Knee OsteoarthritisPhase 2HILT on KOANCT06632119
Immediate Effects of High-intensity Laser Therapy on Knee Joint Position Sense and Knee Muscle Strength in Patients with Knee Osteoarthritis
A Phase 2 study testing high-intensity laser therapy in people with Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to compare whether HILT versus Sham-HILT is effective to reduce pain, improve knee joint position sense, and knee muscle strength. Participants will undergo a single-session of HILT or Sham-HILT, the measurements of pain, knee joint position sense error, and knee muscle strength will… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- high-intensity laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jan 2024to 1 Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee pain greater than 3 on the Visual Analog Scale (VAS) for more than 3 months
- diagnosed with unilateral knee osteoarthritis by a physician or meeting the American College of Rheumatology Classification Criteria for clinical knee osteoarthritis
- the severity of knee osteoarthritis is classified as grades 0-3 according to the Kellgren-Lawrence (KL) classification
- should not have undergone any specific treatments in the 3 months preceding the recruitment for the study, such as steroid injections.
Who cannot join
- any other musculoskeletal problems associated with knee pain
- musculoskeletal problems associated with the hip and ankle joints
- a history of lower limb fracture
- neurological conditions
- contraindications for laser therapy
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to compare whether HILT versus Sham-HILT is effective to reduce pain, improve knee joint position sense, and knee muscle strength.
Participants will undergo a single-session of HILT or Sham-HILT, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.
Read the detailed description
The investigators would like to investigate whether single session of high-intensity laser therapy (HILT) is promising to see the changes in individuals with knee osteoarthritis (KOA)-related knee pain regarding pain intensity, knee joint position sense, and knee muscle strength.
The objectives of this study is to compare pre and post, and between the two groups (HILT versus Sham-HILT) at after interventions regarding pain, knee joint position sense, and knee muscle strength.
Participants will undergo a single-session of HILT or Sham-HILT by an experienced musculoskeletal physical therapist, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.
- Conditions
- Knee Osteoarthritis
- Being tested
- high-intensity laser therapy, Sham-HILT
- Keywords
- HILT, Laser therapy, joint sense, muscle strength, pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity laser therapyDevice
high-intensity laser therapy (HILT) machine, ASA laser
Sham-HILTDevice
Sham-HILT, HILT machine without laser release
| Study group | Role | What they receive |
|---|---|---|
| HILT | Active comparator | high-intensity laser therapy (HILT) Receives: Device: high-intensity laser therapy |
| Sham_HILT | Placebo comparator | Sham-HILT, the HILT without laser release Receives: Device: Sham-HILT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee joint position sense
Knee joint position sense, the investigators used the joint position repositioning technique. The participants were measured for joint position reposition technique with a smartphone application "Measure App" (iPhone 12 Pro Max, Apple Inc., USA). The smartphone attached at shank of tibia bone at the malleolar level. The participants sat in the starting position knee flexion 90°. Then the participants with eyes closed were actively guided to the knee flexion 45 degrees and hold for 3 seconds. The data was recorded the difference between performed position and targeted position.
Measured: Baseline, immediately after, 24-hour after intervention
Secondary outcomes (2)
Knee muscle strength
The muscle strength measured both quadriceps and hamstring muscles by the handheld dynamometer at 90°.
Measured: Baseline, immediately after, 24-hour after intervention
Pain
The participants rated the pain scores using a 10-cm visual analog scale (VAS) ranged from 0 "no pain at all" on the left end to 10 "worst pain imaginable" on the right end.
Measured: Baseline, immediately after, 24-hour after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start5 Jan 2024
- Primary completion31 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasert Sakulsriprasert, Mahidol University
- Investigators
- Prasert Sakulsriprasert, Ph.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632119
- Sponsor's protocol ID
- MU_CIRB 2024/003.0401
- Acronym
- HILT on KOA
- Status last verified
- Jan 2024
- First submitted
- 6 Oct 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a pilot study
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of High-intensity Laser Therapy on Knee Joint Position Sense and Knee Muscle Strength in Patients with Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06632119
- Acronym / sponsor ID
- HILT on KOA / MU_CIRB 2024/003.0401
- Conditions
- Knee Osteoarthritis
- Keywords
- HILT, Laser therapy, joint sense, muscle strength, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare whether HILT versus Sham-HILT is effective to reduce pain, improve knee joint position sense, and knee muscle strength.
Participants will undergo a single-session of HILT or Sham-HILT, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.
Detailed description
The investigators would like to investigate whether single session of high-intensity laser therapy (HILT) is promising to see the changes in individuals with knee osteoarthritis (KOA)-related knee pain regarding pain intensity, knee joint position sense, and knee muscle strength.
The objectives of this study is to compare pre and post, and between the two groups (HILT versus Sham-HILT) at after interventions regarding pain, knee joint position sense, and knee muscle strength.
Participants will undergo a single-session of HILT or Sham-HILT by an experienced musculoskeletal physical therapist, the measurements of pain, knee joint position sense error, and knee muscle strength will be done at before, immediately after, and 24-hour after the single-session intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HILT | Active comparator | Device: high-intensity laser therapyhigh-intensity laser therapy (HILT) |
| Sham_HILT | Placebo comparator | Device: Sham-HILTSham-HILT, the HILT without laser release |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- knee pain greater than 3 on the Visual Analog Scale (VAS) for more than 3 months
- diagnosed with unilateral knee osteoarthritis by a physician or meeting the American College of Rheumatology Classification Criteria for clinical knee osteoarthritis
- the severity of knee osteoarthritis is classified as grades 0-3 according to the Kellgren-Lawrence (KL) classification
- should not have undergone any specific treatments in the 3 months preceding the recruitment for the study, such as steroid injections.
Key exclusion criteria (5 listed)
- any other musculoskeletal problems associated with knee pain
- musculoskeletal problems associated with the hip and ankle joints
- a history of lower limb fracture
- neurological conditions
- contraindications for laser therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensity laser therapyhigh-intensity laser therapy (HILT) machine, ASA laser | Device | HILT |
| Sham-HILTSham-HILT, HILT machine without laser release | Device | Sham_HILT |
Primary outcome
Knee joint position sense
Time frame: Baseline, immediately after, 24-hour after intervention
Knee joint position sense, the investigators used the joint position repositioning technique. The participants were measured for joint position reposition technique with a smartphone application "Measure App" (iPhone 12 Pro Max, Apple Inc., USA). The smartphone attached at shank of tibia bone at the malleolar level. The participants sat in the starting position knee flexion 90°. Then the participants with eyes closed were actively guided to the knee flexion 45 degrees and hold for 3 seconds. The data was recorded the difference between performed position and targeted position.
2 secondary outcomes
Knee muscle strength
Time frame: Baseline, immediately after, 24-hour after intervention
Pain
Time frame: Baseline, immediately after, 24-hour after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No. This is a pilot study
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prasert Sakulsriprasert, Ph.D. principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high-intensity laser therapy in people with Knee Osteoarthritis, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee joint position sense (time frame: Baseline, immediately after, 24-hour after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.