Clinical trial NCT06406231: Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis
Official title: Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis: a Head-to-head Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: response to physical therapy
timeFrame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary outcomes:
measure: reduction of pain
timeFrame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
measure: Consumption of paracetamol
timeFrame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
measure: assessing safety
timeFrame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
measure: assessing patients satisfaction
timeFrame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
measure: stiffness and function improvement
timeFrame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
Study officials:
References: