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

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ClinicalTrials.gov Identifier: NCT04796103
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

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.


Condition or disease Intervention/treatment Phase
Chondromalacia Patellae Procedure: Dextrose Prolotherapy Procedure: Serum Physiological Group (placebo control group) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effectiveness of Prolotherapy (%5 Dextros) in the Treatment of Patients With Chondromalacia Patella: a Randomized Controlled Trial
Actual Study Start Date : September 19, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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.




Primary Outcome Measures :
  1. Knee Pain [ Time Frame: initial, 4th week 7th week 24th week pain change ]
    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 :
  1. Patello Femoral Pain Intensity Scale [ Time Frame: initial, 4th week 7th week 24th week pain change ]
    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.


Other Outcome Measures:
  1. Kuala Patellofemoral Scoring System [ Time Frame: initial, 4th week 7th week 24th week changes ]
    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.

  2. Short Form-36 (SF-36) [ Time Frame: initial, 4th week 7th week 24th week changes ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796103


Contacts
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Contact: Burak BAYIR, MD +903122911511 yunusburakbayir@gmail.com
Contact: Özlem KÖROĞLU, MD +903122911620 drozlemkoroglu@gmail.com

Locations
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Turkey
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital Recruiting
Ankara, Turkey, 06800
Contact: Burak BAYIR, MD    +903122911511    yunusburakbayir@gmail.com   
Sponsors and Collaborators
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Investigators
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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
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Responsible Party: Yasin Demir, Physical Medicine and Rehabilitation Specialist, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04796103    
Other Study ID Numbers: 9
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yasin Demir, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital:
prolotherapy
knee pain
ultrasound
exercise
Additional relevant MeSH terms:
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Cartilage Diseases
Chondromalacia Patellae
Musculoskeletal Diseases
Connective Tissue Diseases