Radiculopathy LumbarPLANNCT06143813
Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
A study testing Selective nerve root block (SNRB) in people with Radiculopathy Lumbar and Radiculopathy Sacral, run by University of Aarhus at 1 site in Denmark.
Trial summary
The overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (LDH), foraminal stenosis (FS), and recess stenosis (RS), and hence identify the patients that will benefit from surgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy Lumbar, Radiculopathy Sacral, Herniated Disc
- What is being tested?
- Selective nerve root block (SNRB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Nov 2023to 1 Nov 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Suspected lumbar radiculopathy persistent ≥ 8 weeks
- Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)
Who cannot join
- Prior lumbar spine surgery
- Mental illness
- Language barrier in Danish
- Severe physical co-morbidity
- Known allergies to medicine used in the study
- Pregnant
- Plans to move abroad during the next 12-months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mikkel Rasmussen, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus C, 8000
David Kocemba, MD, davkoc@rm.dk
Mikkel Rasmussen, MD, mikkrasm@rm.dk
About this study
The overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (LDH), foraminal stenosis (FS), and recess stenosis (RS), and hence identify the patients that will benefit from surgical intervention.
Read the detailed description
The study is designed as a prospective randomized controlled trial, using a two-group stratified block-randomization, evaluating the effect of adding the outcome of a diagnostic SNRB to surgical decision-making. Stratification will be based on the study site. Block size will be 4, 6, or 8 and in random order.
All patients referred to our departments with suspected radiculopathy and radiological evidence of root compression are eligible for inclusion. Patients will be randomized to either standard care or SNRB after the consultation. Results of the SNRB will be available to the surgeon before deciding finally whether to operate or not. Hence, the intervention adds the outcome of the diagnostic SNRB to the shared surgical decision-making.
Study outline:
Baseline:
Demographics, Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
1-month follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
3-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
12-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
Randomization:
Using RedCap patients will be randomized to receive a SNRB as part of the pre-operative workup or to direct operation.
SNRB-procedure:
At Aarhus University, the SNRB will be performed using CT-guidance; at Private Hospital Moelholm, the SNRB procedure will be guided by fluoroscopy. Drugs used are omnipaque (0,2 ml), betamethasone (0,5 ml) and bupivacain (0,5 ml)
- Conditions
- Radiculopathy Lumbar, Radiculopathy Sacral, Herniated Disc, Foraminal Stenosis, Stenosis, Spinal
- Being tested
- Selective nerve root block (SNRB)
- Medical subject headings
- Intervertebral Disc Displacement, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective nerve root block (SNRB)Diagnostic test
Also called Transforaminal nerve root block
CT/Fluoroscopy guided nerve root block
| Study group | Role | What they receive |
|---|---|---|
| Block | Active comparator | This group will receive standard of care + a selective nerve root block as part of the diagnostic work up. Receives: Diagnostic Test: Selective nerve root block (SNRB) |
| No-block | No intervention | This group will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum clinically important difference (MCID)
Difference in mean change on numerical rating scale for leg pain (NRS-LP) 3 months after surgery. The margin of non-inferiority will be set to = 1.6 points. Comparison will be made between patients in the SNRB group and patients in the control group surgery.
Measured: 3 months after surgery/decision not to operate
Secondary outcomes (6)
Leg pain
Difference in proportions reaching 1.6 points on NRS-LP 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Measured: 3 months after surgery/decision not to operate
Back pain
Mean change in numerical rating scale for back pain (NRS-BP) 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Measured: 3 months after surgery/decision not to operate
SF-36 (Short form 36)
SF-36 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Measured: 3 months after surgery/decision not to operate
EQ5D (EuroQol 5D)
EQ5D 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Measured: 3 months after surgery/decision not to operate
ODI
Oswestry Disability Index (ODI) 3 months after surgery/decision to not to operate. Comparison will be made between the SNRB group and the standard of care group.
Measured: 3 months after surgery/decision not to operate
Subanalysis
Fraction of patients not reaching minimum clinically important difference (MCID) on the numerical rating scale for leg pain (NRS-LP) 3 months after surgery (MCID NRS-LP = 1.6 points). Comparison will be made between patients in the SNRB group who underwent surgery and patients in the control group that underwent surgery.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start9 Nov 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiculopathy LumbarStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Private Hospital Moelholm
- Responsible party
- Sponsor
- Investigators
- David Kocemba, MD, Principal investigator, University of AarhusMikkel Rasmussen, MD, Study director, University of AarhusBent Uhrbrand, MD, Study chair, Private Hospital Moelholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143813
- Sponsor's protocol ID
- PLAN
- Acronym
- PLAN
- Status last verified
- Nov 2023
- First submitted
- 9 Nov 2023
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocemba D, Andersen PA, Carlsen JG, Schulz MK, Uhrbrand B, Dinesen H, Mikkelsen R, Thygesen M, Rasmussen MM. The PLAN trial: precision treatment of lumbar spine surgery with advanced nerve root blockade - protocol for a prospective, investigator-initiated, randomized non-inferiority trial. BMC Musculoskelet Disord. 2025 Dec 12;27(1):39. doi: 10.1186/s12891-025-09395-0.
PubMed 41388268
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
- ClinicalTrials.gov ID
- NCT06143813
- Acronym / sponsor ID
- PLAN / PLAN
- Conditions
- Radiculopathy Lumbar, Radiculopathy Sacral, Herniated Disc, Foraminal Stenosis, Stenosis, Spinal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Private Hospital Moelholm
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 22 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 overall purpose of the study is to investigate whether selective spinal nerve root blocks can improve diagnostics of radiculopathy due to lumbar disc herniation (LDH), foraminal stenosis (FS), and recess stenosis (RS), and hence identify the patients that will benefit from surgical intervention.
Detailed description
The study is designed as a prospective randomized controlled trial, using a two-group stratified block-randomization, evaluating the effect of adding the outcome of a diagnostic SNRB to surgical decision-making. Stratification will be based on the study site. Block size will be 4, 6, or 8 and in random order.
All patients referred to our departments with suspected radiculopathy and radiological evidence of root compression are eligible for inclusion. Patients will be randomized to either standard care or SNRB after the consultation. Results of the SNRB will be available to the surgeon before deciding finally whether to operate or not. Hence, the intervention adds the outcome of the diagnostic SNRB to the shared surgical decision-making.
Study outline:
Baseline:
Demographics, Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
1-month follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
3-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
12-months follow-up after surgery: Oswestry Disability Index, Eq5D, SF-36, NRS-LP, and NRS-BP will be recorded
Randomization:
Using RedCap patients will be randomized to receive a SNRB as part of the pre-operative workup or to direct operation.
SNRB-procedure:
At Aarhus University, the SNRB will be performed using CT-guidance; at Private Hospital Moelholm, the SNRB procedure will be guided by fluoroscopy. Drugs used are omnipaque (0,2 ml), betamethasone (0,5 ml) and bupivacain (0,5 ml)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block | Active comparator | Diagnostic Test: Selective nerve root block (SNRB)This group will receive standard of care + a selective nerve root block as part of the diagnostic work up. |
| No-block | No intervention | –This group will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years old
- Suspected lumbar radiculopathy persistent ≥ 8 weeks
- Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)
Key exclusion criteria (7 listed)
- Prior lumbar spine surgery
- Mental illness
- Language barrier in Danish
- Severe physical co-morbidity
- Known allergies to medicine used in the study
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 |
|---|---|---|
| Selective nerve root block (SNRB)Also: Transforaminal nerve root blockCT/Fluoroscopy guided nerve root block | Diagnostic test | Block |
Primary outcome
Minimum clinically important difference (MCID)
Time frame: 3 months after surgery/decision not to operate
Difference in mean change on numerical rating scale for leg pain (NRS-LP) 3 months after surgery. The margin of non-inferiority will be set to = 1.6 points. Comparison will be made between patients in the SNRB group and patients in the control group surgery.
6 secondary outcomes
Leg pain
Time frame: 3 months after surgery/decision not to operate
Back pain
Time frame: 3 months after surgery/decision not to operate
SF-36 (Short form 36)
Time frame: 3 months after surgery/decision not to operate
EQ5D (EuroQol 5D)
Time frame: 3 months after surgery/decision not to operate
ODI
Time frame: 3 months after surgery/decision not to operate
Subanalysis
Time frame: 3 months after surgery
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 2 May 2024.
- Derived from this study: PubMed 41388268Kocemba D, Andersen PA, Carlsen JG, Schulz MK, Uhrbrand B, Dinesen H, Mikkelsen R, Thygesen M, Rasmussen MM. The PLAN trial: precision treatment of lumbar spine surgery with advanced nerve root blockade - protocol for a prospective, investigator-initiated, randomized non-inferiority trial. BMC Musculoskelet Disord. 2025 Dec 12;27(1):39. doi: 10.1186/s12891-025-09395-0.
- Individual participant dataSharing planned: No
Related trials for Radiculopathy Lumbar
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Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
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Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
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Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
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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.
Mikkel Rasmussen, MD contact
David Kocemba, MD principal investigator
University of Aarhus
Mikkel Rasmussen, MD study director
University of Aarhus
Bent Uhrbrand, MD study chair
Private Hospital Moelholm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective nerve root block (SNRB) in people with Radiculopathy Lumbar and Radiculopathy Sacral, run by University of Aarhus at 1 site in Denmark.
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 7 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 2 May 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 Denmark. 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 David Kocemba, MD (+45 23882198, davkoc@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimum clinically important difference (MCID) (time frame: 3 months after surgery/decision not to operate). 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 NCT06143813, which also lists 1 linked publication.
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 2 May 2024.