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

NCT ID: NCT05471089

Last Updated: 2023-02-13

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

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-26

Study Completion Date

2023-02-10

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.

Detailed Description

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Conditions

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Patellofemoral Pain Syndrome Patellofemoral Pain Patello Femoral Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants were unaware of the treatment group. Researchers in charge of assessment were blinded. Investigator in charge of data analysis was blinded about treatments. Only care providers known about the different treatments

Study Groups

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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)

Group Type EXPERIMENTAL

Diathermy by emission of Radiofrequency

Intervention Type DEVICE

Applied only to experimental group

Therapeutic exercise

Intervention Type OTHER

Applied to both arms/groups

Control

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.

Group Type ACTIVE_COMPARATOR

Therapeutic exercise

Intervention Type OTHER

Applied to both arms/groups

Interventions

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Diathermy by emission of Radiofrequency

Applied only to experimental group

Intervention Type DEVICE

Therapeutic exercise

Applied to both arms/groups

Intervention Type OTHER

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jaén

OTHER

Sponsor Role lead

Responsible Party

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Alfonso Javier Ibáñez-Vera

Professor of the Department of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro de Salud San José de la Rinconada

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PFPS 3

Identifier Type: -

Identifier Source: org_study_id

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