Clinical trial NCT05571046: Glucocorticoid Injection in Patients With Lumbar Radicular Pain
Official title: Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Radiculopathy Lumbar
Keywords: glucocorticoid
radicular pain
lumbar radiculopathy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Lumbar radicular pain
timeFrame: Week 1
measure: Lumbar radicular pain
timeFrame: Month 1
measure: Lumbar radicular pain
timeFrame: Month 3
measure: Disability
timeFrame: Month 1
measure: Disability
timeFrame: Month 3
measure: Health related quality of Life
timeFrame: Month 1
measure: Health related quality of Life
timeFrame: Month 3
Secondary outcomes:
measure: Electrophysiological evaluation (Sensory NCS)
timeFrame: Month 1
measure: Electrophysiological evaluation (Motor NCS)
timeFrame: Month 1
measure: Electrophysiological evaluation (F wave)
timeFrame: Month 1
measure: Electrophysiological evaluation (H reflex)
timeFrame: Month 1
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
affiliation: Cukurova University
name: Sibel Basaran, MD, Prof
role: STUDY_DIRECTOR
References: