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Completed

NCT Number: NCT04598854

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-service general hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Intravascular laser irradiation of blood (Sham)

Device

zero intensity of the laser energy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2020
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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