Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:02 PM
Study NCT ID:
NCT06063356
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Dextrose Prolotherapy in Patients With Knee Osteoarthritis
Sponsor:
Istanbul University
Organization:
Study Overview
Official Title:
Effects of Dextrose Prolotherapy on Pain, Muscle Strength, Proprioception and Quality of Life in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
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:
In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis.
Detailed Description:
Patients admitted to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation Outpatient Clinic with a diagnosis of knee osteoarthritis and who meet the inclusion criteria will be included in the study. Patients will be informed verbally and in writing about the purpose, duration and method of the study and will be asked to sign an "Informed Consent Form" after their consent is obtained.
In our study, the investigators aimed to evaluate the effects of dextrose prolotherapy injections in patients with chronic knee osteoarthritis. The duration of the study was determined as 8 months and it was planned to include 33 patients for each group to be randomized by computer program according to the order of application and 66 patients in total.
Patients who meet the inclusion and exclusion criteria will be randomized into 2 groups and the first group will receive Dextrose Prolotherapy and home exercise program and the second group will receive saline injection and home exercise program.
After the application, patients will be questioned in terms of side effects and complications.
History and demographic characteristics such as age, gender, height, weight, marital status, educational level and occupation will be questioned, and medical history such as history of comorbidities and treatment approaches will be determined. In the physical examination, knee tests (ROM measurements, ligament tests, meniscus tests, tests for osteoarthritis) will be performed and TUG (Timed Up and Go) Test will be evaluated. Direct knee radiographs will be evaluated according to Kellgren-Lawrence Gonarthrosis Staging. The average and maximum level of pain during activity, at rest and at night will be questioned with the Visual Analog Scale (0-10 points). WOMAC pain score and WOMAC total scores will be questioned. Isokinetic muscle strength and proprioception will be evaluated with Biodex Isokinetic Dynamometer in our clinic. Functional status will be evaluated with Euro-Qol Quality of Life Scale. The evaluations will be performed by the researcher who is blinded to the applications.
Assessments will be made before treatment, 1 month, 3 months and 6 months after treatment.
In our study, the investigators aimed to evaluate the effects of dextrose prolotherapy injections in patients with chronic knee osteoarthritis. The duration of the study was determined as 8 months and it was planned to include 33 patients for each group to be randomized by computer program according to the order of application and 66 patients in total.
Patients who meet the inclusion and exclusion criteria will be randomized into 2 groups and the first group will receive Dextrose Prolotherapy and home exercise program and the second group will receive saline injection and home exercise program.
After the application, patients will be questioned in terms of side effects and complications.
History and demographic characteristics such as age, gender, height, weight, marital status, educational level and occupation will be questioned, and medical history such as history of comorbidities and treatment approaches will be determined. In the physical examination, knee tests (ROM measurements, ligament tests, meniscus tests, tests for osteoarthritis) will be performed and TUG (Timed Up and Go) Test will be evaluated. Direct knee radiographs will be evaluated according to Kellgren-Lawrence Gonarthrosis Staging. The average and maximum level of pain during activity, at rest and at night will be questioned with the Visual Analog Scale (0-10 points). WOMAC pain score and WOMAC total scores will be questioned. Isokinetic muscle strength and proprioception will be evaluated with Biodex Isokinetic Dynamometer in our clinic. Functional status will be evaluated with Euro-Qol Quality of Life Scale. The evaluations will be performed by the researcher who is blinded to the applications.
Assessments will be made before treatment, 1 month, 3 months and 6 months after treatment.
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?: