The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella
1 other identifier
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2020
CompletedFirst Submitted
Initial submission to the registry
December 19, 2020
CompletedFirst Posted
Study publicly available on registry
March 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedOctober 20, 2021
October 1, 2021
1 year
December 19, 2020
October 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Patello Femoral Pain Intensity Scale
initial, 4th week 7th week 24th week pain change
Other Outcomes (2)
Kuala Patellofemoral Scoring System
initial, 4th week 7th week 24th week changes
Short Form-36 (SF-36)
initial, 4th week 7th week 24th week changes
Study Arms (2)
Dextrose Prolotherapy Group
ACTIVE COMPARATORPatients diagnosed with chondromalacia patella
Serum Physiological Group
PLACEBO COMPARATORPatients diagnosed with chondromalacia patella
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Ankara, 06800, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Özlem KÖROĞLU, MD
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- PRINCIPAL INVESTIGATOR
Burak BAYIR, MD
SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Medicine and Rehabilitation Specialist
Study Record Dates
First Submitted
December 19, 2020
First Posted
March 12, 2021
Study Start
September 19, 2020
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
October 20, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share