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

NCT06406231 | Recruiting

• 1 other identifier: 35/2023/CLPP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• reduction of pain

  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

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

• assessing patients satisfaction

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

• stiffness and function improvement

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

Study Arms (2)

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

ACTIVE COMPARATOR

Device: comparing efficacy of TENS and PEMF in knee osteoarthritis

Group 2: Patients treated with magnetotherapy (PEMF)

ACTIVE COMPARATOR

Device: comparing efficacy of TENS and PEMF in knee osteoarthritis

Interventions

comparing efficacy of TENS and PEMF in knee osteoarthritis 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 1: Patients treated with transcutaneous electrical nerve stimulation (TENS); Group 2: Patients treated with magnetotherapy (PEMF)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Military Hospital of Tunis

Tunis, 1008, Tunisia

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Emna RAZGALLAH, medical resident

CONTACT

25484674; emna.razgallah123@gmail.com

Maroua SLOUMA, Medical doctor

CONTACT

55117316; maroua.slouma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical resident

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 9, 2024
• Study Start: September 15, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

TU (1)