Myofascial Trigger Point Pain Clinical Trial
Official title:
Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid
This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital. Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study. The primary output of our study was NRS scores. The study of Manchikanti. L et al. (control group NRS reduction 4.4 ± 1.8; α margin of error 0.05, power 99%) (3) was taken as the basis for determining the sample size. Using the G Power 3 calculator program, 72 patients were identified to reduce their NRS scores by 25%. With a 20% exclusion rate, the total number of patients was calculated as 90
Status | Recruiting |
Enrollment | 72 |
Est. completion date | December 20, 2024 |
Est. primary completion date | December 20, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Low back or leg pain that has been going on for at least 2 months, - Patients between the ages of 18-70, - Disc herniation or radiculopathy in lumbar MRI examination .To be mentally competent to understand and evaluate NRS, ODI, and SF-36 forms. exclusion criteria - Being pregnant or lactating, - Presence of spinal canal stenosis, - The presence of bleeding diathesis, - Presence of disease with progressive neurological deficit, - The presence of serious psychiatric illness, - Presence of progressive neurological deficit or incontinence, - Having an epidural steroid injection in the last 6 months, Having uncontrolled diabetes mellitus Having hypertension, - Known history of allergy to local anesthetics or corticosteroids, - The patient does not want treatment, - Local infection at the injection site, - Infections such as discitis, spondylodiscitis, and sacroiliitis. |
Country | Name | City | State |
---|---|---|---|
Turkey | Abant Izzet Baysal University Medical School, | Bolu |
Lead Sponsor | Collaborator |
---|---|
Abant Izzet Baysal University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical Rating Scale (NRS) score | NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain | basaline, | |
Primary | Numerical Rating Scale (NRS) score | NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain | after ESI 3 weeks, | |
Primary | Numerical Rating Scale (NRS) score | NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain | after ESI 6 weeks | |
Primary | Numerical Rating Scale (NRS) score | NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain | after ESI12 weeks | |
Secondary | Oswestry Disability Index | used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible | basaline | |
Secondary | Oswestry Disability Index | used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible | after ESI 3 weeks | |
Secondary | Oswestry Disability Index | used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible | after ESI 6 weeks | |
Secondary | Oswestry Disability Index | used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible | after ESI12 weeks | |
Secondary | Short Form-36 | used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | basaline | |
Secondary | Short Form-36 | used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | after ESI 3 weeks, | |
Secondary | Short Form-36 | used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | ,after ESI 6 weeks | |
Secondary | Short Form-36 | used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | after ESI12 weeks |
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