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

Primary Purpose

Chondromalacia Patellae

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Dextrose Prolotherapy

Serum Physiological Group (placebo control group)

About this trial

This is an interventional treatment trial for Chondromalacia Patellae focused on measuring prolotherapy, knee pain, ultrasound, exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dextrose Prolotherapy Group

Serum Physiological Group

Arm Description

Patients diagnosed with chondromalacia patella

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04796103

First Posted

December 19, 2020

Last Updated

October 19, 2021

Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04796103

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

September 19, 2020 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chondromalacia Patellae

Keywords

prolotherapy, knee pain, ultrasound, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dextrose Prolotherapy Group

Arm Type

Active Comparator

Arm Description

Patients diagnosed with chondromalacia patella

Arm Title

Serum Physiological Group

Arm Type

Placebo Comparator

Arm Description

Patients diagnosed with chondromalacia patella

Intervention Type

Procedure

Intervention Name(s)

Dextrose Prolotherapy

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Serum Physiological Group (placebo control group)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Knee Pain

Description

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

Time Frame

initial, 4th week 7th week 24th week pain change

Secondary Outcome Measure Information:

Title

Patello Femoral Pain Intensity Scale

Description

Time Frame

initial, 4th week 7th week 24th week pain change

Other Pre-specified Outcome Measures:

Title

Kuala Patellofemoral Scoring System

Description

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.

Time Frame

initial, 4th week 7th week 24th week changes

Title

Short Form-36 (SF-36)

Description

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.

Time Frame

initial, 4th week 7th week 24th week changes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Özlem KÖROĞLU, MD

Organizational Affiliation

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Burak BAYIR, MD

Organizational Affiliation

SBU,Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

City

Ankara

ZIP/Postal Code

06800

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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