None listed
Conditions
Brief summary
As a disease-modifying intervention for knee osteoarthritis (KOA) is still unknown, rehabilitation exercise has been frequently combined with physical modalities, and among the recent is low-level (LLLT) and high-intensity laser therapy (HILT). However, it is uncertain which combination is more efficient. Moreover, available treatment guidelines have yet to include LLLT or HILT due to a lack of supporting evidence. Hence, this study aimed to investigate the effects of LLLT versus HILT as an adjunct to rehabilitation exercise on clinical outcomes in KOA. This study will be a randomized placebo-control design and will adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. This study will involve 60 adults aged between 18 to 75 years with mild to moderate KOA which will be recruited from the Sports Medicine Unit, Department of Rehabilitation Medicine, and Department of Primary Care Medicine (UMMC). The inclusion criteria will be : (i) diagnosed with symptomatic (pain and/or stiffness) KOA based on American College of Rheumatology criteria; and (ii) Kellgren-Lawrence classification of grade 3 (moderate) or less according to knee radiograph. Participants will be randomly allocated into three equal-size groups; LLLT+E, HILT+E and PL+E. In addition to their usual rehabilitation, LLLT+E (n = 20) and HILT+E (n = 20) groups will receive an active application of LLLT and HILT, respectively. Whereas, PL+E (n = 20) group will be given a placebo laser in addition to their usual rehabilitation. Interventions will be conducted twice a week for six weeks. The outcomes measures (questionaries and physical performance tests) will be evaluated at four different intervals; pre-mid-post intervention, and follow-up at week-18.
Interventions
The recruited participants (n = 60) will be allocated into three equal-size groups by simple block randomization based on age and gender; Group 1 (Low-level laser therapy + Exercise), Group 2 (High-intensity laser therapy + Exercise), and Group 3 (Placebo laser + Exercise). All participants will receive their usual physiotherapy care provided by the Sports Medicine Unit of the University Malaya Medical Centre (UMMC). The usual physiotherapy care is a rehabilitation exercise program that is indiv
The recruited participants (n = 60) will be allocated into three equal-size groups by simple block randomization based on age and gender; Group 1 (Low-level laser therapy + Exercise), Group 2 (High-intensity laser therapy + Exercise), and Group 3 (Placebo laser + Exercise). All participants will receive their usual physiotherapy care provided by the Sports Medicine Unit of the University Malaya Medical Centre (UMMC). The usual physiotherapy care is a rehabilitation exercise program that is individually tailored to the participant's needs and will be prescribed and progressed based on recommended knee osteoarthritis (KOA) treatment guidelines (to ensure uniformity in rehabilitation programs). This exercise program will take approximately one hour per session, and examples of the exercises are active movement exercises, stretching, flexibility, muscle strengthening, knee stabilization exercise, and functional training. The usual physiotherapy treatment will be administered by qualified physiotherapists from the Sports Medicine Unit (UMMC) who are unaware of participants’ grouping. In addition to the usual rehabilitation, participants in the Group 1 (LLLT+E, n = 20) and Group 2 (HILT+E, n = 20) will receive an active application of LLLT and HILT, respectively. Interventions will be conducted twice a week for a consecutive six weeks, and the laser interventions will be carried out by the same physiotherapist who will not involve in the outcome’s assessment. A regular phone call reminder and attendance checklist will be used to monitor participants' adherence to the intervention program. Details of the interventions for Group 1 and 2 are as follows: Group 1 LLLT+E (n = 20) Low-level laser therapy (LLLT) in addition to usual physiotherapy care, twice a week for six weeks; laser model GA diode (BTL), wavelength 830 nm, energy density 50 Jcm2, total energy 1250 Joule per session, 15 minutes of laser treatment per session (5 minutes of analgesic mode and 10 minutes of biostimulation mode), and the laser treatment will be applied at the medial and lateral knee joint lines. Group 2 HILT+E (n = 20) High-intensity laser therapy (HILT) in addition to usual physiotherapy care, twice a week for six weeks; laser model GA diode (BTL-5000 laser), wavelength 1064 nm, energy density 100 Jcm2, total energy 2400 Joule per session, 15 minutes of laser treatment per session (5 minutes of analgesic mode and 10 minutes of biostimulation mode), and the laser treatment will be applied at the medial and lateral knee joint lines.
Sponsors
BTL Industries Malaysia Sdn Bhd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria will be: (1) adults of both genders aged 18 to 75 years, (2) diagnosed with symptomatic (pain and/or stiffness) unilateral or bilateral knee osteoarthritis based on the American College of Rheumatology criteria (Nazari et al., 2019), (3) persistent knee pain with intensity at least 3 on a 10-cm visual analog scale (VAS) for more than 3 months during activities such as going up-and downstairs, sitting or squatting (Alayat et al., 2017, Nazari et al., 2019), (4) degenerative osteoarthritic knee of grade 2 (mild) to 3 (moderate) or less according to the Kellgren-Lawrence classification; verified by knee radiograph performed during the last 6 months (Kheshie et al., 2014). For bilateral knee osteoarthritis, the most painful knee based on pain score will be taken for evaluation; whereas, if findings were identical, the dominant side of the knee would be included (Yurtkuran et al., 2007, Kheshie et al., 2014)
Exclusion criteria
The exclusion criteria will be as follows: (1) severe knee osteoarthritis (grade 4) according to the Kellgren-Lawrence classification, (2) other pathological conditions such as rheumatic disease, previous hip or knee joint replacement, congenital dysplasia, osteochondritis dissecans, intra-articular fractures, septic arthritis, Perthes disease, ligament or meniscus injury and plica syndrome, (3) history of acute traumatic injuries to the knee or lower extremities (Nazari et al., 2019), (4) patients who had received intra-articular injections (e.g., corticosteroid, hyaluronic acid, or blood-derived products) for knee osteoarthritis during the last 6 months (Kheshie et al., 2014, Alayat et al., 2017, Nazari et al., 2019), (5) uncontrolled medical conditions (e.g., heart, blood, or respiratory disease) that would limit participation with the assessments and intervention program (Alayat et al., 2017), and (6) current participation in another knee osteoarthritis-related interventional study.
Outcome results
None listed