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Caudal Epidural Steroid and Trigger Point Injection

Primary Purpose

Myofascial Trigger Point Pain

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Trigger point injection (lidocaine)
Caudal epidural Group (bupivacaine + triamcinolone + NaCl)
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring Caudal Epidural Steroid Injection, Trigger Point Injection, NRS score

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abant Izzet Baysal University Medical School,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group C

Group CT

Arm Description

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

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

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
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
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
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
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.
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.
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.
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.

Full Information

First Posted
October 18, 2022
Last Updated
March 29, 2023
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05792111
Brief Title
Caudal Epidural Steroid and Trigger Point Injection
Official Title
Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
Keywords
Caudal Epidural Steroid Injection, Trigger Point Injection, NRS score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Trigger point injection was added to the gluteus medius and gluteus Maximus muscles in addition to caudal epidural steroids.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Experimental
Arm Description
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).
Arm Title
Group CT
Arm Type
Active Comparator
Arm Description
Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.
Intervention Type
Drug
Intervention Name(s)
Trigger point injection (lidocaine)
Other Intervention Name(s)
lidocaine
Intervention Description
trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.
Intervention Type
Drug
Intervention Name(s)
Caudal epidural Group (bupivacaine + triamcinolone + NaCl)
Other Intervention Name(s)
triamsinolon asetonid
Intervention Description
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
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) score
Description
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Time Frame
basaline,
Title
Numerical Rating Scale (NRS) score
Description
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Time Frame
after ESİ 3 weeks,
Title
Numerical Rating Scale (NRS) score
Description
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Time Frame
after ESİ 6 weeks
Title
Numerical Rating Scale (NRS) score
Description
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Time Frame
after ESİ12 weeks
Secondary Outcome Measure Information:
Title
Oswestry Disability Index
Description
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Time Frame
basaline
Title
Oswestry Disability Index
Description
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Time Frame
after ESİ 3 weeks
Title
Oswestry Disability Index
Description
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Time Frame
after ESİ 6 weeks
Title
Oswestry Disability Index
Description
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Time Frame
after ESİ12 weeks
Title
Short Form-36
Description
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.
Time Frame
basaline
Title
Short Form-36
Description
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.
Time Frame
after ESİ 3 weeks,
Title
Short Form-36
Description
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.
Time Frame
,after ESİ 6 weeks
Title
Short Form-36
Description
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.
Time Frame
after ESİ12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
murat bilgi, prof.dr
Phone
+90505 374 50 59
Email
drmuratbilgi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
murat bilgi, prof.dr
Phone
+90374 253 46 26
Ext
3123
Facility Information:
Facility Name
Abant Izzet Baysal University Medical School,
City
Bolu
ZIP/Postal Code
14280
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murat Bilgi, MD
Phone
5053745059
Email
drmuratbilgi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Caudal Epidural Steroid and Trigger Point Injection

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