Knee OsteoarthritisNCT06406231
Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis
A study testing comparing efficacy of TENS and PEMF in knee osteoarthritis in people with Knee Osteoarthritis, run by University Tunis El Manar at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- comparing efficacy of TENS and PEMF in knee osteoarthritis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- 15 Sep 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Military Hospital of Tunis
Tunis, 1008
Najla Mouhli, MD, 54448048 ext. +216, najla.mouhli@gmail.com
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- comparing efficacy of TENS and PEMF in knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comparing efficacy of TENS and PEMF in knee osteoarthritisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Patients treated with transcutaneous electrical nerve stimulation (TENS) | Active comparator | Not described Receives: Device: comparing efficacy of TENS and PEMF in knee osteoarthritis |
| Group 2: Patients treated with magnetotherapy (PEMF) | Active comparator | Not described Receives: Device: comparing efficacy of TENS and PEMF in knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
response to physical therapy
a 20 percent decrease in the total score of WOMAC pain
Measured: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Secondary outcomes (5)
reduction of pain
Reduction in visual analog scale (VAS) pain scores at rest and during activity.
Measured: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Consumption of paracetamol
Measured: 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.
Measured: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
assessing patients satisfaction
Satisfaction VAS
Measured: 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
Measured: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 Sep 2023
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAZGALLAH Emna, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406231
- Sponsor's protocol ID
- 35/2023/CLPP
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Field Therapy Versus Transcutaneous Electrical Nerve-stimulation in Knee Osteoarthritis: a Head-to-head Trial
- ClinicalTrials.gov ID
- NCT06406231
- Acronym / sponsor ID
- 35/2023/CLPP
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- For both groups, we did not include:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comparing efficacy of TENS and PEMF in knee osteoarthritisSessions 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. | Device | Group 1: Patients treated with transcutaneous electrical nerve stimulation (TENS), Group 2: Patients treated with magnetotherapy (PEMF) |
Primary outcome
response to physical therapy
Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
a 20 percent decrease in the total score of WOMAC pain
5 secondary outcomes
reduction of pain
Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Consumption of paracetamol
Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
assessing safety
Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
assessing patients satisfaction
Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
stiffness and function improvement
Time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comparing efficacy of TENS and PEMF in knee osteoarthritis in people with Knee Osteoarthritis, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emna RAZGALLAH, medical resident (25484674 ext. +216, emna.razgallah123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response to physical therapy (time frame: one week before the beginning and 3 weeks after the finishing of the rehabilitation program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.