To evaluate the effects of LLLT and light therapy post knee replacement in order to enhance the quality of life
Design
Randomized, parallel groups trial with blinded outcome assessment. All the patients will allocated into 3 groups (Light, Laser and Control).In the present study, 45 patients were enrolled between 2018 Feb to 2019 Feb. Randomization was performed by the four-block technique.
Settings and conduct
The study will run in the Imam Khomeini Hospital. all the patients will allocated into 3 groups (Laser. Light and control). Patient and assessor who gathered the data were blinded about the type of treatment modality (Double-Blinded)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
All patients who underwent TKA for primary knee osteoarthritis
Exclusion Criteria:
The patients with TKA due to secondary osteoarthritis such as rheumatoid arthritis and other rheumatologic condition, posttraumatic arthritis
The patients who had cognitive dysfunction or mental retardation
The patients with comorbidities such as diabetes or other neurological problems
The revision TKA patients
The patients who developed deep vein thrombosis or infections in postoperative period
The patients who were unwilling to participate in the study
Intervention groups
light (Bioptron light) in one intervention group and LLLT (RJ laser) another group.
First Group received Low-Level Laser during first 3 days after the operation in combination with exercise program with ice. (Laser)
The second Group received (Bioptron) light and the same exercise program quadriceps isometric with ice (Light)
The third group just received an exercise program with ice as in all groups (Control).
Main outcome variables
The knee range of motion (ROM), Knee Society Score (KSS), Functional KSS will measured preoperative and 3 months postoperative. Pain and swelling will measured preoperative and early postoperative.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160809029286N4
Registration date:2020-03-28, 1399/01/09
Registration timing:retrospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Alireza Moharrami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 7418
Email address
a-moharrami@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-02, 1396/11/13
Expected recruitment end date
2019-02-01, 1397/11/12
Actual recruitment start date
2018-02-02, 1396/11/13
Actual recruitment end date
2019-02-01, 1397/11/12
Trial completion date
2019-02-01, 1397/11/12
Scientific title
The Comparison of clinical outcome Low Level Laser and Light Therapy on TKA patients: A randomized clinical trial
Public title
The comparison of clinical outcome Laser and Light Method following Total Knee Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who underwent TKA for primary knee osteoarthritis at our institution
The patients with inform consent to participate in the study
Exclusion criteria:
The patients with TKA due to secondary osteoarthritis such as rheumatoid arthritis and other rheumatologic condition, posttraumatic arthritis
The patients who had difficulty in communication due to cognitive dysfunction or mental retardation
The patients with comorbidities such as diabetes or other neurological problems
Revision TKA patients
The patients who developed deep vein thrombosis or infections in postoperative period
The patients who were unwilling to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
15
The sample size was calculated based on the study by Eid et al (2015) [28] that used LLLT for the treatment of hemarthrosis in hemophilic patients. For sample size calculation we considered the β value of 20% and α of 5%. We used the Range of knee flexion (ROM) 6 week after treatment (Group 1: 106 ±5.7 Vs Group 2: 100.13 ±4.99) as a reference value for sample size calculation. Therefore, the calculation resulted in 15 patients in each group and 45 patients in total
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the type of modalities we will use during rehabilitation after TKA, 45 patients will randomize into three groups including control, LLLT and light (15 patients per group). Randomization will performed by the four-block technique. Patient and assessor who will gather the data will blinded about the type of treatment modality (Double-Blinded). We will use a randomization table and will divide all the patients into four blocks. The patients will allocate to three groups based on the treatment including Light, LLLT, and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization will performed by the four-block technique. Patient and assessor who will gather the data will blinded about the type of treatment modality (Double-Blinded). The patient and investigator will blinded about type of Intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethic Committee
Street address
Imam Khomeini Hospital, End of Keshavarz blvd, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2017-09-01, 1396/06/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.4777
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
Knee Society Score
Timepoint
Preoperative and 3 months post operative
Method of measurement
Based on the Knee Society Score form (0-100)
2
Description
Functional Knee Society Score
Timepoint
Preoperative and 3 months post operative
Method of measurement
Based on the Knee Society Score form (0-100)
3
Description
Pain Visual Analog Scale (VAS)
Timepoint
preoperative, first day, second day and third day postoperative, 3 months post operative
Method of measurement
Based on the pain in Visual Analog Scale (VAS) (0-10 scores)
4
Description
Knee Range of Motion
Timepoint
preoperative, first day, second day and third day postoperative, 3 months post operative
Method of measurement
Based on the measurement between full flexion and full extension by goniometer (0 to 140 degrees)
5
Description
Swelling
Timepoint
preoperative, first day, second day and third day postoperative, 3 months post operative
Method of measurement
the measure around of proximal of leg base on mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: light (Bioptron light) , The patients received (Bioptron) light and the same exercise program quadriceps isometric with ice which applied during first 3days after the operation.
Category
Rehabilitation
2
Description
Intervention group: LLLT (Low-Level Laser) or RJ laser, The patients received 804 nm GA AL AS LLLT (RJ laser) at power out of 500 mv and a degree of dosage 10J per session in 2 points (5J/Point) on posterior of the knee, which applied during first 3days after the operation. They receive same exercise and ice.
Category
Rehabilitation
3
Description
Control group: The Patients just received an exercise program with ice as in all groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Complex Hospital
Full name of responsible person
Dr Seyed Mohammad Javad Mortazavi
Street address
Imam Khomeini Hospital, End of Keshavarza Blvd, Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
Http://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Joint Reconstruction Research Center
Full name of responsible person
Dr Seyed Mohammad Javad Mortazavi
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
Http://www.ikch.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
Proportion provided by this source
1
Public or private sector
Private
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
Tehran University of Medical Sciences
Full name of responsible person
Alireza Moharrami
Position
Orthopaedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran , IRAN
City
Tehran
Province
Tehran
Postal code
1955743849
Phone
+98 21 6119 0000
Fax
Email
a-moharrami@student.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Javad Mortazavi
Position
Hip and Knee surgeon
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6653 1354
Fax
Email
smjmort@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Moharrami
Position
Orthopaedic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Orthopaedic Ward, Imam Khomeini Hospital, End of Keshavarz Blvd, Tehran , IRAN
City
Tehran
Province
Tehran
Postal code
1955743849
Phone
+98 21 6119 0000
Fax
Email
a-moharrami@student.tums.ac.ir
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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The article will published
When the data will become available and for how long
2021 January
To whom data/document is available
All faculty membership
Under which criteria data/document could be used
none
From where data/document is obtainable
Alireza Moharrami Email: a.moharramy@gmail.com
What processes are involved for a request to access data/document