The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Conditions
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Surgery, Physical Disability, Low Back Pain, Recurrent

Intervention / Treatment
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* Behavioral: Rehabilitation with a biopsychosocial focus
* Behavioral: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>usual care | Behavioral: Control group<br>* usual care<br>|
| Experimental: Intervention group<br>Rehabilitation with a biopsychosocial focus | Behavioral: Rehabilitation with a biopsychosocial focus<br>* Rehabilitation with a biopsychosocial focus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 1 week | 
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 6 weeks | 
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 3 months | 
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 6 months | 
| Oswestry Disability Index (ODI) | questionnaire measuring disability related to low back pain | Postoperative: 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating scale (NRS) | 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.) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| Tampa scale for Kinesiophobia (TSK) | 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.) | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| Pain Catastrophizing scale (PCS) | questionnaire measuring catastrophizing | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| Depression Anxiety stress scale (DASS) | questionnaire measuring depression | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| EuroQol five dimensions questionnaire (EQ-5D) | questionnaire measuring general health | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| Sit-to-stand | time to perform 5 times sit-to-stand-to-sit | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| Patient Specific Functional Scale (PSFS) | 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. | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year | 
| Return-to-work | questionnaire on work resumption | Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year |