Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

NCT04598854 | Completed

• 1 other identifier: 109WFE0110237
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Intravascular laser irradiation of blood; Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Serum Interleukin 6 (IL6)

  3 months

• Serum cartilage oligomeric matrix protein (COMP)

  3 months

• Serum procollagen type II N-terminal propeptide (PIIANP)

  3 months

• Serum calcitonin gene-related peptide (CGRP)

  3 months

• Substance P

  3 months

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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)

Interventions

Intravascular laser irradiation of blood DEVICE

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.

Treatment group

Intravascular laser irradiation of blood (Sham) DEVICE

zero intensity of the laser energy

Control group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 22891782 BACKGROUND

• 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.

  PMID: 28001759 BACKGROUND

• 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.

  PMID: 28070154 BACKGROUND

• 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.

  PMID: 31401621 BACKGROUND

• 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.

  PMID: 29107060 BACKGROUND

• 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.

  PMID: 24710545 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Liang-Cheng Chen, MD,MS

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Department of Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2020
• First Posted: October 22, 2020
• Study Start: October 28, 2020
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: March 18, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)