Protocol summary

Study aim
comparing the reduction of back pain, the level of impact on the improvement of quality of life and satisfaction in patients with myofascial pain syndrome who underwent caudal-epidural injection and those with corticosteroid injection in trigger points under ultrasound guidance.
Design
sample size: n= C x [(P 1(1 - P 1) + P 2(1 - P 2)/ (P 2 – P 1 ) 2 ] n=30 For control group, 30 people are considered in the plan.
Settings and conduct
This clinical trial, after obtaining permission from the Ethics Committee of Shahid Beheshti University of Medical Sciences, is conducted on 60 patients with myofascial pain syndrome in chronic back pain between the ages of 20 and 75 in Imam Hossein and Akhtar Hospital.. After informing the patients , written informed consent will be obtained from them. The course of pain of patients in two groups is followed by caudal-epidural injection and trigger point for 6 weeks.
Participants/Inclusion and exclusion criteria
Participants: women and men with myofascial pain syndrome in back pain aged 20 to 75 years People excluded: Patients with diabetes, heart failure, hypertension, seizure history, sensitivity to local anesthesia, skin diseases, back surgery and drug addiction
Intervention groups
In one group, corticosteroid injection and local anesthesia (2 mg of ropivacaine) were performed under ultrasound guidance in the caudal-epidural area. In control group, with the same dose as the first group under ultrasound guidance in trigger points.
Main outcome variables
The main outcome variables are sleep quality, stress and anxiety, and deep muscle pain.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241017063397N1
Registration date: 2024-12-15, 1403/09/25
Registration timing: prospective

Last update: 2024-12-15, 1403/09/25
Update count: 0
Registration date
2024-12-15, 1403/09/25
Registrant information
Name
Maryam Nasoohi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2209 1492
Email address
nasoohi_m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-21, 1403/10/01
Expected recruitment end date
2025-08-23, 1404/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two caudal-epidural methods and regional myofascial injection in patients with back pain
Public title
Effect of caudal-epidural analgesia in back pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women and men with myofascial pain syndrome in back pain aged 20 to 75 years
Exclusion criteria:
People with diabetes, heart failure, blood pressure, skin diseases, back surgery, seizures and drug addiction
Age
From 20 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University of Medical Sciences
Street address
saadat abad
City
Tehran
Province
Tehran
Postal code
1997989518
Approval date
2024-10-27, 1403/08/06
Ethics committee reference number
IR.SBMU.MSP.REC.1403.403

Health conditions studied

1

Description of health condition studied
BACK PAIN
ICD-10 code
G97.1
ICD-10 code description
Other reaction to spinal and lumbar puncture

Primary outcomes

1

Description
low back pain
Timepoint
6 WEEKS
Method of measurement
VAS

Secondary outcomes

1

Description
VAS score
Timepoint
6 weak
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Women and men with myofascial pain syndrome in low back pain
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar hospital
Full name of responsible person
Mahshid Ghasemi
Street address
Fereshteh aveneue
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2200 1072
Email
nasoohi_m@yahoo.com

2

Recruitment center
Name of recruitment center
Emam hossein hospital
Full name of responsible person
Dr. Mehrdad Taheri
Street address
nezam abad
City
tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 7343 3000
Email
nasoohi_m@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Khodadoost
Street address
Velenjak- koodakyar St
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 23871
Email
nasoohi_m@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Nasoohi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
saadat abad
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2209 1492
Email
nasoohi_m@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahshid Ghasemi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
pain
Street address
Akhtar hospital
City
tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2200 1072
Email
nasoohi_m@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Nasoohi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
saadat abad
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 2209 1492
Email
nasoohi_m@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparison of two caudal-epidural methods and regional myofascial injection in patients with back pain
When the data will become available and for how long
Aftar 1404-1405
To whom data/document is available
Anesthesiologists and pain fellowship
Under which criteria data/document could be used
The data can be helpful in generalizing and increasing samples and final results in similar studies.
From where data/document is obtainable
Scientific sites such as PubMed or email to the researcher
What processes are involved for a request to access data/document
If the article cannot be accessed, email should be sent to the researcher.
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