Protocol summary

Study aim
The effect of core stability exercises on pain and inflammation in patients with piriformis syndrome
Design
The clinical trial has two experimental and control groups, non-blind, non-random and includes 20 patients.
Settings and conduct
In this study, among patients with piriformis syndrome referred to medical centers in Arak; 20 people are purposefully selected and non-randomly divided into two groups of 10 control and experimental. During a few sessions, the necessary explanations and explanations about the reason for conducting the research, the purpose and the possible useful results are made and the necessity of regular participation in the exercises and how to conduct the research is explained to the subjects. Then, written consent is obtained from all subjects and the personal information questionnaire is completed by them. Using the McGill Pain Questionnaire, the subjects' pain was assessed and recorded, and their inflammation was assessed by a physician using MRI images. After the implementation of the training protocol, the post-test is performed on the control and experimental groups.
Participants/Inclusion and exclusion criteria
Criteria for entering the research 1. The sexuality of the subjects is male. 2. The age range of the subjects is 25-40 years. 3. Patients must be approved by a rehabilitation specialist and a specialist doctor. Exclusion criteria 1. There is a history of any surgery or discomfort such as disc herniation, spondylitis, fracture, discopathy, etc. 2. Patients with metabolic and neurological diseases. 3. Patients with severe osteoarthritis and rheumatoid arthritis.
Intervention groups
Core stability exercises are exercises that improve and strengthen the central area of ​​the body.
Main outcome variables
core stability exercises; pain and inflammation in patients with piriformis syndrome

General information

Reason for update
Acronym
(piriformis syndrome)PS
IRCT registration information
IRCT registration number: IRCT20211003052662N1
Registration date: 2021-11-01, 1400/08/10
Registration timing: registered_while_recruiting

Last update: 2021-11-01, 1400/08/10
Update count: 0
Registration date
2021-11-01, 1400/08/10
Registrant information
Name
Rashid Doosti Irani
Name of organization / entity
The University of Arak
Country
Iran (Islamic Republic of)
Phone
+98 86 3262 0000
Email address
rashiddoostiirani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-27, 1400/08/05
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of core stability exercises on pain and inflammation in patients with piriformis syndrome
Public title
The effect of core stability exercises on pain and inflammation in patients with piriformis syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. The sexuality of the subjects is male. 2. The age range of the subjects is 25-40 years. 3. Patients must be approved by a rehabilitation specialist and a specialist doctor.
Exclusion criteria:
1. There is a history of any surgery or discomfort such as disc herniation, spondylitis, fracture, discopathy, etc. 2. Patients with metabolic and neurological diseases. 3. Patients with severe osteoarthritis and rheumatoid arthritis.
Age
From 25 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study includes two control and experimental groups that the experimental group received one type of intervention and the control group did not receive any intervention in the relevant time period.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Alam al-Huda St, Shahid Shiroodi St, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2021-09-05, 1400/06/14
Ethics committee reference number
IR.ARAKMU.REC.1400.157

Health conditions studied

1

Description of health condition studied
piriformis syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
pain-In this study, pain intensity was measured using the McGill Pain Questionnaire and referred to scores that indicate the subject's pain.
Timepoint
Pain is measured before the test(training protocol) and after the exercises.
Method of measurement
The McGill Pain Questionnaire is used in this study to measure pain intensity. This questionnaire consists of 22 questions that the subjects fill in before the start and after the end of the exercises and their pain is evaluated and recorded.

2

Description
inflammation
Timepoint
Inflammation is assessed before the test (training protocol) and after the exercises.
Method of measurement
In this study, MRI images were used by a specialist physician to evaluate sciatica (with scores of zero and one).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Core stability exercises_6 weeks Core stability stretching exercises, including piriformis muscle stretching exercises.
Category
Rehabilitation

2

Description
Control group: The control group will continue its normal life during the mentioned period.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Faraji Medical Clinic
Full name of responsible person
Fardin Faraji
Street address
Dey specialized medical complex, beginning of Shokraei St, Armenian Three Ways, Shahid Beheshti St, Arak.
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3224 6797
Email
fardin.faraji@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University
Full name of responsible person
Dr. Massoud Golpayegani
Street address
Arak University, Karbala Boulevard, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 0000
Email
rashiddoostiirani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University
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
The University of Arak
Full name of responsible person
Rashid Doosti Irani
Position
Master's Degree
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises
Street address
Arak University, Karbala Boulevard, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 0000
Fax
Email
rashiddoostiirani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Arak
Full name of responsible person
Rashid Doosti Irani
Position
Master's Degree
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises
Street address
Arak University, Karbala Boulevard, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 0000
Fax
Email
rashiddoostiirani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Arak
Full name of responsible person
Rashid Doosti Irani
Position
Master's Degree
Latest degree
Bachelor
Other areas of specialty/work
Corrective Exercises
Street address
Arak University, Karbala Boulevard, Basij Square, Arak.
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3262 0000
Fax
Email
rashiddoostiirani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Misuse of relevant data by others.
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
There is no more information.
When the data will become available and for how long
The access period starts from 1401.
To whom data/document is available
The information will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
It is allowed to send the provided information without any changes.
From where data/document is obtainable
Rashid Doosti Irani Faculty of Sports Sciences, Arak University, Arak University. rashiddoostiirani@gmail.com
What processes are involved for a request to access data/document
One week after the application is submitted, the relevant information will be provided to the applicant.
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