Musculoskeletal Pain Clinical Trial
— HiAforskOfficial title:
Health in Work - a Measure for Increased Coping and Work Inclusion - An Analysis of Effect of Preventive Information Given at the Workplace - Part 1: Quantitative Data Collection
Verified date | November 2023 |
Source | University Hospital of North Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Health in work - a measure for increased coping and work participation -An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study. The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.
Status | Active, not recruiting |
Enrollment | 1383 |
Est. completion date | July 1, 2035 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria for workplaces/workplace units: - minimum 8 employees - accessible data on sickness absence (both self- and physician-certified) in the workplace/workplace unit for the past two years prior to inclusion Inclusion Criteria for the individual employees: - all staff employed > 20% in the participating workplaces/workplace units - Norwegian-speaking Exclusion Criteria for workplaces/workplace units: - ongoing profound reorganisation at the workplace/workplace unit (>20% change of employees within workplace unit) Exclusion Criteria for the individual employees: - none |
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital of Nothern Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | Helse Nord, Norwegian Labour and Welfare Administration, University of Tromso |
Norway,
Hoper AC, Terjesen CL, Fleten N. Comparing the New Interdisciplinary Health in Work Intervention With Conventional Monodisciplinary Welfare Interventions at Norwegian Workplaces: Protocol for a Pragmatic Cluster Randomized Trial. JMIR Res Protoc. 2022 Apr 7;11(4):e36166. doi: 10.2196/36166. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level) | Sickness absence data from workplace-registers; Difference-in-difference analyses of sickness absence within and between intervention and control group (% of planned workdays). | Time period 24 months prior to randomization compared to the time period 12-24 months after randomization | |
Primary | Change in healthcare utilization | Difference-in-difference analyses of health service refunds from National register of control and health service refunds (KUHR database, Helsedirektoratet) and Norwegian Patient Register (NPR, Helsedirektoratet) within and between intervention and control group. | Time period 24 months prior to randomization compared to the time period 12-24 months after randomization | |
Primary | Change in health-related quality of life (HRQoL) by EQ-5D-5L utility value, including EQ-VAS score | Difference-in-difference analyses of HRQoL within and between intervention and control groups by use of EQ-5D/EQ-VAS.The EuroQol descriptive system EQ-5D-5L describes health along five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Participants rate each dimension along five severity levels from no problems (1) to extreme problems (5).The resulting combination (5 to the power of 5 = 3,125 possible combinations) is attached a utility value based on a national value set on a scale from 1(best health) to a 0(or even lower) for worst health.A Norwegian value set is currently being developed.The EQ-VAS (EuroQol vertical visual analogue scale;0 as worst,100 as best possible score) is an integral part that has to be included when using the EQ-5D questionnaire.It offers important, complementary information on respondents' valuations of their HRQoL that are not necessarily captured by use of the 5 dimensional descriptive part of this instrument. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization | |
Primary | Health-economic analyses | Cost-effectiveness analysis based on primary outcome 3 and cost-benefit analyses based on primary outcome 1 and 2.
Comparing the intervention arms in terms of incremental costs based on direct- and indirect costs related to interventions throughout the intervention period. |
Time period 24 months prior to randomization through 24 months after randomization | |
Secondary | Change in physician-certified sickness absence rates (individual level) | Data from the Norwegian national register of sickness absence (NAV sykefraværsregister); Difference-in-difference analyses of individual sickness absence rates within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Time period 24 months prior to randomization compared to the time period 12-24 months after randomization | |
Secondary | Change in self-certified sickness absence rates (individual level) | Data from the questionnaires; Difference-in-difference analyses of self-certified sickness absence rates within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization | |
Secondary | Change in psychosocial work environment by Demand-Control-Support-Questionnaire score | Demand-Control-Support-Questionnaire, short Swedish version (Theorell et al 1991), 11 items on demand and control, and 6 items on support, each with scores 1-4, subscales for demand, control and support. Low scores indicate low demand, control and support. Difference-in-difference analyses of psychosocial work environment within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization | |
Secondary | Change in social support from colleagues by NDSS-16 score | Nondirective and Directive support Survey (NDSS-16). 16 items scored 1-5. Subscales for directive support (8 items, scale 8-40) and non-directive support (8 items, scale 8-40), the higher the score the more support. Difference-in-difference analyses of social support from colleagues within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization | |
Secondary | Change in job satisfaction by GJS score | Global Job Satisfaction (GJS). Quinn and Shepard, 1974, 5 items scores 1-5 and 1-3, highest number indicate best job satisfaction. Difference-in-difference analyses of job satisfaction within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization | |
Secondary | Change in subjective health complaints by SHC score | Subjective Health Complaints (SHC), Eriksen et al. 1999, 29 items scored with 4 levels from 0 (no complaints) to 3 (serious complaints), total score and subscale for mental complaints and musculoskeletal pain. Difference-in-difference analyses of subjective health complaints within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization | |
Secondary | Change in health anxiety by Whitheley index score | Change in score of the revised version of the Whiteley Index-6 scale (WI-6-R).The WI-6-R includes questions regarding health anxiety covering different dimensions such as self-experienced health concern, frequency and severity of health concerns, influence of media on subjective health concerns and experiencing of health symptoms. Each response is graded on a 0-4 Likert Scale, where "0=not at all" to "4=a great deal", enabling to calculate a product score of maximum 24, a higher value indicating higher level of health anxiety.
Difference-in-difference analyses of health anxiety within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. |
Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization; comparison with Tromsø Study 7 | |
Secondary | Change in Satisfaction of life by SWLS score | Satisfaction of life scale (SWLS). Five items where each has response options ranged from 1 (strongly disagree) to 7 (strongly agree), sum score is calculated. The higher the sum score, the higher is the satisfaction of life. Change in sum score of the first 3 items (the last two are sensitive to age). Difference-in-difference analyses of subjective health complaints within and between intervention and control group. Possible impact of Covid-19 pandemic will be addressed. | Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05046249 -
Swiss Chiropractic Cohort (Swiss ChiCo) Study: A Nationwide Practice-Based Research Network Project
|
||
Completed |
NCT04053686 -
An Intervention to Reduce Prolonged Sitting in Police Staff
|
N/A | |
Completed |
NCT05071469 -
Comparison of Two Different Treatment Methods
|
N/A | |
Recruiting |
NCT04285112 -
SPRINT: Signature for Pain Recovery IN Teens
|
||
Enrolling by invitation |
NCT05946018 -
Physiatrist Ergonomic Intervention on Work Related Musculoskeletal Pain in Surgeons
|
N/A | |
Active, not recruiting |
NCT03537573 -
Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care
|
N/A | |
Completed |
NCT02920853 -
Enhanced Biofeedback for Musculoskeletal Pain
|
N/A | |
Completed |
NCT02438384 -
Patient Education to Improve Pain Management in Older Adults With Acute Musculoskeletal Pain: A Pilot Randomized Trial
|
N/A | |
Active, not recruiting |
NCT02378519 -
Interactive Web-based Program and CBT-coaching With Physiotherapy for Patients With Chronic Musculoskeletal Pain
|
N/A | |
Enrolling by invitation |
NCT02485795 -
Observational Study of the Impact of Genetic Testing on Healthcare Decisions and Care in Interventional Pain Management
|
N/A | |
Completed |
NCT02121587 -
Osteopathy, Mindfulness and Acceptance-based Programme for Patients With Persistent Pain
|
N/A | |
Terminated |
NCT01992770 -
A Stepped-care Model of Tailored Behavioural Medicine Pain Intervention in Primary Care
|
N/A | |
Completed |
NCT04575974 -
Lifestyle in Adolescence and Persistent Musculoskeletal Pain in Young Adulthood
|
||
Recruiting |
NCT05220202 -
MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression
|
N/A | |
Completed |
NCT04029285 -
Exergaming Experience of Older People With Chronic Musculoskeletal Pain
|
N/A | |
Completed |
NCT06069011 -
Direct Access Physiotherapy in the Pediatric Emergency Department
|
N/A | |
Completed |
NCT04704375 -
Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation Therapy on Low Back Pain in Adults.
|
N/A | |
Completed |
NCT04498663 -
The Pain & Stress Interview Study for People With Chronic Pain
|
N/A | |
Completed |
NCT04009369 -
Impacts of Physiotherapy Services in a Quebec Emergency Department
|
N/A | |
Not yet recruiting |
NCT06119698 -
Improving Health for Older Adults With Pain Through Engagement
|
N/A |