Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-10-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiculopathy Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Glucocorticoid injection

Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate)

Group Type ACTIVE_COMPARATOR

Glucocorticoids

Intervention Type DRUG

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

Placebo injection

Intramuscular saline (%0.9 isotonic sodium chloride)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Glucocorticoids

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Diprospan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No