Lumbar RadiculopathyNCT06145620
Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery
A study testing Physiotherapy in people with Lumbar Radiculopathy, run by Cardenal Herrera University at 1 site in Spain.
Trial summary
The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2025to Apr 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older, diagnosed with lumbar radiculopathy, and scheduled for surgery. The symptoms will be predominantly leg pain with or without neurological deficit, with surgical decompression justified.
Who cannot join
- Patients currently receiving any other non-pharmacological treatment or physical therapy for the management of lumbar radiculopathy.
- Proposed for surgery with instrumentation (e.g., spinal fusion, arthrodesis).
- Suffering from a chronic pain-related condition (e.g., fibromyalgia, chronic fatigue syndrome).
- Symptoms of spinal cord compression.
- Diagnosed with a malignant tumor.
- Mental illness.
- Previously undergone spinal surgery.
- No access to any internet-enabled device.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
María Dolores Arguisuelas contact
About this study
Official title: Effects of a Prehabilitation Program Based on Therapeutic Exercise, Back Care Education and Neuroscience Pain Education in Patients Undergoing Lumbar Radiculopathy Surgery
The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.
Read the detailed description
So far, there are no previous studies that analyze the effects of a prehabilitation program including therapeutic exercise, back care education and pain neuroscience education through the visualization of videos in patients undergoing lumbar radiculopathy surgery.
This is a multicenter randomized clinical trial aimed at analyzing the effects of a 4 weeks prehabilitation program based on video visualization versus the performance of standardized written exercises in patients undergoing lumbar radiculopathy surgery.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Physiotherapy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
The intervention involves the visualization of different videos explaining the performance of lumbar strengthening exercises, measures for back care, and neuroscience pain education.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic exercise, back care and pain neuroscience education group | Experimental | Not described Receives: Other: Physiotherapy |
| Standarized written exercise group | Active comparator | Not described Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Disability score (0-100). Higher score indicates higher disability.
Measured: 4 weeks
Secondary outcomes (8)
SF-McGill Pain Questionnaire (SF-MGPQ)
Pain score (0-45). Higher score indicates higher pain level
Measured: 4 weeks
Numerical Rating Scale (NRS)
Pain score 0-10. Higher score indicates higher pain intensity.
Measured: 4 weeks
EuroQol-5D (EQ-5D)
Quality of life score (-0.5 to 1).Higher score indicates higher health-related quality of life
Measured: 4 weeks
Fear avoidance beliefs questionnaire (FABQ)
FABQ-Work subscale (ranging from 0 to 42) and FABQ-Physical Activity subscale (ranging from 0 to 24). Higher score indicates more signs of fear avoidance
Measured: 4 weeks
Hospital Anxiety and Depression Scale (HADS)
Anxiety and depression score (0-21). Hhigher score indicates greater symptoms of anxiety and depression.
Measured: 4 weeks
Pain catastrophizing scale (PCS)
pain catastrophizing score (0-52). Higher scores indicate greater pain catastrophizing
Measured: 4 weeks
Tampa scale for kinesiophobia (TSK-11SV)
kinesiophobia score (11-44). Higher scores indicate greater kinesiophobia
Measured: 4 weeks
International Physical Activity Questionnaire (IPAQ)
Physical activity level (MET minutes a week). Higher scores indicate higher physical activity level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardenal Herrera University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARGUISUELAS MARTINEZ MARÍA DOLORES, Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145620
- Sponsor's protocol ID
- CEEI23/459
- Status last verified
- Feb 2025
- First submitted
- 17 Nov 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15.
PubMed 29253630Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4.
PubMed 23478459Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053.
PubMed 30921465
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Prehabilitation Program Based on Therapeutic Exercise, Back Care Education and Neuroscience Pain Education in Patients Undergoing Lumbar Radiculopathy Surgery
- ClinicalTrials.gov ID
- NCT06145620
- Acronym / sponsor ID
- CEEI23/459
- Conditions
- Lumbar Radiculopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cardenal Herrera UniversityUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Nov 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 purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.
Detailed description
So far, there are no previous studies that analyze the effects of a prehabilitation program including therapeutic exercise, back care education and pain neuroscience education through the visualization of videos in patients undergoing lumbar radiculopathy surgery.
This is a multicenter randomized clinical trial aimed at analyzing the effects of a 4 weeks prehabilitation program based on video visualization versus the performance of standardized written exercises in patients undergoing lumbar radiculopathy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic exercise, back care and pain neuroscience education group | Experimental | Other: Physiotherapy |
| Standarized written exercise group | Active comparator | Other: Physiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older, diagnosed with lumbar radiculopathy, and scheduled for surgery. The symptoms will be predominantly leg pain with or without neurological deficit, with surgical decompression justified.
Key exclusion criteria (8 listed)
- Patients currently receiving any other non-pharmacological treatment or physical therapy for the management of lumbar radiculopathy.
- Proposed for surgery with instrumentation (e.g., spinal fusion, arthrodesis).
- Suffering from a chronic pain-related condition (e.g., fibromyalgia, chronic fatigue syndrome).
- Symptoms of spinal cord compression.
- Diagnosed with a malignant tumor.
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 |
|---|---|---|
| PhysiotherapyThe intervention involves the visualization of different videos explaining the performance of lumbar strengthening exercises, measures for back care, and neuroscience pain education. | Other | Standarized written exercise group, Therapeutic exercise, back care and pain neuroscience education group |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 4 weeks
Disability score (0-100). Higher score indicates higher disability.
8 secondary outcomes
SF-McGill Pain Questionnaire (SF-MGPQ)
Time frame: 4 weeks
Numerical Rating Scale (NRS)
Time frame: 4 weeks
EuroQol-5D (EQ-5D)
Time frame: 4 weeks
Fear avoidance beliefs questionnaire (FABQ)
Time frame: 4 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
Pain catastrophizing scale (PCS)
Time frame: 4 weeks
Tampa scale for kinesiophobia (TSK-11SV)
Time frame: 4 weeks
International Physical Activity Questionnaire (IPAQ)
Time frame: 4 weeks
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 12 Feb 2025.
- Background: PubMed 29253630Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15.
- Background: PubMed 23478459Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4.
- Background: PubMed 30921465Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053.
- 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.
María Dolores Arguisuelas contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Lumbar Radiculopathy, run by Cardenal Herrera University at 1 site in Spain.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 12 Feb 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 Spain. 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 María Dolores Arguisuelas (96 136 90 00, doloresarguisuelas@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (ODI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06145620, which also lists 3 linked publications.
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 12 Feb 2025.