NCT05571046

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

1.4 years

First QC Date

September 30, 2022

Last Update Submit

October 31, 2023

Conditions

Radiculopathy Lumbar

Keywords

glucocorticoidradicular painlumbar radiculopathy

Outcome Measures

Primary Outcomes (7)

  • Lumbar radicular pain

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

    Week 1

  • Lumbar radicular pain

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

    Month 1

  • Lumbar radicular pain

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

    Month 3

  • Disability

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

    Month 1

  • Disability

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

    Month 3

  • 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)

    Month 1

  • 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)

    Month 3

Secondary Outcomes (4)

  • Electrophysiological evaluation (Sensory NCS)

    Month 1

  • Electrophysiological evaluation (Motor NCS)

    Month 1

  • Electrophysiological evaluation (F wave)

    Month 1

  • Electrophysiological evaluation (H reflex)

    Month 1

Study Arms (2)

Glucocorticoid injection

ACTIVE COMPARATOR

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

Drug: Glucocorticoids

Placebo injection

PLACEBO COMPARATOR

Intramuscular saline (%0.9 isotonic sodium chloride)

Other: Placebo

Interventions

GlucocorticoidsDRUG

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

Also known as: Diprospan
Glucocorticoid injection
PlaceboOTHER

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

Placebo injection

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

Related Publications (1)

  • Boga Vijdan E, Basaran S, Balal M. Efficacy of intramuscular glucocorticoid injection in patients with lumbar radicular pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Jul 4;26(1):650. doi: 10.1186/s12891-025-08897-1.

    PMID: 40616084DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

Glucocorticoidsbetamethasone dipropionate, betamethasone sodium phosphate drug combination

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Sibel Basaran, MD, Prof

    Cukurova University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 7, 2022

Study Start

June 1, 2022

Primary Completion

October 12, 2023

Study Completion

October 26, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

TU(1)