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

Primary Purpose

Patellofemoral Pain Syndrome, Patellofemoral Pain, Patello Femoral Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diathermy by emission of Radiofrequency
Therapeutic exercise
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring knee pain, electrophysical agents

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro de Salud San José de la Rinconada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Knee pain
Pain measured with Visual Analogue Scale
Knee pain
Pain measured with Visual Analogue Scale
Knee pain
Pain measured with Visual Analogue Scale
Knee function
Knee function measured with "Lower Extremity Functional Scale"
Knee function
Knee function measured with "Lower Extremity Functional Scale"
Knee function
Knee function measured with "Lower Extremity Functional Scale"
Knee function
Knee function measured with "Kujala score"
Knee function
Knee function measured with "Kujala score"
Knee function
Knee function measured with "Kujala score"

Secondary Outcome Measures

Full Information

First Posted
July 11, 2022
Last Updated
February 10, 2023
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT05471089
Brief Title
Long-term Effects of the Addition of Diathermy by Emission of Radiofrequency to Therapeutic Exercise in Patellofemoral Pain Syndrome Patients
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain Syndrome, Patellofemoral Pain, Patello Femoral Syndrome
Keywords
knee pain, electrophysical agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind Randomized Controlled Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Diathermy by emission of Radiofrequency
Intervention Description
Applied only to experimental group
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
Applied to both arms/groups
Primary Outcome Measure Information:
Title
Knee pain
Description
Pain measured with Visual Analogue Scale
Time Frame
Baseline
Title
Knee pain
Description
Pain measured with Visual Analogue Scale
Time Frame
At three weeks
Title
Knee pain
Description
Pain measured with Visual Analogue Scale
Time Frame
Through study completion, an average of 6 months
Title
Knee function
Description
Knee function measured with "Lower Extremity Functional Scale"
Time Frame
Baseline
Title
Knee function
Description
Knee function measured with "Lower Extremity Functional Scale"
Time Frame
At three weeks
Title
Knee function
Description
Knee function measured with "Lower Extremity Functional Scale"
Time Frame
Through study completion, an average of 6 months
Title
Knee function
Description
Knee function measured with "Kujala score"
Time Frame
Baseline
Title
Knee function
Description
Knee function measured with "Kujala score"
Time Frame
At three weeks
Title
Knee function
Description
Knee function measured with "Kujala score"
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Centro de Salud San José de la Rinconada
City
Seville
ZIP/Postal Code
41300
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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