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

Not Applicable

Completed

• Conditions: Chondromalacia Patellae
• Interventions: Procedure: Dextrose Prolotherapy; Procedure: Serum Physiological Group (placebo control group)

• Registration Number: NCT04796103
• Lead Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-09-19
• Study First Submitted: 2020-12-19
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-19
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serum Physiological Group	Dextrose Prolotherapy	Patients diagnosed with chondromalacia patella
Serum Physiological Group	Serum Physiological Group (placebo control group)	Patients diagnosed with chondromalacia patella
Dextrose Prolotherapy Group	Dextrose Prolotherapy	Patients diagnosed with chondromalacia patella
Dextrose Prolotherapy Group	Serum Physiological Group (placebo control group)	Patients diagnosed with chondromalacia patella

Primary Outcome Measures

Name	Time	Method
Knee Pain	initial, 4th week 7th week 24th week pain change	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

Secondary Outcome Measures

Name	Time	Method
Patello Femoral Pain Intensity Scale	initial, 4th week 7th week 24th week pain change	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.

Trial Locations

Locations (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; 🇹🇷 Ankara, Turkey