Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Phase 4

Completed

• Conditions: Radiculopathy Lumbar
• Interventions: Other: Placebo; Drug: Glucocorticoids

• Registration Number: NCT05571046
• Lead Sponsor: Cukurova University

Brief Summary

The purpose of this study is to demonstrate the efficacy of intramuscular betamethasone injection on pain and other clinical parameters in patients with radicular pain due to lumbar disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.

Detailed Description

Low back pain is an important health problem that causes difficulties in daily living activities, loss of work performance and disability. Some patients with low back pain have radicular symptoms due to intervertebral disc herniation. Lumbar radiculopathy is characterized by radiating buttock and leg pain in a lumbar nerve root distribution.

The pathophysiology of radiculopathy is related to compression of the nerve, as well as the local release of inflammatory cytokines. Systemic corticosteroids have been used for treatment of lumbar radicular pain for a long time. The effects of corticosteroids are related to their anti-inflammatory effects, which may help reduce swelling and related compression on the affected nerve. Corticosteroids can be used systemically (i.e. oral, intravenous, or intramuscular routes) or administered directly into spinal structures through injections.

In the current study, the investigators aimed to demonstrate the efficacy of intramuscular betamethasone injection on pain, disability and health related quality of life in patients with lumbar radicular pain due to disc herniation. The investigators also aimed to determine the effects on electrophysiological findings.

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2022-09-30
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Status Verified: 2023-10
• Primary Completion: 2023-10-12
• Study Completion: 2023-10-26
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients aged between 18 and 65 years old with acute (less than 6 weeks) lumbar radicular pain due to intervertebral disc herniation.
• Neurological findings such as sensory, motor and reflex abnormality matching the L4, L5 or S1 nerve distribution.
• Patients who confirmed to have root compression (radiculopathy) by electrophysiological investigations.

Exclusion Criteria

• Contraindication for steroid usage (acute infection, uncontrolled diabetes and hypertension, severe cardiac failure), hypersensitivity to steroids
• Acute trauma
• Inflammatory low back pain
• Indications for neurosurgery (pronounced motor weakness or cauda equina syndrome)
• Lumbar spinal stenosis
• History of back surgery, history of steroid injection in the last 3 months
• Pregnancy, lactation
• Malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	Placebo	Intramuscular saline (%0.9 isotonic sodium chloride)
Glucocorticoid injection	Glucocorticoids	Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate)

Primary Outcome Measures

Name	Time	Method
Lumbar radicular pain	Month 3	Visual analog; (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Disability	Month 3	Oswestry Disability Index; (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Health related quality of Life	Month 3	Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)

Secondary Outcome Measures

Name	Time	Method
Electrophysiological evaluation (Sensory NCS)	Month 1	Sensory nerve conduction study (m/s)
Electrophysiological evaluation (F wave)	Month 1	F wave (m/s)
Electrophysiological evaluation (H reflex)	Month 1	H reflex (m/s)
Electrophysiological evaluation (Motor NCS)	Month 1	Motor nerve conduction study (m/s)

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Turkey