Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome.

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

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome
• Intervention / Treatment: Device: Diathermy; Other: Supervised knee exercises

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 Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Seville
    • San José de la Rinconada, Seville, Spain, 41300
      • Centro de Salud San José de la Rinconada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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].

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diathermy; Participants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration	Device: Diathermy; 10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement; Other: Supervised knee exercises; Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.
Active Comparator: Control; Participants that perform supervised exercises for three weeks	Other: Supervised knee exercises; Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	Three weeks after there first session of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	Baseline
Knee function	Functional Scale of the Lower Extremity (LEFS). The score goes from 0 (low function) to 80 (great function)	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	Baseline
Knee flexion range of movement	Active knee joint range of movement. Knee range of movements goes from -10º to 150º	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	Baseline
Knee extension range of movement	Active knee joint range of movement. Knee range of movements goes from -10º to 150º	Three weeks after there first session of treatment

Collaborators and Investigators

• Sponsor: University of Jaen
• Collaborators: Andaluz Health Service; University of Seville; Universidad de Extremadura
• Investigators: Principal Investigator: Manuel Albornoz-Cabello, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): October 2, 2020
• Study Completion (Actual): October 2, 2020

Study Registration Dates

• First Submitted: August 25, 2020
• First Submitted That Met QC Criteria: August 30, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: October 3, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: knee pain; patellofemoral pain syndrome; diathermy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: PFPS US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participants did not allow to share their data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No