The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Status: Completed

Conditions: Chondromalacia Patellae

Treatments: Procedure: Serum Physiological Group (placebo control group); Procedure: Dextrose Prolotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04796103

9

Details and patient eligibility

About

Dextrose prolotherapy is a form of treatment in which hypertonic dextrose solution is used as a stimulant solution and regeneration is increased by stimulating the body's natural healing mechanisms after injection.

The aim of this study is to compare the dextrose prolotherapy applied with home exercise program and saline injections as a control group in patients who applied to our clinic with knee pain and diagnosed with chondromalacia patella, and to investigate the effectiveness of dextrose and saline on the job to determine the superiority of the injections to each other.

Full description

The study was designed as prospective, randomized, controlled trial. 48 people who met the inclusion criteria were randomized into two groups of 24 people. The first group will be designated as Dextrose Prolotherapy Group and dextrose prolotherapy and exercise program will be applied to these patients. Patients in the second group will be designated as the Serum Physiological Group, and injections with saline and home exercise program will be applied in accordance with the prolotherapy protocol.Participants were evaluated with Visual Analogue Scale (VAS), Patello Femoral Pain Severity Scale (PFPSS), Kuala Patellofemoral Scoring System (KPSS) and Short Form 36 (SF-36).Knee cartilage thickness measurements and the presence of suprapatellar effusion of the participants whose evaluations are completed will be evaluated bilaterally by ultrasonography and the findings will be recorded.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female / male aged> 18 years
• Diagnosis of chondromalacia patella after physical examination and imaging (direct radiography, MRI)
• Those whose symptoms persist> 3 months
• Does not have a disease that will prevent him from exercising
• Participation in the study voluntarily and regularly

Exclusion criteria

• Pregnant patients
• History of previous knee surgery
• Having received physical therapy from the knee area in the last 3 months
• Drug allergy
• Previous prolotherapy or any injection up to 3 months ago
• Those with pain reflected from waist or hip
• Patients with neuropathic pain
• Tumor, infectious, psychiatric illness, history of bleeding diathesis
• Having a trauma history in the last 6 months
• Those with systemic diseases such as diabetes, hepatitis, coagulopathy
• Those with cerebrovascular event disease in which bleeding continues actively
• Those who received NSAID treatment within the last week
• Patients with a BMI> 40
• Finding leg length difference

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups, including a placebo group

Dextrose Prolotherapy Group

Active Comparator group

Description:

Patients diagnosed with chondromalacia patella

Treatment:

Procedure: Serum Physiological Group (placebo control group)

Procedure: Dextrose Prolotherapy

Serum Physiological Group

Placebo Comparator group

Description:

Patients diagnosed with chondromalacia patella

Treatment:

Procedure: Serum Physiological Group (placebo control group)

Procedure: Dextrose Prolotherapy