Patellofemoral Pain SyndromeNCT05471089
Long-term Effects of the Addition of Diathermy by Emission of Radiofrequency to Therapeutic Exercise in Patellofemoral Pain Syndrome Patients
A study testing Diathermy by emission of Radiofrequency and Therapeutic exercise in people with Patellofemoral Pain Syndrome and Patellofemoral Pain, run by University of Jaén at 1 site in Spain.
Trial summary
Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise (TE) to improve muscle strength and motor control. Recent studies suggest that the addition of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE alone. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Patellofemoral Pain Syndrome, Patellofemoral Pain, Patello Femoral Syndrome
- What is being tested?
- Diathermy by emission of Radiofrequency and Therapeutic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- 26 Jul 2022to 10 Feb 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects between 30 and 50 years old without radiological findings of osteoarthritis.
- Subjects referring during the last month almost three points of pain in the anterior surface of knee measured with Visual Analogue Scale.
Who cannot join
- Subjects with contraindications for the treatment with radiofrequency diathermy (tumors, use of pacemakers or any other implanted electronic device, thrombophlebitis or deep venous thrombosis, pregnancy, fever, active tuberculosis, infections and rheumatoid arthritis).
- Subjects who have received corticoid or hyaluronic acid or platelet-rich plasma injections treatment in the knee.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Radiofrequency Diathermy and Supervised Therapeutic Exercise in Patellofemoral Pain Syndrome. A Single Blind Randomized Controlled Trial With a Six-month Follow-up
Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise (TE) to improve muscle strength and motor control. Recent studies suggest that the addition of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE alone. As there is no follow up data, the aim of this research is to assess the long-term effects of adding RFD to TE on pain, function and quality of life on PFP patients.
Methods: a single-blind randomized controlled trial will be conducted. Participants diagnosed of PFP will be allocated in either a TE group or a RFD+TE one. Sociodemographic data, knee pain, and lower limb function will be collected. Each group will performed 20 min of daily knee and hip supervised TE along three weeks with the addition of ten sessions of RFD for the RFD+TE group.
- Being tested
- Diathermy by emission of Radiofrequency, Therapeutic exercise
- Keywords
- knee pain, electrophysical agents
- 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.
Diathermy by emission of RadiofrequencyDevice
Applied only to experimental group
Therapeutic exerciseOther
Applied to both arms/groups
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Application of radiofrequency diathermy in addition to the exercises protocol same Exercise protocol than control group. Ten sessions of treatment were applied: daily the first week (Monday to Friday), three the second week (Monday, Wednesday, Friday) and two the last week (Monday and Thursday) Receives: Device: Diathermy by emission of Radiofrequency; Other: Therapeutic exercise |
| Control | Active comparator | Exercise protocol consisting of: eccentric and concentric strengthening of quadriceps (three squat series of 20 repetitions), hamstrings (three series of 20 seconds performing the bridge exercise), gluteus medius (three series of 20 seconds performing the clam exercise), gastrocnemius and soleus (three series of stretching exercises for 1 minute each). These exercises will be performed along 20 minutes approximately with a minute of rest between each exercise series, never exceeding 3mm in VAS. Participants have to assist to a local facility center to be supervised at doing the exercises daily (from Monday two Friday) along three weeks. Receives: Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain
Pain measured with Visual Analogue Scale
Measured: Baseline
Knee pain
Pain measured with Visual Analogue Scale
Measured: At three weeks
Knee pain
Pain measured with Visual Analogue Scale
Measured: Through study completion, an average of 6 months
Knee function
Knee function measured with "Lower Extremity Functional Scale"
Measured: Baseline
Knee function
Knee function measured with "Lower Extremity Functional Scale"
Measured: At three weeks
Knee function
Knee function measured with "Lower Extremity Functional Scale"
Measured: Through study completion, an average of 6 months
Knee function
Knee function measured with "Kujala score"
Measured: Baseline
Knee function
Knee function measured with "Kujala score"
Measured: At three weeks
Knee function
Knee function measured with "Kujala score"
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start26 Jul 2022
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
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
- Double-blind Randomized Controlled Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Javier Ibáñez-Vera, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471089
- Sponsor's protocol ID
- PFPS 3
- Status last verified
- Feb 2023
- First submitted
- 11 Jul 2022
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Radiofrequency Diathermy and Supervised Therapeutic Exercise in Patellofemoral Pain Syndrome. A Single Blind Randomized Controlled Trial With a Six-month Follow-up
- ClinicalTrials.gov ID
- NCT05471089
- Acronym / sponsor ID
- PFPS 3
- Keywords
- knee pain, electrophysical agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 22 Jul 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.
Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise (TE) to improve muscle strength and motor control. Recent studies suggest that the addition of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE alone. As there is no follow up data, the aim of this research is to assess the long-term effects of adding RFD to TE on pain, function and quality of life on PFP patients.
Methods: a single-blind randomized controlled trial will be conducted. Participants diagnosed of PFP will be allocated in either a TE group or a RFD+TE one. Sociodemographic data, knee pain, and lower limb function will be collected. Each group will performed 20 min of daily knee and hip supervised TE along three weeks with the addition of ten sessions of RFD for the RFD+TE group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Diathermy by emission of Radiofrequency, Other: Therapeutic exerciseApplication of radiofrequency diathermy in addition to the exercises protocol same Exercise protocol than control group. Ten sessions of treatment were applied: daily the first week (Monday to Friday), three the second week (Monday, Wednesday, Friday) and two the last week (Monday and Thursday) |
| Control | Active comparator | Other: Therapeutic exerciseExercise protocol consisting of: eccentric and concentric strengthening of quadriceps (three squat series of 20 repetitions), hamstrings (three series of 20 seconds performing the bridge exercise), gluteus medius (three series of 20 seconds performing the clam exercise), gastrocnemius and soleus (three series of stretching exercises for 1 minute each). These exercises will be performed along 20 minutes approximately with a minute of rest between each exercise series, never exceeding 3mm in VAS. Participants have to assist to a local facility center to be supervised at doing the exercises daily (from Monday two Friday) along three weeks. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects between 30 and 50 years old without radiological findings of osteoarthritis.
- Subjects referring during the last month almost three points of pain in the anterior surface of knee measured with Visual Analogue Scale.
Key exclusion criteria (2 listed)
- Subjects with contraindications for the treatment with radiofrequency diathermy (tumors, use of pacemakers or any other implanted electronic device, thrombophlebitis or deep venous thrombosis, pregnancy, fever, active tuberculosis, infections and rheumatoid arthritis).
- Subjects who have received corticoid or hyaluronic acid or platelet-rich plasma injections treatment in the knee.
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 |
|---|---|---|
| Diathermy by emission of RadiofrequencyApplied only to experimental group | Device | Experimental |
| Therapeutic exerciseApplied to both arms/groups | Other | Control, Experimental |
Primary outcome
Knee pain
Time frame: Baseline
Pain measured with Visual Analogue Scale
Knee pain
Time frame: At three weeks
Pain measured with Visual Analogue Scale
Knee pain
Time frame: Through study completion, an average of 6 months
Pain measured with Visual Analogue Scale
Knee function
Time frame: Baseline
Knee function measured with "Lower Extremity Functional Scale"
Knee function
Time frame: At three weeks
Knee function measured with "Lower Extremity Functional Scale"
Knee function
Time frame: Through study completion, an average of 6 months
Knee function measured with "Lower Extremity Functional Scale"
Knee function
Time frame: Baseline
Knee function measured with "Kujala score"
Knee function
Time frame: At three weeks
Knee function measured with "Kujala score"
Knee function
Time frame: Through study completion, an average of 6 months
Knee function measured with "Kujala score"
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 13 Feb 2023.
- 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 Diathermy by emission of Radiofrequency and Therapeutic exercise in people with Patellofemoral Pain Syndrome and Patellofemoral Pain, 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 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: finished, as of the sponsor's last update on 13 Feb 2023. 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 9 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 13 Feb 2023.