Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Radiculopathy Lumbar Clinical Trial

Official title:

Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05571046
• Other study ID #: Cukurova14980
• Secondary ID: TTU-2022-14980
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: October 26, 2023

Study information

• Verified date: October 2023
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 26, 2023
• Est. primary completion date: October 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Radiculopathy
• Radiculopathy Lumbar

Intervention

Drug:
• Glucocorticoids
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)

Other:
• Placebo
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumbar radicular pain	Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)	Week 1
Primary	Lumbar radicular pain	Visual analog; (VAS, min-max values: 0-100, higher scores mean a worse outcome)	Month 1
Primary	Lumbar radicular pain	Visual analog; (VAS, min-max values: 0-100, higher scores mean a worse outcome)	Month 3
Primary	Disability	Oswestry Disability Index; (ODI, min-max values: 0-100, higher scores mean a worse outcome)	Month 1
Primary	Disability	Oswestry Disability Index; (ODI, min-max values: 0-100, higher scores mean a worse outcome)	Month 3
Primary	Health related quality of Life	Nottingham Health Profile; (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)	Month 1
Primary	Health related quality of Life	Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)	Month 3
Secondary	Electrophysiological evaluation (Sensory NCS)	Sensory nerve conduction study (m/s)	Month 1
Secondary	Electrophysiological evaluation (Motor NCS)	Motor nerve conduction study (m/s)	Month 1
Secondary	Electrophysiological evaluation (F wave)	F wave (m/s)	Month 1
Secondary	Electrophysiological evaluation (H reflex)	H reflex (m/s)	Month 1