Patellofemoral Pain SyndromeNCT04462718
Efficacy Analysis in Long Term of Radiofrecuency Combined vs. T.E. in the Treatment of Patellofemoral Pain Syndrome.
A study testing Radiofrecuency and Therapeutic Exercise in people with Patellofemoral Pain Syndrome, run by University of Seville at 1 site in Spain.
Trial summary
The present study aims to promote research in the field of Physiotherapy, focusing on a health problem of maximum relevance, such as patellofemoral pain syndrome. Although these treatments seem to be based on theoretical reasoning, the evidence for the efficacy of these interventions is not well established. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patellofemoral Pain Syndrome
- What is being tested?
- Radiofrecuency and Therapeutic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 30 Mar 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 55
- . 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) 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.
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.
About this study
Official title: Analysis of the Efficacy in the Lomg Term (Six Months Follow up) of the Combination of Radiofrecuency and Therapeutic Exercise Versus Therapeutic Exercise Alone in the Treatment of Patellofemoral Pain Syndrome.
The present study aims to promote research in the field of Physiotherapy, focusing on a health problem of maximum relevance, such as patellofemoral pain syndrome.
Although these treatments seem to be based on theoretical reasoning, the evidence for the efficacy of these interventions is not well established. Therefore, we select from among all the therapeutic tools available in physiotherapy, a procedure of therapeutic physical exercise.
Read more
Main objectives:
To know the efficacy of a therapeutic physical exercise protocol in the reduction of pain and the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS).
Secondary objectives:
- Quantify the reduction of pain in the anterior aspect of the knee in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
- To evaluate the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
Study hypothesis:
The treatment of patellofemoral pain syndrome (PFPS) with a therapeutic physical exercise protocol produces statistically significant changes in the reduction of pain and functional disability and the normalization of the anthropometric values of the joint balance of the knee
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 EPIDAR 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: You will be provided exclusively therapeutic exercises protocol to develop supervised by Physical Therapist that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate.
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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist.
The treatment is administered with a Diathermy equipment and inductive electrodes of 100 W peak power, with a frequency of application of twice daily with a dose submitis (grade I), for 10 min, with a frequency of repetition of the impulses of 46 Hz and a pulse duration of 0.2 ms
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.Those measurements will be evaluated at the end of that three weeks period and six moths later in order to have at least three timepoints to evaluate.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- Radiofrecuency, Therapeutic Exercise
- Keywords
- Musculoskeletal, Physical Medicine / Rehabilitation, Physiotherapy, Knee Pain
- 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.
RadiofrecuencyOther
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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist.
Therapeutic ExerciseOther
CONTROL GROUP: will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate.
| Study group | Role | What they receive |
|---|---|---|
| CONTROL GROUP: | Active comparator | You will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks. Receives: Other: Therapeutic Exercise |
| EXPERIMENTAL GROUP | Experimental | 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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist.
The treatment is administered with a pulsatile short-wave equipment and inductive electrodes of 100 W peak power, with a frequency of application of twice daily with a dose submitis (grade I), for 10 min, with a frequency of repetition of the impulses of 46 Hz and a pulse duration of 0.2 ms. Receives: Other: Radiofrecuency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The perception of pain through the Visual Analogue Scale (EVA).
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: Time point 1: before the intervention
The perception of pain through the Visual Analogue Scale (EVA).
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: Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)
The perception of pain through the Visual Analogue Scale (EVA).
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: Time point 3: six months later the initial evaluation.
Kujala Score.
The functional disability, quantified by means of the tests: Kujala Score.
Measured: Time point 1: before the intervention
Kujala Score.
The functional disability, quantified by means of the tests: Kujala Score.
Measured: Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)
Kujala Score.
The functional disability, quantified by means of the tests: Kujala Score.
Measured: Time point 3: six months later the initial evaluation.
Secondary outcomes (3)
Active and Pasive Knee's Range of Movement
In addition an anthropometric study of knee joint range of movement will be performed. Evaluating the Active and Pasive Knee's Range of Movement using universal goniometer measurement. we pay special attention to the possible restrictions in the normal range of motion
Measured: Time point 1: before the intervention.
Active and Pasive Knee's Range of Movement
In addition an anthropometric study of knee joint range of movement will be performed. Evaluating the Active and Pasive Knee's Range of Movement using universal goniometer measurement. we pay special attention to the possible restrictions in the normal range of motion
Measured: Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)
Active and Pasive Knee's Range of Movement
In addition an anthropometric study of knee joint range of movement will be performed. Evaluating the Active and Pasive Knee's Range of Movement using universal goniometer measurement. we pay special attention to the possible restrictions in the normal range of motion
Measured: Time point 3: six months later the initial evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Oct 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 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
- Patients diagnosed with unilateral or bilateral PFPS will be divided into two groups, randomly selected (experimental group and control group), of 45 subjects each. Allocation was concealed and it was done by central randomisation by computer (EPIDARcomputer program). The subjects of the experimental group will undergo a program of supervised physical therapeutic exercise. And the subjects of the control group will follow the medical-pharmacological treatment and the ergonomic recommendations according to the established protocol. The target population will be all patients diagnosed with patellofemoral pain syndrome (PFPS) unilaterally or bilaterally, from the health area of La Rinconada while the eligible population will be composed of all those patients residing in or around Seville who can and wish to be part of it. of the study and that they meet the inclusion and exclusion criteria
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Albornoz Cabello, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462718
- Sponsor's protocol ID
- RvsTE6MFU
- Status last verified
- Aug 2020
- First submitted
- 26 Jun 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Efficacy in the Lomg Term (Six Months Follow up) of the Combination of Radiofrecuency and Therapeutic Exercise Versus Therapeutic Exercise Alone in the Treatment of Patellofemoral Pain Syndrome.
- ClinicalTrials.gov ID
- NCT04462718
- Acronym / sponsor ID
- RvsTE6MFU
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- Musculoskeletal, Physical Medicine / Rehabilitation, Physiotherapy, Knee Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 8 Jul 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.
The present study aims to promote research in the field of Physiotherapy, focusing on a health problem of maximum relevance, such as patellofemoral pain syndrome.
Although these treatments seem to be based on theoretical reasoning, the evidence for the efficacy of these interventions is not well established. Therefore, we select from among all the therapeutic tools available in physiotherapy, a procedure of therapeutic physical exercise.
Main objectives:
To know the efficacy of a therapeutic physical exercise protocol in the reduction of pain and the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS).
Secondary objectives:
- Quantify the reduction of pain in the anterior aspect of the knee in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
- To evaluate the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
Study hypothesis:
The treatment of patellofemoral pain syndrome (PFPS) with a therapeutic physical exercise protocol produces statistically significant changes in the reduction of pain and functional disability and the normalization of the anthropometric values of the joint balance of the knee
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 EPIDAR 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: You will be provided exclusively therapeutic exercises protocol to develop supervised by Physical Therapist that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate.
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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist.
The treatment is administered with a Diathermy equipment and inductive electrodes of 100 W peak power, with a frequency of application of twice daily with a dose submitis (grade I), for 10 min, with a frequency of repetition of the impulses of 46 Hz and a pulse duration of 0.2 ms
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.Those measurements will be evaluated at the end of that three weeks period and six moths later in order to have at least three timepoints to evaluate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients diagnosed with unilateral or bilateral PFPS will be divided into two groups, randomly selected (experimental group and control group), of 45 subjects each. Allocation was concealed and it was done by central randomisation by computer (EPIDARcomputer program). The subjects of the experimental group will undergo a program of supervised physical therapeutic exercise. And the subjects of the control group will follow the medical-pharmacological treatment and the ergonomic recommendations according to the established protocol. The target population will be all patients diagnosed with patellofemoral pain syndrome (PFPS) unilaterally or bilaterally, from the health area of La Rinconada while the eligible population will be composed of all those patients residing in or around Seville who can and wish to be part of it. of the study and that they meet the inclusion and exclusion criteria
| Arm | Type | Receives |
|---|---|---|
| CONTROL GROUP: | Active comparator | Other: Therapeutic ExerciseYou will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks. |
| EXPERIMENTAL GROUP | Experimental | Other: RadiofrecuencyAfter 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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist. The treatment is administered with a pulsatile short-wave equipment and inductive electrodes of 100 W peak power, with a frequency of application of twice daily with a dose submitis (grade I), for 10 min, with a frequency of repetition of the impulses of 46 Hz and a pulse duration of 0.2 ms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age from 18 to 55
- . 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) 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.
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 |
|---|---|---|
| RadiofrecuencyEXPERIMENTAL 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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist. | Other | EXPERIMENTAL GROUP |
| Therapeutic ExerciseCONTROL GROUP: will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate. | Other | CONTROL GROUP: |
Primary outcome
The perception of pain through the Visual Analogue Scale (EVA).
Time frame: Time point 1: before the intervention
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.
The perception of pain through the Visual Analogue Scale (EVA).
Time frame: Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)
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.
The perception of pain through the Visual Analogue Scale (EVA).
Time frame: Time point 3: six months later the initial evaluation.
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.
Kujala Score.
Time frame: Time point 1: before the intervention
The functional disability, quantified by means of the tests: Kujala Score.
Kujala Score.
Time frame: Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)
The functional disability, quantified by means of the tests: Kujala Score.
Kujala Score.
Time frame: Time point 3: six months later the initial evaluation.
The functional disability, quantified by means of the tests: Kujala Score.
3 secondary outcomes
Active and Pasive Knee's Range of Movement
Time frame: Time point 1: before the intervention.
Active and Pasive Knee's Range of Movement
Time frame: Time point 2: when the intervention was finished (after 10 sesions : 2 weeks)
Active and Pasive Knee's Range of Movement
Time frame: Time point 3: six months later the initial evaluation.
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 17 Aug 2020.
- 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.
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 Radiofrecuency and Therapeutic Exercise in people with Patellofemoral Pain Syndrome, run by University of Seville 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 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 17 Aug 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?
The perception of pain through the Visual Analogue Scale (EVA). (time frame: Time point 1: before the intervention). The study lists 6 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 17 Aug 2020.