Clinical trial NCT06692816: Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions
Official title: Clinical Efficacy of Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions: Double-Blind Randomized Sham-Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Meniscus Lesion
Pain
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
* 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.
* Acute infections, presence of tuberculosis

Primary outcomes:
measure: Visual Pain Scale (VAS) - night - rest - movement
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: KOOS ( KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE)
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: Lysholm Knee Scoring Scale
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: Western Ontario Meniscus Assessment Questionnaire
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Secondary outcomes:
measure: Knee joint range of motion (ROM)
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: Tegner Activity Level Scale
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: Lower Extremity Y Dynamic Balance Test:
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: SF -36
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
measure: Isokinetic Evaluation of Knee
timeFrame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Other outcomes:
Locations:
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: SEVDA ADAR
role: PRINCIPAL_INVESTIGATOR
References: