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Comparison Investigation of the Effectiveness of Aquatic Exercises and Knee Kinesiotaping, Water-Based Neuromuscular Exercise, and Common Aquatic Exercises on Pain and Function of Patients with Knee Osteoarthritis

Protocol summary

Study aim
Determining the effectiveness of Aquatic Exercises and Knee Kinesiotaping, Water-Based Neuromuscular Exercise, and Common Aquatic Exercises on Pain and Function of Patients with Knee Osteoarthritis
Design
This is a randomized clinical trial with a parallel design. This is a non-blinded study, phase 2-3 will be conducted on 51 eligible patients with knee osteoarthritis. A table of random numbers is used for randomization and the participants are assigned to three intervention groups.
Settings and conduct
This study, which will be conducted in Shahid Fattahi Clinic in Kermanshah, is a non-blinded one. After the initial evaluation of the entry criteria, the candidates will be randomly divided into three intervention groups and will receive the interventions related to their group. At the beginning of the study and eight weeks after the intervention, the outcomes of pain intensity, and performance of patients in three groups will be examined and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 40 and 65 years; Body mass index less than 30; Not doing sports in the last two years; Having a minimum score of 5 in pain intensity based on the visual pain scale Exclusion criteria: Allergy to kensiotype; Use of intra-articular injection drug in the last three months
Intervention groups
In the first intervention group, exercise in water and kensiotype will be used simultaneously for 8 weeks, three sessions a week and each session will be 40-70 minutes. In the second intervention group, neuromuscular exercises in water will be used for 8 weeks, three sessions a week and each session will be 40-70 minutes. In the third intervention group, only common hydrotherapy exercises are used for 8 weeks, three sessions a week and each session lasts 40-70 minutes.
Main outcome variables
Intensity of pain, Patients' performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N194
Registration date: 2023-01-28, 1401/11/08
Registration timing: prospective

Last update: 2023-01-28, 1401/11/08
Update count: 0
Registration date
2023-01-28, 1401/11/08
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-04, 1401/11/15
Expected recruitment end date
2023-04-14, 1402/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Investigation of the Effectiveness of Aquatic Exercises and Knee Kinesiotaping, Water-Based Neuromuscular Exercise, and Common Aquatic Exercises on Pain and Function of Patients with Knee Osteoarthritis
Public title
The effectiveness of three treatment methods on pain intensity and performance of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 and 65 years Body mass index less than 30 Radiographic severity according to Lawrence and Kellgren criteria with Ι grade II Not doing sports in the last two years Having a minimum score of 5 in pain intensity based on the visual pain scale
Exclusion criteria:
Allergy to kensiotype Use of intra-articular injection drug in the last three months A history of skin and infectious diseases that can be transmitted by water
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 51
Randomization (investigator's opinion)
Randomized
Randomization description
Using a table of random numbers. Single-digit numbers between 0 and 9 will be assigned to the sample number from the random number table. For studies with three groups, the numbers 0-9 are divided into three equal blocks so that the probability of assigning a person to each block is 0.5. Block 1-3 can be used for the first group, block 4-6 for the second group, and block 7-9 for the third group.
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-10-23, 1401/08/01
Ethics committee reference number
IR.KUMS.MED.REC.1401.162

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.10
ICD-10 code description
Unilateral primary osteoarthritis, unspecified knee

Primary outcomes

1

Description
Intensity of pain
Timepoint
The beginning of the study and the end of the study (eight weeks after the start of the study)
Method of measurement
Using a visual pain scale

2

Description
Patients' performance
Timepoint
The beginning of the study and the end of the study (eight weeks after the start of the study)
Method of measurement
Using Western Ontario and McMaster Universities Arthritis Index

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group, exercise in water and kensiotype will be used simultaneously for 8 weeks, three sessions a week and each session will be 40-70 minutes
Category
Treatment - Other

2

Description
In the second intervention group, neuromuscular exercises in water will be used for 8 weeks, three sessions a week and each session will be 40-70 minutes.
Category
Treatment - Other

3

Description
In the third intervention group, only common hydrotherapy exercises are used for 8 weeks, three sessions a week and each session lasts 40-70 minutes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Fatahi Clinic
Full name of responsible person
Negin Sharafkhani
Street address
Shahid Fatahi Clinic, beginning of the second Si-Metri St
City
Kermanshah
Province
Kermanshah
Postal code
6715847143
Phone
+98 83 3837 8098
Email
Sharafkhani.negin@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Cyrus Jalili
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
cjalili@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Sharafkhani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
Sharafkhani.negin@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Parviz Sufivand
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Shahid Fatahi Clinic, beginning of the second Si-Metri St
City
Kermanshah
Province
Kermanshah
Postal code
6715847143
Phone
00988378098
Email
parvizsoufivand@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Negin Sharafkhani
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, parastar boulvarde
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 4618
Email
Sharafkhani.negin@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
There is no further information
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
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