Outcome of Transforminal Epidural Injections in Patients with Lumbar Radicular Pain

October 22, 2024 updated by: Muhammad Aamir Latif
Back pain is the most common chronic pain disorder of adult population. Lumbar radicular pain occurs due to irritation or compression of the nerve roots in the lower back. Various non-surgical methods can also be exercised that have been used to treat lumbar radicular pain since the ancient times. Despite the availability of various treatment options, achieving optimal pain relief and functional recovery remains challenging. Lumbar Transforaminal Epidural Steroid Injections (TFESI) are commonly used to manage this condition, but there is variability in patient response and limited data on the effectiveness of TFESI in different demographic and clinical subgroups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Mayo Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both genders
  • Aged between 45 and 80 years
  • Experiencing lumbar radicular pain

Exclusion Criteria:

  • History of spinal fracture or previous spinal surgery
  • Recurrent pain within 3 months of prior treatment
  • Ongoing steroid therapy
  • IKnown allergy to dexamethasone or lidocaine

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TFESI
Lumbar Transforaminal Epidural Steroid Injections was administered, consisting of 4 mg dexamethasone and 0.33% lidocaine in a 3 ml solution.
Drug: Transforaminal Epidural Steroid Injections
Transforaminal Epidural Steroid Injections
Other Names:
  • Lumbar transforaminal epidural steroid Injection was administered, consisting of 4 mg dexamethasone and 0.33% lidocaine in a 3 ml solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: 4-week
Patients were monitored for four weeks post-treatment, with follow-up visits scheduled at 1 week and 4 weeks. Pain scores were reassessed using visual analog scale (scores between 1 to 10). Lower scores meant lower pain whereas higher scores meant higher degree of pain
4-week

Collaborators and Investigators

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

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Muhammad Zarak Awais, MBBS, Department of Orthopedic Surgery, Mayo Hospital, Lahore, Pakistan

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)

October 1, 2021

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mayo-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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