1. Home
  2. Approved trials
  3. » فارسی

The effect of a course of rehabilitation exercises combined with blood flow restriction on pain, function, and muscle electrical activity in patients with patellofemoral pain syndrome.

Protocol summary

Study aim
Investigating the effect of a course of rehabilitation exercises with blood flow restriction on pain, function and electrical activity of muscles in patients with patellofemoral pain syndrome Investigating the effect of a course of rehabilitation exercises with blood flow restriction on pain in patients with patellofemoral pain syndrome Investigating the effect of a course of rehabilitation exercises with blood flow restriction on the performance of patients with patellofemoral pain syndrome Investigating the effect of a course of rehabilitation exercises with blood flow restriction on the electrical activity of muscles in patients with patellofemoral pain syndrome
Design
The clinical trial will be controlled, with parallel groups, unblinded, randomized, phase 2, and will be conducted on 30 patients.
Settings and conduct
Patients with patellofemoral pain syndrome, semi-experimental and randomized, in the laboratory of the University of Zabol.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All individuals with pain in the patellofemoral joint for at least 6 weeks, exacerbation of patellofemoral joint pain in at least 2 of the following activities: squatting, kneeling, and going up and down stairs. Exclusion criteria: not participating in regular exercises, history of any surgery on the knee joint, any internal knee joint problem, presence of neurological, cardiovascular conditions related to blood, and tissue or joint injuries after performing rehabilitation exercises.
Intervention groups
1- Rehabilitation exercise group with blood flow restriction 2- Rehabilitation exercise group without blood flow restriction
Main outcome variables
Pain, function, electrical activity of muscles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211201053244N2
Registration date: 2024-12-22, 1403/10/02
Registration timing: registered_while_recruiting

Last update: 2024-12-22, 1403/10/02
Update count: 0
Registration date
2024-12-22, 1403/10/02
Registrant information
Name
Mohammadreza Rezaeipour
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3113 2241
Email address
rezaeipour@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-05, 1403/09/15
Expected recruitment end date
2025-01-04, 1403/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a course of rehabilitation exercises combined with blood flow restriction on pain, function, and muscle electrical activity in patients with patellofemoral pain syndrome.
Public title
Pain, function, and electrical activity of muscles
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patellofemoral pain syndrome Woman
Exclusion criteria:
Failure to provide permission to participate in sports activities
Age
From 35 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The simple randomization model will be used with the intervention and control groups being secretly recorded on paper and selected by the participants. In this method, the type of treatment assigned to the two groups is completely unpredictable.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Sistan and Baluchestan
Street address
University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745785
Approval date
2024-11-09, 1403/08/19
Ethics committee reference number
IR.USB.REC.1403.033

Health conditions studied

1

Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Electrical activity of muscles
Timepoint
Before starting rehabilitation exercises, 6 weeks after starting exercises
Method of measurement
Surface electromyography recording device

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Rehabilitation exercises with blood flow restriction: The number of people in this group is 15, the training period is 6 weeks, and they perform 3 sessions of rehabilitation exercises with blood flow restriction per week, and a cuff will be used for restriction.
Category
Rehabilitation

2

Description
Control group: Rehabilitation exercises without restricting blood flow, the number of people in this group is 15, the training duration is 6 weeks, and they perform 3 sessions of rehabilitation exercises without restricting blood flow per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Zabol
Full name of responsible person
Dr. Hadi Akbari
Street address
2nd km of Banjar Road
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861335856
Phone
+98 54 3322 2736
Email
h.akbari@uoz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Dr. Nour Mohammad Yaghoubi
Street address
University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745845
Phone
+98 54 3113 6245
Email
yaghoubi@mgmt.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Sistan and Baluchestan
Proportion provided by this source
20
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
University of Sistan and Baluchestan
Full name of responsible person
Mohammadreza Rezaeipour
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Sports Medicine
Street address
University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3113 2674
Email
rezaeipour@ped.usb.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Mohammadreza Rezaeipour
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Sports Medicine
Street address
University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3113 2674
Email
rezaeipour@ped.usb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
Mohammadreza Rezaeipour
Position
Associate Professor
Latest degree
Medical doctor
Other areas of specialty/work
Sports Medicine
Street address
University Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3113 2674
Email
rezaeipour@ped.usb.ac.ir

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
Requires review and obtaining necessary permissions, including from patients.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...