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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06030570
Other study ID # S67679
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 22, 2023
Est. completion date December 2024

Study information

Verified date September 2023
Source KU Leuven
Contact Sofie Rummens, MD
Phone 003216338700
Email sofie.rummens@uzleuven.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this research project is to evaluate the effectiveness of the current interdisciplinary rehabilitation program (Revita) and follow-up trajectory for chronic lumbar spine disorders in the University Hospitals Leuven.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Adults, age > 18 years - Spine problem for > 6 weeks, needing interdisciplinary care (risk factors, failure of first line treatment, etc) - Inclusion in Revita program - Informed consent to participate Exclusion criteria - Patients without sufficient understanding of the Dutch language - Unable to participate in 2h rehabilitation sessions with exercises

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rehabilitation program (Revita)
Multidisciplinary programs in an outpatient hospital setting are coordinated by specialists in Physical and Rehabilitation Medicine. These programs combine a physical part (e.g., specific exercises, manual techniques) with at least one other element (psychological, social, educational or occupational intervention). In a multidisciplinary spine rehabilitation program, a maximum of 36 sessions over a maximum time period of 6 months is offered. Afterwards, a (monodisciplinary) follow-up trajectory (K15) is possible, consisting of maximum 104 sessions a year.

Locations

Country Name City State
Belgium University Hospitals Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Oswestry Disability Index (ODI) Change in functional impairment (before vs. after rehabilitation program)
minimum score: 0 maximum score: 100 a higher score corresponds with more functional impairment
baseline - 6 months - 1 year
Primary Change in pain Change in numeric rating scale (NRS) for low back/leg pain (before vs. after rehabilitation program)
minimum score: 0 maximum score: 10 a higher score corresponds with more pain
baseline - 6 months - 1 year
Secondary Effect on quality of life Change in EuroQoL 5D (before vs. after rehabilitation program)
5 items with 3 levels Scale to assess health: 0-100 a higher score corresponds with better health
baseline - 6 months - 1 year
Secondary Effect on risk stratification tool Change in Örebro score (before vs. after rehabilitation program)
minimum score: 0 maximum score: 100 a higher score corresponds with a higher risk profile
baseline - 6 months - 1 year
Secondary Effect on anxiety and depression Change in Hospital Anxiety and Depression Scale (HADS) (before vs. after rehabilitation program)
minimum score: 0 maximum score: 21 (anxiety) - 21 (depression) a higher score corresponds with a higher suspicion for anxiety/depression
baseline - 6 months - 1 year
Secondary Effect on kinesiophobia Change in Tampa scale for Kinesiophobia (TSK) score (before vs. after rehabilitation program)
minimum score: 17 maximum score: 68 a higher score corresponds with an increasing degree of kinesiophobia
baseline - 6 months - 1 year
Secondary Effect on fear-avoidance beliefs Change in Fear Avoidance Beliefs Questionnaire (FABQ) score (before vs. after rehabilitation program)
minimum score: 0 maximum score: 96 a higher score corresponds with stronger fear avoidance beliefs
baseline - 6 months - 1 year
Secondary Effect on body awareness Change in Fremantle Back Awareness Scale Questionnaire score (before vs. after rehabilitation program)
minimum score: 0 maximum score: 36 a higher score corresponds with a worse back-specific body perception
baseline - 6 months - 1 year
Secondary Treatment experience Patient Global impression of change (PGIC)
minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change
6 months - 1 year
Secondary Return to Work self-efficacy "the Return to Work Self-Efficacy" questionnaire
minimum score: 1 maximum score: 6 a higher score corresponds with a higher level of self-efficacy
baseline - 6 months - 1 year
Secondary Return to work number of days to return to work baseline - 6 months - 1 year
Secondary Effect on functioning Change in Patient Specific Functional scale (PSFS)
minimum score: 0 maximum score: 10 a higher score corresponds with a better functional level
baseline - 6 months - 1 year
Secondary Effect on medication use Change in Medication Quantification Scale (MQS)
a higher score corresponds with a higher medication use
baseline - 6 months - 1 year
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