Patellofemoral PainNCT05497661
Ultrasound Patellar Tendon Assessment
A study testing 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population. in people with Patellofemoral Pain and Ultrasonography, run by Universidad de Granada at 1 site in Spain.
Trial summary
448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain, Ultrasonography
- What is being tested?
- 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 14 Oct 2022to 12 Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18-65 years.
- Sporty people with at least 3 days of training per week
Who cannot join
- Suffer from knee pain.
- Sedentary people
Trial locations and contacts
1 site in 1 country.
Maria Aguilar Garcia contact
Spain1 site
Clínica Ana González
Málaga
Ana González Muñoz, 0034665116747, maguilar.fisioterapia@gmail.com
Santiago Navarro Ledesma, Phd
About this study
Official title: Ultrasound Patellar Tendon Assessment and Thermography After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population
448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.
Read the detailed description
Patellar tendon injuries is is one of the most common musculoskeletal disorders, presenting a high prevalence in sport populations. Many factors have been proposed as the cause of pain and dysfunction, however there are no studies analysing possibilities of preventing patellar tendon injuries by using a radiofrequency stimulus.
The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.
The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the patellar tendon will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.
The stimulus will be carried out on the patellar tendon region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.
- Conditions
- Patellofemoral Pain, Ultrasonography
- Being tested
- 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population., Placebo comparator
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.Other
448kilohertz Capacitive Resistive Radiofrequency Stimulation on Patellar tendon in a Sporty Population.
Placebo comparatorOther
To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the non dominant patellar tendon
| Study group | Role | What they receive |
|---|---|---|
| Effects of Capacitive Resistive Monopolar Radiofrequency in patellar tendon | Experimental | 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant patellar tendon. Receives: Other: 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.; Other: Placebo comparator |
| Placebo Comparator: Placebo Monopolar Radiofrequency stimulus | Placebo comparator | To simulate the application of Monopolar Radiofrequency stimulus on the dominant patellar tendon Receives: Other: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in patellar tendon measured by quantified elastography imaging at 3 months [ Time Frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)] ]
The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity
Measured: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start14 Oct 2022 (estimated)
- Primary completion14 Jun 2023 (estimated)
- Study completion12 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral PainStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Aguilar García, Universidad de Granada
- Investigators
- Santiago Navarro Ledesma, Principal investigator, University of MalagaAna González Muñoz, Study chair, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497661
- Sponsor's protocol ID
- UGranadaPatellarTendon
- Status last verified
- Aug 2022
- First submitted
- 10 Jul 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Patellar Tendon Assessment and Thermography After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population
- ClinicalTrials.gov ID
- NCT05497661
- Acronym / sponsor ID
- UGranadaPatellarTendon
- Conditions
- Patellofemoral Pain, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 14 Oct 2022 (estimated)
- Primary completion
- 14 Jun 2023 (estimated)
- Study completion
- 12 Jun 2024 (estimated)
- First posted
- 11 Aug 2022 (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.
448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.
Detailed description
Patellar tendon injuries is is one of the most common musculoskeletal disorders, presenting a high prevalence in sport populations. Many factors have been proposed as the cause of pain and dysfunction, however there are no studies analysing possibilities of preventing patellar tendon injuries by using a radiofrequency stimulus.
The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.
The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the patellar tendon will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.
The stimulus will be carried out on the patellar tendon region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of Capacitive Resistive Monopolar Radiofrequency in patellar tendon | Experimental | Other: 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population., Other: Placebo comparator448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant patellar tendon. |
| Placebo Comparator: Placebo Monopolar Radiofrequency stimulus | Placebo comparator | Other: Placebo comparatorTo simulate the application of Monopolar Radiofrequency stimulus on the dominant patellar tendon |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18-65 years.
- Sporty people with at least 3 days of training per week
Key exclusion criteria (2 listed)
- Suffer from knee pain.
- Sedentary people
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 |
|---|---|---|
| 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.448kilohertz Capacitive Resistive Radiofrequency Stimulation on Patellar tendon in a Sporty Population. | Other | Effects of Capacitive Resistive Monopolar Radiofrequency in patellar tendon |
| Placebo comparatorTo simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the non dominant patellar tendon | Other | Effects of Capacitive Resistive Monopolar Radiofrequency in patellar tendon, Placebo Comparator: Placebo Monopolar Radiofrequency stimulus |
Primary outcome
Change from Baseline in patellar tendon measured by quantified elastography imaging at 3 months [ Time Frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)] ]
Time frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Maria Aguilar Garcia contact
Santiago Navarro Ledesma principal investigator
University of Malaga
Ana González Muñoz study chair
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population. in people with Patellofemoral Pain and Ultrasonography, run by Universidad de Granada 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 2 inclusion and 2 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 11 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Aguilar Garcia (0034665116747, maguilar.fisioterapia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in patellar tendon measured by quantified elastography imaging at 3 months [ Time Frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)] ] (time frame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)). 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 11 Aug 2022.