Knee InjuriesNCT06420882
Comparison of Different Treatment Methods in Patella Chondromalacia
A study testing The experimental group. and The home exercise group in people with Knee Injuries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Knee Injuries
- What is being tested?
- The experimental group. and The home exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 3 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-65 years of age.
- Being diagnosed with chondromalacia
- Participate in the work on a voluntary basis
- Obtaining informed consent from them
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gamze Demircioğlu
Istanbul, None Selected, 34353
About this study
Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1).
Read the 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 .
- Conditions
- Knee Injuries
- Being tested
- The experimental group., The home exercise group
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The experimental group.Other
In the experimental group, in addition to home exercises, patella mobilization, muscle strengthening exercises, range of motion exercises and home exercises will be performed 3 days a week for 3 sessions with a therapist.
The home exercise groupOther
Participants in both groups will be included in a 3-week treatment programme.
| Study group | Role | What they receive |
|---|---|---|
| The rehabilitation group. | Experimental | rehabilitation group. Receives: Other: The experimental group. |
| The home exercise group | Active comparator | The home exercise group Receives: Other: The home exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC
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).
Measured: 3 weeks
Stair climbing test
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.
Measured: 3 weeks
Range of motion of the joint
Knee joint range of motion will be measured with a goniometer.
Measured: 3 weeks
Star balance test
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
Measured: 3 weeks
Horizontal jump test
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
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start15 May 2024
- Primary completion6 Aug 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gamze demircioglu, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420882
- Sponsor's protocol ID
- E-10840098-772.02-7994
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Treatment Methods in Patella Chondromalacia
- ClinicalTrials.gov ID
- NCT06420882
- Acronym / sponsor ID
- E-10840098-772.02-7994
- Conditions
- Knee Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The rehabilitation group. | Experimental | Other: The experimental group.rehabilitation group. |
| The home exercise group | Active comparator | Other: The home exercise groupThe home exercise group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-65 years of age.
- Being diagnosed with chondromalacia
- Participate in the work on a voluntary basis
- Obtaining informed consent from them
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The experimental group.In the experimental group, in addition to home exercises, patella mobilization, muscle strengthening exercises, range of motion exercises and home exercises will be performed 3 days a week for 3 sessions with a therapist. | Other | The rehabilitation group. |
| The home exercise groupParticipants in both groups will be included in a 3-week treatment programme. | Other | The home exercise group |
Primary outcome
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).
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.
Range of motion of the joint
Time frame: 3 weeks
Knee joint range of motion will be measured with a goniometer.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The experimental group. and The home exercise group in people with Knee Injuries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC (time frame: 3 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.