Knee OsteoarthritisMT-MW-EXNCT04866745
Magnetotherapy Versus Microwave Combined With Exercise for Knee Osteoarthritis.
A study testing Magnetotherapy plus exercise and Microwave plus exercise in people with Knee Osteoarthritis and Pain, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The high prevalence of knee osteoarthritis and the absence of well-defined protocols for the application of Magnetotherapy (MT), makes it necessary to investigate the effect of this therapy on patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Pain
- What is being tested?
- Magnetotherapy plus exercise and Microwave plus exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2021to 25 Jul 2023
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 45 years old
- Unilateral or bilateral knee osteoarthritis.
- Kellgren and Lawrence (K-L) grade II or III.
- Visual analog scale (VAS) greater than 40mm.
- Affectation of more than one year of evolution.
- Sign and understand the informed consent form.
Who cannot join
- Secondary cause osteoarthritis
- History of uncontrolled metabolic diseases.
- Decompensated or uncontrolled pathologies
- Tumor processes.
- Collagenopathies and neurological diseases.
- Changes in medication or invasive treatments at least 1 month prior to treatment.
Show all 12Show fewer
- Receiving physiotherapy treatment or having received it one month prior to the start of the osteoarthritis study.
- Patients with alterations in thermal sensitivity.
- Pacemaker
- Skin alterations (recent wounds or burns).
- Knee prosthesis
- Thrombophlebitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Magnetotherapy and Microwaves Combined With Therapeutic Exercise in Patients With Knee Osteoarthritis.
The high prevalence of knee osteoarthritis and the absence of well-defined protocols for the application of Magnetotherapy (MT), makes it necessary to investigate the effect of this therapy on patients with knee osteoarthritis. Furthermore, no studies are comparing the effectiveness of the two interventions proposed in this project (MT) and microwaves (MW), which are routinely applied in clinical practice, without solid scientific evidence to justify their use.
The purpose of the present clinical trial is to compare MT with MW both combined with a therapeutic exercise program in patients with painful knee osteoarthritis and its influence on pain and function.
Read the detailed description
This study is a double-blinded, sham-controlled, randomized clinical trial whose main objective is to investigate the effect on pain and function in people with moderate knee osteoarthritis of the intervention with Magnetotherapy (MT) combined with an exercise program compared to microwave (MW) application combined with an exercise program and to MT placebo combined with an exercise program. The study will take place at several centers of primary healthcare centers in Spain. After receiving the approval of the Ethics and Clinical Research Committee of Talavera de la Reina Hospital (Toledo). It is proposed to perform the study between May 2021 to May 2022.
The secondary objectives are:
- To investigate the effect of intervention with MT and MW plus exercise on quality of life and psychosocial factors of pain in people with osteoarthritis of the knee.
- To evaluate the effect of both interventions on knee joint kinematics and range of motion and lower limb strength.
- To evaluate the success of the blinding method of participants and professionals.
- To measure the possible adverse effects of the application of MT and MW in patients with moderate osteoarthritis of the knee.
The participants will be randomly assigned in three groups:
- Group A: Magnetotherapy combined plus exercise program.
- Group B: Sham magnetotherapy plus exercise program.
- Group C: Microwaves combined plus exercise program.
A minimum of 60 adults, older than 45 years old, diagnosed with osteoarthritis of the knee who meet the inclusion criteria will be recruited by voluntary admission.
- Conditions
- Knee Osteoarthritis, Pain
- Being tested
- Magnetotherapy plus exercise, Microwave plus exercise, Sham Magnetotherapy plus exercise
- Keywords
- Knee osteoarthritis, Pain, Function, Phychosocial
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetotherapy plus exerciseDevice
Also called Magnetotherapy, VARIMAG-4E.
The VARIMAG-4E magnetotherapy device will be used. It is a pulsed radiofrequency energy device. The device has a voltage of 220V, 4 amps of intensity, 50 Hz of frequency and a maximum power of 100 Gauss. For the active treatment application, the patient will be in supine position and will introduce both knees in the 50 cm coil in case of bilateral knee osteoarthritis. In the case of unilateral knee osteoarthritis, the affected knee will be introduced in the 30cm coil. The duration of the treatment will be 20 minutes, the frequency administered will be 50 Hz and a power of 100 Gauss.
Microwave plus exerciseDevice
Also called Deep heating therapy, VARITRON 250-EP.
The application of deep heating therapy will be with the patient in a sitting position. The VARITRON 250-EP microwave device will be used with a frequency of 2450 MHz and a maximum output power of 250W. In the case of unilateral knee osteoarthritis, the circular applicator with a diameter of 170mm will be placed approximately 15 cm from the knee. The duration of the session will be 20 minutes, 10 minutes over the internal face and 10 minutes over the external face of the knee. In the case of bilateral knee osteoarthritis, the large lumbar applicator will be placed approximately 15 cm from the anterosuperior face of both knees for 20 minutes. The patient will have to perceive a moderate heat sensation.
Sham Magnetotherapy plus exerciseDevice
Also called Sham Magnetotherapy, VARIMAG-4E.
The protocol and device will be the same in the active/placebo treatment. The sham device does not emit an electromagnetic field. The energy from the active device is not felt by the user, and the active device cannot be distinguished in any way from the placebo device.
| Study group | Role | What they receive |
|---|---|---|
| Magnetotherapy plus exercise | Experimental | The patients will receive a total of 12 sessions, 3 sessions per week of magnetotherapy. The duration of treatment will be 20 minutes with a magnetic field frequency of 50Hz and a power of 100 Gauss.
After the magnetotherapy treatment, the patient will have to perform 12 sessions, 3 sessions per week of a program of therapeutic exercise with a duration of 25 minutes. This exercise program will be the same in the microwave and sham groups. Receives: Device: Magnetotherapy plus exercise |
| Sham Magnetotherapy plus exercise | Placebo comparator | The patients will receive a total of 12 sessions, 3 sessions per week of sham magnetotherapy. For the simulated/sham magnetotherapy group, it will be applied in the same way as the real MT group, but the equipment will be programmed to apply 0 Gauss. The physiotherapist performing the application will not have access to the magnetotherapy parameters on the display of the device, but will only have to enter the code. After the application of sham magnetotherapy, the patient will have to perform a program of therapeutic exercise. Receives: Device: Sham Magnetotherapy plus exercise |
| Microwave plus exercise | Active comparator | The patients will receive a total of 12 sessions, 3 sessions per week of microwave therapy. The duration of the session will be 20 minutes, 10 minutes on the anterior side and 10 minutes on the posterior side of the joint in case of unilateral knee osteoarthritis. In the case of bilateral knee osteoarthritis, the MW will be applied 20 minutes over the anterosuperior side of both knees. After the microwave session, the patient will have to perform a program of therapeutic exercise. Receives: Device: Microwave plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain
The knee pain perceived in motion and at rest will be measured with the standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. Being the value 0 "no pain" and the value 10 "worst pain".
Measured: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in function
Physical function, pain, and stiffness will be measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC-24). It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
Daily knee pain
The daily level of knee pain will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst functionality.
Measured: Before each treatment session. 3 sessions per week (total 4 weeks)
Daily level of functionality
The level of functionality will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst functionality.
Measured: Before each treatment session (during 4 weeks)
Daily quality of sleep
The quality of sleep will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst.
Measured: Before each treatment session (during 4 weeks)
Daily intake of oral non-opioid analgesic medication
Daily intake of oral non-opioid analgesic medication (number of pills per day) during the 24 hours interval before each treatment session being the value 0 the best and 10 the worst.
Measured: Before each treatment session (during 4 weeks)
Change in balance and fall risk
Test timed up and go (TUG) will be expressed in seconds. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down. The test will be performed 3 times. The mean of the three tests will be used. Less time performing this test indicates better mobility.
Measured: Mean differences from baseline at 4 weeks, 1 month and 4 months after intervention.
Secondary outcomes (7)
Change in patient quality of life
The European Quality of life 5 Dimensions (EuroQoL 5D-5L) is a questionnaire that evaluates the generic quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each health state is usually represented using a 5-digit number (profile) where 11111 indicates perfect health and 55555 the worst health state.
Measured: Index change from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in lower limb strength
Maximal isometrical knee extension and flexion strength will be measure with a hand dynamometer and will be expressed in Kgs. The researcher will perform three measurements and the final result will be the average of the three.
Measured: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
Blinding assesment
The success of participant and assessor blinding will be evaluated through a questionnaire after each intervention with five questions: (1) "Strongly believe the applied intervention is new treatment"; (2) "Somewhat believe the applied intervention is new treatment"; (3) "Somewhat believe the applied intervention is a placebo", (4) "Strongly believe the applied intervention is a placebo", or (5) "Do not know".
Measured: Post treatment at 4 weeks
Number of participants with adverse effects
The number of participants who suffered adverse effects will be reported by the researcher (for example skin erythema, rush, or itching...).
Measured: Post each treatment session (during 4 weeks)
Change in knee range of motion
Knee active and passive range of motion will be measure with the WERIUM sensors. It will be expressed in degrees. The mean of 3 movements of flexion and extension will be calculated.
Measured: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in perceived generic health status
The European Quality of life 5 Dimensions (EuroQoL 5D-5L) questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
Doses of analgesic and antidepressant medication
The doses of analgesic and antidepressant medication will be recorded at baseline.
Taking into account the therapeutic steps of the World Health Organization and the dosage, 4 values will be established concerning the basal state: "increases, decreases, it is eliminated or it is maintained".
Measured: Change from baseline at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start10 Jun 2021
- Primary completion26 Jan 2023
- Study completion25 Jul 2023
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
- Model description
- Double-blinded, sham-controlled, randomized clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Salud Talavera Centro y Centro de Salud La Algodonera., Clínica Radiodiagnóstico Marazuela, Empresa Helios Electromedicina S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866745
- Sponsor's protocol ID
- magneto-gifto
- Acronym
- MT-MW-EX
- Status last verified
- May 2021
- First submitted
- 25 Mar 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Congress presentation in a poster format Publication in a scientific journal Social media
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Magnetotherapy and Microwaves Combined With Therapeutic Exercise in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT04866745
- Acronym / sponsor ID
- MT-MW-EX / magneto-gifto
- Conditions
- Knee Osteoarthritis, Pain
- Keywords
- Knee osteoarthritis, Pain, Function, Phychosocial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Centro de Salud Talavera Centro y Centro de Salud La Algodonera., Clínica Radiodiagnóstico Marazuela, Empresa Helios Electromedicina S.L.
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 30 Apr 2021 (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 high prevalence of knee osteoarthritis and the absence of well-defined protocols for the application of Magnetotherapy (MT), makes it necessary to investigate the effect of this therapy on patients with knee osteoarthritis. Furthermore, no studies are comparing the effectiveness of the two interventions proposed in this project (MT) and microwaves (MW), which are routinely applied in clinical practice, without solid scientific evidence to justify their use.
The purpose of the present clinical trial is to compare MT with MW both combined with a therapeutic exercise program in patients with painful knee osteoarthritis and its influence on pain and function.
Detailed description
This study is a double-blinded, sham-controlled, randomized clinical trial whose main objective is to investigate the effect on pain and function in people with moderate knee osteoarthritis of the intervention with Magnetotherapy (MT) combined with an exercise program compared to microwave (MW) application combined with an exercise program and to MT placebo combined with an exercise program. The study will take place at several centers of primary healthcare centers in Spain. After receiving the approval of the Ethics and Clinical Research Committee of Talavera de la Reina Hospital (Toledo). It is proposed to perform the study between May 2021 to May 2022.
The secondary objectives are:
- To investigate the effect of intervention with MT and MW plus exercise on quality of life and psychosocial factors of pain in people with osteoarthritis of the knee.
- To evaluate the effect of both interventions on knee joint kinematics and range of motion and lower limb strength.
- To evaluate the success of the blinding method of participants and professionals.
- To measure the possible adverse effects of the application of MT and MW in patients with moderate osteoarthritis of the knee.
The participants will be randomly assigned in three groups:
- Group A: Magnetotherapy combined plus exercise program.
- Group B: Sham magnetotherapy plus exercise program.
- Group C: Microwaves combined plus exercise program.
A minimum of 60 adults, older than 45 years old, diagnosed with osteoarthritis of the knee who meet the inclusion criteria will be recruited by voluntary admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blinded, sham-controlled, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Magnetotherapy plus exercise | Experimental | Device: Magnetotherapy plus exerciseThe patients will receive a total of 12 sessions, 3 sessions per week of magnetotherapy. The duration of treatment will be 20 minutes with a magnetic field frequency of 50Hz and a power of 100 Gauss. After the magnetotherapy treatment, the patient will have to perform 12 sessions, 3 sessions per week of a program of therapeutic exercise with a duration of 25 minutes. This exercise program will be the same in the microwave and sham groups. |
| Sham Magnetotherapy plus exercise | Placebo comparator | Device: Sham Magnetotherapy plus exerciseThe patients will receive a total of 12 sessions, 3 sessions per week of sham magnetotherapy. For the simulated/sham magnetotherapy group, it will be applied in the same way as the real MT group, but the equipment will be programmed to apply 0 Gauss. The physiotherapist performing the application will not have access to the magnetotherapy parameters on the display of the device, but will only have to enter the code. After the application of sham magnetotherapy, the patient will have to perform a program of therapeutic exercise. |
| Microwave plus exercise | Active comparator | Device: Microwave plus exerciseThe patients will receive a total of 12 sessions, 3 sessions per week of microwave therapy. The duration of the session will be 20 minutes, 10 minutes on the anterior side and 10 minutes on the posterior side of the joint in case of unilateral knee osteoarthritis. In the case of bilateral knee osteoarthritis, the MW will be applied 20 minutes over the anterosuperior side of both knees. After the microwave session, the patient will have to perform a program of therapeutic exercise. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients older than 45 years old
- Unilateral or bilateral knee osteoarthritis.
- Kellgren and Lawrence (K-L) grade II or III.
- Visual analog scale (VAS) greater than 40mm.
- Affectation of more than one year of evolution.
Key exclusion criteria (12 listed)
- Secondary cause osteoarthritis
- History of uncontrolled metabolic diseases.
- Decompensated or uncontrolled pathologies
- Tumor processes.
- Collagenopathies and neurological diseases.
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 |
|---|---|---|
| Magnetotherapy plus exerciseAlso: Magnetotherapy, VARIMAG-4E.The VARIMAG-4E magnetotherapy device will be used. It is a pulsed radiofrequency energy device. The device has a voltage of 220V, 4 amps of intensity, 50 Hz of frequency and a maximum power of 100 Gauss. For the active treatment application, the patient will be in supine position and will introduce both knees in the 50 cm coil in case of bilateral knee osteoarthritis. In the case of unilateral knee osteoarthritis, the affected knee will be introduced in the 30cm coil. The duration of the treatment will be 20 minutes, the frequency administered will be 50 Hz and a power of 100 Gauss. | Device | Magnetotherapy plus exercise |
| Microwave plus exerciseAlso: Deep heating therapy, VARITRON 250-EP.The application of deep heating therapy will be with the patient in a sitting position. The VARITRON 250-EP microwave device will be used with a frequency of 2450 MHz and a maximum output power of 250W. In the case of unilateral knee osteoarthritis, the circular applicator with a diameter of 170mm will be placed approximately 15 cm from the knee. The duration of the session will be 20 minutes, 10 minutes over the internal face and 10 minutes over the external face of the knee. In the case of bilateral knee osteoarthritis, the large lumbar applicator will be placed approximately 15 cm from the anterosuperior face of both knees for 20 minutes. The patient will have to perceive a moderate heat sensation. | Device | Microwave plus exercise |
| Sham Magnetotherapy plus exerciseAlso: Sham Magnetotherapy, VARIMAG-4E.The protocol and device will be the same in the active/placebo treatment. The sham device does not emit an electromagnetic field. The energy from the active device is not felt by the user, and the active device cannot be distinguished in any way from the placebo device. | Device | Sham Magnetotherapy plus exercise |
Primary outcome
Change in knee pain
Time frame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
The knee pain perceived in motion and at rest will be measured with the standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. Being the value 0 "no pain" and the value 10 "worst pain".
Change in function
Time frame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
Physical function, pain, and stiffness will be measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC-24). It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Daily knee pain
Time frame: Before each treatment session. 3 sessions per week (total 4 weeks)
The daily level of knee pain will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst functionality.
Daily level of functionality
Time frame: Before each treatment session (during 4 weeks)
The level of functionality will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst functionality.
Daily quality of sleep
Time frame: Before each treatment session (during 4 weeks)
The quality of sleep will be measured before every session of treatment using a standard 10 cm Visual Analog Scale (VAS). It will be expressed in mm. The value 0 will be the best and 10 the worst.
Daily intake of oral non-opioid analgesic medication
Time frame: Before each treatment session (during 4 weeks)
Daily intake of oral non-opioid analgesic medication (number of pills per day) during the 24 hours interval before each treatment session being the value 0 the best and 10 the worst.
Change in balance and fall risk
Time frame: Mean differences from baseline at 4 weeks, 1 month and 4 months after intervention.
Test timed up and go (TUG) will be expressed in seconds. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down. The test will be performed 3 times. The mean of the three tests will be used. Less time performing this test indicates better mobility.
7 secondary outcomes
Change in patient quality of life
Time frame: Index change from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in lower limb strength
Time frame: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
Blinding assesment
Time frame: Post treatment at 4 weeks
Number of participants with adverse effects
Time frame: Post each treatment session (during 4 weeks)
Change in knee range of motion
Time frame: Mean difference from baseline at 4 weeks, 1 month and 4 months after intervention.
Change in perceived generic health status
Time frame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.
Doses of analgesic and antidepressant medication
Time frame: Change from baseline at 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: Yes. Congress presentation in a poster format Publication in a scientific journal Social media
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetotherapy plus exercise and Microwave plus exercise in people with Knee Osteoarthritis and Pain, run by University of Castilla-La Mancha at 1 site in Spain.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 4 Apr 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain (time frame: Change from baseline at 4 weeks, 1 month and 4 months after intervention.). The study lists 7 primary outcomes in all. 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 4 Apr 2024.