The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection

The primary objective was to evaluate the effectiveness of thoracic interlaminar epidural injections in alleviating pain and enhancing function in patients suffering from chronic mid and/or upper back pain.

Materials and Methods One hundred patients were randomly divided into two groups, each consisting of 50 patients. Group I received only a local anesthetic, while Group II received a combination of local anesthetic and steroids. The random assignment to either Group I or Group II was determined using a simple computer-generated sequence.

Outcomes were evaluated using the Numeric Rating Scale (NRS) and the revised Oswestry Disability Index (rODI). Patients who showed significant improvement for more than four weeks after the first two procedures were deemed successful. Those who did not were classified as failed participants. Significant improvement was defined as a reduction of more than 50% in both NRS and rODI scores, with assessments conducted at baseline and at 3, 6, and 12 months post-treatment.

The center where the study was conducted: Ankara University, Faculty of Medicine, Department of Anesthesiology and Reanimation, Division of Algology, Ankara, Turkey

Study Overview

• Status: Completed
• Conditions: Back Pain; Chest Pain; Chronic Postoperative Pain
• Intervention / Treatment: Drug: thoracic interlaminar epidural injection

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• > 18 years old
• > 6 months pain duration
• Failed conservative management (including medication, physical therapy, and exercise programs)
• Facet joint pain ruled out (confirmed through diagnostic blocks)

Exclusion Criteria:

• < 18 years old
• Having a psychological illness
• Allergies to local anesthetics or steroids
• Thoracic facet joint pain
• Significant disc herniation
• Infection ( which were ruled out by pre-procedure blood tests and C-reactive protein levels)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Local Group; Group I received thoracic interlaminar epidural injections of 6 mL of 2% preservative-free prilocaine.	Drug: thoracic interlaminar epidural injection; . Injections were administered under sedation and sterile conditions, with all patients positioned prone and monitored. A single physician performed all injections using an 18 gauge Tuohy needle, employing the loss of resistance technique and confirming the epidural space placement with 5 mL of nonionic contrast.
Other: Local+steroid Group; Group II received injections of 4 mL of 2% preservative-free prilocaine combined with 2 mL or 8 mg of dexamethasone, totaling 6 mL	Drug: thoracic interlaminar epidural injection; . Injections were administered under sedation and sterile conditions, with all patients positioned prone and monitored. A single physician performed all injections using an 18 gauge Tuohy needle, employing the loss of resistance technique and confirming the epidural space placement with 5 mL of nonionic contrast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of thoracic epidural injection on upper back pain	Change in Visual Analog Score after the procedure. The visual analog scale (VAS) of pain intensity consists of a line, most often 100 mm long, with 2 descriptors representing extremes of pain intensity (eg, no pain and extreme pain)at each end. The findings suggested that 100-mm VASratings of 0 to 4 mmcanbeconsidered nopain; 5 to 44mm,mildpain; 45 to 74mm, moderate pain; and 75 to 100 mm, severe pain.	1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain	Change The Oswestry Disability Index (ODI) after the procedure: ODI is an index used by clinicians and researchers to quantify disability for low back pain and quality of life. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. 0% -20%: Minimal disability;21%-40%: Moderate Disability;41%-60%: Severe Disability;61%-80%: Crippling back pain;81%-100%;The patient is either bed-bound or has an exaggeration of their symptoms.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain	Body mass index difference between groups	1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain	Difference between groups in duration of pain	1 year
The effect of thoracic epidural steroid and local anesthetic injection on upper back pain	Gender difference between groups	1 year

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): July 18, 2024
• Last Update Submitted That Met QC Criteria: July 12, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Chronic thoracic pain; chest wall pain; thoracic interlaminar epidural injections
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chest Pain
• Other Study ID Numbers: i7-487-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No