- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06420882
Comparison of Different Treatment Methods in Patella Chondromalacia
May 15, 2024 updated by: gamze demircioglu, Istanbul Medipol University Hospital
Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patellofemoral pain syndrome (PFPS) is the most common type of pain in runners with a prevalence of 17%; it is limited to the anterior knee or the area behind the patella between the edges of the patella.
Although PFPS and CMP are often considered to be the same disease, there is still controversy about the subject.
It is caused by decreased quadriceps muscle strength, change in mechanical loading, lower limb kinematics and differentiation in muscle activation patterns during running .
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gamze Demircioglu, PhD
- Phone Number: 05348689544
- Email: gamzekantardemircioglu@gmail.com
Study Locations
-
-
None Selected
-
Istanbul, None Selected, Turkey, 34353
- Recruiting
- Gamze Demircioğlu
-
Contact:
- Gamze Demircioğlu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion criteria:
- 18-65 years of age.
- Being diagnosed with chondromalacia
- Participate in the work on a voluntary basis
- Obtaining informed consent from them
Exclusion criteria:
- Fracture, ligament or muscle tear in the lower extremity within the last 3 months.
- Having a systemic disease
- Having a serious injury in the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The rehabilitation group.
rehabilitation group.
|
In the rehabilitation group, patella mobilisation, muscle strengthening exercises, range of motion exercises will be performed 3 days a week with a therapist for 3 sessions per week
|
|
Active Comparator: The home exercise group
|
Participants in both groups will be included in a 3-week treatment programme.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
WOMAC
Time Frame: 3 weeks
|
The Turkish version of the WOMAC scale will be used to evaluate the pain, stiffness and physical function of the individuals included in the study.
The score of each section is calculated within itself and the total score varies between 0 and 100.
High scores indicate an increase in pain and stiffness and impairment in physical function (12,13).
|
3 weeks
|
|
Stair climbing test
Time Frame: 3 weeks
|
Stair ascent and descent test: The patient's ascent and descent time of the 11-step staircase with a height of 14 cm and a depth of 29 cm were recorded separately with a stopwatch.
|
3 weeks
|
|
Range of motion of the joint
Time Frame: 3 weeks
|
Knee joint range of motion will be measured with a goniometer.
|
3 weeks
|
|
Star balance test
Time Frame: 3 weeks
|
The test is a simple but time-consuming test in terms of its application and is used to measure dynamic postural balance (1).
The test is based on the ability to reach the farthest possible distance on the supporting leg with the free foot in 8 different directions
|
3 weeks
|
|
Horizontal jump test
Time Frame: 3 weeks
|
They jump to the farthest distance they can jump using their single and double legs and the best result obtained after at least 2 trials is recorded in cm.
In this test, it should be noted that when contact with the ground after the jump, the measurement should be made at the heel level of the back foot, which is close to the starting line.
Another point to be considered is that the participant should be stationary at the starting line.
The participant cannot come to the line running and jump.
But it is allowed to make a springing movement in front of the line
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2024
Primary Completion (Estimated)
June 6, 2024
Study Completion (Estimated)
November 21, 2024
Study Registration Dates
First Submitted
May 15, 2024
First Submitted That Met QC Criteria
May 15, 2024
First Posted (Actual)
May 20, 2024
Study Record Updates
Last Update Posted (Actual)
May 20, 2024
Last Update Submitted That Met QC Criteria
May 15, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-10840098-772.02-7994
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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