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

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

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.

Study Overview

• Status: Completed
• Conditions: Chondromalacia Patellae
• Intervention / Treatment: Procedure: Dextrose Prolotherapy; Procedure: Serum Physiological Group (placebo control group)

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06800
    • Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dextrose Prolotherapy Group; Patients diagnosed with chondromalacia patella	Procedure: 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.; Procedure: 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.
Placebo Comparator: Serum Physiological Group; Patients diagnosed with chondromalacia patella	Procedure: 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.; Procedure: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kuala Patellofemoral Scoring System	Kuala Patellofemoral Scoring System was used to determine the functional levels of the patients. Participants were evaluated over a minimum of 0 and a maximum of 100 points.	initial, 4th week 7th week 24th week changes
Short Form-36 (SF-36)	Short Form (SF-36) was used to investigate the quality of life of the patients.The reliability and validity of the Turkish version of SF-36 has been demonstrated. SF-36 consists of 36 questions on eight different subscales including physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, energy and fatigue, vitality, social functioning, role limitations due to emotional problems and general mental health. Each subscale of SF-36 is scored between 0 and 100, and higher scores show better QoL.	initial, 4th week 7th week 24th week changes

Collaborators and Investigators

• Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
• Investigators: Principal Investigator: Burak BAYIR, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital; Study Director: Özlem KÖROĞLU, MD, SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2020
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: exercise; ultrasound; knee pain; prolotherapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Cartilage Diseases; Chondromalacia Patellae
• Other Study ID Numbers: 9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No