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Glucocorticoid Injection in Patients With Lumbar Radicular Pain

Primary Purpose

Radiculopathy Lumbar

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Glucocorticoids
Placebo
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy Lumbar focused on measuring glucocorticoid, radicular pain, lumbar radiculopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Glucocorticoid injection

Placebo injection

Arm Description

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

Intramuscular saline (%0.9 isotonic sodium chloride)

Outcomes

Primary Outcome Measures

Lumbar radicular pain
Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Lumbar radicular pain
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Lumbar radicular pain
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Disability
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Disability
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Health related quality of Life
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Health related quality of Life
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)

Secondary Outcome Measures

Electrophysiological evaluation (Sensory NCS)
Sensory nerve conduction study (m/s)
Electrophysiological evaluation (Motor NCS)
Motor nerve conduction study (m/s)
Electrophysiological evaluation (F wave)
F wave (m/s)
Electrophysiological evaluation (H reflex)
H reflex (m/s)

Full Information

First Posted
September 30, 2022
Last Updated
October 12, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT05571046
Brief Title
Glucocorticoid Injection in Patients With Lumbar Radicular Pain
Official Title
Efficacy of Intramuscular Glucocorticoid Injection in Patients With Lumbar Radicular Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 12, 2023 (Actual)
Study Completion Date
October 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy Lumbar
Keywords
glucocorticoid, radicular pain, lumbar radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glucocorticoid injection
Arm Type
Active Comparator
Arm Description
Intramuscular glucocorticoid (5 mg betamethasone dipropionate and 2 mg betamethasone sodium phosphate)
Arm Title
Placebo injection
Arm Type
Placebo Comparator
Arm Description
Intramuscular saline (%0.9 isotonic sodium chloride)
Intervention Type
Drug
Intervention Name(s)
Glucocorticoids
Other Intervention Name(s)
Diprospan
Intervention Description
Intramuscular injection of single dose of 1 ml betamethasone, Paracetamol (500 mg, 2 times a day)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intramuscular injection of %0.9 isotonic sodium chloride, Paracetamol (500 mg, 2 times a day)
Primary Outcome Measure Information:
Title
Lumbar radicular pain
Description
Visual analog scale (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Week 1
Title
Lumbar radicular pain
Description
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Month 1
Title
Lumbar radicular pain
Description
Visual analog (VAS, min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Month 3
Title
Disability
Description
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Month 1
Title
Disability
Description
Oswestry Disability Index (ODI, min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Month 3
Title
Health related quality of Life
Description
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Month 1
Title
Health related quality of Life
Description
Nottingham Health Profile (NHP, 6 subscales, for each subscale min-max values: 0-100, higher scores mean a worse outcome)
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Electrophysiological evaluation (Sensory NCS)
Description
Sensory nerve conduction study (m/s)
Time Frame
Month 1
Title
Electrophysiological evaluation (Motor NCS)
Description
Motor nerve conduction study (m/s)
Time Frame
Month 1
Title
Electrophysiological evaluation (F wave)
Description
F wave (m/s)
Time Frame
Month 1
Title
Electrophysiological evaluation (H reflex)
Description
H reflex (m/s)
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sibel Basaran, MD, Prof
Phone
00 90 322 3386060
Ext
3161
Email
sibasaran@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ezgi Boga, MD
Phone
00 90 322 3386060
Ext
3161
Email
ezgiboga@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Basaran, MD, Prof
Organizational Affiliation
Cukurova University
Official's Role
Study Director
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sibel Basaran, MD, Prof
Phone
00 90 322 3386060
Ext
3161
Email
sibasaran@gmail.com
First Name & Middle Initial & Last Name & Degree
Ezgi Boga, MD
Phone
00 90 322 3386060
Ext
3161
Email
ezgiboga@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sibel Basaran, MD, Prof
First Name & Middle Initial & Last Name & Degree
Ezgi Boga, MD
First Name & Middle Initial & Last Name & Degree
Mehmet Balal, MD

12. IPD Sharing Statement

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Glucocorticoid Injection in Patients With Lumbar Radicular Pain

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