Low Back Pain, Recurrent, Physical Disability, Surgery
Conditions
Brief summary
To compare the current rehabilitation pathway with the implementation of a newly developed rehabilitation pathway for patients with a single and double level lumbar arthrodesis.
Detailed description
This involves a prospective interventional study with a one year follow-up. The investigators will compare the outcomes of the current rehabilitation pathway with a newly developed (based on systematic review and delphi study) rehabilitation pathway for patients with a single and double level lumbar arthrodesis. The usual care group (n= 30) will be compared with the intervention group (n= 30).
Interventions
BEHAVIORALRehabilitation with a biopsychosocial focus
Rehabilitation with a biopsychosocial focus
BEHAVIORALControl group
usual care
Sponsors
KU Leuven
UHasselt
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Lumbar single and double level arthrodesis * Signed informed consent * Posterior Lumbar interbody fusion (PLIF), Posterolateral lumbar fusion (PLF) and Transforaminal lumbar interbody fusion (TLIF)
Exclusion criteria
* Previous arthrodesis in the lumbar spine * Musculoskeletal disorders which interfere with functional outcome, f.e. severe lower limb problems not related to the lumbar surgery * Presence of one of the following pathologies:Parkinson Multiple sclerose (MS), Cerebral vascular accident (CVA), Peripheral neuropathies, Circulatory disorders, Gout, Rheumatoid disorders, Neoplasia, Septic arthritis, Pregnancy, Vestibular disorder, Infectious diseases * Accident at work or lawsuit * Low cognition * Not able to speak Dutch
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | Postoperative: 1 week | questionnaire measuring disability related to low back pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tampa scale for Kinesiophobia (TSK) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | The Tampa Scale for Kinesiophobia (TSK), which ranges from 17 ('low') to 68 ('high'), was completed to identify fear of (re)injury following movements or activities in the participants with low back pain (Kori, K.S., Miller, R.P., Todd, D.D. (1990). Kinesiophobia: A new view of chronic pain behaviour. Pain 3, 35-43.) |
| Pain Catastrophizing scale (PCS) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | People are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is yielded (ranging from 0-52), along with three subscale scores assessing rumination, magnification and helplessness. |
| Depression Anxiety stress scale (DASS) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | A higher score on the DASS indicates greater severity or frequency of negative emotional symptoms, ranging from 0-126. |
| Numeric Rating scale (NRS) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | Severity of low back pain will be scored by the Numerical Rating Scale (NRS) from zero ('no pain') to ten ('worst pain imaginable') (Jensen, M.P., Karoly, P., Braver, S. (1986). The measurement of clinical pain intensity: a comparison of six methods. Pain 27, 117-126.) |
| Sit-to-stand | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | time to perform 5 times sit-to-stand-to-sit |
| Patient Specific Functional Scale (PSFS) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | The PSFS is a questionnaire measuring disability related to low back pain. The Scale is developed by Stratford, P., Gill, C., Westaway, M., & Binkley, J. (1995). Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada, 47, 258-263. Three to five activities are scored on a Visual Analogue Scale (VAS) from 0 ('not able to perform activity') to 10 ('can perform activity without any problems'). Lower scores indicate a worse outcome on function. The total score is the sum of the VAS scores of the 3 to 5 activities. |
| Return-to-work | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | questionnaire on work resumption |
| EuroQol five dimensions questionnaire (EQ-5D) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | questionnaire measuring general health |
Countries
Belgium
Outcome results
None listed