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

Patellofemoral Pain Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05471089
• Other study ID #: PFPS 3
• Status: Completed
• Phase: N/A
• Start date: July 26, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2023
• Source: University of Jaén
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Patello Femoral Syndrome
• Patellofemoral Pain
• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Device:
• Diathermy by emission of Radiofrequency
Applied only to experimental group

Other:
• Therapeutic exercise
Applied to both arms/groups

Locations

Country	Name	City	State
Spain	Centro de Salud San José de la Rinconada	Seville

Sponsors (1)

Lead Sponsor	Collaborator
University of Jaén

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee pain	Pain measured with Visual Analogue Scale	Baseline
Primary	Knee pain	Pain measured with Visual Analogue Scale	At three weeks
Primary	Knee pain	Pain measured with Visual Analogue Scale	Through study completion, an average of 6 months
Primary	Knee function	Knee function measured with "Lower Extremity Functional Scale"	Baseline
Primary	Knee function	Knee function measured with "Lower Extremity Functional Scale"	At three weeks
Primary	Knee function	Knee function measured with "Lower Extremity Functional Scale"	Through study completion, an average of 6 months
Primary	Knee function	Knee function measured with "Kujala score"	Baseline
Primary	Knee function	Knee function measured with "Kujala score"	At three weeks
Primary	Knee function	Knee function measured with "Kujala score"	Through study completion, an average of 6 months