Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

Osteoarthritis, Knee Clinical Trial

Official title:

The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04598854
• Other study ID #: 109WFE0110237
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: March 2024
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Background 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 expression of blood cells after the treatment and as well as the molecular mechanism of low-energy intravenous laser therapy on hematopoietic stem cells. fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes. Pain control is indicated in such treatment, but still lacking evidence of improving the symptoms of degenerative knee arthritis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• clear conscious and be able to communicate.

• 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 intraarticular injection with hyaluronic acid or steroid within 6 months

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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

Locations

Country	Name	City	State
Taiwan	Tri-service general hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Tri-Service General Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) of the degree of pain	with the score ranging from 10 (tremendous pain) to 0 (no pain). Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Primary	The Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The higher score means more severity. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Primary	Lequesne 's severity index	Three domain: pain or discomfort, maximum distance walked, activities of daily living. Score range of 0-26. The higher score means more severity. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Primary	Balance function test	Test standing balance,including static, dynamic with opening and closing eyes, and single leg stance. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Secondary	Serum Interleukin 6 (IL6)	chemiluminescent enzyme immunometric assay method. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Secondary	Serum cartilage oligomeric matrix protein (COMP)	immunoassay ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Secondary	Serum procollagen type II N-terminal propeptide (PIIANP)	ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Secondary	Serum calcitonin gene-related peptide (CGRP)	immunosorbent assay (ELISA). Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Secondary	Substance P	Substance P Immunoassay Test. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
Secondary	The number of synovium-derived stem cell with CD73, CD90, CD105	flow cytometry, Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months