Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

Herniated Disc Clinical Trial

— PLAN  

Official title:

Precision Treatment of Lumbar Spine Surgery Through Advanced Nerve Root Blockade

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143813
• Other study ID #: PLAN
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: David Kocemba, MD
• Phone: +45 23882198
• Email: davkoc[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Foraminal Stenosis
• Herniated Disc
• Intervertebral Disc Displacement
• Radiculopathy
• Radiculopathy Lumbar
• Spinal Stenosis
• Stenosis, Spinal

Intervention

Diagnostic Test:
• Selective nerve root block (SNRB)
CT/Fluoroscopy guided nerve root block

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Private Hospital Moelholm

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	3 months after surgery/decision not to operate
Secondary	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
Secondary	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
Secondary	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
Secondary	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