UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060248 |
|---|---|
| Receipt number | R000068909 |
| Scientific Title | Comparative Effects of High-Energy and Low-Energy Laser Therapy on Clinical Outcomes and Neuromuscular Function in Patients with Knee Osteoarthritis (HELLO-KOA Trial) |
| Date of disclosure of the study information | 2026/01/03 |
| Last modified on | 2026/01/03 16:12:27 |
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Basic information
Public title
Comparison of High- and Low-Energy Laser Therapy in Patients with Knee Osteoarthritis
Acronym
High-Energy Laser vs Low-Energy Laser in Osteoarthritis of the Knee
Scientific Title
Comparative Effects of High-Energy and Low-Energy Laser Therapy on Clinical Outcomes and Neuromuscular Function in Patients with Knee Osteoarthritis (HELLO-KOA Trial)
Scientific Title:Acronym
Comparative Effects of High-Energy and Low-Energy Laser Therapy on Clinical Outcomes and Neuromuscular Function in Knee Osteoarthritis
Region
| Asia(except Japan) |
Condition
Condition
Knee osteoarthritis (KOA)
Classification by specialty
| Geriatrics | Orthopedics | Rehabilitation medicine |
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to compare the clinical effectiveness of high-energy laser therapy and low-energy laser therapy in individuals with knee osteoarthritis.
Secondary objectives include comparing their effects on neuromuscular function, including muscle stiffness, muscle co-activation, and balance control, as well as exploring the clinical applicability of high-energy laser therapy as a non-invasive physical treatment approach.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the change in overall clinical effectiveness, assessed by knee pain intensity using the Visual Analogue Scale (VAS). Pain levels will be measured at baseline and after completion of the intervention period to compare the therapeutic effects of high-energy laser therapy and low-energy laser therapy in individuals with knee osteoarthritis.
Key secondary outcomes
The secondary outcomes include changes in neuromuscular function and postural performance. Specifically, lower-limb muscle stiffness will be assessed using ultrasound-based elastography, muscle co-activation patterns will be evaluated using surface electromyography during functional tasks, and balance control will be assessed using standardized balance tests. All secondary outcomes will be measured at baseline and after the intervention period to compare the additional effects of high-energy and low-energy laser therapy.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants will receive high energy laser therapy targeting the painful knee region. The intervention will be delivered using a high energy laser device with a maximum output power of up to 30 W, employing combined multi wavelength laser emission. Treatment will be administered in continuous or pulsed modes, with pulse duty cycles adjustable between 1% and 99%, according to individual tolerance. A rolling massage style applicator with a treatment depth of >=15 mm will be used to address deep pain and inflammatory tissues. Each session will be conducted under standardized parameters for treatment duration and frequency, consistent with the study protocol.
Interventions/Control_2
Participants will receive low-level laser therapy applied to the same knee region. The intervention will be delivered using a conventional low-level laser device with substantially lower output power than the high-energy laser. Treatment will be administered in accordance with established low-level laser therapy parameters, including fixed wavelength, power density, and exposure duration. Sessions will be matched in frequency and overall treatment period to the high-energy laser group.
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 50 to 75 years.
Clinical diagnosis of knee osteoarthritis according to established criteria (e.g., American College of Rheumatology criteria).
Presence of chronic knee pain for at least 3 months, with a pain intensity >= 40 mm on a 0 to 100 mm Visual Analogue Scale (VAS) at baseline.
Radiographic evidence of knee osteoarthritis classified as Kellgren Lawrence grade II to III.
Ability to walk independently without assistive devices.
No participation in other physical therapy, laser therapy, or injection treatments for knee pain within the previous 3 months.
Willingness to comply with the intervention protocol and assessment schedule.
Provision of written informed consent prior to participation.
Key exclusion criteria
Prior knee surgery, knee replacement, or major lower limb surgery within the past 12 months.
Inflammatory arthritis (e.g., rheumatoid arthritis, gout) or other systemic musculoskeletal or neurological disorders affecting lower limb function.
Severe knee osteoarthritis (Kellgren Lawrence grade IV).
Intra-articular injection, systemic corticosteroid use, or physical therapy for knee pain within the previous 3 months.
Contraindications to laser therapy, including malignancy, photosensitivity disorders, pregnancy, or implanted electronic medical devices.
Skin infection, open wound, or dermatological conditions at the treatment site.
Inability to comply with the intervention protocol or outcome assessments.
Target sample size
60
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
TEL
+60172870427
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, Qufu, Shandong, China
Institute
Department
Personal name
Ping Liu
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
yangyuewei@163.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
None
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 | 01 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 01 | 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 | 01 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068909
