A comparative study of lateral hamstring strengthening versus overall hamstring strengthening on pain, disability, and quality of life, and foot loading pattern in patients with primary osteoarthritis and varus deformity: randomized clinical trial
The purpose of this study is to compare the effect of exercise with the aim of increasing the activity of external hamstring, compared to the overall strengthening of hamstring on pain, disability and quality of life in patients with knee osteoarthritis.
Design
Patients will be allocated into two groups based on simple randomization using sealed envelope. With alpha 0.05 and beta 0.20 (80% power), at least 20 people in each group will be required.
Settings and conduct
Physical Therapy clinic of Qaem Hospital
Participants/Inclusion and exclusion criteria
People with knee osteoarthritis will be confirmed by an orthopedic surgeon. Patients are randomly divided into two groups of novel physiotherapy (external hamstring enhancement) and conventional physiotherapy (general hamstring enhancement) based on inclusion and exclusion criteria.
Intervention groups
Treatment will be performed in four consecutive weeks and three sessions per week. Each session includes 20 minutes of electrotherapy, 5 minutes of warm-up exercise, 5 minutes of aerobic exercise and 35 minutes of therapeutic exercise. The intervention group will perform strengthening exercises for quadriceps and hamstring muscle including isometric exercises, hamstring curl, hamstring bridge, standing and sitting knee flexion and hamstring curl with the ball. In the intervention group, all therapeutic exercises related to hamstring are performed with external rotation of the tibia. Also in this group, we focus the stretching of the hamstring muscle on its inner part.
Main outcome variables
KOOS, OAKHQOL, Tegner activity scale and pain score based on VAS criteria
General information
Reason for update
Acronym
MOAS
IRCT registration information
IRCT registration number:IRCT20161221031506N5
Registration date:2021-04-15, 1400/01/26
Registration timing:registered_while_recruiting
Last update:2021-04-15, 1400/01/26
Update count:0
Registration date
2021-04-15, 1400/01/26
Registrant information
Name
Salman Nazary-Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 6713
Email address
nazaryms@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-10-21, 1400/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of lateral hamstring strengthening versus overall hamstring strengthening on pain, disability, and quality of life, and foot loading pattern in patients with primary osteoarthritis and varus deformity: randomized clinical trial
Public title
Comparative effect of two hamstring strengthening methods in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee pain on last six months.
Pain scale (VAS) should be higher than 4 out of 10.
OA patients will have Knee varrus deformity, knee crepitus, and significant limited ROM.
Graded 2, and 3 based on Kellgren and Lawrence scale.
Exclusion criteria:
Any knee alignment corrective surgery
Candidate for joint replacement surgery
Any severe change in patient's gait due to pain and limited ROM
ligament instability (Grade 3)
The involvement of the patellofemoral joint or the lateral femoral condyle is greater than the medial condyle (diagnosed by X-ray)
Any disorders that limit daily movements and activities
Corticosteroids usage for the knee pain in the last three months
Use assistive devices such as knee orthoses and walker
Patients with varrus deformity (grade 1, and 3)
Cognitive problems diagnosed using EMMSE questionnaire
Spinal stenosis, and lumbar disc herniation
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method will be the block randomization method and based on that, the randomization unit will be individual.
Randomization will be done using a sealed envelope.
The grouping will be done by the secretary of the physiotherapy department. The secretary of the physiotherapy department will select a card from the envelope after referring the person to the physiotherapy department. The patients will be assigned to one of two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The assessor will be blinded from the patient’s grouping. The statistical analysis will be performed by one of authors who blinded about the label of grouping.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Head Office of Mashhad University of Medical Science, Qoreishi Center, Daneshgah st., Mashhad, Iran
At the time of referral - after 12 sessions of treatment
Method of measurement
Using a foot scan device
Intervention groups
1
Description
Intervention group: All hamstring therapy exercises in this group will be performed with external rotation of the tibia and the stretch will focus on medial hamstring muscle.
Category
Rehabilitation
2
Description
Control group: In this group, hamstring exercises will be applied on the muscle in general and the hamstring muscle will be stretched completely.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Therapy Clinic of Ghaem Hospital
Full name of responsible person
Mr Javad Zarandi
Street address
First floor, Narjes building, Qaem Hospital-Dr. Shariati Square, beginning of Ahmadabad Avenue, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 1538
Email
zarandiMJ1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Head Office of Mashhad University of Medical Science, Qoreishi Center, Daneshgah st., Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Personal Grant (Dr Salman Nazary-Moghadam)
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Mamipour Gharanjick
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Room 313, 2st Floor, Department of Physiotherapy, School of Paramedical Sciences, Mashhad University of Medical Sciences. Vakilabad Blvd, Bahonar Blvd, Pardis campus, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
hamed.mamipour72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Mamipour Gharanjick
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Room 313, 2st Floor, Department of Physiotherapy, School of Paramedical Sciences, Mashhad University of Medical Sciences. Vakilabad Blvd, Bahonar Blvd, Pardis campus, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
hamed.mamipour72@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Mamipour Gharanjick
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Room 313, 2st Floor, Department of Physiotherapy, School of Paramedical Sciences, Mashhad University of Medical Sciences. Vakilabad Blvd, Bahonar Blvd, Pardis campus, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3869 8719
Email
hamed.mamipour72@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
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
All reports will be reported in one research paper. Raw data will be delivered to researchers only for meta analysis.
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
For researchers
Under which criteria data/document could be used
Only for meta-analysis
From where data/document is obtainable
Nazary_salman@yahoo.com
What processes are involved for a request to access data/document
The response will be sent 3 months after considering the researcher's request.