The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Surgery Clinical Trial

Official title:

The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03427099
• Other study ID #: KU/UZ Leuven S60109 - 3
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 3, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain
• Low Back Pain, Recurrent
• Physical Disability
• Surgery

Intervention

Behavioral:
• Rehabilitation with a biopsychosocial focus
Rehabilitation with a biopsychosocial focus
• Control group
usual care

Locations

Country	Name	City	State
Belgium	UZ/KU Leuven	Leuven	Vlaams Brabant

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	KU Leuven, UHasselt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	questionnaire measuring disability related to low back pain	Postoperative: 1 week
Primary	Oswestry Disability Index (ODI)	questionnaire measuring disability related to low back pain	Postoperative: 6 weeks
Primary	Oswestry Disability Index (ODI)	questionnaire measuring disability related to low back pain	Postoperative: 3 months
Primary	Oswestry Disability Index (ODI)	questionnaire measuring disability related to low back pain	Postoperative: 6 months
Primary	Oswestry Disability Index (ODI)	questionnaire measuring disability related to low back pain	Postoperative: 1 year
Secondary	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
Secondary	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
Secondary	Pain Catastrophizing scale (PCS)	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.	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Secondary	Depression Anxiety stress scale (DASS)	A higher score on the DASS indicates greater severity or frequency of negative emotional symptoms, ranging from 0-126.	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Secondary	EuroQol five dimensions questionnaire (EQ-5D)	questionnaire measuring general health	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Secondary	Sit-to-stand	time to perform 5 times sit-to-stand-to-sit	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Secondary	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
Secondary	Return-to-work	questionnaire on work resumption	Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year