Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee ArthroplastyNCT07091773
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
A study testing OLIZ Photobiomodulation Device in people with Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty, run by LTBIO Co., Ltd..
Trial summary
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
- What is being tested?
- OLIZ Photobiomodulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥19 years and <80 years at the time of consent
- Radiographic evidence (X-ray) within 24 weeks prior to total knee arthroplasty (TKA) showing Kellgren-Lawrence (KL) grade 4 in the surgical knee
- Surgical site pain confirmed as a visual analog scale (VAS) score ≥50.0
- Willingness to refrain from any treatments not permitted by the study protocol, aside from concomitant medications or therapies allowed during the study period
- Voluntary participation in the clinical trial with written informed consent provided after being fully informed of the study procedures
- Willingness and ability to comply with the requirements of the clinical trial protocol
Who cannot join
- Subjects will be excluded from this clinical trial if they meet any of the following criteria:
- History of surgery, other than total knee arthroplasty, in the area of the knee joint being evaluated (or scheduled for surgery).*
- Includes total/partial knee arthroplasty, knee cartilage surgery, knee ligament reconstruction, autologous chondrocyte implantation, knee fracture surgery, knee synovectomy/loose body removal, patellar reconstruction, patellar realignment, bursectomy, synovectomy, etc.
- History of using steroids or immunosuppressants at the time of screening, meeting one or more of the following:
- Immunosuppressants (e.g., cyclosporin A or azathioprine) within 6 weeks.
- Oral steroids or antidepressants within 4 weeks.
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- Intra-articular injection into the target knee joint within 12 weeks.
- Includes steroids, hyaluronic acid, polynucleotide, PDRN (polydeoxyribonucleotide), etc.
- Determined to be unable to wear the device due to one or more of the following:
- Individuals with photosensitive skin.
- Individuals taking medications that may cause light sensitivity (refer to the precautions of the medication being taken).
- Individuals with sensitive skin due to an allergic constitution.
- Individuals with implanted electronic medical devices.
- Meeting one or more of the following physical examination or laboratory test results at the time of screening:
- Fever exceeding 37.8°C.
- PT (INR) or aPTT ≥ 1.5 x ULN (upper limit of normal).
- Serum creatinine > 1.5 x ULN.
- AST or ALT ≥ 2.0 x ULN.
- (Only for those with a history of diabetes) Glycosylated hemoglobin (HbA1c) > 11%.
- History of one or more of the following medical conditions or diseases confirmed at the time of screening:
- Secondary osteoarthritis such as rheumatoid arthritis, Paget's disease, or gouty arthritis (however, traumatic osteoarthritis is permitted for enrollment).
- History of cardiac disease such as myocardial infarction or congestive heart failure.
- Uncontrolled hypertension (SBP > 160 mmHg or DBP > 100 mmHg).
- History of uncontrolled endocrine abnormalities or diseases (e.g., thyroid disease, parathyroid disease, pituitary disease).
- Immune system-related diseases (e.g., infectious diseases, systemic lupus erythematosus).
- History of malignancy within the last 5 years (however, individuals with a history of basal cell or squamous cell skin cancer and non-invasive carcinomas are eligible to participate in the clinical trial only if adequately treated).
- Pregnant or lactating women.
- Women of childbearing potential who do not agree to use medically acceptable birth control methods* during the clinical trial period.
- Hormonal contraception, intrauterine devices, tubal ligation, double barrier methods (combined use of barrier methods such as male condoms, female condoms, cervical caps, diaphragms, contraceptive sponges), or a single barrier method combined with spermicide.
- Currently participating in another clinical trial or having participated in another clinical trial within 30 days prior to the screening date.
- Any other case where, in the investigator's judgment, participation in the clinical trial is deemed inappropriate due to ethical reasons or potential impact on the clinical trial results.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Trial to Evaluate the Safety and Effectiveness of "OLIZ," a Combined Wavelength Photobiomodulation Medical Device, for Surgical Site Pain Relief in Patients Who Have Undergone Total Knee Arthroplasty (TKA) : A Multicenter, Controlled, and Randomized Clinical Trial
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
Read the detailed description
This multicenter, controlled, randomized clinical trial is designed to evaluate the safety and effectiveness of "OLIZ," a medical device that utilizes combined-wavelength photobiomodulation (PBM) therapy, for relieving postoperative pain at the surgical site in patients undergoing total knee arthroplasty (TKA).
Photobiomodulation therapy employs specific wavelengths of light to modulate biological processes at the cellular level, such as reducing inflammation, enhancing microcirculation, and promoting tissue repair. OLIZ delivers dual-wavelength light in the red and near-infrared spectrum, targeting key cellular pathways involved in postoperative pain and recovery.
Participants in the study will be randomly assigned to receive either the active PBM treatment using OILZ or a control intervention. Treatment will begin within 3 days after surgery and continue for a defined period based on the postoperative care protocol. VAS, WOMAC, and recovery metrics will be monitored at multiple time points during the inpatient stay and follow-up period.
The study also aims to assess the safety of repeated PBM exposure in a post-surgical setting by evaluating local and systemic adverse events. Through this trial, investigators seek to generate robust clinical evidence to support the use of OLIZ as a non-pharmacologic modality for pain management and recovery enhancement in TKA patients.
- Conditions
- Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
- Being tested
- OLIZ Photobiomodulation Device
- Keywords
- photobiomodualtion, Total knee arthroplasty, Postoperative pain, Rehabilitation, Pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OLIZ Photobiomodulation DeviceDevice
OLIZ device utilizes dual-wavelength technology combining specific red (660nm) and near-infrared (850nm) light parameters optimized for post-surgical tissue healing. The device features controlled power density, precise treatment duration protocols, and targeted application to knee arthroplasty surgical sites. Treatment parameters include specific irradiance levels, treatment session duration of 15 minutes, and 3 times of daily application frequency designed.
| Study group | Role | What they receive |
|---|---|---|
| OLIZ Photobiomodulation Treatment | Experimental | Participants will receive photobiomodulation therapy using the OLIZ device, which delivers dual-wavelength light therapy (red and near-infrared spectrum) to the surgical site. Treatment will begin within 3 days post-surgery and continue according to the postoperative care protocol. The OLIZ device targets cellular pathways involved in inflammation reduction, microcirculation enhancement, and tissue repair to manage postoperative pain and promote recovery in total knee arthroplasty patients. Receives: Device: OLIZ Photobiomodulation Device |
| Standard care control | No intervention | Participants will receive standard postoperative care including conventional pain management protocols without photobiomodulation therapy. All other aspects of postoperative care will be identical to the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VAS Pain Score
Primary efficacy endpoint measuring the change in pain intensity using Visual Analog Scale from baseline to 11 weeks post-baseline. VAS scores range from 0mm (no pain) to 100mm (worst possible pain).
Measured: Baseline and 11 weeks post-baseline
Secondary outcomes (4)
Change in VAS Pain Score at 5 weeks
Secondary efficacy endpoint measuring the change in pain intensity using Visual Analog Scale from baseline to 5 weeks post-baseline. VAS scores range from 0mm (no pain) to 100mm (worst possible pain).
Measured: Baseline and 5 weeks post-baseline
Change from baseline in WOMAC total score at Week 5 and Week 11
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score assesses pain, stiffness, and physical function. The change from baseline to Week 5 and Week 11 post-surgery will be measured to evaluate the effectiveness of the intervention on postoperative recovery.
Measured: Baseline, Week 5, and Week 11 post-surgery
Change from baseline in knee joint range of motion (ROM) at Week 5 and Week 11
Range of motion (ROM) of the knee joint, including flexion and extension, will be measured using a goniometer. The change in ROM from baseline to Week 5 and Week 11 post-surgery will be assessed to evaluate the effect of the intervention on functional recovery.
Measured: Baseline, Week 5, and Week 11 post-surgery
Change from baseline in the cumulative dose of rescue and prescribed analgesic medications at Week 5 and Week 11
The total cumulative dose (in mg) of prescribed and rescue analgesic medications (e.g., acetaminophen, NSAIDs, opioids) taken by each participant will be recorded. The change from baseline to Week 5 and Week 11 will be assessed to evaluate the effect of the intervention on the need for pharmacologic pain management.
Measured: Baseline, Week 5, and Week 11 post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start20 Aug 2025 (estimated)
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LTBIO Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Inje University, InjeUniversityIlsanPaikHospital, Gangnam Severance Hospital, National Medical Center, Seoul, National Health Insurance Service Ilsan Hospital, Korea University Anam Hospital, Samsung Medical Center, The Catholic University of Korea Uijeongbu St.Marys Hostpial
- Responsible party
- Sponsor
- Investigators
- Kyung Wook Nha, M.D., Ph.D, Principal investigator, Inje University Ilsan Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091773
- Sponsor's protocol ID
- LT_Knee_Pain-02
- Status last verified
- Jul 2025
- First submitted
- 21 Jul 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality concerns that cannot be adequately addressed with de-identification methods, particularly given the small sample size and unique characteristics of the study population.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Safety and Effectiveness of "OLIZ," a Combined Wavelength Photobiomodulation Medical Device, for Surgical Site Pain Relief in Patients Who Have Undergone Total Knee Arthroplasty (TKA) : A Multicenter, Controlled, and Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07091773
- Acronym / sponsor ID
- LT_Knee_Pain-02
- Conditions
- Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
- Keywords
- photobiomodualtion, Total knee arthroplasty, Postoperative pain, Rehabilitation, Pain management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- LTBIO Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Inje University, InjeUniversityIlsanPaikHospital, Gangnam Severance Hospital, National Medical Center, Seoul, National Health Insurance Service Ilsan Hospital, Korea University Anam Hospital, Samsung Medical Center, The Catholic University of Korea Uijeongbu St.Marys Hostpial
- Study start
- 20 Aug 2025 (estimated)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Jul 2025 (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.
A Clinical Trial to Evaluate the Safety and Effectiveness of OLIZ, a Photobiomodulation Medical Device for Surgical Site Pain Relief in Patients After Total Knee Arthroplasty
Detailed description
This multicenter, controlled, randomized clinical trial is designed to evaluate the safety and effectiveness of "OLIZ," a medical device that utilizes combined-wavelength photobiomodulation (PBM) therapy, for relieving postoperative pain at the surgical site in patients undergoing total knee arthroplasty (TKA).
Photobiomodulation therapy employs specific wavelengths of light to modulate biological processes at the cellular level, such as reducing inflammation, enhancing microcirculation, and promoting tissue repair. OLIZ delivers dual-wavelength light in the red and near-infrared spectrum, targeting key cellular pathways involved in postoperative pain and recovery.
Participants in the study will be randomly assigned to receive either the active PBM treatment using OILZ or a control intervention. Treatment will begin within 3 days after surgery and continue for a defined period based on the postoperative care protocol. VAS, WOMAC, and recovery metrics will be monitored at multiple time points during the inpatient stay and follow-up period.
The study also aims to assess the safety of repeated PBM exposure in a post-surgical setting by evaluating local and systemic adverse events. Through this trial, investigators seek to generate robust clinical evidence to support the use of OLIZ as a non-pharmacologic modality for pain management and recovery enhancement in TKA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLIZ Photobiomodulation Treatment | Experimental | Device: OLIZ Photobiomodulation DeviceParticipants will receive photobiomodulation therapy using the OLIZ device, which delivers dual-wavelength light therapy (red and near-infrared spectrum) to the surgical site. Treatment will begin within 3 days post-surgery and continue according to the postoperative care protocol. The OLIZ device targets cellular pathways involved in inflammation reduction, microcirculation enhancement, and tissue repair to manage postoperative pain and promote recovery in total knee arthroplasty patients. |
| Standard care control | No intervention | –Participants will receive standard postoperative care including conventional pain management protocols without photobiomodulation therapy. All other aspects of postoperative care will be identical to the treatment group. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥19 years and <80 years at the time of consent
- Radiographic evidence (X-ray) within 24 weeks prior to total knee arthroplasty (TKA) showing Kellgren-Lawrence (KL) grade 4 in the surgical knee
- Surgical site pain confirmed as a visual analog scale (VAS) score ≥50.0
- Willingness to refrain from any treatments not permitted by the study protocol, aside from concomitant medications or therapies allowed during the study period
- Voluntary participation in the clinical trial with written informed consent provided after being fully informed of the study procedures
Key exclusion criteria (32 listed)
- Subjects will be excluded from this clinical trial if they meet any of the following criteria:
- History of surgery, other than total knee arthroplasty, in the area of the knee joint being evaluated (or scheduled for surgery).*
- Includes total/partial knee arthroplasty, knee cartilage surgery, knee ligament reconstruction, autologous chondrocyte implantation, knee fracture surgery, knee synovectomy/loose body removal, patellar reconstruction, patellar realignment, bursectomy, synovectomy, etc.
- History of using steroids or immunosuppressants at the time of screening, meeting one or more of the following:
- Immunosuppressants (e.g., cyclosporin A or azathioprine) within 6 weeks.
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 |
|---|---|---|
| OLIZ Photobiomodulation DeviceOLIZ device utilizes dual-wavelength technology combining specific red (660nm) and near-infrared (850nm) light parameters optimized for post-surgical tissue healing. The device features controlled power density, precise treatment duration protocols, and targeted application to knee arthroplasty surgical sites. Treatment parameters include specific irradiance levels, treatment session duration of 15 minutes, and 3 times of daily application frequency designed. | Device | OLIZ Photobiomodulation Treatment |
Primary outcome
Change in VAS Pain Score
Time frame: Baseline and 11 weeks post-baseline
Primary efficacy endpoint measuring the change in pain intensity using Visual Analog Scale from baseline to 11 weeks post-baseline. VAS scores range from 0mm (no pain) to 100mm (worst possible pain).
4 secondary outcomes
Change in VAS Pain Score at 5 weeks
Time frame: Baseline and 5 weeks post-baseline
Change from baseline in WOMAC total score at Week 5 and Week 11
Time frame: Baseline, Week 5, and Week 11 post-surgery
Change from baseline in knee joint range of motion (ROM) at Week 5 and Week 11
Time frame: Baseline, Week 5, and Week 11 post-surgery
Change from baseline in the cumulative dose of rescue and prescribed analgesic medications at Week 5 and Week 11
Time frame: Baseline, Week 5, and Week 11 post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality concerns that cannot be adequately addressed with de-identification methods, particularly given the small sample size and unique characteristics of the study population.
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.
Kyung Wook Nha, M.D., Ph.D principal investigator
Inje University Ilsan Paik Hospital
Questions about this trial
What is this clinical trial studying?
A study testing OLIZ Photobiomodulation Device in people with Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty, run by LTBIO Co., Ltd..
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 6 inclusion and 32 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: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jae Young Kim, master (+82-31-608-1059, summerday@ltbio.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VAS Pain Score (time frame: Baseline and 11 weeks post-baseline). 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 29 Jul 2025.