Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Device: Intravascular laser irradiation of blood; Device: Intravascular laser irradiation of blood (Sham)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Sham Comparator: 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.	Device: Intravascular laser irradiation of blood (Sham); zero intensity of the laser energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Substance P	Substance P Immunoassay Test. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.	3 months
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

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Liang-Cheng Chen, MD,MS, Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Osteoarthritis, Knee; Intravascular laser irradiation of blood
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 109WFE0110237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No