Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731011
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-02-06
Brief Title:
Effects of Physical Therapy on Oxidative Stress in Female Patients With Gonarthrosis
Sponsor:
Baskent University
Organization:
Baskent University
Study Overview
Official Title:
Effects of Physical Therapy on Oxidative Stress
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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 study aimed to investigate the production of reactive oxygen derivatives ROS and reactive nitrogen derivatives RNT in female patients with knee OA and their effects on oxidative stress by evaluating before and after physical therapy in female patients with gonarthrosis who have Kellegren-Lawrence Staging Scale Stage II and III aimed To this study All female cases over the age of 40 who applied to Başkent University Ankara Hospital and were diagnosed with knee OA by a specialist doctor will be included
Method After the cases participating in the study were checked by a specialist physician the cases that did not prevent them from being included in the study It will be graded according to the Kellegren-Lawrence Staging Scale Stage II and III cases will be included in the study Sociodemographic characteristics of the patients will be recorded before the treatment 10 sessions of physical therapy program will be applied to the patients Treatment program 20 minutes Hot pack HP 60-100 Hz frequency range 60 pulse duration and 20 minutes of conventional TENS Enraf-NoniusBDelftechpark 39 2600 AV Delft The Netherlands with the patient comfortable feeling and 10 minutes continuous around the knee A home exercise program will be given with ultrasound Enraf-Nonius-B Delftechpark 39 1-MHz 15 wattscm2 to strengthen the muscles around the knees Those with acute inflammation of the knee joint those who underwent surgery in the knee joint for any reason or any trauma to the lower extremity those with a history of uncontrollable high blood pressure any neurological or vestibular problems those who have used steroid injections in the last two months and any For this reason patients with systemic diseases that will affect the study will be excluded from the study
Staging criteria according to Kellegren-Lawrence Staging Scale Stage 0 Normal Stage 1 Possible osteophyte Stage 2 Definite osteophyte suspected narrowing of joint space Stage 3 Moderate osteophyte definite narrowing Stage 4 Extensive osteophyte marked narrowing sclerosis Kellegren and Lawrence 1957
Biochemical analyzes
To this study Blood samples will be taken before and after treatment from a female patient over 40 years old who was diagnosed with knee OA at Başkent University Ankara Hospital Total antioxidant level TAS It will be determined by an automatic measurement method based on the fact that the characteristic color formed by the 22azino-bis 3-ethylbenz-thiazoline-6-sulfonic acid ABTS radical is brightened by the antioxidants in the sample added to the medium Erel 2004 Results will be given in mmol Trolox eqivalenL
Total oxidant level TOS will be determined by automatic measurement method Erel 2005 The oxidants in the sample have the task of converting the ferrous ion complex to a ferric ion Ferric ion Fe3 formed by oxidation of iron Fe2 to its more stable form Fe2O3 creates color with xylenol orange in acidic environment The intensity of the color measured spectrophotometrically is related to the total amount of oxidant molecules present in the sample The measurement is calibrated with hydrogen peroxide H2O2 and the results will be given as micromolar H2O2 equivalent per liter µmol H2O2 equivL Sydow 1985
Nitric oxide NO Serum nitric oxide concentration Mirand et al 2001 will be measured in a spectrophotometer according to the method PowerWawe XS BioTek USA Serum samples will be deproteinized with 10 zinc sulfate In this method nitrate was converted to nitrite with Vanadium III chloride It is based on the measurement of the complex diazonium compound as a result of the reaction of nitrite and sulfanilamide N-1-Naphthy ethylene diamine dihydrochloride in an acidic medium
High-density lipoprotein HDL It will be run in an autoanalyzer using the Biotrol trademark kit and given in mgdl The results will be recorded for each individual on the information sheet
Method After the cases participating in the study were checked by a specialist physician the cases that did not prevent them from being included in the study It will be graded according to the Kellegren-Lawrence Staging Scale Stage II and III cases will be included in the study Sociodemographic characteristics of the patients will be recorded before the treatment 10 sessions of physical therapy program will be applied to the patients Treatment program 20 minutes Hot pack HP 60-100 Hz frequency range 60 pulse duration and 20 minutes of conventional TENS Enraf-NoniusBDelftechpark 39 2600 AV Delft The Netherlands with the patient comfortable feeling and 10 minutes continuous around the knee A home exercise program will be given with ultrasound Enraf-Nonius-B Delftechpark 39 1-MHz 15 wattscm2 to strengthen the muscles around the knees Those with acute inflammation of the knee joint those who underwent surgery in the knee joint for any reason or any trauma to the lower extremity those with a history of uncontrollable high blood pressure any neurological or vestibular problems those who have used steroid injections in the last two months and any For this reason patients with systemic diseases that will affect the study will be excluded from the study
Staging criteria according to Kellegren-Lawrence Staging Scale Stage 0 Normal Stage 1 Possible osteophyte Stage 2 Definite osteophyte suspected narrowing of joint space Stage 3 Moderate osteophyte definite narrowing Stage 4 Extensive osteophyte marked narrowing sclerosis Kellegren and Lawrence 1957
Biochemical analyzes
To this study Blood samples will be taken before and after treatment from a female patient over 40 years old who was diagnosed with knee OA at Başkent University Ankara Hospital Total antioxidant level TAS It will be determined by an automatic measurement method based on the fact that the characteristic color formed by the 22azino-bis 3-ethylbenz-thiazoline-6-sulfonic acid ABTS radical is brightened by the antioxidants in the sample added to the medium Erel 2004 Results will be given in mmol Trolox eqivalenL
Total oxidant level TOS will be determined by automatic measurement method Erel 2005 The oxidants in the sample have the task of converting the ferrous ion complex to a ferric ion Ferric ion Fe3 formed by oxidation of iron Fe2 to its more stable form Fe2O3 creates color with xylenol orange in acidic environment The intensity of the color measured spectrophotometrically is related to the total amount of oxidant molecules present in the sample The measurement is calibrated with hydrogen peroxide H2O2 and the results will be given as micromolar H2O2 equivalent per liter µmol H2O2 equivL Sydow 1985
Nitric oxide NO Serum nitric oxide concentration Mirand et al 2001 will be measured in a spectrophotometer according to the method PowerWawe XS BioTek USA Serum samples will be deproteinized with 10 zinc sulfate In this method nitrate was converted to nitrite with Vanadium III chloride It is based on the measurement of the complex diazonium compound as a result of the reaction of nitrite and sulfanilamide N-1-Naphthy ethylene diamine dihydrochloride in an acidic medium
High-density lipoprotein HDL It will be run in an autoanalyzer using the Biotrol trademark kit and given in mgdl The results will be recorded for each individual on the information sheet
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None