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Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis

Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis: a Head-to-head Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06406231
Enrollment
60
Registered
2024-05-09
Start date
2023-09-15
Completion date
2024-12-31
Last updated
2024-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Brief summary

The effectiveness of PEMF in improving physical function among Osteoarthritic (OA) patients remains a topic of debate, leading to the American College of Rheumatology not yet endorsing its use in OA treatment. Therefore, it's essential to investigate PEMF therapy's efficacy in alleviating joint pain, stiffness, and enhancing physical function in knee OA patients Our study objectives were to evaluate the effectiveness and safety of PEMF therapy and to compare its efficacy with TENS in knee OA management.

Interventions

DEVICEcomparing efficacy of TENS and PEMF in knee osteoarthritis

Sessions will be conducted by a physiotherapist from the center, trained in the technique.Three sessions per week for three weeks. We used an Automatic Program (approximately 20 minutes). For each group, the physical therapy was given as below: G2: Patients treated with magnetotherapy: -Device used: a prototype of a Health magnetic therapy (H.M.T) generator developed by a group of engineering researchers at the University of Tunis El Manar, employing low-frequency electromagnetic waves. The chosen program is Analgesia. An applicator containing magnets will be placed on the affected knees. The patient will sit on a chair bending knees. G1 : Patients treated with TENS -Device used: TENS from ECO2 from Schwa Medico, 2016, France. We chose the Gate control program (high frequency). The patient will sit with bent knees on a chair and adhesive patches will be placed on the affected knee. The intensity will be adapted to the patient's tolerance in both groups.

Sponsors

University Tunis El Manar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* We included patients who had knee pain due to knee OA diagnosed according to the American College of Rheumatology including: * Knee pain AND presence of at least three of the following 6 criteria: * Age \> 50 years * Morning stiffness \< 30 minutes * Crepitus during movement * Periarticular bone pain * Periarticular bone hypertrophy * Absence of increased local warmth.

Exclusion criteria

* For both groups, we did not include: * Patients with a pacemaker, implantable defibrillator, cochlear implant, or any metal implant contraindicating MRI (knee prosthesis, hip prosthesis, etc.). * Pregnant women * Patients with an active infection * Profound hypoesthesia or thermoalgic sensitivity disorder * Poorly vascularized areas: arteritis, phlebitis, ischemia * Patients on anti-vitamin K treatment or with a coagulation disorder. Patients with long-term corticosteroid therapy or having a total knee replacement, those who have received therapies for knee osteoarthritis including intra-articular corticosteroid injection or viscosupplementation in the last 4 months, and Patients with knee pain of non-osteoarthritic origin were also not included in the study.

Design outcomes

Primary

MeasureTime frameDescription
response to physical therapyone week before the beginning and 3 weeks after the finishing of the rehabilitation programa 20 percent decrease in the total score of WOMAC pain

Secondary

MeasureTime frameDescription
reduction of painone week before the beginning and 3 weeks after the finishing of the rehabilitation programReduction in visual analog scale (VAS) pain scores at rest and during activity.
Consumption of paracetamolone week before the beginning and 3 weeks after the finishing of the rehabilitation program
assessing safetyone week before the beginning and 3 weeks after the finishing of the rehabilitation programoccurrence of adverse effects requiring temporary or permanent discontinuation of the technique.
assessing patients satisfactionone week before the beginning and 3 weeks after the finishing of the rehabilitation programSatisfaction VAS
stiffness and function improvementone week before the beginning and 3 weeks after the finishing of the rehabilitation program• Improvement in all three domains of WOMAC and overall WOMAC score: Stiffness (2 questions) and function (17 questions) WOMAC subscales

Countries

Tunisia

Contacts

Primary ContactEmna RAZGALLAH, medical resident
emna.razgallah123@gmail.com25484674
Backup ContactMaroua SLOUMA, Medical doctor
maroua.slouma@gmail.com55117316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026