Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee
NCT ID: NCT04598854
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2020-10-28
2023-07-30
Brief Summary
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Detailed Description
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Purpose This research is designed through randomization, control, and double-blind trial to explore the clinical effectiveness of intravenous laser irradiation of blood for knee degenerative arthritis; and to explore the changes in body's balance function. Furthermore to establish a new way of clinical rehabilitation therapy. The research will further study the special biomarker to investigate the mechanism of low-energy intravenous laser therapy for osteoarthritis.
Method The investigators plan to recruit 20 patients who are between the ages of 50 to 75 years old, but younger than 75 years old. The participants are required to have clear conscious and be able to communicate. Their symptoms of degenerative arthritis could be one or both knees which last more than six months; with knee pain greater than 4 points when walking. The treatment group will receive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 2.5 \~ 3.0Mw, 60 minutes each time, once a day for five consecutive days. The steps for the control group are the same, except that the output power is adjusted to zero intensity. This plan will be explained to the patient in detail during the outpatient visit and patients will sign the consent form upon agreement. Before intravenous laser irradiation, three days, one month, and three months after the therapy, 20 ml of autologous peripheral venous blood need to be drawn for basic blood tests and biomarker tests. At the same time, the clinical functions of patients will be evaluated, including visual analogous scale, Lequesne 's severity index, WOMAC scale, and balance function test.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group
The treatment groupreceive an intravenous helium-neon laser phototherapy. A vein indwelling needle will be placed in their veins located in the upper elbow, and the laser fiber catheter will be introduced through the indwelling cannula. The power is set between 2.5 \~ 3.0Mw, 60 minutes each time, once a day for five consecutive days. The steps for the control group are the same, except that the output power is adjusted to zero intensity.
Intravascular laser irradiation of blood
Low intensity intravascular laser irradiation of blood phototherapy is a method of a 632.8 nm red light penetrate into a vein through fiber and the brightness is 100 fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes.
Control group
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
Intravascular laser irradiation of blood (Sham)
zero intensity of the laser energy
Interventions
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Intravascular laser irradiation of blood
Low intensity intravascular laser irradiation of blood phototherapy is a method of a 632.8 nm red light penetrate into a vein through fiber and the brightness is 100 fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes.
Intravascular laser irradiation of blood (Sham)
zero intensity of the laser energy
Eligibility Criteria
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Inclusion Criteria
* the symptoms of degenerative arthritis could be one or both knees which last more than six months
* with knee pain greater than 4 points when walking
Exclusion Criteria
* had ever received nonsteroidal anti-inflammatory drugs or steroid therapy within 1 week
* neoplasm of joint and peripheral soft tissue
* malignancy
* had ever received total knee arthroplasty or other major surgery
* rheumatoid arthritis
* coagulopathy
* unable to take balance test due to other chronic disease
50 Years
75 Years
ALL
No
Sponsors
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Tri-Service General Hospital
OTHER
Responsible Party
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Liang-Cheng Chen
Clinical Professor of Department of Physical Medicine and Rehabilitation
Principal Investigators
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Liang-Cheng Chen, MD,MS
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Locations
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Tri-service general hospital
Taipei, , Taiwan
Countries
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References
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Huang SF, Tsai YA, Wu SB, Wei YH, Tsai PY, Chuang TY. Effects of intravascular laser irradiation of blood in mitochondria dysfunction and oxidative stress in adults with chronic spinal cord injury. Photomed Laser Surg. 2012 Oct;30(10):579-86. doi: 10.1089/pho.2012.3228. Epub 2012 Aug 14.
Thunshelle C, Hamblin MR. Transcranial Low-Level Laser (Light) Therapy for Brain Injury. Photomed Laser Surg. 2016 Dec;34(12):587-598. doi: 10.1089/pho.2015.4051.
de Freitas LF, Hamblin MR. Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron. 2016 May-Jun;22(3):7000417. doi: 10.1109/JSTQE.2016.2561201.
Munjal A, Bapat S, Hubbard D, Hunter M, Kolhe R, Fulzele S. Advances in Molecular biomarker for early diagnosis of Osteoarthritis. Biomol Concepts. 2019 Aug 9;10(1):111-119. doi: 10.1515/bmc-2019-0014.
Watt FE. Osteoarthritis biomarkers: year in review. Osteoarthritis Cartilage. 2018 Mar;26(3):312-318. doi: 10.1016/j.joca.2017.10.016. Epub 2017 Oct 26.
Campbell DD, Pei M. Surface markers for chondrogenic determination: a highlight of synovium-derived stem cells. Cells. 2012 Nov 16;1(4):1107-20. doi: 10.3390/cells1041107.
Other Identifiers
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109WFE0110237
Identifier Type: -
Identifier Source: org_study_id
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