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

NCT ID: NCT06406231

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-12-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Patients treated with transcutaneous electrical nerve stimulation (TENS)

Group Type: ACTIVE_COMPARATOR

comparing efficacy of TENS and PEMF in knee osteoarthritis

Intervention Type: DEVICE

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.

Group 2: Patients treated with magnetotherapy (PEMF)

Group Type: ACTIVE_COMPARATOR

comparing efficacy of TENS and PEMF in knee osteoarthritis

Intervention Type: DEVICE

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.

Interventions

comparing 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

RAZGALLAH Emna

medical resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Military Hospital of Tunis

Tunis, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Emna RAZGALLAH, medical resident

Role: CONTACT

emna.razgallah123@gmail.com

25484674 ext. +216

Maroua SLOUMA, Medical doctor

Role: CONTACT

maroua.slouma@gmail.com

55117316 ext. +216

Facility Contacts

Najla Mouhli, MD

Role: primary

najla.mouhli@gmail.com

54448048 ext. +216

Other Identifiers

35/2023/CLPP

Identifier Type: -

Identifier Source: org_study_id