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GonarthrosisNCT05731011

Effects of Physical Therapy on Oxidative Stress in Female Patients With Gonarthrosis

An observational study of Gonarthrosis and Antioxidative Stress, run by Baskent University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 90 years, women only
Conditions the study is for
Gonarthrosis, Antioxidative Stress
What is being tested?
antioxidative stress and electrotherapy
Type of treatment
Medical device
How many people
31 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Aug 2023to 30 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: 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. Cases with Stage II and III will be included in the study.

Who may be able to join

  • Cases with Grade II and III Study Grades according to the Kellgren-Lawrence Staging Scale
  • women over 40

Who cannot join

  • Patients with acute inflammation of the knee joint,
  • undergoing surgery in the knee joint for any reason or any trauma to the lower extremity,
  • a history of uncontrollable high blood pressure,
  • any neurological or vestibular problem,
  • use of steroid injections in the last two months,
  • any cases with systemic disease that may affect the study

Trial locations and contacts

1 site in 1 country.

Mustafa Gulsen, assocc.prof contact

5300407325

mgulsen81@hotmail.com

Turkey (Türkiye)1 site
  • The Effects of Physical Therapy on Oxidative Stress in Female Patients With Gonarthrosis

    Ankara

    Mustafa Gulsen

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Physical Therapy on Oxidative Stress

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; 1.5 watts/cm2) 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.

Read more

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 2,2'azino-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 eqivalen/L.

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 equiv./L) (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 mg/dl. The results will be recorded for each individual on the information sheet.

Being tested
antioxidative stress, electrotherapy
Keywords
gonarthrosis, antioxidative stress
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • antioxidative stressOther

    Also called electrotherapy

    blood interventions

  • electrotherapyDevice

    hotpack,Tens, ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. antioxidant level

    Blood samples will be taken before and after treatment. Total antioxidant level (TAS): It will be determined by an automatic measurement method based on the fact that the characteristic color formed by the 2,2'azino-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 eqivalen/L.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start25 Aug 2023 (estimated)
  3. Primary completion15 Nov 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05731011
Sponsor's protocol ID
KA22/363
Status last verified
Jul 2023
First submitted
6 Feb 2023
Last updated
27 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Gonarthrosis and Antioxidative Stress, run by Baskent University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mustafa Gulsen, assocc.prof (5300407325, mgulsen81@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

antioxidant level (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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