Physical DisabilityNCT03427099
The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis
A study testing Rehabilitation with a biopsychosocial focus in people with Physical Disability and Low Back Pain, Recurrent, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Physical Disability, Low Back Pain, Recurrent, Surgery
- What is being tested?
- Rehabilitation with a biopsychosocial focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Jan 2018to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar single and double level arthrodesis
- Signed informed consent
- Posterior Lumbar interbody fusion (PLIF), Posterolateral lumbar fusion (PLF) and Transforaminal lumbar interbody fusion (TLIF)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Physical Disability, Low Back Pain, Recurrent, Surgery
- Being tested
- Rehabilitation with a biopsychosocial focus, Control group
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with a biopsychosocial focusBehavioural
Rehabilitation with a biopsychosocial focus
Control groupBehavioural
usual care
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | usual care Receives: Behavioral: Control group |
| Intervention group | Experimental | Rehabilitation with a biopsychosocial focus Receives: Behavioral: Rehabilitation with a biopsychosocial focus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Measured: Postoperative: 1 week
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Measured: Postoperative: 6 weeks
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Measured: Postoperative: 3 months
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Measured: Postoperative: 6 months
Oswestry Disability Index (ODI)
questionnaire measuring disability related to low back pain
Measured: Postoperative: 1 year
Secondary outcomes (8)
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.)
Measured: 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.)
Measured: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
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.
Measured: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Depression Anxiety stress scale (DASS)
A higher score on the DASS indicates greater severity or frequency of negative emotional symptoms, ranging from 0-126.
Measured: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
EuroQol five dimensions questionnaire (EQ-5D)
questionnaire measuring general health
Measured: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Sit-to-stand
time to perform 5 times sit-to-stand-to-sit
Measured: 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.
Measured: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Return-to-work
questionnaire on work resumption
Measured: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start3 Jan 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, UHasselt
- Responsible party
- Sponsor
- Investigators
- Bart Depreitere, PhD, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenThijs Swinnen, MSc, PT, Principal investigator, Universitaire Ziekenhuizen KU LeuvenTinne Thys, MSc, PT, Principal investigator, Universitaire Ziekenhuizen KU LeuvenWim Dankaerts, PhD, PT, Principal investigator, KU LeuvenSimon Brumagne, PhD, PT, Principal investigator, KU LeuvenPeter Van Wambeke, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenLieven Moke, PhD, MD, Principal investigator, Universitaire Ziekenhuizen KU LeuvenSebastiaan Schelfaut, MD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03427099
- Sponsor's protocol ID
- KU/UZ Leuven S60109 - 3
- Status last verified
- Dec 2023
- First submitted
- 26 Jan 2018
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Developed Perioperative Rehabilitation Pathway Following Lumbar Arthrodesis
- ClinicalTrials.gov ID
- NCT03427099
- Acronym / sponsor ID
- KU/UZ Leuven S60109 - 3
- Conditions
- Physical Disability, Low Back Pain, Recurrent, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, UHasselt
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Control groupusual care |
| Intervention group | Experimental | Behavioral: Rehabilitation with a biopsychosocial focusRehabilitation with a biopsychosocial focus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lumbar single and double level arthrodesis
- Signed informed consent
- Posterior Lumbar interbody fusion (PLIF), Posterolateral lumbar fusion (PLF) and Transforaminal lumbar interbody fusion (TLIF)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation with a biopsychosocial focusRehabilitation with a biopsychosocial focus | Behavioural | Intervention group |
| Control groupusual care | Behavioural | Control group |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Postoperative: 1 week
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
Time frame: Postoperative: 6 weeks
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
Time frame: Postoperative: 3 months
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
Time frame: Postoperative: 6 months
questionnaire measuring disability related to low back pain
Oswestry Disability Index (ODI)
Time frame: Postoperative: 1 year
questionnaire measuring disability related to low back pain
8 secondary outcomes
Numeric Rating scale (NRS)
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Tampa scale for Kinesiophobia (TSK)
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Pain Catastrophizing scale (PCS)
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Depression Anxiety stress scale (DASS)
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Sit-to-stand
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Patient Specific Functional Scale (PSFS)
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Return-to-work
Time frame: Postoperative: 1 week, 6 weeks, 3 months, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Physical Disability
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Recruiting
Adapting, Implementing and Evaluating the Effectiveness of HARP for People With Disabilities
Disabilities Physical, Falls
RecruitingPhase 2
Targeting Muscle Strength Loss Due to Hospitalization in Older Adults by Blood-flow Restriction Combined With an Electromyography-driven Serious Game.
Hospital Associated Disability, Immobility
Not yet recruiting
Examining the Health Impact of and Promoting Sitting Light Volleyball in the Greater Bay Area
Physial Disabilities
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Depreitere, PhD, MD principal investigator
Universitaire Ziekenhuizen KU Leuven
Thijs Swinnen, MSc, PT principal investigator
Universitaire Ziekenhuizen KU Leuven
Tinne Thys, MSc, PT principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation with a biopsychosocial focus in people with Physical Disability and Low Back Pain, Recurrent, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: Postoperative: 1 week). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.