The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection

NCT06507995 | Completed

• 1 other identifier: i7-487-21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Postoperative Pain; Chest Pain; Back Pain

Keywords

Chronic thoracic pain; chest wall pain; thoracic interlaminar epidural injections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The effect of thoracic epidural steroid and local anesthetic injection on upper back pain

  1 year

• The effect of thoracic epidural steroid and local anesthetic injection on upper back pain

  1 year

• The effect of thoracic epidural steroid and local anesthetic injection on upper back pain

  1 year

Study Arms (2)

Local Group

OTHER

Group I received thoracic interlaminar epidural injections of 6 mL of 2% preservative-free prilocaine.

Drug: thoracic interlaminar epidural injection

Local+steroid Group

OTHER

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

Interventions

thoracic interlaminar epidural injection DRUG

. 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.

Local Group; Local+steroid Group

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• \< 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)

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Chest Pain; Back Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 18, 2024
• Study Start: August 15, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

TU (1)