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Completed

NCT Number: NCT06507995

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

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Key information

Conditions

Chronic Postoperative Pain Back Pain Chest Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. The effect of thoracic epidural injection on upper back pain

    Time frame: 1 year

    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.

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

    Time frame: 1 year

    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.

Secondary outcomes

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

    Time frame: 1 year

    Body mass index difference between groups

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

    Time frame: 1 year

    Difference between groups in duration of pain

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

    Time frame: 1 year

    Gender difference between groups

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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