Determining the effect of hip abductor exercises on pain, function and balance parameters in patients with knee osteoarthritis
Design
The study is a randomized controlled double-blind clinical trial. In this study, patients will divide into two groups of intervention and control by permuted block stratified randomization.
Settings and conduct
Razmjo Moghadam Physiotherapy Clinic Zahedan Islamic Republic of Iran
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 40 to 70 years; patients with osteoarthritis of the knee with chronic knee pain for 6 months or more; having grade 2 or 3 osteoarthritis of the knee according to the Kellgren-Lawrence grade; no history of knee surgery and no history of intra-articular injection and physiotherapy in the last 6 months; no more severe radiographic signs of the knee joint in the lateral side than in the medial side; no history of osteoarthritis or trauma or pathological lesion in the Hip joint ;no history of musculoskeletal, articular, neurological disorders affecting balance. Exclusion criteria: receiving other therapeutic interventions during the study, unwillingness to continue treatment, exacerbation of the patient's symptoms.
Intervention groups
Control group: Routine physiotherapy treatments, general exercises, progressive quadriceps strengthening program
Intervention group: Routine physiotherapy treatments, general exercises, progressive quadriceps and hip abductor muscles
Main outcome variables
Pain; function; balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210529051427N1
Registration date:2021-07-25, 1400/05/03
Registration timing:registered_while_recruiting
Last update:2021-07-25, 1400/05/03
Update count:0
Registration date
2021-07-25, 1400/05/03
Registrant information
Name
Mahla Rakhshani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3322 5114
Email address
m.rakhshani@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-20, 1400/04/29
Expected recruitment end date
2021-12-20, 1400/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Hip Abductor Exercises on Pain, Function and Balance Parameters in Patients with Knee Osteoarthritis
Public title
The Effect of Hip Abductor Exercises on Pain, Function and Balance Parameters in Patients with Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 70 years
Patients with osteoarthritis of the knee with chronic knee pain for 6 months or more
Having grade 2 or 3 osteoarthritis of the knee according to the Kellgren-Lawrence grade
No history of knee surgery and no history of intra-articular injection and physiotherapy in the last 6 months
No more severe radiographic signs of the knee joint in the lateral side than in the medial side
No osteoarthritis or trauma or pathological lesion in the Hip joint
No history of musculoskeletal, articular, neurological disorders affecting balance
Exclusion criteria:
Exclusion criteria: receiving other therapeutic interventions during the study, unwillingness to continue treatment, exacerbation of the patient's symptoms
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to the two groups is done by permuted block stratified randomization. First, eligible patients are classified according to age, sex and BMI, respectively. Then, based on 4 blocks (consisting of two groups A (intervention) and B (control) and two replicates for each), which were randomly selected from all possible modes of permutations; They are assigned to the desired group. These blocks were created using R statistical software version 4.0.2.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients with osteoarthritis of the knee and responsible for data collection and statistical data analysis are kept blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.ZAUMS.REC.1400.078
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Balance
Timepoint
Before and after the period of the interventions
Method of measurement
Biodex system
Secondary outcomes
1
Description
Pain
Timepoint
Before and after the period of the interventions
Method of measurement
Visual Analog Scale (VAS) questionnaire
2
Description
Function
Timepoint
Before and after the period of the interventions
Method of measurement
WOMAC questionnaire
Intervention groups
1
Description
Control group: Routine physiotherapy treatments (TENS and hot pack for 20 minutes, ultrasound for 5 minutes), general exercises (passive rectus femoris stretching, hamstrings, iliotibial band, cuff muscles and posterior capsule of the knee joint in 3 sets with 30 seconds holding and 15 second break, a progressive quadriceps strengthening program with three sessions per week for 6 consecutive weeks
Category
Rehabilitation
2
Description
Intervention group: Routine physiotherapy treatments, general exercises, progressive quadriceps and hip abductor muscles strengthening program with three sessions per week for 6 consecutive weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razmjo Moghadam Physiotherapy Clinic
Full name of responsible person
Dr. Ahmadreza Askari Ashtiani
Street address
Razmjo Moghadam Laboratory, Ayatollah Kafami St.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
64855-98136
Phone
+98 54 3321 7006
Email
ahmadaskary@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Noor mohammad Bakhshani
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
64855-98136
Phone
+98 54 3329 5796
Email
nmbakhsha@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ahmadreza Askari Ashtiani
Position
Ph.D in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
00985433372151-55
Email
ahmadaskary@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ahmadreza Askari Ashtiani
Position
Ph.D in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
00985433372151-55
Email
ahmadaskary@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ahmadreza Askari Ashtiani
Position
Ph.D in Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
00985433372151-55
Email
ahmadaskary@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All of the data can be shared.
When the data will become available and for how long
One year after article publication
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers and specialists in this field It must be ensured that data will not be misused
From where data/document is obtainable
ahmadaskary@gmail.com
rakhshanim500@gmail.com
What processes are involved for a request to access data/document
The applicant must and clearly and concisely state his / her intention to apply. He will receive the data as soon as possible after verification