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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella: a Randomized Controlled Trial

Conditions
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Chondromalacia Patellae

Intervention / Treatment
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* Procedure: Dextrose Prolotherapy
* Procedure: Serum Physiological Group (placebo control group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dextrose Prolotherapy Group<br>Patients diagnosed with chondromalacia patella | Procedure: Dextrose Prolotherapy<br>* In the patients in the prolotherapy injection group, at the 1st, 4th and 7th weeks, the insertion points of the ligaments and tendons that are sensitive with pressure around the knee (medial collateral ligament (2), lateral collateral ligament (2), quadriceps tendon (1) and patellar tendon (1)) A total of 6 ml of 5% dextrose, 1 ml each, will be applied periarticularly. In addition, home exercise program will be given to this group.<br>Procedure: Serum Physiological Group (placebo control group)<br>* In the patients in serum physiological injection group, at the 1st, 4th and 7th weeks, the insertion points of the ligaments and tendons that are sensitive with pressure around the knee (medial collateral ligament (2), lateral collateral ligament (2), quadriceps tendon (1) and patellar tendon (1)) A total of 6 ml of saline will be applied periarticularly. In addition, home exercise program will be given to this group.<br>|
| Placebo Comparator: Serum Physiological Group<br>Patients diagnosed with chondromalacia patella | Procedure: Dextrose Prolotherapy<br>* In the patients in the prolotherapy injection group, at the 1st, 4th and 7th weeks, the insertion points of the ligaments and tendons that are sensitive with pressure around the knee (medial collateral ligament (2), lateral collateral ligament (2), quadriceps tendon (1) and patellar tendon (1)) A total of 6 ml of 5% dextrose, 1 ml each, will be applied periarticularly. In addition, home exercise program will be given to this group.<br>Procedure: Serum Physiological Group (placebo control group)<br>* In the patients in serum physiological injection group, at the 1st, 4th and 7th weeks, the insertion points of the ligaments and tendons that are sensitive with pressure around the knee (medial collateral ligament (2), lateral collateral ligament (2), quadriceps tendon (1) and patellar tendon (1)) A total of 6 ml of saline will be applied periarticularly. In addition, home exercise program will be given to this group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Pain | Severity of pain was assessed using the standard 10 cm VAS with 0 meant no pain at one end, and 10 meant unbearable pain at the other end | initial, 4th week 7th week 24th week pain change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patello Femoral Pain Intensity Scale | Patello Femoral Pain Intensity Scale to evaluate patients' pain in climbing / descending stairs, squatting, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activityStair climbing / descending, crouching, walking, jogging, sprinting, sports, sitting for 20 minutes with knees flexed at 90 °, standing on the knee, resting and resting after an activity, travel 10 cm as standard 0 no pain at one end, 10 At the other end it was rated as excruciating pain with a total score of 100. | initial, 4th week 7th week 24th week pain change | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolotherapy, knee pain, ultrasound, exercise