Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Device: Intravascular laser irradiation of blood
* Device: Intravascular laser irradiation of blood (Sham)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>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<br>* 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.<br>|
| Sham Comparator: Control group<br>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)<br>* zero intensity of the laser energy<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intravascular laser irradiation of blood, Osteoarthritis, Knee