Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04538508
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2020-08-25
Brief Title:
Radiofrecuency and Supervised Exercise Versus Supervised Exercise in the Treatment of Patellofemoral Pain Syndrome
Sponsor:
University of Jaén
Organization:
University of Jaén
Study Overview
Official Title:
Short Term Efficacy of the Combination of Radiofrecuency Diathermy and Supervised Exercise Versus Supervised Exercise Alone in the Treatment of Patellofemoral Pain Syndrome
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Outcomes to measure will include pain knee function and quality of life
Detailed Description:
At first a meeting will be held with the patients under study where they will be informed and any doubts that may arise in relation to the investigation will be resolved In addition the correct adaptation of these to the inclusion and exclusion criteria of our study will be verified Subsequently they will be given individually the informed consent prepared expressly for the present study the doubts arising with respect to this one will be resolved and their signature will proceed At this time and individually again we will proceed to the development of the Clinical History of Physiotherapy where only the information necessary for our study will be collected To emphasize in this point that the participants will grant their consent for the treatment of the data obtained for scientific purposes according to the legal norms
Next the patients will be randomly assigned to two groups control group and experimental group The randomization of the sample was done through the EPIDAT software in version 31 between the Experimental Group and the Control Group Subsequently the evaluations and measurements of the study variables will be carried out by the research team
CONTROL GROUP them will be provided exclusively therapeutic exercises protocol that you must be performed supervised by a physiotherapist following a daily activity for three weeks
EXPERIMENTAL GROUP After the initial evaluation the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week three sessions on alternate days in the second week and two sessions on alternate days in the third week 3 weeks in total applying the monopolar dielectric diathermy by radiofrequency in the anterior aspect of the knee in dynamic application in one of the members affect or randomized uni or bilateral pathology respectively This diathermy will be combined with the same supervised therapeutic exercise program of the control group
The treatment is administered with a pulsed non-invasive radiofrequency device with 30V peak power along 12 minutes with a dose submitis grade I for three weeks The first week daily treatment will be perform from Monday to Friday second week on Monday Wednesday and Friday and the third week on Monday and Thursday
After the tenth treatment session all the measurements will be repeated following the same environmental conditions as at the beginning and by the evaluators themselves to the components of both groups
Next the patients will be randomly assigned to two groups control group and experimental group The randomization of the sample was done through the EPIDAT software in version 31 between the Experimental Group and the Control Group Subsequently the evaluations and measurements of the study variables will be carried out by the research team
CONTROL GROUP them will be provided exclusively therapeutic exercises protocol that you must be performed supervised by a physiotherapist following a daily activity for three weeks
EXPERIMENTAL GROUP After the initial evaluation the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week three sessions on alternate days in the second week and two sessions on alternate days in the third week 3 weeks in total applying the monopolar dielectric diathermy by radiofrequency in the anterior aspect of the knee in dynamic application in one of the members affect or randomized uni or bilateral pathology respectively This diathermy will be combined with the same supervised therapeutic exercise program of the control group
The treatment is administered with a pulsed non-invasive radiofrequency device with 30V peak power along 12 minutes with a dose submitis grade I for three weeks The first week daily treatment will be perform from Monday to Friday second week on Monday Wednesday and Friday and the third week on Monday and Thursday
After the tenth treatment session all the measurements will be repeated following the same environmental conditions as at the beginning and by the evaluators themselves to the components of both groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None