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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05471089
Other study ID # PFPS 3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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