Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06446973 |
| Other study ID # |
Istanbula |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2022 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
June 2024 |
| Source |
Istanbul Aydin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
