Caudal Epidural Steroid and Trigger Point Injection

NCT05792111 | Unknown Phase 4

• 1 other identifier: AİBU-Med-MB-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Myofascial Trigger Point Pain

Keywords

Caudal Epidural Steroid Injection; Trigger Point Injection; NRS score

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Oswestry Disability Index

  basaline

• Oswestry Disability Index

  after ESİ 3 weeks

• Oswestry Disability Index

  after ESİ 6 weeks

• Oswestry Disability Index

  after ESİ12 weeks

• Short Form-36

  basaline

Study Arms (2)

Group C

EXPERIMENTAL

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)

Group CT

ACTIVE COMPARATOR

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

Drug: Trigger point injection (lidocaine); Drug: Caudal epidural Group (bupivacaine + triamcinolone + NaCl)

Interventions

Trigger point injection (lidocaine) DRUG

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

Also known as: lidocaine

Group CT

Caudal epidural Group (bupivacaine + triamcinolone + NaCl) 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

Also known as: triamsinolon asetonid

Group C; Group CT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University Medical School,

Bolu, 14280, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Lidocaine; Bupivacaine; Triamcinolone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

murat bilgi, prof.dr

CONTACT

+90505 374 50 59; drmuratbilgi@gmail.com

murat bilgi, prof.dr

CONTACT

+90374 253 46 26

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr

Model Details: Trigger point injection was added to the gluteus medius and gluteus Maximus muscles in addition to caudal epidural steroids.

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: March 31, 2023
• Study Start: October 12, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2024
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)