Meniscus LesionNCT06692816
Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions
A study testing Rehabilitation in people with Meniscus Lesion and Pain, run by Afyonkarahisar Health Sciences University.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Meniscus Lesion, Pain
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee pain for at least 2 months
- MRI findings of meniscus degeneration
- The health condition is suitable for rehabilitation
- Ability to understand commands
Who cannot join
- 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,
Show all 16Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Efficacy of Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions: Double-Blind Randomized Sham-Controlled Study
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.
Read the 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.
- Conditions
- Meniscus Lesion, Pain
- Being tested
- Rehabilitation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Secondary outcomes (5)
Knee joint range of motion (ROM)
In measuring knee range of motion, flexion and extension movements are measured with a goniometer while the patient lies on his back, including active and passive measurements of the knee.
Measured: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Tegner Activity Level Scale
This scale aims to evaluate the activity level of people with knee injuries. The patient's activity is scored between 0 and 10. 0 indicates the lowest activity level, while 10 indicates the highest activity level. There is a Turkish validity and reliability study.
Measured: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Lower Extremity Y Dynamic Balance Test:
Balance is maintained on the Y dynamic balance test platform by keeping the hands fixed on the waist area and the foot fixed at the center point. Then, while maintaining the fixed stance with one foot, the blocks are pushed with the toe tip with the other foot in the anterior (0°), posteromedial (45°) and posterolateral (45°) directions (each time bringing the foot back to the fixed stance point without touching the ground) . After the test is repeated 3 times in each of the three directions ( anterior , posteromedial , posterolateral ), the normalization formula is used. The sum of the 3 directions is divided by 3 times the leg length and multiplied by 100.
Measured: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
SF -36
SF -36 is a generic quality of life scale. It provides the opportunity to ev.aluate the health status of the person in 10 sub-parameters such as physical function, body pain, limitation due to physical problems, emotional well-being, social function, energy/fatigue, general health perception. It contains a total of 36 items. It is evaluated between 0-100 points. It was created to evaluate the health status.
Measured: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Isokinetic Evaluation of Knee
Isokinetic systems are complex systems used for both rehabilitation and patient evaluation. Isokinetic contraction is defined as a contraction at a constant speed throughout the entire range of motion and is equal in speed at every angle of motion. No matter how much force the person applies to the device, they can never exceed the predetermined speed (e.g. 90 degrees per second). The ability to evaluate the desired muscle or muscle groups in isolation and the repeatability and comparability of the measurements are advantageous features.
Measured: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevda Adar, Afyonkarahisar Health Sciences University
- Investigators
- SEVDA ADAR, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06692816
- Sponsor's protocol ID
- SAPEMT
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Pulsed Electromagnetic Field Therapy (PEMT) in Patients With Degenerative Meniscus Lesions: Double-Blind Randomized Sham-Controlled Study
- ClinicalTrials.gov ID
- NCT06692816
- Acronym / sponsor ID
- SAPEMT
- Conditions
- Meniscus Lesion, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEMT | Experimental | Other: RehabilitationIt 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. |
| SHAM | Sham comparator | Other: RehabilitationIt 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee pain for at least 2 months
- MRI findings of meniscus degeneration
- The health condition is suitable for rehabilitation
- Ability to understand commands
Key exclusion criteria (16 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationAs 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 | PEMT, SHAM |
Primary outcome
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.
5 secondary outcomes
Knee joint range of motion (ROM)
Time frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Tegner Activity Level Scale
Time frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Lower Extremity Y Dynamic Balance Test:
Time frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
SF -36
Time frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Isokinetic Evaluation of Knee
Time frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEVDA ADAR principal investigator
Afyonkarahisar Health Sciences University
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Meniscus Lesion and Pain, run by Afyonkarahisar Health Sciences University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEVDA ADAR (+905325940725, drsevdaadar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Pain Scale (VAS) - night - rest - movement (time frame: Before treatment (T0) At the end of treatment (4 weeks) (T1) At 6 months (T2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.