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Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Intravascular laser irradiation of blood
Intravascular laser irradiation of blood (Sham)
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Intravascular laser irradiation of blood, Osteoarthritis, Knee

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tri-service general hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment group

Control group

Arm Description

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.

The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Serum Interleukin 6 (IL6)
chemiluminescent enzyme immunometric assay method. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Serum cartilage oligomeric matrix protein (COMP)
immunoassay ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Serum procollagen type II N-terminal propeptide (PIIANP)
ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Serum calcitonin gene-related peptide (CGRP)
immunosorbent assay (ELISA). Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Substance P
Substance P Immunoassay Test. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
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.

Full Information

First Posted
October 18, 2020
Last Updated
April 9, 2023
Sponsor
Tri-Service General Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04598854
Brief Title
Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee
Official Title
The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
Collaborators
Ministry of Science and Technology, Taiwan

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Intravascular laser irradiation of blood, Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
The steps for the control group are the same as the treatment group, except that the output power is adjusted to zero intensity.
Intervention Type
Device
Intervention Name(s)
Intravascular laser irradiation of blood
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Intravascular laser irradiation of blood (Sham)
Intervention Description
zero intensity of the laser energy
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS) of the degree of pain
Description
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.
Time Frame
3 months
Title
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Description
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.
Time Frame
3 months
Title
Lequesne 's severity index
Description
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.
Time Frame
3 months
Title
Balance function test
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Serum Interleukin 6 (IL6)
Description
chemiluminescent enzyme immunometric assay method. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Time Frame
3 months
Title
Serum cartilage oligomeric matrix protein (COMP)
Description
immunoassay ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Time Frame
3 months
Title
Serum procollagen type II N-terminal propeptide (PIIANP)
Description
ELISA. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Time Frame
3 months
Title
Serum calcitonin gene-related peptide (CGRP)
Description
immunosorbent assay (ELISA). Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Time Frame
3 months
Title
Substance P
Description
Substance P Immunoassay Test. Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Time Frame
3 months
Title
The number of synovium-derived stem cell with CD73, CD90, CD105
Description
flow cytometry, Measure before intravenous laser irradiation, three days, one month, and three months after the therapy.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang-Cheng Chen, MD,MS
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-service general hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
22891782
Citation
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.
Results Reference
background
PubMed Identifier
28001759
Citation
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.
Results Reference
background
PubMed Identifier
28070154
Citation
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.
Results Reference
background
PubMed Identifier
31401621
Citation
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.
Results Reference
background
PubMed Identifier
29107060
Citation
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.
Results Reference
background
PubMed Identifier
24710545
Citation
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.
Results Reference
background

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Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee

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