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

NCT05471089 | Completed

• 1 other identifier: PFPS 3
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Patellofemoral Pain Syndrome; Patellofemoral Pain; Patello Femoral Syndrome

Keywords

knee pain; electrophysical agents

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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; Other: Therapeutic exercise

Control

ACTIVE COMPARATOR

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

Interventions

Diathermy by emission of Radiofrequency DEVICE

Applied only to experimental group

Experimental

Therapeutic exercise OTHER

Applied to both arms/groups

Control; Experimental

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Centro de Salud San José de la Rinconada

Seville, 41300, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Department of Health Sciences

Model Details: Double-blind Randomized Controlled Trial

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 22, 2022
• Study Start: July 26, 2022
• Primary Completion: February 10, 2023
• Study Completion: February 10, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)