Glucocorticoid Injection in Patients With Lumbar Radicular Pain

October 31, 2023 updated by: Sibel Basaran, Cukurova University

Efficacy of Intramuscular 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sibel Basaran, MD, Prof
  • Phone Number: 3161 00 90 322 3386060
  • Email: sibasaran@gmail.com

Study Contact Backup

Study Locations

  • Turkey
      • Adana, Turkey, 01330
        • Çukurova university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glucocorticoid injection
Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate)
Drug: Glucocorticoids
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)
Other Names:
  • Diprospan
Placebo Comparator: Placebo injection
Intramuscular saline (%0.9 isotonic sodium chloride)
Other: Placebo
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lumbar radicular pain
Time Frame: Week 1
Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Week 1
Lumbar radicular pain
Time Frame: Month 1

Visual analog

(VAS, min-max values: 0-100, higher scores mean a worse outcome)
Month 1
Lumbar radicular pain
Time Frame: Month 3

Visual analog

(VAS, min-max values: 0-100, higher scores mean a worse outcome)
Month 3
Disability
Time Frame: Month 1

Oswestry Disability Index

(ODI, min-max values: 0-100, higher scores mean a worse outcome)
Month 1
Disability
Time Frame: Month 3

Oswestry Disability Index

(ODI, min-max values: 0-100, higher scores mean a worse outcome)
Month 3
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)
Month 1
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)
Month 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrophysiological evaluation (Sensory NCS)
Time Frame: Month 1
Sensory nerve conduction study (m/s)
Month 1
Electrophysiological evaluation (Motor NCS)
Time Frame: Month 1
Motor nerve conduction study (m/s)
Month 1
Electrophysiological evaluation (F wave)
Time Frame: Month 1
F wave (m/s)
Month 1
Electrophysiological evaluation (H reflex)
Time Frame: Month 1
H reflex (m/s)
Month 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Director: Sibel Basaran, MD, Prof, Çukurova university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Actual)

October 12, 2023

Study Completion (Actual)

October 26, 2023

Study Registration Dates

First Submitted

September 30, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cukurova14980
  • TTU-2022-14980 (Other Grant/Funding Number: Cukurova University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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