Comparison of the effect of high-level laser and quadriceps muscle strengthening exercises using biofeedback on pain and function in patients with knee osteoarthritis
Investigating the effect of high-power laser and quadriceps muscle strengthening exercises using biofeedback on pain and function of patients with knee osteoarthritis
Design
People were randomly divided into two treatment groups A and B in a blocked way through block randomization.
Settings and conduct
Birjand, Iran
Participants/Inclusion and exclusion criteria
The study sample in this study includes knee osteoarthritis patients referred to the clinic of Imam Reza hospital in Birjand, who was referred by a specialist after the diagnosis of knee osteoarthritis.
Intervention groups
Group A was treated with high-power laser and exercise therapy for 10 sessions and group B was treated with quadriceps muscle strengthening exercises using biofeedback and exercise therapy for 10 sessions.
Main outcome variables
-Evaluation of knee pain severity scores of patients based on VAS criteria
-Completion of the WOMAC questionnaire for all participants
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221115056509N1
Registration date:2023-03-17, 1401/12/26
Registration timing:retrospective
Last update:2023-03-17, 1401/12/26
Update count:0
Registration date
2023-03-17, 1401/12/26
Registrant information
Name
Fatemeh Jazebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3242 2111
Email address
jazebi1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-01-24, 1401/11/04
Actual recruitment start date
2022-04-21, 1401/02/01
Actual recruitment end date
2023-01-24, 1401/11/04
Trial completion date
2023-01-25, 1401/11/05
Scientific title
Comparison of the effect of high-level laser and quadriceps muscle strengthening exercises using biofeedback on pain and function in patients with knee osteoarthritis
Public title
The effect of high power laser and quadriceps strengthening exercises on osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being on stage two or three of knee osteoarthritis
A history of continuous knee pain caused by osteoarthritis for at least 6 months
Minimum pain intensity of 3 based on Visual Analog Scale (VAS) criteria before the intervention
Body mass index less than or equal to 30 kg/m2
No using non-steroidal anti-inflammatory drugs and steroids before or during the intervention
A healthy mental state and full satisfaction to participate in the research
Exclusion criteria:
Patients under 18 years old
pregnant women
Non-completion of evaluation and treatment programs
Irregular attendance in the treatment program
The use of intra-articular injections during the last year before the study and during the study
A history of knee injury and surgery
Suffering from neuromuscular diseases and malignant tumors
Having bone implants in the lower limbs
Suffering from any rheumatological disease that requires steroid drugs
Participation in exercise therapy and physiotherapy programs during the last 6 months
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After meeting the inclusion criteria, people were randomly divided into two treatment groups (A and B) through block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
People were randomly divided into two treatment groups (A and B) through block randomization, and they were unaware of the way of intervention in the other group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Ghaffari St., Birjand University of Medical Sciences, Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
9717853076
Approval date
2022-05-16, 1401/02/26
Ethics committee reference number
IR.BUMS.REC.1401.083
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15-M19
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue(M00-M99)
Primary outcomes
1
Description
Evaluation of pain using a visual analogue scale (VAS)
Timepoint
After 10 sessions of laser therapy and after biofeedback and exercise therapy
Method of measurement
VAS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A was treated with high-power laser and exercise therapy for 10 sessions
Category
Rehabilitation
2
Description
Intervention group: or group B that was treated with quadriceps muscle strengthening exercises using biofeedback and exercise therapy for 10 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Clinic of Imam Reza Hospital, Birjand
Full name of responsible person
Fatemeh Jazebi
Street address
Ghaffari St, Birjand, Iran
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Jazebi1998@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam Sadat Rahimi
Street address
Ghaffari St, Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Jazebi1998@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Maryam Rahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Ghaffari St., Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Jazebi1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Maryam sadat Rahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Ghaffari St,.Birjand
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Jazebi1998@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fateme Jazebi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Ghaffari St., Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
9717853076
Phone
+98 56 3239 5000
Email
Jazebi1998@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 information to publish
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Only a part of the data, such as the information related to the main result can be shared.
When the data will become available and for how long
The access period starts 6 months after publishing the result
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
For professors and students
From where data/document is obtainable
Send a request email to Jazebi1998@gmail.com
What processes are involved for a request to access data/document