Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome.

NCT04538508 | Completed

• 1 other identifier: PFPS US
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study will analyze the effects of a non-invasive radiofrequency diathermy device added to knee exercises on the symptoms of patellofemoral pain syndrome. For this aim, a randomized clinical trial will be carried out with a control group that will perform supervised exercises and an experimental group that will add radiofrequency diathermy to supervised exercises. Diathermy treatment will be performed along three weeks, ten treatment sessions in total, while supervised exercises will be performed daily. Outcomes to measure will include pain, knee function and quality of life

Conditions

Patellofemoral Pain Syndrome

Keywords

patellofemoral pain syndrome; knee pain; diathermy

Outcome Measures

Primary Outcomes (2)

• Knee pain

  The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain

  Baseline

• Knee pain

  The perception of pain through the Visual Analogue Scale (EVA). This variable has been obtained through a validated scale of 10 centimeters (0-10), where the subject self-positioned from absence of pain to the worst bearable pain

  Three weeks after there first session of treatment

Secondary Outcomes (8)

• Knee functional disability

  Baseline

• Knee functional disability

  Three weeks after there first session of treatment

• Knee function

  Baseline

• Knee function

  Three weeks after there first session of treatment

• Knee flexion range of movement

  Baseline

Study Arms (2)

Diathermy

EXPERIMENTAL

Participants that receive 10 sessions of radiofrequency diathermy of 12 minutes of duration

Device: Diathermy; Other: Supervised knee exercises

Control

ACTIVE COMPARATOR

Participants that perform supervised exercises for three weeks

Other: Supervised knee exercises

Interventions

Diathermy DEVICE

10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement

Diathermy

Supervised knee exercises OTHER

Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.

Control; Diathermy

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with patellofemoral pain syndrome more than 6 months old.
• Have an age between 18 years and 50 years.
• Adult patients with anterior knee pain were referred by a primary care physician at a public health center in southern Spain. Those participants with a self-reported pain intensity = 30 mm on the Visual Analog Scale (VAS) and a score \<45 points in personal psychology The Apprehension Scale (PPAS) \[bathrobe 2017\], were invited to participate. The PPAS is a valid, reliable and easy-to-use tool for assessing the apprehension of subjects to receive electrical stimulation therapy \[bathrobe 2005\].

You may not qualify if:

• Any contraindication for the use of MDR
• Present cognitive alterations.
• Have undergone conservative or surgical treatment of the knee in less than 6 months.
• Having received injections of corticosteroids or hyaluronic acid; impaired cognition or communication; and be involved in an ongoing medical-legal dispute.

Sponsors & Collaborators

• University of Jaén: lead
• University of Seville: collaborator
• Andaluz Health Service: collaborator
• Universidad de Extremadura: collaborator

Study Sites (1)

Centro de Salud San José de la Rinconada

San José de la Rinconada, Seville, 41300, Spain

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Fever

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics

Study Officials

• Manuel Albornoz-Cabello, PhD

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not be aware about the treatment any participants will/had received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 4, 2020
• Study Start: September 7, 2020
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)