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Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Ç

Çukurova University

Status and phase

Completed
Phase 4

Conditions

Radiculopathy Lumbar

Treatments

Drug: Glucocorticoids
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05571046
TTU-2022-14980 (Other Grant/Funding Number)
Cukurova14980

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Glucocorticoid injection
Active Comparator group
Description:
Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate)
Treatment:
Drug: Glucocorticoids
Placebo injection
Placebo Comparator group
Description:
Intramuscular saline (%0.9 isotonic sodium chloride)
Treatment:
Other: Placebo

Trial contacts and locations

1

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Central trial contact

Sibel Basaran, MD, Prof; Ezgi Boga, MD

Data sourced from clinicaltrials.gov

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