The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Universitaire Ziekenhuizen KU Leuven

Status: Active, not recruiting

Conditions: Surgery; Physical Disability; Low Back Pain, Recurrent

Treatments: Behavioral: Control group; Behavioral: Rehabilitation with a biopsychosocial focus

Study type: Interventional

Funder types: Other

Identifiers

NCT03427099

KU/UZ Leuven S60109 - 3

Details and patient eligibility

About

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.

Full 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).

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Control group

Active Comparator group

Description:

usual care

Treatment:

Behavioral: Control group

Intervention group

Experimental group

Description:

Rehabilitation with a biopsychosocial focus

Treatment:

Behavioral: Rehabilitation with a biopsychosocial focus