The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-03

Study Completion Date

2024-12-31

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.

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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).

Conditions

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Physical Disability Low Back Pain, Recurrent Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

usual care

Group Type ACTIVE_COMPARATOR

Control group

Intervention Type BEHAVIORAL

usual care

Intervention group

Rehabilitation with a biopsychosocial focus

Group Type EXPERIMENTAL

Rehabilitation with a biopsychosocial focus

Intervention Type BEHAVIORAL

Rehabilitation with a biopsychosocial focus

Interventions

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Rehabilitation with a biopsychosocial focus

Intervention Type BEHAVIORAL

Control group

usual care

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No