Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04598854
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2020-10-18
Brief Title:
Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
The Investigation of Therapeutic Effect and Molecular Mechanism After Intravascular Laser Irradiation of Blood for Osteoarthritis of Knee
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 bodys 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 bodys 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 bodys 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 25 30Mw 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
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 bodys 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 25 30Mw 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None