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

NCT ID: NCT04538508

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-07

Study Completion Date

2020-10-02

Brief Summary

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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

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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

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Patellofemoral Pain Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Outcomes assessor will not be aware about the treatment any participants will/had received

Study Groups

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Diathermy

Participants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration

Group Type EXPERIMENTAL

Diathermy

Intervention Type DEVICE

10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement

Supervised knee exercises

Intervention Type OTHER

Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.

Control

Participants that perform supervised exercises for three weeks

Group Type ACTIVE_COMPARATOR

Supervised knee exercises

Intervention Type OTHER

Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.

Interventions

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Diathermy

10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement

Intervention Type DEVICE

Supervised knee exercises

Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Seville

OTHER

Sponsor Role collaborator

Andaluz Health Service

OTHER_GOV

Sponsor Role collaborator

Universidad de Extremadura

OTHER

Sponsor Role collaborator

University of Jaén

OTHER

Sponsor Role lead

Responsible Party

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Alfonso Javier Ibáñez-Vera

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manuel Albornoz-Cabello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Seville

Locations

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Centro de Salud San José de la Rinconada

San José de la Rinconada, Seville, Spain

Site Status

Countries

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Spain

Other Identifiers

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PFPS US

Identifier Type: -

Identifier Source: org_study_id

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