Non-specific low back pain Musculoskeletal Diseases Non-specific low back pain (nsLBP)
Conditions
Interventions
Randomisation is done at the level of the participating physical therapy practices. Participating primary care physical therapy practices will be randomized by an independent researcher to either the
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Applying for physical therapy for LBP 2. Aged 18 years or older 3. Non-specific LBP, defined as pain in the lumbosacral region (sometimes associated with radiating pain to the buttock or leg) in the absence of an identifiable underlying cause 4. Possessing a smartphone or tablet with access to the internet 5. Able to communicate in the Dutch language fluently
Exclusion criteria
Exclusion criteria: 1. Diagnosed with LBP due to a possible specific cause trough medical imaging or a doctor (e.g. osteoporotic fractures, spinal nerve compromise, malignancy, ankylosing spondylitis, canal stenosis, or severe spondylolisthesis) 2. Serious comorbidities (i.e. malignancy, stroke) 3. Pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Short-term improvement of low-back-related physical functioning assessed using the Oswestry Disability Index version 2.1a at the baseline, after 3 months, after 12 months and after 24 months 2. Long-term reduction of low-back-pain-related costs assessed using 8 retrospective cost questionnaires every 3 months from the baseline to the 24 months follow-up. Cost effectiveness is determined after 12 months and after 24 months, based on patient's healthcare utilisation and (unpaid) productivity losses due to LBP (based on responses to the cost questionnaires). Healthcare utilization will be valued using Dutch standards costs. If these are unavailable, prices reported by professional organizations will be used. Unpaid productivity losses will be valued in accordance with the “Dutch Manual of Costing”. Paid productivity losses comprise of both sickness absence and presenteeism (i.e. reduced productivity while at work). Sickness absence will be valued in accordance with the “Friction Cost Approach” (FCA), with a friction period of 23 weeks and an elasticity of 0.8, using age- and gender-specific price weights. The FCA assumes that production losses are confined to the “friction period” (i.e. time needed to replace a sick worker) and that a 100 percent loss of labor input corresponds with an 80 percent reduction in productivity (i.e. an elasticity of 0.8)(63). The participants’ level of presenteeism will be measured using the “World Health Organization – Work Performance Questionnaire” as well as the “Productivity and Disease Questionnaire”, and valued using age- and gender specific price weights. The costs of e-Exercise LBP will be estimated using a bottom-up microcosting approach. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/04/2021: The following will be assessed at the baseline, after 3 months, after 12 months and at the 24 months follow-up: 1. Pain intensity, assessed using the Numeric Pain Rating Scale (NPRS) 2. Physical activity, assessed using Activ8 activity monitor 3. Adherence to prescribed home exercises, assessed using Exercise Adherence Rating Scale (EARS) and Utrecht Home-based Exercise Adherence Questionnaire (UHAQ). EARS is a self-reported questionnaire and UHAQ is an interview-based questionnaire, which will be used by the physical therapist during face-to-face care, to determine qualitative performance of the recommended recommended home exercises and the agreement between recommended home exercises and patient reported adherence 4. Psychological function, assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS) 5. Self-efficacy, assessed using the Generalized Self-Efficacy (GSE) scale 6. Self-management skills, assessed using the Dutch version of the Pain Activation Measure (PAM13-Dutch) 7. Health-related quality of life, assessed using the EQ-5D-5L 8. Number of recurrent low back pain episodes, assessed every 3 months from the baseline until the 24 months follow-up. This is measured using the number of self-reported LBP episodes during the follow-up period (a recurrent LBP episode is defined as return of LBP with a minimum duration of 24 hours with a minimum pain intensity of 3 or more on the NRS since the date of recovery. For recovery, a minimum duration of 4 weeks pain-free is used) Previous secondary outcome measures: The following will be assessed at the baseline, after 3 months, after 12 months and at the 24 months follow-up: 1. Pain intensity, assessed using the Numeric Pain Rating | — |
Countries
Netherlands
Contacts
Public ContactTjarco;Remco Koppenaal;Arensman
;
Outcome results
None listed