Skip to main content
OpenTrials
Completed

NCT Number: NCT05571046

Glucocorticoid Injection in Patients With Lumbar Radicular Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Radiculopathy Lumbar Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cukurova University

Adana, 01330, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucocorticoids

Drug

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

Other names: Diprospan

Placebo

Other

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

Primary outcomes

  1. Lumbar radicular pain

    Time frame: Week 1

    Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)

  2. Lumbar radicular pain

    Time frame: Month 1

    Visual analog

    (VAS, min-max values: 0-100, higher scores mean a worse outcome)

  3. Lumbar radicular pain

    Time frame: Month 3

    Visual analog

    (VAS, min-max values: 0-100, higher scores mean a worse outcome)

  4. Disability

    Time frame: Month 1

    Oswestry Disability Index

    (ODI, min-max values: 0-100, higher scores mean a worse outcome)

  5. Disability

    Time frame: Month 3

    Oswestry Disability Index

    (ODI, min-max values: 0-100, higher scores mean a worse outcome)

  6. Health related quality of Life

    Time frame: Month 1

    Nottingham Health Profile

    (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)

  7. Health related quality of Life

    Time frame: Month 3

    Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)

Secondary outcomes

  1. Electrophysiological evaluation (Sensory NCS)

    Time frame: Month 1

    Sensory nerve conduction study (m/s)

  2. Electrophysiological evaluation (Motor NCS)

    Time frame: Month 1

    Motor nerve conduction study (m/s)

  3. Electrophysiological evaluation (F wave)

    Time frame: Month 1

    F wave (m/s)

  4. Electrophysiological evaluation (H reflex)

    Time frame: Month 1

    H reflex (m/s)

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2022
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.