Long-term Effects of the Addition of Diathermy by Emission of Radiofrequency to Therapeutic Exercise in Patellofemoral Pain Syndrome Patients

Study Overview
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Brief Summary
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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.

Official Title
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Non-invasive Radiofrequency Diathermy and Supervised Therapeutic Exercise in Patellofemoral Pain Syndrome. A Single Blind Randomized Controlled Trial With a Six-month Follow-up

Conditions
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Patellofemoral Pain Syndrome, Patellofemoral Pain, Patello Femoral Syndrome

Intervention / Treatment
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* Device: Diathermy by emission of Radiofrequency
* Other: Therapeutic exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind Randomized Controlled Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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) | Device: Diathermy by emission of Radiofrequency<br>* Applied only to experimental group<br>Other: Therapeutic exercise<br>* Applied to both arms/groups<br>|
| Active Comparator: Control<br>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. | Other: Therapeutic exercise<br>* Applied to both arms/groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain | Pain measured with Visual Analogue Scale | Baseline | 
| Knee pain | Pain measured with Visual Analogue Scale | At three weeks | 
| Knee pain | Pain measured with Visual Analogue Scale | Through study completion, an average of 6 months | 
| Knee function | Knee function measured with Lower Extremity Functional Scale | Baseline | 
| Knee function | Knee function measured with Lower Extremity Functional Scale | At three weeks | 
| Knee function | Knee function measured with Lower Extremity Functional Scale | Through study completion, an average of 6 months | 
| Knee function | Knee function measured with Kujala score | Baseline | 
| Knee function | Knee function measured with Kujala score | At three weeks | 
| Knee function | Knee function measured with Kujala score | Through study completion, an average of 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee pain, electrophysical agents