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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06406231
• Other study ID #: 35/2023/CLPP
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Tunis El Manar
• Contact: Emna RAZGALLAH, medical resident
• Phone: 25484674
• Email: emna.razgallah123[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Tunisia	Military Hospital of Tunis	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to physical therapy	a 20 percent decrease in the total score of WOMAC pain	one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary	reduction of pain	Reduction in visual analog scale (VAS) pain scores at rest and during activity.	one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary	Consumption of paracetamol		one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary	assessing safety	occurrence of adverse effects requiring temporary or permanent discontinuation of the technique.	one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary	assessing patients satisfaction	Satisfaction VAS	one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary	stiffness and function improvement	• Improvement in all three domains of WOMAC and overall WOMAC score: Stiffness (2 questions) and function (17 questions) WOMAC subscales	one week before the beginning and 3 weeks after the finishing of the rehabilitation program