Clinical trial NCT05792111: Caudal Epidural Steroid and Trigger Point Injection
Official title: Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myofascial Trigger Point Pain
Keywords: Caudal Epidural Steroid Injection
Trigger Point Injection
NRS score
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trigger point injection was added to the gluteus medius and gluteus Maximus muscles in addition to caudal epidural steroids.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: Demographic information of all patients included in the study; name, surname, telephone number, age, gender, educational status, profession, and marital status will be recorded. The duration of the pain, the onset of the pain, the accompanying leg pain, the activities that increase or decrease the pain, the presence of neurological symptoms, the analgesic agents used in the last week, and the previous treatments will be noted. Lumbar MRI findings and the level of pathology causing low back and hip pain will be recorded. History, family history, comorbidities (hypertension, diabetes mellitus, hyperlipidemia, cardiac disease, hypothyroidism), and detailed physical examinations of the patients will be recorded. Examinations of the patients before and 3, 6, and 12 weeks after the injection will be performed, and NRS scores at 3 and 6 weeks. The procedures will be repeated for patients who are over 4 years old. During the pre-procedural evaluation, the patients will be informed about the study, information about the Numeric Rating Score (NRS), Oswestry Disability Index (ODI), Short Form-36 (SF-36) to be used for post-procedure analgesia, and both verbal and written consents will be obtained. The staff who will make the evaluation will not know which group the patients belong to, and the study will be blinded.

Eligibility criteria: 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.

Primary outcomes:
measure: Numerical Rating Scale (NRS) score
timeFrame: basaline,
measure: Numerical Rating Scale (NRS) score
timeFrame: after ESİ 3 weeks,
measure: Numerical Rating Scale (NRS) score
timeFrame: after ESİ 6 weeks
measure: Numerical Rating Scale (NRS) score
timeFrame: after ESİ12 weeks
Secondary outcomes:
measure: Oswestry Disability Index
timeFrame: basaline
measure: Oswestry Disability Index
timeFrame: after ESİ 3 weeks
measure: Oswestry Disability Index
timeFrame: after ESİ 6 weeks
measure: Oswestry Disability Index
timeFrame: after ESİ12 weeks
measure: Short Form-36
timeFrame: basaline
measure: Short Form-36
timeFrame: after ESİ 3 weeks,
measure: Short Form-36
timeFrame: ,after ESİ 6 weeks
measure: Short Form-36
timeFrame: after ESİ12 weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Medical School,
Study officials:
References: