Low Back Pain
Conditions
Keywords
Low back pain, Return to work, Sickness absence, Rehabilitation, Occupational intervention
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALOccupational intervention
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
OTHERUsual care
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
Sponsors
Bispebjerg Hospital
Frederiksberg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Working age adults 18-65 * Low back pain (current episode of 2-4 weeks) * Self-reported physically demanding work * Sick-listed or at risk * Speak, read and understand Danish * Accept workplace visit by the occupational physicians * Be in gainful employment for at last 30 hours/week
Exclusion criteria
* Severe somatic or psychiatric comorbidity * Pregnancy * Cancer or metastatic disease * LBP treatment or referral to outside providers (e.g. back-surgery) * Contraindications for having a MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accumulated duration of self-assessed sick leave due to LBP | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fear Avoidance Beliefs scores | 6 months | Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured. |
| Changes in pain level | 6 months | 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). |
| Change in Disability | 6 months | The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability. |
| Satisfaction with the intervention | 6 months | Measured on an 11-point NRS with the anchors not at all satisfied to extremely satisfied. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Predictors of outcome | Baseline | 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). |
| MRI findings | Baseline | Degree of degenerative MRI findings in the lumbar spine predicts outcome (sick leave) |
| Accumulated duration of self-assessed sick leave due to LBP | 12 months | — |
Countries
Denmark
Outcome results
None listed