An interventional study of OLIZ Photobiomodulation Device in Postoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty, sponsored by LTBIO Co., Ltd.. Not yet recruiting. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by LTBIO Co., Ltd. · Not applicable, Interventional, and Treatment
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
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 68 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →This is the only study on the registry with LTBIO Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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).
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.
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.
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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.
Device: OLIZ Photobiomodulation Device
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.
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.
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).
Time frame: Baseline and 11 weeks post-baseline
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).
Time frame: 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.
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
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.
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
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.
Time frame: Baseline, Week 5, and Week 11 post-surgery
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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