Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions

NCT06692816 | Not Yet Recruiting

• 1 other identifier: SAPEMT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Meniscus Lesion; Pain

Outcome Measures

Primary Outcomes (4)

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

  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.

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

• KOOS ( KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE)

  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.

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

• Lysholm Knee Scoring Scale

  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.

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

• Western Ontario Meniscus Assessment Questionnaire

  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.

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

Secondary Outcomes (5)

• 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)

Study Arms (2)

PEMT

EXPERIMENTAL

It was planned for this group to apply PEMT to the painful knee region with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057, May, 2012 Arcugnano (VI)-Italia) with a physiotherapist who is trained in using the device and has at least 5 years of experience, at a frequency of 50 Hz, an intensity of 85 Gauss (8.5 milliTesla) and for 30 minutes. The treatment period was planned as a total of 20 sessions, 5 days a week for 4 weeks. As a therapeutic exercise program, it was planned to apply joint range of motion, walking, balance, coordination, cycling, isometric and isotonic strengthening exercises by a trained physiotherapist with at least 5 years of experience and that the patients would do these exercises three times a day, in 3 sets, with 10 repetitions.

Other: Rehabilitation

SHAM

SHAM COMPARATOR

It was planned for this group to receive sham PEMT, with the electromagnetic field device turned off, for a total of 20 sessions, 5 days a week for 4 weeks, for 30 minutes each session, and a therapeutic exercise program, for a total of 20 sessions, 5 days a week for 4 weeks, for 30 minutes each session, including range of motion, walking, balance, coordination, cycling, isometric and isotonic strengthening exercises, by a trained physiotherapist with at least 5 years of experience, and for the patients to do these exercises three times a day, in 3 sets, with 10 repetitions.

Other: Rehabilitation

Interventions

Rehabilitation OTHER

As a therapeutic exercise program, it was planned to apply joint range of motion, walking, balance, coordination, cycling, isometric and isotonic strengthening exercises by a trained physiotherapist with at least 5 years of experience and that the patients would do these exercises three times a day, in 3 sets, with 10 repetitions.

PEMT; SHAM

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Neurological diseases (multiple sclerosis, history of cerebrovascular disease, myopathic diseases, epilepsy, febrile convulsions, etc.),
• Cardiac pacemaker,
• Malignancy,
• Bleeding diathesis,
• An electronic or battery system body implant.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

MeSH Terms

Conditions

Pain

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• SEVDA ADAR

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SEVDA ADAR

CONTACT

+905325940725; drsevdaadar@gmail.com

ONURHAN APAYDIN

CONTACT

+905347293989; onurhanapaydinmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 18, 2024
• Study Start: December 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share