Clinical trial NCT04796103: The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella
Official title: The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chondromalacia Patellae
Keywords: prolotherapy
knee pain
ultrasound
exercise
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Pain
timeFrame: initial, 4th week 7th week 24th week pain change
Secondary outcomes:
measure: Patello Femoral Pain Intensity Scale
timeFrame: initial, 4th week 7th week 24th week pain change
Other outcomes:
measure: Kuala Patellofemoral Scoring System
timeFrame: initial, 4th week 7th week 24th week changes
measure: Short Form-36 (SF-36)
timeFrame: initial, 4th week 7th week 24th week changes
Locations:
city: Ankara
country: Turkey
facility: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Study officials:
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Özlem KÖROĞLU, MD
role: STUDY_DIRECTOR
affiliation: SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Burak BAYIR, MD
role: PRINCIPAL_INVESTIGATOR
References: