PLAN: Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

• Sponsor: University of Aarhus (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06143813
• Collaborator: Private Hospital Moelholm (Other)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 47.7
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Radiculopathy Lumbar; Radiculopathy Sacral; Herniated Disc; Foraminal Stenosis; Stenosis, Spinal	Diagnostic Test: Selective nerve root block (SNRB)	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade
• Actual Study Start Date: Nov 9, 2023
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Nov 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Block This group will receive standard of care + a selective nerve root block as part of the diagnostic work up.	Diagnostic Test: Selective nerve root block (SNRB); CT/Fluoroscopy guided nerve root block; Other Names: Transforaminal nerve root block
No Intervention: No-block This group will receive standard of care.

Outcome Measures

Primary Outcome Measures

1. Minimum clinically important difference (MCID) [1 year after surgery]

   Fraction of patients not reaching minimum clinically important difference (MCID) on the numerical rating scale for leg pain (NRS-LP) one year following surgery.

Secondary Outcome Measures

1. Leg pain, numerical rating scale-leg pain (NRS-LP) [1 year after surgery]

   Mean change in NRS-LP score from baseline to one year after surgery

2. Back pain, numerical rating scale-back pain (NRS-BP) [1 year after surgery]

   Mean change in NRS-BP score from baseline to one year after surgery

3. Patient health: Short-Form 36 (SF-36) [1 year after surgery]

   Mean change in SF-36 score from baseline to one year after surgery

4. Quality of life: EQ-5D [1 year after surgery]

   Mean change in EQ5D score from baseline to one year after surgery

5. Disability: Oswestry Disability Index (ODI) [1 year after surgery]

   Mean change in ODI score from baseline to one year after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >18 years old

• Suspected lumbar radiculopathy persistent ≥ 8 weeks

• Radiological evidence of lumbar nerve root compression (herniated disc, recess stenosis, foraminal stenosis)

Exclusion Criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital	Aarhus C		Denmark	8000

Sponsors and Collaborators

• University of Aarhus
• Private Hospital Moelholm

Investigators

• Principal Investigator: David Kocemba, MD, University of Aarhus
• Study Director: Mikkel Rasmussen, MD, University of Aarhus
• Study Chair: Bent Uhrbrand, MD, Private Hospital Moelholm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT06143813
• Other Study ID Numbers: PLAN
• First Posted: Nov 22, 2023
• Last Update Posted: Nov 22, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Intervertebral Disc Displacement; Spinal Stenosis; Radiculopathy; Constriction, Pathologic

Study Results

No Results Posted as of Nov 22, 2023