The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella
NCT ID: NCT04796103
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2020-09-19
2021-09-30
Brief Summary
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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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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Dextrose Prolotherapy Group
Patients diagnosed with chondromalacia patella
Dextrose Prolotherapy
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.
Serum Physiological Group (placebo control group)
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.
Serum Physiological Group
Patients diagnosed with chondromalacia patella
Dextrose Prolotherapy
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.
Serum Physiological Group (placebo control group)
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.
Interventions
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Dextrose Prolotherapy
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.
Serum Physiological Group (placebo control group)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
OTHER
Responsible Party
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Yasin Demir
Physical Medicine and Rehabilitation Specialist
Principal Investigators
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Özlem KÖROĞLU, MD
Role: STUDY_DIRECTOR
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Burak BAYIR, MD
Role: PRINCIPAL_INVESTIGATOR
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Locations
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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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9
Identifier Type: -
Identifier Source: org_study_id