Effects of Dextrose Prolotherapy in Patients With Knee Osteoarthritis

Istanbul University

Status: Active, not recruiting

Conditions: Knee Osteoarthritis

Treatments: Procedure: Intra-articular and extra-articular Saline injection; Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06063356

IstanbulU-2023-77979112

Details and patient eligibility

About

In this prospective, randomized, controlled, single-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with chronic knee osteoarthritis.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral or bilateral symptomatic knee pain resistant to conservative treatment for at least three months
• Presence of Kellgren-Lawrence stage 2-3 osteoarthritis on current anterior-posterior knee radiographs
• 40-65 years of age
• Functional ambulation scale stage 4-5

Exclusion criteria

• Kellgren-Lawrence stage 1 or stage 4 osteoarthritis on current anterior-posterior knee radiographs
• Intra-articular knee injection within the last six months
• History of severe trauma to the knee within the past six months
• Concomitant severe meniscus or ligament injury, surgery applied to the knee area
• Presence of severe effusion, inflammatory joint disease, infection, hematological and oncological disease in the knee.
• Having a bleeding disorder and / or using warfarin
• Patients with hemoglobin less than 11g/dL and platelet count of less than 150,000 platelets per microliter
• Presence of uncontrolled diabetes mellitus
• Presence of cardiac or systemic disease that may affect exercise
• The presence of neurological disease and psychiatric disease such as Parkinson's disease, stroke history that may affect balance
• Body Mass Index ≥35 kg/m²
• Allergy to local anesthetic

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Dextrose Prolotherapy

Active Comparator group

Description:

Intra-articular Injection: A total of 5 cc of 25% dextrose solution (4 cc of 30% dextrose + 1 cc of saline) will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique using a sterile injector with a 20 gauge needle tip.

Treatment:

Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection

Procedure: Intra-articular and extra-articular Saline injection

Saline

Active Comparator group

Description:

Intra-articular Injection: Using a sterile syringe with a 20 gauge needle tip, a total of 5 cc of saline will be administered to the patellofemoral joint space in each patient with the same technique using the supero-lateral technique.

Treatment:

Procedure: Intra-articular and extra-articular Dextrose Prolotherapy injection

Procedure: Intra-articular and extra-articular Saline injection