Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889885
Status:
COMPLETED
Last Update Posted:
2021-05-17
First Post:
2021-05-07
Brief Title:
Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Short Term Efficacy of High-intensity Laser Therapy to Alleviate Pain in Patients With Knee Osteoarthritis a Double-blinded Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Knee osteoarthritis KOA is one of the most common health problems around the world According to this several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction behavior modification and physical therapy Recently high-intensity laser therapy HILT has been used to treat patients with KOA The results of previous studies showed that HILT could help to reduce pain as well as improved function in patients with mild to moderate KOA However there were still no standardized guidelines for HILT treatment in KOA Also no previous studies evaluated the efficacy of HILT in patients with severe KOA The present study therefore recruited not only mild to a moderate degree but also severe degree The study aim was to determine the efficacy of HILT in terms of pain relief in patients with mild moderate and severe KOA The hypothesis was HILT would effectively reduce pain in patients with KOA compared to sham laser plus conservative treatment
Detailed Description:
This study is a double-blinded randomized control trial that compared the efficacy of HPLT to sham laser in patients with KOA
42 patients who had KOA diagnosed by the American college of rheumatology ACR 2016 guidelines were recruited including a drop out of 20
The participants were then randomly allocated into two groups 21 participants per group mainly HILT and sham laser Also both groups received conservative treatment such as disease education exercise and advice for weight reduction
The intervention group received HILT which was applied on the medial lateral and posterior part of the knee joint The total energy was 5625 J per session which was done 2-3 sessions a week for a total of 10 sessions
The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group
The outcome measures VAS and T-WOMAC score were recorded before and at the end of the study
Statistical analysis was performed using SPSS 180 version to evaluate the statistically significant change within the same group and the difference between groups
42 patients who had KOA diagnosed by the American college of rheumatology ACR 2016 guidelines were recruited including a drop out of 20
The participants were then randomly allocated into two groups 21 participants per group mainly HILT and sham laser Also both groups received conservative treatment such as disease education exercise and advice for weight reduction
The intervention group received HILT which was applied on the medial lateral and posterior part of the knee joint The total energy was 5625 J per session which was done 2-3 sessions a week for a total of 10 sessions
The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group
The outcome measures VAS and T-WOMAC score were recorded before and at the end of the study
Statistical analysis was performed using SPSS 180 version to evaluate the statistically significant change within the same group and the difference between groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None