The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Not Applicable

Active, not recruiting

• Conditions: Surgery; Low Back Pain, Recurrent; Physical Disability
• Interventions: Behavioral: Rehabilitation with a biopsychosocial focus; Behavioral: Control group

• Registration Number: NCT03427099
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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).

Study Timeline

• Study Start: 2018-01-03
• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-09
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-28
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	Rehabilitation with a biopsychosocial focus	Rehabilitation with a biopsychosocial focus
Control group	Control group	usual care

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	Postoperative: 1 year	questionnaire measuring disability related to low back pain

Secondary Outcome Measures

Name	Time	Method
Return-to-work	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year	questionnaire on work resumption
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.)
EuroQol five dimensions questionnaire (EQ-5D)	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year	questionnaire measuring general health
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.)
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.
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.
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.

Trial Locations

Locations (1)

UZ/KU Leuven; 🇧🇪 Leuven, Vlaams Brabant, Belgium