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Clinical Trials/NCT06692816
NCT06692816
Not yet recruiting
Not Applicable

Clinical Efficacy of Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions: Double-Blind Randomized Sham-Controlled Study

Afyonkarahisar Health Sciences University0 sites80 target enrollmentDecember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Meniscus Lesion
Sponsor
Afyonkarahisar Health Sciences University
Enrollment
80
Primary Endpoint
Visual Pain Scale (VAS) - night - rest - movement
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

Pulse Electromagnetic Field Therapy (PEMT) is effective in the treatment of many diseases, especially musculoskeletal system diseases, due to its analgesic effect with the effect of induced currents, and also its anti-inflammatory , edema reducing, antispasmodic and blood flow accelerating effects with additional mechanisms. The aim of our study is to evaluate the effects of Pulsed Electromagnetic Field Therapy (PEMT) degenerative To investigate the effects on pain, quality of life and function in patients with meniscal lesions.

Detailed Description

Menisci are responsible for carrying the load in the knee joint, transmitting the load, absorbing impacts, lubricating the joint and stabilizing the joint .The menisci to perform their functions properly, the integrity of their anterior and posterior roots at their attachment points on the tibial plateau must be preserved. The male/female ratio of meniscus injuries is 2.5/1, with an incidence of around 60-70 per 100,000. Medial meniscus tears, lateral It is detected 3 times more frequently than meniscus tears. In patients under the age of 30, trauma and in patients over the age of 30, degenerative causes often cause tears. Meniscus tears can be divided into two groups: traumatic and degenerative . Traumatic tears occur in healthy menisci , most often in young people, as a result of excessive and inappropriate loading. Degenerative tears are common in the elderly, occurring in degenerated menisci under normal load or after minimal trauma . Traumatic injuries most often occur when the body rotates on the knee while the foot is fixed on the ground. meniscus tears can be divided into two groups : conservative (pharmacological and non -pharmacological) and surgical. Non -pharmacological treatment approaches consist of programs such as patient education, use of assistive devices, lifestyle changes, weight control, and conventional physical therapy methods. Magnetic Field Therapy is a cheap, non-invasive and safe physical therapy method with no known significant side effects. It is suggested that Pulse Electromagnetic Field Therapy (PEMT) is effective in the treatment of many diseases, especially musculoskeletal system diseases, due to its analgesic effect with the effect of induced currents, and also its anti-inflammatory , edema reducing, antispasmodic and blood flow accelerating effects with additional mechanisms. Current literature suggests that magnetic field therapy may be effective in the treatment of fracture union, knee osteoarthritis , cervical fusion, lumbar and cervical There are studies on its effectiveness in the treatment of various musculoskeletal problems such as discopathy. Pulsed electromagnetic field therapy (PEMT) has been shown to enhance healing of meniscal tears and reduce post- traumatic osteoarthritis in a rat model . However, in the literature Pulsed electromagnetic field therapy (PEMT) degenerative No clinical studies have been found on the effectiveness of meniscus lesions.The aim of our study is to evaluate the effects of Pulsed Electromagnetic Field Therapy (PEMT) degenerative To investigate the effects on pain, quality of life and function in patients with meniscal lesions.

Registry
clinicaltrials.gov
Start Date
December 1, 2024
End Date
February 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Afyonkarahisar Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Sevda Adar

Assistant Professor

Afyonkarahisar Health Sciences University

Eligibility Criteria

Inclusion Criteria

  • Knee pain for at least 2 months
  • MRI findings of meniscus degeneration
  • The health condition is suitable for rehabilitation
  • Ability to understand commands

Exclusion Criteria

  • Inability to cooperate fully and lack of literacy skills
  • NSAID use
  • Planning pregnancy during pregnancy or treatment process
  • A history of physical therapy and rehabilitation for the knee area in the last 6 months.
  • A history of local injection treatment to the knee area within the last 6 months,
  • A history of trauma, surgery, or fracture in the lower extremity on the side of pain in the last 6 months,
  • Lumbar radiculopathy
  • Presence of advanced gonarthrosis (Kellgren Lawrence stage 3-4)
  • Ligament injury or tear of the knee
  • Systemic inflammatory rheumatic disease (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, vasculitis etc.

Outcomes

Primary Outcomes

Visual Pain Scale (VAS) - night - rest - movement

Time Frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)

In treatments applied for knee pain, the primary goal is to focus on the restoration of pain and movement function. Visual Pain Scale (VAS), which is easy to understand, apply and interpret, and provides valid and reliable data in a short time, is the most commonly used method in clinics. With a 100 mm visual linear scale, the patient is told that there is no pain at 0, and that the most severe pain ever felt at 100, and the patient is asked to mark the point corresponding to rest, movement and night pain.

KOOS ( KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE)

Time Frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)

It is a scale used to evaluate symptoms and functional status related to knee injuries and knee osteoarthritis . It has 5 subgroups: pain, daily living activities (ADL), functional status in sports and leisure activities and quality of life related to the knee. Each question is scored with a total of 5 options between 0-4. The average score in each section is multiplied by 100, divided by 4 and subtracted from 100. The possible score varies between 0 and 100 points in each case. A score of 100 indicates no restrictions due to the affected knee , while a score of 0 indicates excessive problems and restrictions.

Lysholm Knee Scoring Scale

Time Frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)

8 items are asked about symptoms and a total score (0-100) is calculated. A score of 0 indicates the lowest knee function, while a score of 100 indicates the highest knee function. There is a Turkish validity and reliability study.

Western Ontario Meniscus Assessment Questionnaire

Time Frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)

Physical symptoms experienced by patients due to knee problems are questioned. A total of 16 questions in 3 sections are given 0-10 points. The score for each subgroup is obtained by dividing the marked values of the questions in that section by the number of questions and multiplying by 10. For the total score, all marked values are added, divided by 16 and multiplied by 10. The score is between 0-100. 0 indicates the best symptoms and function, while 100 indicates the worst symptoms and function. There is a Turkish validity and reliability study.

Secondary Outcomes

  • Knee joint range of motion (ROM)(Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2))
  • Tegner Activity Level Scale(Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2))
  • Lower Extremity Y Dynamic Balance Test:(Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2))
  • SF -36(Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2))
  • Isokinetic Evaluation of Knee(Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2))

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