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

NCT06446973 | Completed

• 1 other identifier: Istanbula
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Tear; Quality of Life

Keywords

Peniscus tear; Pain; Quality of Life; Balance; Muscle Strenght

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Control group

NO INTERVENTION

35 healthy individuals

Meniscus tear group

ACTIVE COMPARATOR

35 patients diagnosed with meniscus tear

Other: 35 patients with meniscus tear

Interventions

35 patients with meniscus tear OTHER

Have meniscus pathologies in one or both knees confirmed by MRI.

Meniscus tear group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• To be between ages of 18-60,
• Not have any orthopedic, neurological, or systemic conditions,
• Volunteer to participate in the study.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Istanbul Aydın University: lead

Study Sites (1)

Barış CELBEK

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 1, 2024
• First Posted: June 6, 2024
• Study Start: June 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 30, 2023
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

TU (1)