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Completed

NCT Number: NCT05471089

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

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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases Patello Femoral Syndrome Patellofemoral Pain

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Salud San José de la Rinconada

Seville, 41300, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diathermy by emission of Radiofrequency

Device

Applied only to experimental group

Therapeutic exercise

Other

Applied to both arms/groups

Primary outcomes

  1. Knee pain

    Time frame: Baseline

    Pain measured with Visual Analogue Scale

  2. Knee pain

    Time frame: At three weeks

    Pain measured with Visual Analogue Scale

  3. Knee pain

    Time frame: Through study completion, an average of 6 months

    Pain measured with Visual Analogue Scale

  4. Knee function

    Time frame: Baseline

    Knee function measured with "Lower Extremity Functional Scale"

  5. Knee function

    Time frame: At three weeks

    Knee function measured with "Lower Extremity Functional Scale"

  6. Knee function

    Time frame: Through study completion, an average of 6 months

    Knee function measured with "Lower Extremity Functional Scale"

  7. Knee function

    Time frame: Baseline

    Knee function measured with "Kujala score"

  8. Knee function

    Time frame: At three weeks

    Knee function measured with "Kujala score"

  9. Knee function

    Time frame: Through study completion, an average of 6 months

    Knee function measured with "Kujala score"

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2022
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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