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The effect of hip and knee muscles strength exercises in the water with or without use of kinesiotapes) as instant and long term (in improvement of pain, dynamic performance, Disability and the balance in women patients Patellofemoral pain syndrome

Protocol summary

Study aim
The main purpose of this study was to study the effect of strengthening exercises in the thigh and knee muscles in water with and without Kinesiotape (on an on-going and long-term basis) on pain, motor function, disability, balance and quality of life in women with PFPS.
Design
In this study, 45 women with this Patellofemoral pain syndrome were randomly assigned into three groups without kinesiotape (15) and water therapy with kinesiotape (15 patients) and water therapy kinesiotape was permanent (15 people)
Settings and conduct
The present study is a semi-experimental research based on the research design, the method of selecting the subjects, the measurement tools and the intervention, and the research design was pre-test and post-test on the three experimental groups, which for 8 weeks were as (Three sessions a week) conducted the exercises with the appropriate mentor's guidance.
Participants/Inclusion and exclusion criteria
Including Entry Requirements:Diagnosis and confirmation of the presence of patellofemoral pain syndrome by a specialist Positive Clark's test and Patellar Apprehension Womens aged 18 to 45 years Not participating in other sports activities Exclusion criteria: Diseases like osteoarthritis, joint diseases Having an artificial joints in the leg Performing knee surgery in the past Use of pain medications for knee pain in the present Affected by diseases that affect the variables of balance such as: Having no proper vision or any visual impairment, having an internal ear venereal disease
Intervention groups
three groups without kinesiotape (15) and water therapy with kinesiotape (15 patients) and water therapy kinesiotape was permanent (15 people)
Main outcome variables
Reduced pain, increased motor function, decreased disability, increased stagnation in the form of static and dynamic, increased quality of life

General information

Reason for update
Acronym
PFPS
IRCT registration information
IRCT registration number: IRCT20171205037757N1
Registration date: 2018-01-17, 1396/10/27
Registration timing: retrospective

Last update: 2018-01-17, 1396/10/27
Update count: 0
Registration date
2018-01-17, 1396/10/27
Registrant information
Name
Marzieh Mokhtari Karchegani
Name of organization / entity
The University of tehran
Country
Iran (Islamic Republic of)
Phone
+98 31 3775 8601
Email address
mokhtari.marzieh.1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-05, 1395/08/15
Expected recruitment end date
2017-01-29, 1395/11/10
Actual recruitment start date
2016-11-05, 1395/08/15
Actual recruitment end date
2017-01-10, 1395/10/21
Trial completion date
empty
Scientific title
The effect of hip and knee muscles strength exercises in the water with or without use of kinesiotapes) as instant and long term (in improvement of pain, dynamic performance, Disability and the balance in women patients Patellofemoral pain syndrome
Public title
Water therapy to improve patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis and confirmation of the presence of patellofemoral pain syndrome by a specialist Positive Clark's test and Patellar Apprehension Womens aged 18 to 45 years Not participating in other sports activities
Exclusion criteria:
Diseases like osteoarthritis, joint diseases Having an artificial joints in the leg Performing knee surgery in the past Use of pain medications for knee pain in the present Affected by diseases that affect the variables of balance such as: Having no proper vision or any visual impairment, having an internal ear venereal disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher has by no means interfered in test neither in pre-test before exercise or post-test after exercise as the tests were given by individuals who had no clue about the plan.the participants were not alert of test application as well and just acted to instruction.The person who analyzed the data did not know about the study and generally looked at the data.
Placebo
Not used
Assignment
Parallel
Other design features
Use kinesiotape the water

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Pajohesh Intersection ., Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.UMSHA.REC.1395.468

Health conditions studied

1

Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M00-M99
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
The amount of Visual pain
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Use the Visual Analogue Scale ruler

2

Description
The amount of pain
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Using the McGill Pain Questionnaire

3

Description
Motor function
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Use the Kujala questionnaire

4

Description
Disability
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Van Kurf et al. Disability questionnaire

5

Description
Dynamic balance
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Biodegrade System balance

6

Description
Static balance
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Biodegrade System balance

7

Description
Quality of Life
Timepoint
At the beginning of the study before the intervention and 60 days after the exercises
Method of measurement
Sherbourne SF36 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: water therapy without kinesiotape (n=15),A two-month-long therapeutic exercise without the use of a kinesiotape
Category
Rehabilitation

2

Description
Second Intervention group: water therapy with temporary kinesiotaping (n=15), A two-month-long therapeutic exercise using short-term kinesiotap
Category
Rehabilitation

3

Description
Third Intervention group: water therapy with permanent kinesiotaping (n=15), A two-month-long exercise therapy using long-term kinesiotap
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Maryam Bashiri
Street address
Besat Hospital, Motahari BlvdDi, strict 2, Hamedan
City
Hamedan
Province
Hamadan
Postal code
8174784986
Phone
+98 81 3264 0020
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Bu-Ali Sina
Full name of responsible person
Ali Yalfani
Street address
University of Bu-Ali Sina, Pajohesh Intersection ., Mahdieh Street
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3838 1422
Fax
Email
Ali_Yalfani@Yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Bu-Ali Sina
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 Bu-Ali Sina
Full name of responsible person
Marzieh Mokhtari Karchegani
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No.76, Deadend Ershad., Nastoh Street.
City
Esfahan
Province
Isfehan
Postal code
8174784986
Phone
+98 31 3775 8601
Email
Mokhtari.Marzieh.1371@Gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Bu-Ali Sina
Full name of responsible person
Marzieh Mokhtari Karchegani
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No.76, Deadend Ershad., Nastoh Street.
City
Esfahan
Province
Isfehan
Postal code
8174784986
Phone
+98 31 3775 8601
Email
Mokhtari.Marzieh.1371@Gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The University of Bu-Ali Sina
Full name of responsible person
Marzieh Mokhtari Karchegani
Position
Masters Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
No.76, Deadend Ershad., Nastoh Street.
City
Esfahan
Province
Isfehan
Postal code
8174784986
Phone
+98 31 3775 8601
Email
Mokhtari.Marzieh.1371@Gmail.com
Web page address

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
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Title and more details about the data/document
Data and documentation can be shared, but with unidentifiable individuals and private information for subjects
When the data will become available and for how long
Starting data access 1 year after printing results
To whom data/document is available
Researchers in this field are allowed to act for documentation
Under which criteria data/document could be used
Only the type of analysis that can be done in the research can be redefined
From where data/document is obtainable
mokhtari.marzieh.1371@gmail.com
What processes are involved for a request to access data/document
When the applicant submits a document for his / her work area in relation to the subject matter of the thesis, and if the request is reasonable and the commitment not to misuse the data of this research, the data will be sent to him within 1 week of work.
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