishment of either the intervention or control consultations. Six clinicians from the intervention group and four from the control group took part in the focus group interviews. The group discussions focused on feasibility of the study in primary care and particularly on identifying potential biases and confounders in the study. The audio-recorded interviews were transcribed verbatim and analyzed according to a systematic text condensation. The themes for the analysis emerged from the group discussions. RESULTS: A personal interest for back pain, logistic factors at the clinics and an assessment of the patients' capacity to accomplish the study prior to their recruitment was reported. The providers were allowed to provide additional therapy to the intervention and it turned out that some of these could be regarded as opposed to the messages of the intervention. The providers seemed to select different items from the educational package according to personal beliefs and their perception of the patients' acceptance. CONCLUSION: The study disclosed several potential biases to the COPE study which may have impacted on the study results. Awareness of these is highly important when planning and conducting a cluster randomized controlled trial. Procedures in the recruitment of both providers and patients seem to be key factors and the providers should be aware of their role in a scientific study in order to standardize the provision of the intervention.

Identification of Indirect Effects in a Cognitive Patient Education (COPE) Intervention for Low Back Pain.

BACKGROUND: Many interventions for the treatment of low back pain exist, but the mechanisms through which such treatments work are not always clear. This situation is especially true for biopsychosocial interventions that incorporate several different components and methods of delivery. OBJECTIVE: The study objective was to examine the indirect effects of the Cognitive Patient Education (COPE) intervention via illness perceptions, back pain myths, and pain catastrophizing on disability outcome. DESIGN: This study was a secondary analysis of the COPE randomized controlled trial. METHODS: Mediation analysis techniques were employed to examine the indirect effects of the COPE intervention via residualized change (baseline - posttreatment) in the 3 variables hypothesized to be targeted by the COPE intervention on posttreatment disability outcome. Pain intensity at baseline, pain duration, clinician type, and a treatment-mediator interaction term were controlled for in the analysis. RESULTS: Preliminary analyses confirmed that changes in pain catastrophizing and illness perceptions (not back pain myths) were related to both allocation to the intervention arm and posttreatment disability score. The treatment exerted statistically significant indirect effects via changes in illness perceptions and pain catastrophizing on posttreatment disability score (illness perceptions standardized indirect effect = 0.09 [95% CI = 0.03 to 0.16]; pain catastrophizing standardized indirect effect = 0.05 [95% CI = 0.01 to 0.12]). However, the inclusion of an interaction term led to the indirect effects being significantly reduced, with the effects no longer being statistically significant. LIMITATIONS: This study presents a secondary analysis of variables not identified a priori as being potentially important treatment targets; other, unmeasured factors could also be important in explaining treatment effects. CONCLUSIONS: The finding that small indirect effects of the COPE intervention via changes in illness perceptions and pain catastrophizing on posttreatment disability could be estimated indicates that these variables may be viable treatment targets for biopsychosocial interventions; however, this finding must be viewed in light of the adjusted analyses, which showed that the indirect effects were significantly reduced through the inclusion of a treatment-mediator interaction term.

The impact of psychological factors on condition-specific, generic and individualized patient reported outcomes in low back pain.

BACKGROUND: An individualized patient reported outcome (PRO) has recently been recommended within LBP research, but no study has evaluated this instrument with commonly applied PROs. Moreover, the impact of psychological factors has mostly been assessed for disease-specific instruments. The objective of this study was to assess the predictive value of illness perceptions, pain catastrophizing and psychological distress on 12 month outcomes assessed by specific, generic and individualized PROs recommended in low back pain (LBP). METHODS: Secondary analysis of patients with sub-acute or chronic LBP recruited for a cluster randomized controlled trial in primary care who completed a self-administered questionnaire at baseline and 12 months. 12 month scores for the Roland Morris Disability Questionnaire (RMDQ), the EuroQol (EQ-5D), and the Patient Generated Index (PGI) were dependent variables in hierarchical regression analysis. Independent variables included baseline scores for the Brief Illness Perceptions Questionnaire (Brief IPQ), Hopkins Symptom Check List (HSCL-25), Pain Catastrophizing Scale (PCS), health/clinical and sociodemographic variables. RESULTS: Of the 216 eligible patients included, 203 patients responded to the baseline questionnaire and 150 (74%) responded at 12 months. The mean age was 38.3 (SD 10.2) years and 57.6% were female. The Brief IPQ showed a statistically significant variation in the 12-months score of all the PROs, explaining 2.5% in RMDQ, 7.9% in EQ-5D, and 3.6% in PGI. Most of the explained variation for EQ-5D scores related to illness perceptions. The PCS explained 3.7% of the RMDQ and 2.5% in the EQ-5D scores. The HSCL-25 did not make a significant contribution. CONCLUSION: Illness perceptions and pain catastrophizing were associated with 12-month outcomes as assessed by condition-specific, generic and individualized PROs. The Brief IPQ and PCS have relevance to applications in primary care that include interventions designed to enhance psychological aspects of health and where the contribution of such variables to outcomes is of interest. Further studies should assess whether the Brief IPQ perform similarly in LBP populations in other health care settings.

Cognitive Patient Education for Low Back Pain in Primary Care: A Cluster Randomized Controlled Trial and Cost-Effectiveness Analysis.

STUDY DESIGN: A pragmatic cluster randomized controlled trial in primary care. OBJECTIVE: The aim of this study was to estimate the clinical effectiveness and cost-effectiveness of a cognitive-based education program on patients with subacute or chronic low back pain (LBP) in primary care, compared to usual treatment, provided by general practitioners (GP) and physiotherapists (PT). SUMMARY OF BACKGROUND DATA: Patient education has been reported to have a favorable effect on patients with chronic musculoskeletal disorders. In this study, an "Explain Pain" model was adapted to fit into an ordinary clinical setting in Norwegian primary care. METHODS: Sixteen GPs and 20 PTs participated in the study and a total of 216 patients were recruited. The GPs and PTs were randomly assigned to provide either a cognitive patient education or usual treatment. All patients in both groups were provided with four consultations of 30 min with their provider during the study. In the intervention group the patients were educated according to a specific manual written for the purpose of this study. RESULTS: Eighty-one percent responded at 4-week, and 68% at the 12-month follow-up. There was a substantial improvement in function, pain, and sick leave in both groups. After 4 weeks the intervention group scored 0.51 RMDQ points lower than the control group (Beta -0.506 [95% CI -1.76-0.75]). After 12 months the intervention group scored 0.66 RMDQ points higher than the control group (Beta 0.66 [95% CI -0.56-1.88]). There was no significant difference in QALYs in the two treatment groups; the estimated difference was 0.005 (-0.016-0.027) in favor of the intervention. CONCLUSION: This study showed no clinical or health economic benefits as a result of adding a cognitive education program to usual treatment for patients with subacute and chronic LBP. Potential weaknesses such as a long recruiting period and potentially low compliance with the cognitive intervention warrant a careful interpretation of the results.

Individualized quality of life in patients with low back pain: reliability and validity of the Patient Generated Index.

OBJECTIVE: To evaluate the reliability and validity of the improved version of the Patient Generated Index (PGI) in patients with low back pain. METHODS: The PGI was administered to 90 patients attending care in 1 of 6 institutions in Norway and evaluated for reliability and validity. The questionnaire was given out to 61 patients for re-test purposes. RESULTS: The PGI was completed correctly by 80 (88.9%) patients and, of the 61 patients responding to the re-test, 50 (82.0%) completed both surveys correctly. PGI scores were approximately normally distributed, with a median of 40 (range 80), where 100 is the best possible quality of life. There were no floor or ceiling effects. The 5 most frequently listed areas affecting quality of life were pain, sleep, stiffness, socializing and housework. The test-retest intraclass correlation coefficient was 0.73. The smallest detectable changes for individual and group purposes were 32.8 and 4.6, respectively. The correlations between PGI scores and other instrument scores followed a priori hypotheses of low to moderate correlations. DISCUSSION: The PGI has evidence for reliability and validity in Norwegian patients with low back pain at the group level and may be considered for application in intervention studies when a comprehensive evaluation of quality of life is important. However, the smallest detectable change, of approximately 30 points, may be considered too large for individual purposes in clinical applications.

Measurement properties of instruments assessing self-efficacy in patients with rheumatic diseases.

The measurement properties of instruments assessing self-efficacy (SE) in patients with rheumatic diseases were reviewed. The consensus-based standards for the selection of health measurement instruments (COSMIN) checklist was applied following systematic searches of seven electronic databases from 1989 to December 2011. Fifteen articles met the inclusion criteria that included the arthritis SE scales (ASES), generalized SE scale (GSES), joint protection SE scale (JP-SES), Marcus & Resnick SE exercise behaviour (SEEB) instruments, and RA SE scale (RASE). The ASES and RASE have undergone more than one evaluation. There was little formal evaluation of content validity for the instruments. Evidence for the RASE suggests that it is not unidimensional. The JP-SES and SEEB were evaluated using modern psychometric methods. The instruments require further evaluation before application. The quality of the evidence for the ASES and RASE is generally poor. The generic focus of the GSES limits its relevance. The JP-SES and SEEB have only undergone one evaluation and that relating to the latter was narrow in scope. Future studies should address these methodological weaknesses.

Illness perceptions in patients receiving rheumatology rehabilitation: association with health and outcomes at 12 months.

BACKGROUND: Illness perceptions have been found to change over time and following health care. Hence, addressing illness perceptions alongside existing health care interventions may be important for the sustainment of health gains following rehabilitation. The aim of this study was to measure the illness perceptions of patients receiving inpatient rheumatology rehabilitation and assess the association with aspects of health and outcomes at baseline, discharge and 12 months. METHODS: Patients with a rehabilitation stay of one week or more at three institutions in Norway in 2009 were invited to participate in the study. At baseline, discharge and 12 months, patients completed The Rheumatic Disease Illness Perception Questionnaire (RD-IPQ) which includes aspects of illness perceptions important to patients with rheumatic diseases. Stepwise regression analysis was used to assess associations between RD-IPQ scores and different aspects of health at baseline and follow-up after controlling for other aspects of health and sociodemographic variables. RESULTS: For the 134 patients included in the study, baseline RD-IPQ scores had a mean of 58.2 (SD 14.9) on a 0-100 scale, where 100 is the worst possible. Scores showed improvement after the rehabilitation stay which were maintained at 12 months. RD-IPQ scores were positively associated with health and outcomes. At baseline RD-IPQ scores were statistically significant in explaining variation in pain, physical function and SF-36 mental health scores. Baseline RD-IPQ scores were significant in explaining fatigue, pain, SF-36 role limitations and social function scores following rehabilitation and at 12 months. CONCLUSION: Illness perceptions as measured by the RD-IPQ were associated with health and outcomes as measured by rheumatology-specific and generic instruments. The consideration of illness perceptions as a component of rehabilitation may be important in achieving desired outcomes.

Psychometric properties of the Norwegian version of the patient generated index in patients with rheumatic diseases participating in rehabilitation or self-management programmes.

OBJECTIVE: In rehabilitation, treatment is individually tailored to each patient's goals. Individualized instruments allow patients to choose domains that they consider important, which may make them particularly appropriate as evaluative tools in this setting. We aimed to evaluate the psychometric properties of the Norwegian version of the patient generated index (PGI) in patients with rheumatic diseases participating in inpatient rehabilitation or self-management programmes. METHODS: Patients completed the PGI together with other outcome measures at arrival and 5 and 52 weeks after arrival. The PGI was assessed for data quality by completion rates, reliability by the intraclass correlation coefficient (ICC), agreement by standard error of measurement (SEM) and smallest detectable change (SDC). Construct validity was assessed by testing a priori hypotheses regarding correlation between PGI scores and other outcome measures. Responsiveness was assessed by an a priori hypothesis regarding the correlation of different change scores and standardized response means (SRMs). RESULTS: A total of 145 patients participated and 118 (81%) completed the PGI correctly. The ICC was 0.87, SEM 7.25 and SDC 20.10. Ninety-three per cent of the hypotheses of correlation were confirmed in tests for construct validity. Responsiveness was confirmed in 53% and 71% of hypotheses tested at 5 and 52 weeks. SRMs were 0.2 and 0.4, respectively. CONCLUSION: The results support the validity, reliability and responsiveness of the Norwegian version of the PGI in patients with rheumatic diseases and its application as an outcome measure in rehabilitation or self-management programmes. Further research is needed to improve completion rates for the PGI.

Cross-cultural adaptation and validation of the Norwegian version of the Core Outcome Measures Index for low back pain.

PURPOSE: The Core Outcome Measures Index (COMI) is a short multidimensional scale covering all domains recommended to be included as outcome measures for patients with low back pain (LBP). The purpose of the present study was to translate and cross-culturally adapt the COMI into Norwegian and to test clinimetric properties of the Norwegian COMI version in patients with non-specific LBP recruited from various clinical settings. METHODS: Ninety patients with non-specific LBP from primary care and hospital settings participated in the validation part and 61 also in the reproducibility part of the study (1 week apart). Acceptability, data quality, reproducibility and construct validity were investigated. RESULTS: The questionnaire was well accepted and with little missing data and end effects. Reliability in terms of intraclass correlations (ICC) was satisfactory for the COMI index [0.89 (95 % CI 0.82-0.94)] and most single-core items. Agreement was acceptable for the COMI index [standard error of measurement (SEM(agreement)) 0.80, minimal detectable change (MDC(individual)) 2.21], but exceeded the minimal standard of acceptability in some of the individual core items. Construct validity was acceptable for the COMI index. CONCLUSION: The Norwegian version of the COMI index shows acceptable clinimetric properties in our patient population, but some of the sub-items had shortcomings. Our study, however, support the usefulness of the COMI index as an applicable stand-alone global scale when a light respondent burden is advisable.

Cross-cultural adaptation and validation of the Norwegian pain catastrophizing scale in patients with low back pain.

BACKGROUND: Pain catastrophizing has been found to be an important predictor of disability and days lost from work in patients with low back pain. The most commonly used outcome measure to identify pain catastrophizing is the Pain Catastrophizing Scale (PCS). To enable the use of the PCS in clinical settings and research in Norwegian speaking patients, the PCS had to be translated. The purpose of this study was therefore to translate and cross-culturally adapt the PCS into Norwegian and to test internal consistency, construct validity and reproducibility of the PCS. METHODS: The PCS was translated before it was tested for psychometric properties. Patients with subacute or chronic non-specific low back pain aged 18 years or more were recruited from primary and secondary care. Validity of the PCS was assessed by evaluating data quality (missing, floor and ceiling effects), principal components analysis, internal consistency (Cronbach's alpha), and construct validity (Spearman's rho). Reproducibility analyses included standard error of measurement, minimum detectable change, limits of agreement, and intraclass correlation coefficients. RESULTS: A total of 38 men and 52 women (n = 90), with a mean (SD) age of 47.6 (11.7) years, were included for baseline testing. A subgroup of 61 patients was included for test-retest assessments. The Norwegian PCS was easy-to-comprehend. The principal components analysis supported a three-factor structure, internal consistency was satisfactory for the PCS total score (α 0.90) and the subscales rumination (α 0.83) and helplessness (α 0.86), but not for the subscale magnification (α 0.53). In total, 86% of the correlation analyses were in accordance with predefined hypothesis. The reliability analyses showed intraclass correlation coefficients of 0.74 - 0.87 for the PCS total score and subscales. The PCS total score (range 0-52 points) showed a standard error of measurement of 4.6 points and a 95% minimum detectable change estimate of 12.8 points. CONCLUSIONS: The Norwegian PCS total score showed acceptable psychometric properties in terms of comprehensibility, consistency, construct validity, and reproducibility when applied to patients with subacute or chronic LBP from different clinical settings. Our study support the use of the PCS total score for clinical or research purposes identifying or evaluating pain catastrophizing.

The COPE LBP trial: cognitive patient education for low back pain--a cluster randomized controlled trial in primary care.

BACKGROUND: Non-specific low back pain (LBP) is usually self-limiting within 4-6 weeks. Longstanding pain and disability are not predictable from clinical signs or pathoanatomical findings. Pain cognition and physical performance have been shown to improve patients with chronic LBP following neurophysiological education. The primary aim of this study is to evaluate whether a specific cognitive based education programme for patients with LBP in primary care is more effective than normal care in terms of increased function. The secondary aims of the study are to evaluate whether this intervention also results in earlier return to work, decreased pain, increased patient satisfaction, increased quality-of-life, and cost utility. METHODS/DESIGN: Cluster randomised controlled trial with 20 general practitioners and 20 physiotherapists in primary care as the unit of randomisation. Each practitioner will recruit up to 10 patients, aged 20 to 55 years, with non-specific sub-acute/chronic LBP of more than four weeks but less than 1 year's duration. Practitioners in the intervention arm will provide cognitive patient education intervention in up to four weekly sessions, each lasting 30 minutes. Practitioners in the control arm will provide normal treatment, but have to make four appointments for the patients. Patients, outcome assessors, and study statistician will be blinded to group allocation. DISCUSSION: We present the rationale and design of an ongoing RCT study that potentially offers an easily implemented treatment strategy for LBP patients in primary care. The results will be available in 2012. TRIAL REGISTRATION: ISRCTN04323845.