UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063107 |
|---|---|
| Receipt number | R000072231 |
| Scientific Title | High- versus Low-Level Laser Therapy Combined with Exercise Elicits Outcome- and Population-Specific Responses in Knee Osteoarthritis and Healthy Older Adults |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 23:32:34 |
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Basic information
Public title
High- versus Low-Level Laser Therapy Combined with Exercise Elicits Outcome- and Population-Specific Responses in Knee Osteoarthritis and Healthy Older Adults
Acronym
HILT vs LLLT Combined with Exercise in Knee Osteoarthritis
Scientific Title
High- versus Low-Level Laser Therapy Combined with Exercise Elicits Outcome- and Population-Specific Responses in Knee Osteoarthritis and Healthy Older Adults
Scientific Title:Acronym
High-Intensity Laser Therapy (HILT); Low-Level Laser Therapy (LLLT); Knee Osteoarthritis (KOA)
Region
| Asia(except Japan) |
Condition
Condition
Knee osteoarthritis (KOA) and healthy older adults
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of high-intensity laser therapy (HILT) and low-level laser therapy (LLLT), combined with the same standardized exercise program, on muscle stiffness, muscle co-activation, balance, and pain-related outcomes in individuals with knee osteoarthritis and healthy older adults, and to determine whether treatment responses differ between the two populations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in muscle stiffness from baseline to 72 hours after the final intervention, assessed by shear wave elastography and expressed as shear wave velocity (SWV, m/s) in the rectus femoris, vastus medialis, vastus lateralis, biceps femoris, semimembranosus, quadriceps tendon, and hamstring tendon.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
High-intensity laser therapy (HILT) combined with standardized functional exercise. HILT was delivered using a 1064-nm laser at five predefined muscle sites (rectus femoris, vastus medialis, vastus lateralis, biceps femoris, and semimembranosus). Each session lasted 30 minutes, with approximately 8970 J delivered per session. Laser treatment was administered three times per week for 12 weeks (36 sessions). Participants also received the same standardized functional exercise program once weekly for 12 weeks.
Interventions/Control_2
Low-level laser therapy (LLLT) combined with standardized functional exercise. LLLT was delivered using an 830-nm laser at the same five predefined muscle sites. Each session lasted 30 minutes, with approximately 717.6 J delivered per session. Laser treatment was administered three times per week for 12 weeks (36 sessions). Participants also received the same standardized functional exercise program once weekly for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy older adults:
1. Aged 65-75 years.
2. Able to walk independently on level ground and negotiate stairs, with normal knee flexion and extension.
3. No history of hip, knee, or ankle pain, surgery, or trauma within the previous 6 months.
4. Willing to participate voluntarily and able to provide written informed consent.
Participants with knee osteoarthritis (KOA):
1. Aged 65-75 years and community-dwelling.
2. Diagnosed with KOA according to the American College of Rheumatology (ACR) criteria.
3. Radiographic KOA classified as Kellgren-Lawrence grade II-III.
4. KOA symptoms lasting more than 3 months.
5. Medically stable, without severe systemic or major organ disease.
6. No visual or language comprehension impairment preventing understanding of study instructions.
7. Able to stand independently and walk at least 10 m, with or without an assistive device.
8. Independent in basic activities of daily living.
9. Able and willing to provide written informed consent.
Key exclusion criteria
For all participants:
1. Major neurological, musculoskeletal, cardiovascular, cerebrovascular, or psychiatric disorders that could interfere with participation or outcome assessment.
2. Severe systemic or major organ disease, or other medical conditions contraindicating exercise or preventing completion of the study procedures.
3. Inability to cooperate with or complete the intervention or assessment procedures.
4. Inability to provide informed consent.
5. Known allergy or intolerance to surface EMG electrodes.
Additional exclusion criteria for participants with KOA:
6. Failure to meet the diagnostic criteria for KOA.
7. Severe lumbar disc herniation or other serious musculoskeletal conditions affecting lower-limb function.
8. Uncontrolled hypertension or diabetes.
9. Use of beta-blockers associated with exercise intolerance.
10. Recent smoking or alcohol abuse.
11. Inability to perform the required exercise tasks, including maintaining a low-level squat.
12. Severe visual impairment or visual-field defects that could interfere with testing.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ping |
| Middle name | |
| Last name | Liu |
Organization
Qufu Normal University
Division name
College of Physical Education and Sport Science
Zip code
273165
Address
No. 57, Jingxuan West Road, Qufu City, Shandong Province, China
TEL
+8613639443653
liu2578794@gmail.com
Public contact
Name of contact person
| 1st name | Ping |
| Middle name | |
| Last name | Liu |
Organization
Qufu Normal University
Division name
College of Physical Education and Sport Science
Zip code
273165
Address
No. 57, Jingxuan West Road, Qufu City, Shandong Province
TEL
+8613639443653
Homepage URL
liu2578794@gmail.com
Sponsor or person
Institute
Qufu Normal University
Institute
Department
Personal name
Funding Source
Organization
Qingdao Municipal Bureau of Science and Technology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Qufu Normal University
Address
No. 57, Jingxuan West Road, Qufu City, Shandong Province
Tel
+8613639443653
liu2578794@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 29 | Day |
Related information
URL releasing protocol
Not applicable
Publication of results
Unpublished
Result
URL related to results and publications
Not available
Number of participants that the trial has enrolled
150
Results
A total of 150 participants were enrolled and 139 completed post-intervention assessment. Significant population-by-treatment-by-time interactions were observed for VAS, hamstring tendon stiffness, several quadriceps and hamstring muscle stiffness outcomes, and selected co-activation outcomes. In KOA, HILT reduced pain more than LLLT or sham and showed broader effects on muscle stiffness. No significant differential effects were found for WOMAC, BESS, or Y-Balance Test outcomes.
Results date posted
| 2026 | Year | 09 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 150 participants were enrolled, including 75 healthy older adults and 75 participants with knee osteoarthritis (KOA). Each population included 25 participants in the HILT group, 25 in the LLLT group, and 25 in the sham group. Within each population, the three treatment groups were generally comparable at baseline with respect to sex, age, BMI, height, weight, education, dominant limb, smoking, alcohol use, caffeine use, physical activity, VAS, and WOMAC scores. No statistically significant baseline differences were observed among the three treatment groups within either population.
Participant flow
A total of 150 participants were enrolled and randomized, with 25 participants allocated to each of the six study groups. Post-intervention data were available for 139 participants. In the healthy older adult cohort, follow-up was completed by 23 participants in the HILT group, 24 in the LLLT group, and 22 in the sham group. In the KOA cohort, follow-up was completed by 23 participants in the HILT group, 24 in the LLLT group, and 23 in the sham group. Overall, 139 of 150 participants completed the post-intervention assessment.
Adverse events
No serious adverse events or treatment-related adverse events were observed during the study. Safety was monitored at each treatment session, including discomfort, excessive heat sensation, skin irritation, pain aggravation, dizziness, falls, and other unexpected symptoms. No participant discontinued treatment because of a laser-related adverse event.
Outcome measures
Significant population-by-treatment-by-time interactions were observed for VAS, hamstring tendon stiffness, vastus lateralis stiffness, rectus femoris stiffness, vastus medialis stiffness, biceps femoris stiffness, squat-down co-activation, and stand-up co-activation. In participants with KOA, HILT produced greater pain reduction than LLLT or sham treatment. HILT also produced broader changes in muscle stiffness, including significant effects on rectus femoris, vastus medialis, vastus lateralis, and biceps femoris stiffness. LLLT showed more selective effects. No significant population-by-treatment-by-time interactions were found for WOMAC, quadriceps tendon stiffness, semimembranosus stiffness, total squat-cycle co-activation, BESS, YBT-right, or YBT-left. Overall, treatment responses differed according to both outcome and population.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072231
