Low Back PainPROGRESSNCT06030570
Effect of an Interdisciplinary Spine Rehabilitation Program
An observational study of Low Back Pain and Spine Disease, run by KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Spine Disease
- What is being tested?
- Rehabilitation program (Revita)
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Aug 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic spine problems in which a multidisciplinary approach is needed
Who may be able to join
- Adults, age > 18 years
- Spine problem for > 6 weeks, needing interdisciplinary care (risk factors, failure of first line treatment, etc)
- Informed consent to participate
Who cannot join
- Patients without sufficient understanding of the Dutch language
- Unable to participate in 2h rehabilitation sessions with exercises
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Sofie Rummens, MD, sofie.rummens@uzleuven.be
About this study
Official title: PROGRESS: The Effect of an Interdisciplinary Program for Rehabilitation for Spinal Disorders
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.
- Conditions
- Low Back Pain, Spine Disease
- Being tested
- Rehabilitation program (Revita)
- Medical subject headings
- Low Back Pain, Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation program (Revita)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with low back pain | Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA) Receives: Other: Rehabilitation program (Revita) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
Secondary outcomes (11)
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
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
Treatment experience
Patient Global impression of change (PGIC)
minimum score: 1 maximum score: 7 a higher score corresponds with less impression of change
Measured: 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
Return to work
number of days to return to work
Measured: baseline - 6 months - 1 year
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
Measured: baseline - 6 months - 1 year
Effect on medication use
Change in Medication Quantification Scale (MQS)
a higher score corresponds with a higher medication use
Measured: baseline - 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 posted11 Sep 2023
- Study start22 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofie Rummens, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030570
- Sponsor's protocol ID
- S67679
- Acronym
- PROGRESS
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROGRESS: The Effect of an Interdisciplinary Program for Rehabilitation for Spinal Disorders
- ClinicalTrials.gov ID
- NCT06030570
- Acronym / sponsor ID
- PROGRESS / S67679
- Conditions
- Low Back Pain, Spine Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Sep 2023 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with low back pain | – | Other: Rehabilitation program (Revita)Patients of University Hospitals Leuven participating in the interdisciplinary spine rehabilitation program (REVITA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic spine problems in which a multidisciplinary approach is needed
Key inclusion criteria (3 listed)
- Adults, age > 18 years
- Spine problem for > 6 weeks, needing interdisciplinary care (risk factors, failure of first line treatment, etc)
- Informed consent to participate
Key exclusion criteria (2 listed)
- Patients without sufficient understanding of the Dutch language
- Unable to participate in 2h rehabilitation sessions with exercises
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 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. | Other | Subjects with low back pain |
Primary outcome
Change in Oswestry Disability Index (ODI)
Time frame: baseline - 6 months - 1 year
Change in functional impairment (before vs. after rehabilitation program) minimum score: 0 maximum score: 100 a higher score corresponds with more functional impairment
Change in pain
Time frame: baseline - 6 months - 1 year
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
11 secondary outcomes
Effect on quality of life
Time frame: baseline - 6 months - 1 year
Effect on risk stratification tool
Time frame: baseline - 6 months - 1 year
Effect on anxiety and depression
Time frame: baseline - 6 months - 1 year
Effect on kinesiophobia
Time frame: baseline - 6 months - 1 year
Effect on fear-avoidance beliefs
Time frame: baseline - 6 months - 1 year
Effect on body awareness
Time frame: baseline - 6 months - 1 year
Treatment experience
Time frame: 6 months - 1 year
Return to Work self-efficacy
Time frame: baseline - 6 months - 1 year
Return to work
Time frame: baseline - 6 months - 1 year
Effect on functioning
Time frame: baseline - 6 months - 1 year
Effect on medication use
Time frame: baseline - 6 months - 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Spine Disease, run by 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 2 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Rummens, MD (003216338700, sofie.rummens@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) (time frame: baseline - 6 months - 1 year). The study lists 2 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 23 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.