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| Name | Class |
|---|---|
| Private Hospital Moelholm | OTHER |
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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Block | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selective nerve root block (SNRB) | Diagnostic Test | CT/Fluoroscopy guided nerve root block |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after surgery/decision not to operate |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months after surgery/decision not to operate |
| Back pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Kocemba, MD | Contact | +45 23882198 | davkoc@rm.dk | |
| Mikkel Rasmussen, MD | Contact | mikkrasm@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| David Kocemba, MD | University of Aarhus | Principal Investigator |
| Mikkel Rasmussen, MD | University of Aarhus | Study Director |
| Bent Uhrbrand, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Recruiting | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41388268 | Derived | 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. |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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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. |
| 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. | 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. | 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. | 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. | 3 months after surgery |
| Private Hospital Moelholm |
| Study Chair |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |