The Effectiveness of Thoracal Epidural Steroid and Local Anesthetic Injection
NCT Number: NCT06507995
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Postoperative Pain|Chest Pain|Back Pain
Interventions: DRUG: thoracic interlaminar epidural injection
Sponsor: Ankara University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2021-08-15
Completion Date: 2023-12-30
Locations: Ankara University, Ankara, Turkey

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

Primary Outcome Measures: 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: 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