Effect of an Interdisciplinary Spine Rehabilitation Program

Low Back Pain Clinical Trial

— PROGRESS  

Official title:

PROGRESS: The Effect of an Interdisciplinary Program for Rehabilitation for Spinal Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06030570
• Other study ID #: S67679
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Low Back Pain
• Spinal Diseases
• Spine Disease

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