Patellofemoral Pain SyndromeNCT04538508
Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome.
A study testing Diathermy and Supervised knee exercises in people with Patellofemoral Pain Syndrome, run by University of Jaén at 1 site in Spain.
Trial summary
This study will analyze the effects of a non-invasive radiofrequency diathermy device added to knee exercises on the symptoms of patellofemoral pain syndrome. For this aim, a randomized clinical trial will be carried out with a control group that will perform supervised exercises and an experimental group that will… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Diathermy and Supervised knee exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 7 Sep 2020to 2 Oct 2020
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with patellofemoral pain syndrome more than 6 months old.
- Have an age between 18 years and 50 years.
- Adult patients with anterior knee pain were referred by a primary care physician at a public health center in southern Spain. Those participants with a self-reported pain intensity = 30 mm on the Visual Analog Scale (VAS) and a score <45 points in personal psychology The Apprehension Scale (PPAS) [bathrobe 2017], were invited to participate. The PPAS is a valid, reliable and easy-to-use tool for assessing the apprehension of subjects to receive electrical stimulation therapy [bathrobe 2005].
Who cannot join
- Any contraindication for the use of MDR
- Present cognitive alterations.
- Have undergone conservative or surgical treatment of the knee in less than 6 months.
- Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Centro de Salud San José de la Rinconada
San José de la Rinconada, Seville, 41300
About this study
Official title: Short Term Efficacy of the Combination of Radiofrecuency Diathermy and Supervised Exercise Versus Supervised Exercise Alone in the Treatment of Patellofemoral Pain Syndrome.
This study will analyze the effects of a non-invasive radiofrequency diathermy device added to knee exercises on the symptoms of patellofemoral pain syndrome. For this aim, a randomized clinical trial will be carried out with a control group that will perform supervised exercises and an experimental group that will add radiofrequency diathermy to supervised exercises. Diathermy treatment will be performed along three weeks, ten treatment sessions in total, while supervised exercises will be performed daily.
Outcomes to measure will include pain, knee function and quality of life
Read the detailed description
At first, a meeting will be held with the patients under study where they will be informed and any doubts that may arise in relation to the investigation will be resolved. In addition, the correct adaptation of these to the inclusion and exclusion criteria of our study will be verified. Subsequently, they will be given individually the informed consent prepared expressly for the present study, the doubts arising with respect to this one will be resolved and their signature will proceed. At this time, and individually again, we will proceed to the development of the Clinical History of Physiotherapy where only the information necessary for our study will be collected. To emphasize in this point that the participants will grant their consent for the treatment of the data obtained for scientific purposes, according to the legal norms.
Next, the patients will be randomly assigned to two groups: control group and experimental group. The randomization of the sample was done through the EPIDAT software in version 3.1 between the Experimental Group and the Control Group. Subsequently, the evaluations and measurements of the study variables will be carried out by the research team.
CONTROL GROUP: them will be provided exclusively therapeutic exercises protocol that you must be performed supervised by a physiotherapist following a daily activity for three weeks.
EXPERIMENTAL GROUP: After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar dielectric diathermy by radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with the same supervised therapeutic exercise program of the control group.
The treatment is administered with a pulsed non-invasive radiofrequency device with 30V peak power along 12 minutes, with a dose submitis (grade I) for three weeks. The first week, daily treatment will be perform from Monday to Friday, second week on Monday, Wednesday and Friday and the third week on Monday and Thursday.
After the tenth treatment session, all the measurements will be repeated following the same environmental conditions as at the beginning and by the evaluators themselves to the components of both groups.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Diathermy, Supervised knee exercises
- Keywords
- patellofemoral pain syndrome, knee pain, diathermy
- Medical subject headings
- Patellofemoral Pain Syndrome, Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiathermyDevice
10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement
Supervised knee exercisesOther
Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.
| Study group | Role | What they receive |
|---|---|---|
| Diathermy | Experimental | Participants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration Receives: Device: Diathermy; Other: Supervised knee exercises |
| Control | Active comparator | Participants that perform supervised exercises for three weeks Receives: Other: Supervised knee exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
Measured: Baseline
Knee pain
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
Measured: Three weeks after there first session of treatment
Secondary outcomes (8)
Knee functional disability
The functional disability, quantified by means of the tests: Kujala Score. This score goes from 0 (high disability) to 100 (no disability)
Measured: Baseline
Knee functional disability
The functional disability, quantified by means of the tests: Kujala Score. This score goes from 0 (high disability) to 100 (no disability)
Measured: Three weeks after there first session of treatment
Knee function
Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)
Measured: Baseline
Knee function
Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)
Measured: Three weeks after there first session of treatment
Knee flexion range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Measured: Baseline
Knee flexion range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Measured: Three weeks after there first session of treatment
Knee extension range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Measured: Baseline
Knee extension range of movement
Active knee joint range of movement. Knee range of movements goes from -10º to 150º
Measured: Three weeks after there first session of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start7 Sep 2020
- Primary completion2 Oct 2020
- Study completion2 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Collaborators
- University of Seville, Andaluz Health Service, Universidad de Extremadura
- Responsible party
- Principal investigator, Alfonso Javier Ibáñez-Vera, University of Jaén
- Investigators
- Manuel Albornoz-Cabello, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538508
- Sponsor's protocol ID
- PFPS US
- Status last verified
- Oct 2020
- First submitted
- 25 Aug 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants did not allow to share their data
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Efficacy of the Combination of Radiofrecuency Diathermy and Supervised Exercise Versus Supervised Exercise Alone in the Treatment of Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT04538508
- Acronym / sponsor ID
- PFPS US
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain syndrome, knee pain, diathermy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Collaborators
- University of Seville, Andaluz Health Service, Universidad de Extremadura
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 2 Oct 2020 (actual)
- Study completion
- 2 Oct 2020 (actual)
- First posted
- 4 Sep 2020 (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.
This study will analyze the effects of a non-invasive radiofrequency diathermy device added to knee exercises on the symptoms of patellofemoral pain syndrome. For this aim, a randomized clinical trial will be carried out with a control group that will perform supervised exercises and an experimental group that will add radiofrequency diathermy to supervised exercises. Diathermy treatment will be performed along three weeks, ten treatment sessions in total, while supervised exercises will be performed daily.
Outcomes to measure will include pain, knee function and quality of life
Detailed description
At first, a meeting will be held with the patients under study where they will be informed and any doubts that may arise in relation to the investigation will be resolved. In addition, the correct adaptation of these to the inclusion and exclusion criteria of our study will be verified. Subsequently, they will be given individually the informed consent prepared expressly for the present study, the doubts arising with respect to this one will be resolved and their signature will proceed. At this time, and individually again, we will proceed to the development of the Clinical History of Physiotherapy where only the information necessary for our study will be collected. To emphasize in this point that the participants will grant their consent for the treatment of the data obtained for scientific purposes, according to the legal norms.
Next, the patients will be randomly assigned to two groups: control group and experimental group. The randomization of the sample was done through the EPIDAT software in version 3.1 between the Experimental Group and the Control Group. Subsequently, the evaluations and measurements of the study variables will be carried out by the research team.
CONTROL GROUP: them will be provided exclusively therapeutic exercises protocol that you must be performed supervised by a physiotherapist following a daily activity for three weeks.
EXPERIMENTAL GROUP: After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar dielectric diathermy by radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with the same supervised therapeutic exercise program of the control group.
The treatment is administered with a pulsed non-invasive radiofrequency device with 30V peak power along 12 minutes, with a dose submitis (grade I) for three weeks. The first week, daily treatment will be perform from Monday to Friday, second week on Monday, Wednesday and Friday and the third week on Monday and Thursday.
After the tenth treatment session, all the measurements will be repeated following the same environmental conditions as at the beginning and by the evaluators themselves to the components of both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Diathermy | Experimental | Device: Diathermy, Other: Supervised knee exercisesParticipants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration |
| Control | Active comparator | Other: Supervised knee exercisesParticipants that perform supervised exercises for three weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with patellofemoral pain syndrome more than 6 months old.
- Have an age between 18 years and 50 years.
- Adult patients with anterior knee pain were referred by a primary care physician at a public health center in southern Spain. Those participants with a self-reported pain intensity = 30 mm on the Visual Analog Scale (VAS) and a score <45 points in personal psychology The Apprehension Scale (PPAS) [bathrobe 2017], were invited to participate. The PPAS is a valid, reliable and easy-to-use tool for assessing the apprehension of subjects to receive electrical stimulation therapy [bathrobe 2005].
Key exclusion criteria (4 listed)
- Any contraindication for the use of MDR
- Present cognitive alterations.
- Have undergone conservative or surgical treatment of the knee in less than 6 months.
- Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.
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 |
|---|---|---|
| Diathermy10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement | Device | Diathermy |
| Supervised knee exercisesDaily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration. | Other | Control, Diathermy |
Primary outcome
Knee pain
Time frame: Baseline
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
Knee pain
Time frame: Three weeks after there first session of treatment
The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain
8 secondary outcomes
Knee functional disability
Time frame: Baseline
Knee functional disability
Time frame: Three weeks after there first session of treatment
Knee function
Time frame: Baseline
Knee function
Time frame: Three weeks after there first session of treatment
Knee flexion range of movement
Time frame: Baseline
Knee flexion range of movement
Time frame: Three weeks after there first session of treatment
Knee extension range of movement
Time frame: Baseline
Knee extension range of movement
Time frame: Three weeks after there first session of treatment
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 6 Oct 2020.
- Individual participant dataSharing planned: No. Participants did not allow to share their data
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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.
Manuel Albornoz-Cabello, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diathermy and Supervised knee exercises in people with Patellofemoral Pain Syndrome, run by University of Jaén 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 3 inclusion and 4 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 6 Oct 2020. 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. 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?
Knee pain (time frame: Baseline). The study lists 2 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 6 Oct 2020.