Clinical trial NCT06063356: Effects of Dextrose Prolotherapy in Patients With Knee Osteoarthritis
Official title: Effects of Dextrose Prolotherapy on Pain, Muscle Strength, Proprioception and Quality of Life in Patients With Knee Osteoarthritis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline pain score at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
Secondary outcomes:
measure: Change from baseline stiffness and physical function at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change from baseline activity pain score at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change from baseline rest pain score at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change from baseline night pain score at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change from baseline quality of life at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change from baseline functional balance at 1-months, 3-months and 6-months
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Change from baseline muscle strength and proprioception at 3-months and 6-months
timeFrame: Baseline, 3-month, 6-month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Study officials:
affiliation: Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
name: Ekin I Sen, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: