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Clinical trial

Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid

ID
Name
AİBU-Med-MB-01
Description
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
Trial arms
Trial start
2022-10-12
Estimated PCD
2023-12-20
Trial end
2024-12-20
Status
Recruiting
Phase
Early phase I
Treatment
Trigger point injection (lidocaine)
trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.
Arms:
Group CT
Other names:
lidocaine
Caudal epidural Group (bupivacaine + triamcinolone + NaCl)
It will be advanced towards the sacral hiatus and local anesthesia of the skin and subcutaneous tissue will be provided with 2% lidocaine. The caudal epidural space will be entered by puncturing the sacrococcygeal ligament with the tip of a 22 G black needle from the appropriate area and taking a pop sensation. It will be confirmed that there is no bleeding or cerebrospinal fluid in this area by applying saline in real-time sonography and after the caudal epidural spread is observed, aspiration is performed. Afterward, a 10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space
Arms:
Group C, Group CT
Other names:
triamsinolon asetonid
Size
72
Primary endpoint
Numerical Rating Scale (NRS) score
basaline,
Numerical Rating Scale (NRS) score
after ESİ 3 weeks,
Numerical Rating Scale (NRS) score
after ESİ 6 weeks
Numerical Rating Scale (NRS) score
after ESİ12 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Trigger point injection was added to the gluteus medius and gluteus Maximus muscles in addition to caudal epidural steroids.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The staff who will evaluate the patient before and after the procedure will not know which group the patients belong to, and the study will be blinded.', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}
Updated at
2023-03-31

1 organization

2 products

1 indication

Organization
Abant Izzet Baysal University
Product
Trigger point injection
Indication
Myofascial Trigger Point Pain
Product
Caudal epidural Group