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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
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Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.
This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.
The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.
The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.
The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.
Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.
The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occupational intervention | Experimental | Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist. |
|
| Usual care | Active Comparator | Intervention from the patient's general physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occupational intervention | Behavioral | Early coordinated occupational intervention and supervision in physically activities by a physiotherapist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accumulated duration of self-assessed sick leave due to LBP | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain level | Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal, 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst LBP possible). | 6 months |
| Changes in Fear Avoidance Beliefs scores |
| Measure | Description | Time Frame |
|---|---|---|
| Accumulated duration of self-assessed sick leave due to LBP | 12 months | |
| MRI findings | Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave) | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Kryger, MD, PhD | University Hospital Frederiksberg and Bispebjerg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital | Copenhagen | Frederiksberg | 2000 F | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22920158 | Background | Jensen C, Jensen OK, Nielsen CV. Sustainability of return to work in sick-listed employees with low-back pain. Two-year follow-up in a randomized clinical trial comparing multidisciplinary and brief intervention. BMC Musculoskelet Disord. 2012 Aug 25;13:156. doi: 10.1186/1471-2474-13-156. | |
| 33181779 | Derived |
| Label | URL |
|---|---|
| Department of Occupational and Environmental Medicine, Copenhagen University, Hospital Bispebjerg and Frederiksberg | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Usual care | Other | Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician |
|
Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured. |
| 6 months |
| Change in Disability | The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability. | 6 months |
| Satisfaction with the intervention | Measured on an 11-point NRS with the anchors "not at all satisfied" to "extremely satisfied". | 6 months |
| Predictors of outcome | Baseline questionnaires scores (Pain categorization (PainDETECT®), Numeric Pain Rating Scale (NPRS), Fear Avoidance Beliefs, 36-item short-form health-survey (SF36) and Roland Morris Disability) are associated with outcome (sick leave). | Baseline |
| Rosenberg NR, Petersen SB, Begtrup LM, Flachs EM, Petersen JA, Hansen BB, Kirkeskov L, Bliddal H, Christensen R, Kristensen LE, Fournier GL, Kryger AI. Early Occupational Intervention for People with Low Back Pain in Physically Demanding Jobs: 1-year Follow-up Results of the Randomized Controlled GOBACK Trial. Spine (Phila Pa 1976). 2021 Mar 15;46(6):347-355. doi: 10.1097/BRS.0000000000003793. |
| 31419219 | Derived | Hansen BB, Kirkeskov L, Begtrup LM, Boesen M, Bliddal H, Christensen R, Andreasen DL, Kristensen LE, Flachs EM, Kryger AI. Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial. PLoS Med. 2019 Aug 16;16(8):e1002898. doi: 10.1371/journal.pmed.1002898. eCollection 2019 Aug. |
| 31122982 | Derived | Petersen J, Kirkeskov L, Hansen BB, Begtrup LM, Flachs EM, Boesen M, Hansen P, Bliddal H, Kryger AI. Physical demand at work and sick leave due to low back pain: a cross-sectional study. BMJ Open. 2019 May 22;9(5):e026917. doi: 10.1136/bmjopen-2018-026917. |
| 25887302 | Derived | Hansen BB, Kirkeskov L, Christensen R, Begtrup LM, Pedersen EB, Teilya JF, Boesen M, Fournier GL, Bliddal H, Kryger AI. Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial. Trials. 2015 Apr 16;16:166. doi: 10.1186/s13063-015-0684-3. |
| The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |