Occupational rehabilitation programs for musculoskeletal pain and common mental health disorders: study protocol of a randomized controlled trial.

BACKGROUND: Long-term sick leave has considerably negative impact on the individual and society. Hence, the need to identify effective occupational rehabilitation programs is pressing. In Norway, group based occupational rehabilitation programs merging patients with different diagnoses have existed for many years, but no rigorous evaluation has been performed. The described randomized controlled trial aims primarily to compare two structured multicomponent inpatient rehabilitation programs, differing in length and content, with a comparative cognitive intervention. Secondarily the two inpatient programs will be compared with each other, and with a usual care reference group. METHODS/DESIGN: The study is designed as a randomized controlled trial with parallel groups. The Social Security Office performs monthly extractions of sick listed individuals aged 18-60 years, on sick leave 2-12 months, with sick leave status 50% - 100% due to musculoskeletal, mental or unspecific disorders. Sick-listed persons are randomized twice: 1) to receive one of two invitations to participate in the study or not receive an invitation, where the latter "untouched" control group will be monitored for future sick leave in the National Social Security Register, and 2) after inclusion, to a Long or Short inpatient multicomponent rehabilitation program (depending on which invitation was sent) or an outpatient cognitive behavioral therapy group comparative program. The Long program consists of 3 ½ weeks with full rehabilitation days. The Short program consists of 4 + 4 full days, separated by two weeks, in which a workplace visit will be performed if desirable. Three areas of rehabilitation are targeted: mental training, physical training and work-related problem solving. The primary outcome is number of sick leave days. Secondary outcomes include time until full sustainable return to work, health related quality of life, health related behavior, functional status, somatic and mental health, and perceptions of work. In addition, health economic evaluation will be performed, and the implementation of the interventions, expectations and experiences of users and service providers will be investigated with different qualitative methods. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01926574.

Work stress, sleep deficiency, and predicted 10-year cardiometabolic risk in a female patient care worker population.

OBJECTIVES: The aim of this study was to investigate the longitudinal effect of work-related stress, sleep deficiency, and physical activity on 10-year cardiometabolic risk among an all-female worker population. METHODS: Data on patient care workers (n=99) was collected 2 years apart. Baseline measures included: job stress, physical activity, night work, and sleep deficiency. Biomarkers and objective measurements were used to estimate 10-year cardiometabolic risk at follow-up. Significant associations (P<0.05) from baseline analyses were used to build a multivariable linear regression model. RESULTS: The participants were mostly white nurses with a mean age of 41 years. Adjusted linear regression showed that having sleep maintenance problems, a different occupation than nurse, and/or not exercising at recommended levels at baseline increased the 10-year cardiometabolic risk at follow-up. CONCLUSIONS: In female workers prone to work-related stress and sleep deficiency, maintaining sleep and exercise patterns had a strong impact on modifiable 10-year cardiometabolic risk.

H-coil repetitive transcranial magnetic stimulation does not improve executive function in patients with chronic peripheral neuropathic pain: a randomized sham-controlled crossover study.

Introduction: Deep rTMS is an increasingly popular noninvasive brain stimulation technique which has shown promise for treating cognitive impairments. However, few studies have investigated the cognitive effects it could exert in patients with chronic peripheral neuropathic pain. Therefore, we aimed to assess the effects of deep rTMS on executive functioning in patients with peripheral neuropathic pain, in a randomized, double-blind crossover trial. Methods: In total, 17 patients were randomly assigned to receive both active and sham deep H-coil rTMS targeting the primary motor cortex. Each treatment period consisted of five daily rTMS sessions. Selected tests of executive functioning from the CANTAB test battery (paired associates learning, stop signal task, spatial working memory and multitasking test) were performed at baseline, and at 1 week and 3 weeks follow-ups. Results: We did not find any significant interactions between time and treatment for the measures of executive functioning for the patient group, or for patients with reduced cognition compared to normative means. Conclusion: High-frequency deep H-coil rTMS targeting the hand area of the primary motor cortex and delivered over 5 consecutive days did not improve executive functioning in patients with chronic peripheral neuropathic pain. Clinical trial registration: https://clinicaltrials.gov/, identifier NCT05488808.

Associations of long-term clinical recovery and improved quality of life across ICD-11 chronic pain categories in a real-world registry study.

BACKGROUND: There is little knowledge of what factors are needed for successful chronic pain management. We aim to identify psychosocial and treatment predictors of clinical recovery and improved quality of life (QOL) at 12-month follow-up across three chronic pain groups, based on the International Classification of Diseases-11: neuropathic pain, secondary non-neuropathic pain, and primary pain. Furthermore, we investigate baseline differences across diagnostic groups. METHODS: The sample included baseline and 12-month follow-up data from 1056 chronic pain patients from the Oslo University Hospital's Pain Registry. Logistic regression models investigated longitudinal associations between psychosocial and treatment characteristics, and the outcome measures clinical recovery and improved QOL. Characteristics were compared across the diagnostic groups. RESULTS: Increased odds of clinical recovery and improved QOL were seen in patients receiving invasive treatment (OR = 8.04, 95% CI = 3.50-19.40; OR = 5.47, 95% CI = 2.42-12.86), while decreased odds of clinical recovery were seen for secondary non-neuropathic pain patients with pain-related disability (0.05, 95% CI = 0.01-0.29). In comparing baseline characteristics, neuropathic pain patients had lower QOL, and more severe insomnia compared to the other groups. CONCLUSION: Invasive treatment modalities were strongly associated with clinical recovery and improved QOL. Although this could be due to patient selection, it does warrant further examination as an intervention alternative for chronic pain. Intervention efficacy, risk factors and predictors of clinical recovery across diagnostic groups should be further investigated through longitudinal RCTs. SIGNIFICANCE: This observational study indicates a potential advantage in sustained recovery for pre-selected individuals with chronic pain who undergo invasive treatments. The relationship between sustained recovery and psychosocial factors differs across neuropathic, secondary non-neuropathic, and primary pain patients. This suggests that employing ICD-11 for classifying patients into mechanistically distinct pain groups could inform the evaluation and management of chronic pain. Furthermore, factors previously identified as negative indicators for long-term outcomes in chronic pain cohorts were not clinically significant in this study.

Associations between cognitive test scores and pain tolerance: The Tromsø study.

OBJECTIVES: Previous studies have suggested that experimental pain sensitivity is associated with cognitive function. The aim of this study is to assess this relationship in a large population-based sample. METHODS: We included 5,753 participants (aged 40-84 years) from the seventh wave of the population-based Tromsø Study who had been examined with cognitive tests and experimental pain assessments, and for whom information on covariates were available. Cox regression models were fitted using standardized scores on cognitive tests (12-word immediate recall test, digit symbol coding test, and Mini-Mental State Examination [MMS-E]) as the independent variable and cold pressor or cuff pressure pain tolerance as the dependent variables. Statistical adjustment was made for putative confounders, namely, age, sex, education, smoking, exercise, systolic blood pressure, body mass index, symptoms indicating anxiety or depression, analgesic use, and chronic pain. RESULTS: In multivariate analysis, cold pressor tolerance time was significantly associated with test scores on the 12-word immediate recall test (hazard ratio [HR] 0.93, 95% confidence interval [CI] 0.90-0.97, p < 0.001), the digit symbol coding test (HR 0.94, 95% CI 0.89-0.98, p = 0.004), and the MMS-E (HR 0.93, 95% CI 0.90-0.96 p < 0.001). Tolerance to cuff pressure algometry was significantly associated with 12-word immediate recall (HR 0.94-0.97, p < 0.001) and Digit Symbol Coding test scores (HR 0.93, 95% CI 0.89-0.96, p < 0.001) while there was no significant association with Mini Mental State Examination test score (HR 0.98, 95% CI 0.95-1.00, p = 0.082). CONCLUSION: Lower pain tolerance was associated with poorer performance on cognitive tests.

The indirect impact of heart rate variability on cold pressor pain tolerance and intensity through psychological distress in individuals with chronic pain: the Tromsø Study.

INTRODUCTION: Chronic pain (CP) patients often display lower heart rate variability (HRV) and baroreceptor sensitivity (BRS), which are associated with increased evoked pain intensity and decreased pain tolerance. OBJECTIVE: The purpose of this study was to test whether the association between low levels of HRV and BRS and increased evoked pain responsiveness in individuals with CP is mediated by psychological distress and whether this mediation is sex dependent. METHODS: The sample consisted of 877 participants in Wave 6 of the Tromsø population study who reported clinically meaningful CP. Resting HRV and BRS parameters were derived from continuous beat-to-beat blood pressure recordings. Psychological distress was assessed using the Hopkins Symptom Checklist-10. After cardiovascular assessment, participants completed a 106-second cold pressor task (3°C bath), which assessed cold pressor pain intensity (CPI) and cold pressor pain tolerance (CPT). RESULTS: In the full CP sample, mediation analyses showed significant indirect effects, without direct effects, of HRV and BRS on both CPT and CPI via psychological distress. When stratified by sex, significant indirect effects via psychological distress were only found in males for the impact of rMSSD on CPT, the impact of SDNN on CPT, and the impact of BRS on CPT via psychological distress. Moderated mediation analyses revealed that there were no significant sex differences in the indirect effects of HRV and BRS on both CPT and CPI via psychological distress. CONCLUSIONS: The hypoalgesic impact of cardiovascular regulatory systems on evoked pain responses is conveyed via the indirect effects of psychological distress.

MINDflex Training for Cognitive Flexibility in Chronic Pain: A Randomized, Controlled Cross-Over Trial.

Impairments in executive functioning are prevalent in chronic pain conditions, with cognitive inflexibility being the most frequently reported. The current randomized, cross-over trial, piloted a computerized cognitive training (CCT) program based on Relational Frame Theory, targeting improvement in cognitive flexibility. At baseline, 73 chronic pain patients completed testing on pre-selected outcomes of executive functioning, alongside IQ measures. When tested three times over the course of 5 months, there was a drop-out rate of 40% at the third time point, leaving 44 patients who had data at all time points. The results showed that there was a substantial learning effect from the MINDFLEX training and a substantial time-dependent improvement on the primary outcomes of increased flexibility, but that this could not be tied to active training. In conclusion, this small study indicated a learning effect as well as improvement on primary outcomes. Based on the current results, a larger trial with improved feasibility of training is warranted.

Metacognitive Beliefs as Predictors of Return to Work After Intensive Return-to-Work Rehabilitation in Patients With Chronic Pain, Chronic Fatigue and Common Psychological Disorders: Results From a Prospective Trial.

BACKGROUND: Metacognitions are associated with work status, but no research has examined to what extent metacognitions before treatment and change in metacognitions following treatment predict return to work (RTW) prospectively. The present study aims to address these two gaps in knowledge. METHODS: 212 patients on long-term sick leave (>8 weeks) with extensive fatigue, chronic pain conditions and/or mental distress received 3.5 weeks of intensive rehabilitation treatment, aimed at returning them to work. Only part of the population (n = 137) had complete follow-up data on metacognitions. Metacognitions were measured with the Metacognitions Questionnaire 30 (MCQ-30), while RTW was measured using official registry data from the Norwegian Labor and Welfare Service. A registry record of participation in competitive work ≥2.5 days (50% work participation) per week, averaging over 14 weeks, was chosen as an outcome reflecting a successful RTW. The registry data spanned a total of 56 weeks per participant. RESULTS: Our results indicated that baseline MCQ scores was not associated with RTW. This was analyzed for the total MCQ score as well as for all subscales. We observed substantial changes in metacognitions following treatment, and a 1-point change in the total sum of metacognitive beliefs was associated with 5% greater odds for successful RTW at all time points (p = 0.040), while a 1-point change on the subscale of beliefs about the need to control thoughts gave 20% greater odds for successful RTW (p = 0.016). CONCLUSION: Metacognitions concerning the need to control thoughts appear to have a significant influence on patients return to work. Here, we observed that a change in these beliefs following treatment substantially affected RTW over the course of 1 year.

Inpatient multimodal occupational rehabilitation reduces sickness absence among individuals with musculoskeletal and common mental health disorders: a randomized clinical trial.

Objectives This study aimed to investigate whether inpatient multimodal occupational rehabilitation (I-MORE) reduces sickness absence (SA) more than outpatient acceptance and commitment therapy (O-ACT) among individuals with musculoskeletal and mental health disorders. Methods Individuals on sick leave (2-12 months) due to musculoskeletal or common mental health disorders were randomized to I-MORE (N=86) or O-ACT (N=80). I-MORE lasted 3.5 weeks in which participants stayed at the rehabilitation center. I-MORE included ACT, physical exercise, work-related problem solving and creating a return to work plan. O-ACT consisted mainly of 6 weekly 2.5 hour group-ACT sessions. We assessed the primary outcome cumulative SA within 6 and 12 months with national registry-data. Secondary outcomes were time to sustainable return to work and self-reported health outcomes assessed by questionnaires. Results SA did not differ between the interventions at 6 months, but after one year individuals in I-MORE had 32 fewer SA days compared to O-ACT (median 85 [interquartile range 33-149] versus 117 [interquartile range 59-189)], P=0.034). The hazard ratio for sustainable return to work was 1.9 (95% confidence interval 1.2-3.0) in favor of I-MORE. There were no clinically meaningful between-group differences in self-reported health outcomes. Conclusions Among individuals on long-term SA due to musculoskeletal and common mental health disorders, a 3.5-week I-MORE program reduced SA compared with 6 weekly sessions of O-ACT in the year after inclusion. Studies with longer follow-up and economic evaluations should be performed.

The Relationship Between Improvement in Insomnia Severity and Long-Term Outcomes in the Treatment of Chronic Fatigue.

Background: The current treatments of choice for patients with chronic fatigue are moderately effective. One way to advance treatments is identifying process variables associated with good treatment outcomes. There is little knowledge regarding a possible association between insomnia and long-term outcomes in the treatment of chronic fatigue. Aims: Testing whether (1) improvement in insomnia is associated with improvement in levels of fatigue at 1-year follow-up, and (2) if such a relationship remains when controlling for improvement in levels of anxiety and depression, and pain in patients with chronic fatigue. Methods: Patients having been on sick leave 8 weeks or more due to chronic fatigue were referred to a return-to-work program. They received an intensive 3.5-week inpatient treatment program based on acceptance and commitment therapy (ACT). Before treatment and at 1-year follow-up the patients completed questionnaires assessing levels of insomnia severity, pain, anxiety and depression, and fatigue. Results: A regression analysis found that changes in insomnia-severity were associated with changes in fatigue-levels at 1-year follow-up. When changes in levels of anxiety and depression were entered in the regression analysis, anxiety and depression was significantly associated with levels of fatigue but insomnia was not. The association between anxiety and depression and fatigue was at a trend level when pain was entered into the model. Conclusion: Long-term improvement in insomnia severity was significantly associated with long-term improvement in chronic fatigue, but not independently of long-term improvement in anxiety and depression, and pain. Trial Registration: https://clinicaltrials.gov/, identifier NCT01568970.

Metacognitions Are Associated with Subjective Memory Problems in Individuals on Sick Leave due to Chronic Fatigue.

BACKGROUND: Subjective cognitive impairments are frequent, but poorly understood in patients with chronic fatigue. We hypothesized that maladaptive metacognitive beliefs at baseline were associated with baseline subjective cognitive impairments, that they predict subjective cognitive impairments at treatment termination, and that a reduction in maladaptive metacognitive beliefs was associated with less subjective cognitive impairments at treatment termination, independent of changes in fatigue, pain, insomnia, depression, and anxiety. METHODS: In this non-controlled study, patients (n = 137) on sick leave due to chronic fatigue received a 3.5-week inpatient RTW rehabilitation program. Of these patients 69 (50.4%) was referred with a ICPC-2 diagnosis of chronic fatigue. Patients completed questionnaires about metacognitive beliefs, somatic complaints, psychological complaints, and cognitive impairments before and after treatment. To test the hypotheses we performed paired t-tests of change, as well as seven hierarchical linear regressions. RESULTS: RESULTS showed that baseline maladaptive metacognitive beliefs were significantly associated with subjective cognitive impairments at baseline, controlling for symptoms. Score on baseline metacognitive beliefs did not predict impairments post-treatment. Testing specific maladaptive beliefs, pre-treatment scores on cognitive confidence were associated with subjective cognitive impairments both pre and post-treatment, controlling for symptoms. Post-treatment metacognitive beliefs and post-treatment cognitive confidence were associated with post-treatment subjective cognitive impairments, controlling for pre-treatment impairments and pre-treatment metacognitive beliefs, as well as pre and post-scores on symptom measures. CONCLUSION: This study reports associations between maladaptive metacognitive beliefs and subjective cognitive impairments in patients with chronic fatigue. Targeting metacognitive beliefs could prove an effective therapeutic intervention for subjective cognitive impairments in these patients.

Effectiveness of Working Memory Training among Subjects Currently on Sick Leave Due to Complex Symptoms.

Introduction: The current study examined if adaptive working memory training (Cogmed QM) has the potential to improve inhibitory control, working memory capacity, and perceptions of memory functioning in a group of patients currently on sick leave due to symptoms of pain, insomnia, fatigue, depression and anxiety. Participants who were referred to a vocational rehabilitation center volunteered to take part in the study. Methods: Participants were randomly assigned to either a training condition (N = 25) or a control condition (N = 29). Participants in the training condition received working memory training in addition to the clinical intervention offered as part of the rehabilitation program, while participants in the control condition received treatment as usual i.e., the rehabilitation program only. Inhibitory control was measured by The Stop Signal Task, working memory was assessed by the Spatial Working Memory Test, while perceptions of memory functioning were assessed by The Everyday Memory Questionnaire-Revised. Results: Participants in the training group showed a significant improvement on the post-tests of inhibitory control when compared with the comparison group (p = 0.025). The groups did not differ on the post-tests of working memory. Both groups reported less memory problems at post-testing, but there was no sizeable difference between the two groups. Conclusions: Results indicate that working memory training does not improve general working memory capacity per se. Nor does it seem to give any added effects in terms of targeting and improving self-perceived memory functioning. Results do, however, provide evidence to suggest that inhibitory control is accessible and susceptible to modification by adaptive working memory training.

The role of insomnia in the treatment of chronic fatigue.

BACKGROUND: The definition of Chronic Fatigue Syndrome (CFS) overlaps with definitions of insomnia, but there is limited knowledge about the role of insomnia in the treatment of chronic fatigue. AIMS: To test if improvement of insomnia during treatment of chronic fatigue was associated with improved outcomes on 1) fatigue and 2) cortisol recovery span during a standardized stress exposure. METHODS: Patients (n = 122) with chronic fatigue received a 3.5-week inpatient return-to-work rehabilitation program based on Acceptance and Commitment Therapy, and had been on paid sick leave>8 weeks due their condition. A physician and a psychologist examined the patients, assessed medication use, and SCID-I diagnoses. Patients completed self-report questionnaires measuring fatigue, pain, depression, anxiety, and insomnia before and after treatment. A subgroup (n = 25) also completed the Trier Social Stress Test for Groups (TSST-G) before and after treatment. Seven cortisol samples were collected during each test and cortisol spans for the TSST-G were calculated. RESULTS: A hierarchical regression analysis in nine steps showed that insomnia improvement predicted improvement in fatigue, independently of age, gender, improvement in pain intensity, depression and anxiety. A second hierarchical regression analysis showed that improvement in insomnia significantly predicted the cortisol recovery span after the TSST-G independently of improvement in fatigue. CONCLUSION: Improvement in insomnia severity had a significant impact on both improvement in fatigue and the ability to recover from a stressful situation. Insomnia severity may be a maintaining factor in chronic fatigue and specifically targeting this in treatment could increase treatment response.

Describing patients with a duration of sick leave over and under one year in Norway.

OBJECTIVE: This study aimed to describe the somatic, social, psychological, and work-related factors that characterize participants with a duration of sick leave over and under one year. METHODS: During 2012, 181 patients on long-term sick leave were consecutively recruited and asked to answer an extensive survey. Several outcomes were reported, addressing work-related factors and somatic, psychological, and social symptoms. In cross-sectional analyses, sick leave duration was dichotomized as > or < one year, based on Norwegian legislation. Linear and logistic regressions were used to estimate population probabilities and means. RESULTS: The estimated prevalence of pain, fatigue, anxiety, and depression was overall high. There was a tendency towards a higher prevalence of fatigue, anxiety, and depression in those with sick leave duration less than one year, with the exception of sleep problems, which was more frequent in the population with longer duration. Relationship with friends, family, co-workers, and the last workplace were worse in the population with longer duration. CONCLUSIONS: Cross-sectional analyses indicated that social and work-related problems are more adverse in patients with longer duration of sick leave, while psychological and somatic symptoms appear less adverse. This is one of the first studies quantitatively demonstrating these differences through comprehensive, simultaneously measured self-report questionnaires.

Subjective memory complaints among patients on sick leave are associated with symptoms of fatigue and anxiety.

OBJECTIVE: The aim of this study was to identify symptoms associated with subjective memory complaints (SMCs) among subjects who are currently on sick leave due to symptoms of chronic pain, fatigue, depression, anxiety, and insomnia. METHODS: This was a cross-sectional study, subjects (n = 167) who were currently on sick leave were asked to complete an extensive survey consisting of the following: items addressing their sociodemographics, one item from the SF-8 health survey measuring pain, Chalder Fatigue Questionnaire, Hospital Anxiety and Depression Scale, Insomnia Severity Index, and Everyday Memory Questionnaire - Revised. General linear modeling was used to analyze variables associated with SMCs. RESULTS: Symptoms of fatigue (p-value < 0.001) and anxiety (p-value = 0.001) were uniquely and significantly associated with perceived memory failures. The associations with symptoms of pain, depression, and insomnia were not statistically significant. CONCLUSIONS: Subjective memory complaints should be recognized as part of the complex symptomatology among patients who report multiple symptoms, especially in cases of fatigue and anxiety. Self-report questionnaires measuring perceived memory failures may be a quick and easy way to incorporate and extend this knowledge into clinical practice.

The role of stress in absenteeism: cortisol responsiveness among patients on long-term sick leave.

OBJECTIVE: This study aimed to (1) See whether increased or decreased variation relate to subjective reports of common somatic and psychological symptoms for a population on long-term sick leave; and (2) See if this pattern in variation is correlated with autonomic activation and psychological appraisal. METHODS: Our participants (n = 87) were referred to a 3.5-week return-to-work rehabilitation program, and had been on paid sick leave >8 weeks due to musculoskeletal pain, fatigue and/or common mental disorders. An extensive survey was completed, addressing socio-demographics, somatic and psychological complaints. In addition, a physician and a psychologist examined the participants, determining baseline heart rate, medication use and SCID-I diagnoses. During the 3.5-week program, the participants completed the Trier Social Stress Test for Groups. Participants wore heart rate monitors and filled out Visual Analogue Scales during the TSST-G. RESULTS: Our participants presented a low cortisol variation, with mixed model analyses showing a maximal increase in free saliva cortisol of 26% (95% CI, 0.21-0.32). Simultaneously, the increase in heart rate and Visual Analogue Scales was substantial, indicating autonomic and psychological activation consistent with intense stress from the Trier Social Stress Test for Groups. CONCLUSIONS: The current findings are the first description of a blunted cortisol response in a heterogeneous group of patients on long-term sick leave. The results suggest lack of cortisol reactivity as a possible biological link involved in the pathway between stress, sustained activation and long-term sick leave.

Work-family conflict, psychological distress, and sleep deficiency among patient care workers.

This study examined whether work-family conflict was associated with sleep deficiencies, both cross-sectionally and longitudinally. In this two-phase study, a workplace health survey was completed by a cohort of patient care workers (n = 1,572). Additional data were collected 2 years later from a subsample of the original respondents (n = 102). Self-reported measures included work-family conflict, workplace factors, and sleep outcomes. The participants were 90% women, with a mean age of 41 ± 11.7 years. At baseline, after adjusting for covariates, higher levels of work-family conflict were significantly associated with sleep deficiency. Higher levels of work-family conflict also predicted sleep insufficiency nearly 2 years later. The first study to determine the predictive association between work-family conflict and sleep deficiency suggests that future sleep interventions should include a specific focus on work-family conflict.