CClinicalTrials.gg
RecruitingNCT06406231Updated May 9, 2024

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

An interventional study of comparing efficacy of TENS and PEMF in knee osteoarthritis in Knee Osteoarthritis, sponsored by University Tunis El Manar. Recruiting at 1 site in Tunisia. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by University Tunis El Manar · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Sep 2023, registered May 2024).
  • Started Sep 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University Tunis El Manar is the lead sponsor of 73 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

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

    Device: comparing efficacy of TENS and PEMF in knee osteoarthritis

  • Active comparator
    Group 2: Patients treated with magnetotherapy (PEMF)

    Device: comparing efficacy of TENS and PEMF in knee osteoarthritis

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.

06

What researchers measure

Primary outcomes

  1. response to physical therapy

    a 20 percent decrease in the total score of WOMAC pain

    Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

Secondary outcomes

  1. reduction of pain

    Reduction in visual analog scale (VAS) pain scores at rest and during activity.

    Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

  2. Consumption of paracetamol

    Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

  3. assessing safety

    occurrence of adverse effects requiring temporary or permanent discontinuation of the technique.

    Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

  4. assessing patients satisfaction

    Satisfaction VAS

    Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

  5. stiffness and function improvement

    • Improvement in all three domains of WOMAC and overall WOMAC score: Stiffness (2 questions) and function (17 questions) WOMAC subscales

    Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program

07

Study locations

1 of 1 sites recruiting
  • Military Hospital of Tunis
    Tunis, 1008, Tunisia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06406231
Lead sponsor
University Tunis El Manar
Responsible party
RAZGALLAH Emna (medical resident, University Tunis El Manar) — Principal investigator
First posted
May 9, 2024
Start date
Sep 15, 2023
Primary completion
Aug 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
May 9, 2024

Study contacts

Emna RAZGALLAH, medical resident
Contact
emna.razgallah123@gmail.com
25484674 ext. +216
Maroua SLOUMA, Medical doctor
Contact
maroua.slouma@gmail.com
55117316 ext. +216

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion