Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446973
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2024-06-01
Brief Title:
Evaluation Of Pain Balance Functional Performance and Quality of Life in Patients With Meniscus Lesions
Sponsor:
Istanbul Aydın University
Organization:
Istanbul Aydın University
Study Overview
Official Title:
Evaluation Of Pain Balance Functional Performance and Quality of Life in Patients With Meniscus Lesions
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 08 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 participants 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 lifestylework and emotional impact providing a comprehensive view of the participants well-being
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 participants 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 lifestylework and emotional impact providing a comprehensive view of the participants well-being
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None