Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

• ClinicalTrials.gov Identifier: NCT04598854
• Recruitment Status: Unknown
• First Posted: October 22, 2020
• Last Update Posted: October 26, 2020
• Sponsor: Tri-Service General Hospital
• Collaborator: Ministry of Science and Technology, Taiwan
• Information provided by (Responsible Party): Liang-Cheng Chen, Tri-Service General Hospital

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis, Knee	Device: Intravascular laser irradiation of blood; Device: Intravascular laser irradiation of blood (Sham)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee
• Estimated Study Start Date: October 2020
• Estimated Primary Completion Date: April 2021
• Estimated Study Completion Date: July 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Visual Analogue Scale (VAS) of the degree of pain [ Time Frame: 3 months ]
   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.
2. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: 3 months ]
   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. Lequesne 's severity index [ Time Frame: 3 months ]
   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.
4. Balance function test [ Time Frame: 3 months ]
   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.

Secondary Outcome Measures :

1. Serum Interleukin 6 (IL6) [ Time Frame: 3 months ]
   chemiluminescent enzyme immunometric assay method. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
2. Serum cartilage oligomeric matrix protein (COMP) [ Time Frame: 3 months ]
   immunoassay ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
3. Serum procollagen type II N-terminal propeptide (PIIANP) [ Time Frame: 3 months ]
   ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
4. Serum calcitonin gene-related peptide (CGRP) [ Time Frame: 3 months ]
   immunosorbent assay (ELISA). Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
5. Substance P [ Time Frame: 3 months ]
   Substance P Immunoassay Test. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
6. The number of synovium-derived stem cell with CD73, CD90, CD105 [ Time Frame: 3 months ]
   flow cytometry, Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: Liang-Cheng Chen, MD,MS; 886-2-87923311 ext 17068; clctsgh@yahoo.com.tw

Sponsors and Collaborators

Tri-Service General Hospital

Ministry of Science and Technology, Taiwan

Investigators

• Principal Investigator: Liang-Cheng Chen, MD,MS; Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

More Information

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.

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.

• Responsible Party: Liang-Cheng Chen, Clinical Professor of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
• ClinicalTrials.gov Identifier: NCT04598854
• Other Study ID Numbers: 109WFE0110237
• First Posted: October 22, 2020
• Last Update Posted: October 26, 2020
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Liang-Cheng Chen, Tri-Service General Hospital:

Intravascular laser irradiation of blood; Osteoarthritis, Knee

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases