Meniscus TearNCT06446973
Evaluation Of Pain, Balance, Functional Performance and Quality of Life in Patients With Meniscus Lesions
A study testing 35 patients with meniscus tear in people with Meniscus Tear and Quality of Life, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Meniscal tears are common knee injuries, affecting a wide demographic from young athletes to the elderly population, often resulting from traumatic sports-related incidents or degenerative processes associated with aging. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Tear, Quality of Life
- What is being tested?
- 35 patients with meniscus tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Dec 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the research,
- To be between ages of 18-60,
- Not having systemic or neurological issues interfering with assessment completion,
- Have meniscus pathologies in one or both knees confirmed by MRI.
- The criteria for inclusion in the control group;
- To be between ages of 18-60,
- Not have any orthopedic, neurological, or systemic conditions,
- Volunteer to participate in the study.
Who cannot join
- - Having had additional knee surgery or fractures in the affected lower extremity within the last year
- Having had autoimmune or inflammatory diseases,
- Having had involved in a physiotherapy program for the knee in the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
Meniscal tears are common knee injuries, affecting a wide demographic from young athletes to the elderly population, often resulting from traumatic sports-related incidents or degenerative processes associated with aging. The impact of meniscal injuries extends beyond the immediate physical damage, influencing pain perception, balance, functional performance, and ultimately, the quality of life. Despite advancements in diagnostic and therapeutic strategies, the comprehensive effects of meniscal tears on these domains remain inadequately explored, particularly regarding their correlation with objective measures of pain, balance, muscle strength and quality of life.
The meniscus plays a crucial role in knee joint stability, load distribution, and shock absorption. Damage to this fibrocartilaginous structure can significantly impair knee function, leading to altered biomechanics, decreased joint stability, and increased risk of osteoarthritis. Previous research has predominantly focused on the surgical and non-surgical management of meniscal tears, with less attention to the broader implications on patients' daily lives, particularly in terms of postural stability, risk of falls, and overall physical well-being.
Read more
This study aims to bridge this knowledge gap by quantitatively assessing the risk of meniscal tears on pain levels, balance, functional performance, and quality of life. By comparing objective measurements between individuals with meniscal tears and healthy controls, the investigators seek to elucidate the multifaceted impact of these injuries. Understanding these relationships is crucial for developing targeted rehabilitation strategies that address not only the mechanical aspects of the injury but also the associated functional and quality of life concerns.
Our hypothesis was that individuals with meniscal lesions have worse pain, functional performance and quality of life compared to those without such injuries and also pain directly influences balance, functional performance, and quality of life in patients with meniscal injuries.
Read the detailed description
This study included a total of 70 participants, divided into two groups: 35 patients diagnosed with meniscus tear and 35 healthy individuals. The investigators determined this sample size using the G-Power software to ensure a 95% power level and an effect size of 0.8, following the methodology recommended by Faul et al.
The criteria for inclusion in the meniscopathy group;
- Volunteering to participate in the research,
- To be between ages of 18-60,
- Not having systemic or neurological issues interfering with assessment completion,
- Have meniscus pathologies in one or both knees confirmed by MRI.
The criteria for inclusion in the control group;
- To be between ages of 18-60,
- Not have any orthopedic, neurological, or systemic conditions, Volunteer to participate in the study. Exlusion criteria from the study;
- Having had additional knee surgery or fractures in the affected lower extremity within the last year
- Having had autoimmune or inflammatory diseases,
- Having had involved in a physiotherapy program for the knee in the past six months.
Physical Properties and Sociodemographic Assessment Age, sex, height, body weight, dominant lower extremity, occupation was recorded. In addition, the affected side, the duration of complaints, and insights into the participants' activity levels and habits were noted.
Pain Severity and Range of Motion Assessment Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.
Muscle Strength Assessment Hamstring muscle group and Quadriceps Femoris muscle were evaluated. The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions
Balance Assessment Berg Balance Scale (BBS) was utilized to determine fall risk and postural control. This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance. The validity and reliability study of the Turkish version of BBS has been studied
Physical Performance Assessment Physical performance was further assessed via the Timed Up and Go Test (TUG) and the Five Times Sit to Stand Test (5TSTS) , both of which measure balance, walking speed, and functional mobility by timing participants in task-specific movements. For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch. Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.
Quality of Life Assessment The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET), a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being.
- Conditions
- Meniscus Tear, Quality of Life
- Being tested
- 35 patients with meniscus tear
- Keywords
- Peniscus tear, Pain, Quality of Life, Balance, Muscle Strenght
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35 patients with meniscus tearOther
Have meniscus pathologies in one or both knees confirmed by MRI.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 35 healthy individuals |
| Meniscus tear group | Active comparator | 35 patients diagnosed with meniscus tear Receives: Other: 35 patients with meniscus tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity and Range of Motion Assessment
Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.There are numbers from 0 to 10. 0 is classified as no pain and 10 as very severe.
Measured: through study completion, an average of 1 year
Muscle Strength Assessment
Hamstring muscle group and Quadriceps Femoris muscle were evaluated.The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions
Measured: through study completion, an average of 1 year
Balance Assessment
Berg Balance Scale (BBS) was utilized to determine fall risk and postural control.This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance.
Measured: through study completion, an average of 1 year
Physical Performance Assessment- TUG
Timed Up and Go Test (TUG ). For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch
Measured: through study completion, an average of 1 year
Physical Performance Assessment- 5TSTS
Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.
Measured: through study completion, an average of 1 year
Quality of Life Assessment
The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET).a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jun 2022
- Primary completion30 Nov 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış CELBEK, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446973
- Sponsor's protocol ID
- Istanbula
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Pain, Balance, Functional Performance and Quality of Life in Patients With Meniscus Lesions
- ClinicalTrials.gov ID
- NCT06446973
- Acronym / sponsor ID
- Istanbula
- Conditions
- Meniscus Tear, Quality of Life
- Keywords
- Peniscus tear, Pain, Quality of Life, Balance, Muscle Strenght
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Jun 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.
Meniscal tears are common knee injuries, affecting a wide demographic from young athletes to the elderly population, often resulting from traumatic sports-related incidents or degenerative processes associated with aging. The impact of meniscal injuries extends beyond the immediate physical damage, influencing pain perception, balance, functional performance, and ultimately, the quality of life. Despite advancements in diagnostic and therapeutic strategies, the comprehensive effects of meniscal tears on these domains remain inadequately explored, particularly regarding their correlation with objective measures of pain, balance, muscle strength and quality of life.
The meniscus plays a crucial role in knee joint stability, load distribution, and shock absorption. Damage to this fibrocartilaginous structure can significantly impair knee function, leading to altered biomechanics, decreased joint stability, and increased risk of osteoarthritis. Previous research has predominantly focused on the surgical and non-surgical management of meniscal tears, with less attention to the broader implications on patients' daily lives, particularly in terms of postural stability, risk of falls, and overall physical well-being.
This study aims to bridge this knowledge gap by quantitatively assessing the risk of meniscal tears on pain levels, balance, functional performance, and quality of life. By comparing objective measurements between individuals with meniscal tears and healthy controls, the investigators seek to elucidate the multifaceted impact of these injuries. Understanding these relationships is crucial for developing targeted rehabilitation strategies that address not only the mechanical aspects of the injury but also the associated functional and quality of life concerns.
Our hypothesis was that individuals with meniscal lesions have worse pain, functional performance and quality of life compared to those without such injuries and also pain directly influences balance, functional performance, and quality of life in patients with meniscal injuries.
Detailed description
This study included a total of 70 participants, divided into two groups: 35 patients diagnosed with meniscus tear and 35 healthy individuals. The investigators determined this sample size using the G-Power software to ensure a 95% power level and an effect size of 0.8, following the methodology recommended by Faul et al.
The criteria for inclusion in the meniscopathy group;
- Volunteering to participate in the research,
- To be between ages of 18-60,
- Not having systemic or neurological issues interfering with assessment completion,
- Have meniscus pathologies in one or both knees confirmed by MRI.
The criteria for inclusion in the control group;
- To be between ages of 18-60,
- Not have any orthopedic, neurological, or systemic conditions, Volunteer to participate in the study. Exlusion criteria from the study;
- Having had additional knee surgery or fractures in the affected lower extremity within the last year
- Having had autoimmune or inflammatory diseases,
- Having had involved in a physiotherapy program for the knee in the past six months.
Physical Properties and Sociodemographic Assessment Age, sex, height, body weight, dominant lower extremity, occupation was recorded. In addition, the affected side, the duration of complaints, and insights into the participants' activity levels and habits were noted.
Pain Severity and Range of Motion Assessment Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.
Muscle Strength Assessment Hamstring muscle group and Quadriceps Femoris muscle were evaluated. The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions
Balance Assessment Berg Balance Scale (BBS) was utilized to determine fall risk and postural control. This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance. The validity and reliability study of the Turkish version of BBS has been studied
Physical Performance Assessment Physical performance was further assessed via the Timed Up and Go Test (TUG) and the Five Times Sit to Stand Test (5TSTS) , both of which measure balance, walking speed, and functional mobility by timing participants in task-specific movements. For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch. Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.
Quality of Life Assessment The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET), a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –35 healthy individuals |
| Meniscus tear group | Active comparator | Other: 35 patients with meniscus tear35 patients diagnosed with meniscus tear |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Volunteering to participate in the research,
- To be between ages of 18-60,
- Not having systemic or neurological issues interfering with assessment completion,
- Have meniscus pathologies in one or both knees confirmed by MRI.
- The criteria for inclusion in the control group;
Key exclusion criteria (3 listed)
- - Having had additional knee surgery or fractures in the affected lower extremity within the last year
- Having had autoimmune or inflammatory diseases,
- Having had involved in a physiotherapy program for the knee in the past six 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 |
|---|---|---|
| 35 patients with meniscus tearHave meniscus pathologies in one or both knees confirmed by MRI. | Other | Meniscus tear group |
Primary outcome
Pain Severity and Range of Motion Assessment
Time frame: through study completion, an average of 1 year
Pain intensity was quantified using the Visual Analog Scale (VAS), during various states such as activity, rest, and nighttime. Joint Range of Motion (ROM) was evaluated with a goniometer, adhering to established protocols for knee flexion and extension, to increase reliability in our measurements.There are numbers from 0 to 10. 0 is classified as no pain and 10 as very severe.
Muscle Strength Assessment
Time frame: through study completion, an average of 1 year
Hamstring muscle group and Quadriceps Femoris muscle were evaluated.The knee flexion and extension muscle strengths of the subjects were given a value between 0 and 5 according to the resistance applied to the muscle in standard positions
Balance Assessment
Time frame: through study completion, an average of 1 year
Berg Balance Scale (BBS) was utilized to determine fall risk and postural control.This test has a 14-item test that is used to assess the self-perceived balance among individuals. The total score ranges between 0 and 56, with higher scores indicating a better balance.
Physical Performance Assessment- TUG
Time frame: through study completion, an average of 1 year
Timed Up and Go Test (TUG ). For the TUG test, a point 3 m away from the participant's chair was marked and the participant was asked to get up from the chair, walk 3 m, return and sit back down and the completion time of the test was measured with a stopwatch
Physical Performance Assessment- 5TSTS
Time frame: through study completion, an average of 1 year
Participants were instructed to wear comfortable shoes. 5TSTS ; In this test, the patient sat with arms crossed over the chest and back against the chair. Upon the command "Start," the patient was asked to quickly stand up and sit down from a standard chair five times. The elapsed time was measured with a stopwatch and recorded in seconds.
Quality of Life Assessment
Time frame: through study completion, an average of 1 year
The quality of life for those with meniscus pathology was evaluated using the Western Ontario Meniscal Evaluation Tool (WOMET).a Turkish-validated questionnaire that segments 16 questions into physical symptoms, lifestyle/work, and emotional impact, providing a comprehensive view of the participants' well-being
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 6 Jun 2024.
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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 35 patients with meniscus tear in people with Meniscus Tear and Quality of Life, run by Istanbul Aydın University 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 8 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 6 Jun 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?
Pain Severity and Range of Motion Assessment (time frame: through study completion, an average of 1 year). The study lists 6 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 6 Jun 2024.