Evaluation Of Pain, Balance, Functional Performance and Quality of Life in Patients With Meniscus Lesions

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Meniscus Tear
• Intervention / Treatment: Other: 35 patients with meniscus tear

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Barış CELBEK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; 35 healthy individuals
Active Comparator: Meniscus tear group; 35 patients diagnosed with meniscus tear	Other: 35 patients with meniscus tear; Have meniscus pathologies in one or both knees confirmed by MRI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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	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.	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	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Istanbul Aydın University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: June 1, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): June 6, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Balance; Quality of Life; Pain; Muscle Strenght; Peniscus tear
• Other Study ID Numbers: Istanbula

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No