Caudal Epidural Steroid and Trigger Point Injection

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

Study Overview

• Status: Recruiting
• Conditions: Myofascial Trigger Point Pain
• Intervention / Treatment: Drug: Caudal epidural Group (bupivacaine + triamcinolone + NaCl); Drug: Trigger point injection (lidocaine)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: murat bilgi, prof.dr; Phone Number: +90505 374 50 59; Email: drmuratbilgi@gmail.com
• Study Contact Backup: Name: murat bilgi, prof.dr; Phone Number: 3123 +90374 253 46 26

Study Locations

• Turkey
  • Bolu, Turkey, 14280
    • Recruiting
    • Abant Izzet Baysal University Medical School,
    • Contact: Murat Bilgi, MD; Phone Number: 5053745059; Email: drmuratbilgi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	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; Other Names: triamsinolon asetonid
Active Comparator: Group CT; Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.	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; Other Names: triamsinolon asetonid; Drug: Trigger point injection (lidocaine); trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.; Other Names: lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,
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 ESİ 3 weeks,
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 ESİ 6 weeks
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 ESİ12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 ESİ 3 weeks
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 ESİ 6 weeks
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 ESİ12 weeks
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
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 ESİ 3 weeks,
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 ESİ 6 weeks
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 ESİ12 weeks

Collaborators and Investigators

• Sponsor: Abant Izzet Baysal University

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Anticipated): December 20, 2023
• Study Completion (Anticipated): December 20, 2024

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Trigger Point Injection; Caudal Epidural Steroid Injection; NRS score
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Triamcinolone; Bupivacaine
• Other Study ID Numbers: AİBU-Med-MB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No