low back pain
Conditions
Interventions
The selection of adequate patients in the diagnostic phase, as well as the
invasive treatment of patients is usual care, as described in the Guideline low
back pain (NVA, NVvN et al. 2011).
Based
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Chronic (more than 3 months) mechanical low back pain symptoms, age between 18 and 70 years, no improvement of symptoms after at least three months of conservative treatment according to the Dutch guidelines for non-specific low back pain (GP care (advise to stay active and pain medication) and exercise therapy) in primary care. Patients must answer *yes* on the question *is there a 50% or more reduction in pain?*, 30 minutes after the test block, or the disc provocation test must be positive.
Exclusion criteria
Exclusion criteria: Patients with severe psychiatric or severe psychological problems, pregnant women, and patients who are not able to complete the questionnaires. Anticoagulant drug therapy and/or disturbed coagulation Patients with less than 50% reduction in pain after the test block, or a negative disc provocation test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be measuring pain intensity with the NRS, and the perceived improvement in functioning, at 3 months after the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Follow-up will be 12 months. All patients participating in the trial will complete questionnaires at baseline and after 3, 6, 9, and 12 months. (The difference in pain intensity and the perceived improvement in functioning will also be measured at 3 and 6 weeks after the intervention). We will ask patients to complete web-based questionnaires. If patients do not have access to the internet or prefer hard copies, we will provide these. The core set of primary outcomes recommended for low back pain research (Bombardier 2000) will be used: global perceived recovery (7-point scale), functional status (Oswestry Disability Index (ODI)), and pain intensity (leg and back) (11-point NRS). Also general health (Rand-36), quality of life (EuroQol-5D) and patient satisfaction (NRS) are measured. Patient expectation will be measured at baseline, using the CEQ. The Multidimensional Pain Inventory (MPI) will be used to assess a number of dimensions of the chronic pain experience, including pain intensity, emotional distress, cognitive and functional adaptation, and social support. Pain cognition and coping will be measured with the Pain Cognition List and the Pain Coping Inventory. Furthermore, psychological questionnaires will be used at baseline to be able to exclude patients with severe psychiatric or psychological complaints: the 4 Dimensional Symptoms Questionnaire (4DSQ), the Chronic Pain Acceptance Questionnaire (CPAQ) and the Hospital Anxiety Depression Scale (HADS). The economic evaluations will be performed according to the intention-to-treat principle and from a societal perspective. Costs of the interventional procedures, multidisciplinary pain program, other health care costs, patient and family costs, and production losses will be included and relevant data collected using cost diaries. | — |
Countries
Netherlands
Outcome results
None listed