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Trial registered on ANZCTR


Registration number
ACTRN12624000699561p
Ethics application status
Submitted, not yet approved
Date submitted
4/04/2024
Date registered
3/06/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
3/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of high-intensity laser therapy as an adjunct to physiotherapy in knee osteoarthritis
Scientific title
Effects of photobiomodulation as an adjunct to rehabilitation exercise on pain, physical function, and radiographic changes in knee osteoarthritis: a randomized controlled trial
Secondary ID [1] 311827 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis (KOA) 333468 0
Condition category
Condition code
Musculoskeletal 330145 330145 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 330333 330333 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study included both groups: the exposed group (HILT+E); the comparison group (PL+E)

Both groups will receive HILT (BTL-6000: 5 W, 1064 nm, 19 to 150 J/cm2, and 3190 J per session) and sham laser (without emission of energy) as an adjunctive treatment, respectively, in addition to knee rehabilitation exercise (standard physiotherapy care). The same intensity and frequency will be applied for whole session. The laser will be applied on anterior knee for 15 minutes each session. The participants will received one treatment per week for twelve consecutive weeks. The mode of administration will be one-on-one consultation and the participants will be reminded one day before the appointment by phone call.

Both groups participants will engage in exercises based on specific KOA guidelines, with each exercise tailored to their needs, considered there is no difference between both groups.
Intervention code [1] 328354 0
Treatment: Devices
Intervention code [2] 328355 0
Rehabilitation
Comparator / control treatment
The comparison group (Placebo Laser therapy+E)

The participants will received the sham laser therapy on anterior knee for 15 minutes each session for twelve consecutive weeks. The mode of administration will be one-on-one consultation and the participants will be reminded one day before the appointment by phone call.

Both groups participants will engage in exercises based on specific KOA guidelines, with each exercise tailored to their needs, considered there is no difference between both groups.
Control group
Placebo

Outcomes
Primary outcome [1] 337895 0
Knee Injury and Osteoarthritis Outcome Score (KOOS): This validated questionnaire assesses the outcomes and subjective experiences of individuals with knee injuries or osteoarthritis, encompassing domains like pain, symptoms, activities of daily living, sports and recreation, and quality of life.
Timepoint [1] 337895 0
The outcome measures will be evaluated at two distinct intervals:
1. Baseline (pre-intervention): These assessments are conducted before the intervention to establish the initial state of participants' knee osteoarthritis (KOA) condition.
2. Immediately post-completion of the intervention (short term, week-8): These measurements are taken immediately after the last intervention, occurring at week 8.
Secondary outcome [1] 433621 0
Active knee flexion Range of Motion (ROM):The goniometer is reliable for evaluating knee flexion in various positions, including supine, prone, and sitting positions
Timepoint [1] 433621 0
The outcome measures will be evaluated at two distinct intervals:
1. Baseline (pre-intervention): These assessments are conducted before the intervention to establish the initial state of participants' knee osteoarthritis (KOA) condition.
2. Immediately post-completion of the intervention (short term, week-8): These measurements are taken immediately after the last intervention, occurring at week 8.
Secondary outcome [2] 433622 0
Timed Up and Go (TUG) test: to assess the functional mobility
Timepoint [2] 433622 0
The outcome measures will be evaluated at two distinct intervals:
1. Baseline (pre-intervention): These assessments are conducted before the intervention to establish the initial state of participants' knee osteoarthritis (KOA) condition.
2. Immediately post-completion of the intervention (short term, week-8): These measurements are taken immediately after the last intervention, occurring at week 8.
Secondary outcome [3] 433623 0
Knee Radiographic Imaging (X-ray): to assess the changes in the knee joint struture.
Timepoint [3] 433623 0
The outcome measures will be evaluated at two distinct intervals:
1. Baseline (pre-intervention): These assessments are conducted before the intervention to establish the initial state of participants' knee osteoarthritis (KOA) condition.
2. Follow-up (long-term, week-12): The assessments are conducted after the intervention occurring three months after the final treatment session at week 24.

Eligibility
Key inclusion criteria
i. Adults aged 18 years and above of both sexes.
ii. Individuals diagnosed with unilateral or bilateral KOA by an orthopaedic doctor.
iii. Those with a Kellgren-Lawrence classification of mild to moderate KOA based on a knee radiograph conducted within the last six months
iv. Individuals capable of engaging in the intervention and assessment program without restrictions. In cases where both knee joints are affected, the knee with more severe symptoms, based on the pain score, will be included. If symptoms are identical in both knees, the dominant knee will be assessed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Presence of other pathological conditions like rheumatic disease, prior hip or knee joint replacement, congenital dysplasia, osteochondritis dissecans, intra-articular fractures, septic arthritis, ligament or meniscus injury, and any other condition impeding the healing process, including diabetes mellitus and peripheral vascular disease
ii. comorbidities hindering physical evaluation
iii. ongoing participation in another KOA-related interventional study
iv. individuals taking prescription glucosamine sulfate, which might potentially affect the study's outcomes.
v. Participants who had undergone intra-articular knee injections (e.g., corticosteroid, hyaluronic acid, or blood-derived products) for KOA management in the last six months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The group allocation will be concealed using central randomization by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The recruitment of participants (n=40) will be randomly assigned in a 1:1 ratio to one of two intervention groups using a computer-generated table and a simple block randomization method: (i) Group HILT with exercise (HILT+E; n = 20) and (ii) Group placebo laser with exercise (PL+E; n = 20). This randomization process will occur subsequent to participants receiving both verbal and written information about the study protocol and signing the written informed consent form.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data analysis for this study will be conducted using SPSS version 25.0 (SPSS Inc., Chicago, IL, USA) and will adhere to the intention-to-treat principle. All participants, irrespective of their adherence to the intervention, will be included in the analysis. Sociodemographic characteristics of participants at baseline will be described using descriptive statistics and cross-tabulations. The primary statistical analysis for assessing outcomes will involve repeated measures ANOVA, contingent upon meeting assumptions of normality and sphericity. Normality will be evaluated using the Shapiro-Wilk test, with higher values indicating more normal data, while sphericity will be assessed using Mauchly’s test, where lower values closer to 0 suggest more homogenous variance between levels.
The data will undergo two-way repeated measure ANOVA to scrutinize the effects of time, group, and the interaction between the two investigated groups (HILT+E and PL+E). Cohen's d will be applied to ascertain the effect size of each variable, with values of 0.2, 0.5, and 0.8 representing small, medium, and large effects, respectively (Serdar, Cihan et al. 2021). Moreover, the Minimal Clinically Important Difference (MCID) will be considered for the Knee Injury and Osteoarthritis Outcome Score (KOOS), Numeric Pain Rating Scale (NPRS), active knee flexion range, and Timed Up and Go (TUG) test to evaluate the clinical relevance of observed changes. All statistical analyses will maintain an alpha level of 0.05 for significance tests.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26232 0
Malaysia
State/province [1] 26232 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 316167 0
University
Name [1] 316167 0
Geran Galakan Penyelidik Muda (GGPM),under Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Country [1] 316167 0
Malaysia
Primary sponsor type
University
Name
Geran Galakan Penyelidik Muda (GGPM),under Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur.
Address
Country
Malaysia
Secondary sponsor category [1] 318347 0
None
Name [1] 318347 0
Address [1] 318347 0
Country [1] 318347 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314992 0
Research Ethics Committee UKM (RECUKM)
Ethics committee address [1] 314992 0
Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur.
Ethics committee country [1] 314992 0
Malaysia
Date submitted for ethics approval [1] 314992 0
30/04/2024
Approval date [1] 314992 0
16/07/2024
Ethics approval number [1] 314992 0
JEP-2024-541

Summary
Brief summary
A Randomized Controlled Trial to investigate photobiomodulation as adjunctive to rehabilitation exercise in knee osteoarthritis in Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Malaysia. This study is to provide new insights into the long-term disease-modifying effects of high intensity laser therapy as a supplement to rehabilitative activities for individuals with mild-to-moderate knee osteoarthritis. The research hypothesis is combining high intensity laser therapy with rehabilitation exercise will significantly reduce knee pain, improve physical function, and reduce knee-related disability levels among adults with mild to moderate knee osteoarthritis in the long term.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133350 0
Dr Mohd Azzuan Ahmad
Address 133350 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur.
Country 133350 0
Malaysia
Phone 133350 0
+60123297292
Fax 133350 0
Email 133350 0
[email protected]
Contact person for public queries
Name 133351 0
Tay Yan Ling
Address 133351 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur.
Country 133351 0
Malaysia
Phone 133351 0
+601155023810
Fax 133351 0
Email 133351 0
[email protected]
Contact person for scientific queries
Name 133352 0
Mohd Azzuan Ahmad
Address 133352 0
Physiotherapy Programme, Centre for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, 50300, Kuala Lumpur.
Country 133352 0
Malaysia
Phone 133352 0
+60123297292
Fax 133352 0
Email 133352 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.