Caudal Epidural Steroid and Trigger Point Injection

NCT ID: NCT05792111

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-12
• Study Completion Date: 2024-12-20

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.

Conditions

Myofascial Trigger Point Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group C

Group C; caudal epidural steroid injection (10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space).

Group Type: EXPERIMENTAL

Caudal epidural Group (bupivacaine + triamcinolone + NaCl)

Intervention Type: DRUG

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

Group CT

Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.

Group Type: ACTIVE_COMPARATOR

Trigger point injection (lidocaine)

Intervention Type: DRUG

trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.

Caudal epidural Group (bupivacaine + triamcinolone + NaCl)

Intervention Type: DRUG

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

Interventions

Trigger point injection (lidocaine)

trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

lidocaine; triamsinolon asetonid

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Murat Bilgi

Prof.dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Abant Izzet Baysal University Medical School,

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

murat bilgi, prof.dr

Role: CONTACT

drmuratbilgi@gmail.com

+90505 374 50 59

murat bilgi, prof.dr

Role: CONTACT

+90374 253 46 26 ext. 3123

Facility Contacts

Murat Bilgi, MD

Role: primary

drmuratbilgi@gmail.com

5053745059

Other Identifiers

AİBU-Med-MB-01

Identifier Type: -

Identifier Source: org_study_id