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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: comparing efficacy of TENS and PEMF in knee osteoarthritis

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emna RAZGALLAH, medical resident; Phone Number: +216 25484674; Email: emna.razgallah123@gmail.com
• Study Contact Backup: Name: Maroua SLOUMA, Medical doctor; Phone Number: +216 55117316; Email: maroua.slouma@gmail.com

Study Locations

• Tunisia
  • Tunis, Tunisia, 1008
    • Recruiting
    • Military Hospital of Tunis
    • Contact: Najla Mouhli, MD; Phone Number: +216 54448048; Email: najla.mouhli@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Patients treated with transcutaneous electrical nerve stimulation (TENS)	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.
Active Comparator: Group 2: Patients treated with magnetotherapy (PEMF)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Consumption of paracetamol		one week before the beginning and 3 weeks after the finishing of the rehabilitation program
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
assessing patients satisfaction	Satisfaction VAS	one week before the beginning and 3 weeks after the finishing of the rehabilitation program
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

Collaborators and Investigators

• Sponsor: University Tunis El Manar

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 5, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 5, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 35/2023/CLPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No