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

Non-invasive Radiofrequency Diathermy and Supervised Therapeutic Exercise in Patellofemoral Pain Syndrome. A Single Blind Randomized Controlled Trial With a Six-month Follow-up

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.

Study Overview

• Status: Completed
• Conditions: Patellofemoral Pain Syndrome; Patellofemoral Pain; Patello Femoral Syndrome
• Intervention / Treatment: Device: Diathermy by emission of Radiofrequency; Other: Therapeutic exercise

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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)	Device: Diathermy by emission of Radiofrequency; Applied only to experimental group; Other: Therapeutic exercise; Applied to both arms/groups
ACTIVE_COMPARATOR: 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.	Other: Therapeutic exercise; Applied to both arms/groups

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2022
• Primary Completion (ACTUAL): February 10, 2023
• Study Completion (ACTUAL): February 10, 2023

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (ACTUAL): July 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: knee pain; electrophysical agents
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Joint Diseases; Musculoskeletal Diseases; Syndrome; Somatoform Disorders; Patellofemoral Pain Syndrome
• Other Study ID Numbers: PFPS 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No