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Trial registered on ANZCTR


Registration number
ACTRN12619001457134
Ethics application status
Approved
Date submitted
27/05/2019
Date registered
22/10/2019
Date last updated
22/10/2019
Date data sharing statement initially provided
22/10/2019
Date results information initially provided
22/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title

Analysis of the efficacy of supervised therapeutic exercise in Patellofemoral Pain Syndrome
Scientific title

Analysis of the efficacy of supervised therapeutic exercise in Patellofemoral Pain Syndrome
Secondary ID [1] 298341 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Pain Syndrome 312992 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311495 311495 0 0
Physiotherapy
Musculoskeletal 311780 311780 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 EPIDAR software in version 3.1 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: You will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform 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 capacitive diathermy with 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 a therapeutic exercise program supervised by a Physiotherapist.
The treatment is administered with a pulsatile short-wave equipment and inductive electrodes of 100 W peak power, with a frequency of application of twice daily with a dose submitis (grade I), for 10 min, with a frequency of repetition of the impulses of 46 Hz and a pulse duration of 0.2 ms
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.
Intervention code [1] 314585 0
Rehabilitation
Comparator / control treatment
CONTROL GROUP: The patients will be exclusively provided with a protocol of therapeutic exercises to develop at home that must be performed daily for a minium period of three weeks.

The protocol of therapeutic exercises will include a combination between hip and knee-targeted exercises in order to reduce pain and improve the patients' functional outcomes. The hip-targeted exercises will include posterolateral hip musculature. The knee-targetted exercises will include both types of exercises: those that implies body weight bearing and those which not. In the beginning of the protocol we will prefer to introduce hip-targeted exercises withoutaddition of external weight.
An example of non weight bearing exercise would be resisted extensión, paying special atention to the internal component of the quadriceps and an example of weight bearing exercise would be adapted squats.
Control group
Active

Outcomes
Primary outcome [1] 320201 0
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
Timepoint [1] 320201 0
Two evaluations were performed by physiotherapists: before the intervention and when the intervention was finished (after 10 sesions).
Our objective is to study the effects on the short term.
Primary outcome [2] 320203 0
The functional disability, quantified by means of the tests: Kujala Score.
Timepoint [2] 320203 0
Two evaluations were performed by physiotherapists: before the intervention and when the intervention was finished (after 10 sesions).
Our objective is to study the effects on the short term.
Secondary outcome [1] 370858 0
In addition an anthropometric study of knee joint range of movement will be performed. Evaluating the Active and Pasive Knee's Range of Movement using universal goniometer measurement. we pay special attention to the possible restrictions in the normal range of motion.
Timepoint [1] 370858 0
Two evaluations were performed by physiotherapists: before the intervention and when the intervention was finished (after 10 sesions).
Our objective is to study the effects on the short term.
Secondary outcome [2] 372263 0
Functional Scale of the Lower Extremity (LEFS)
Timepoint [2] 372263 0
Two evaluations were performed by physiotherapists: before the intervention and when the intervention was finished (after 10 sesions).
Our objective is to study the effects on the short term.

Eligibility
Key inclusion criteria
INCLUSION CRITERIA:
• Patients diagnosed with patellofemoral pain syndrome more than 6 months old.
• Have an age between 18 years and 50 years.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

EXCLUSION CRITERIA:
• Present cognitive alterations.
• Have undergone conservative or surgical treatment of the knee in less than 6 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients diagnosed with unilateral or bilateral PFPS will be divided into two groups, randomly selected (experimental group and control group), of 30 subjects each.

Allocation was concealed and it was done by central randomisation by computer (EPIDARcomputer program).

The subjects of the experimental group will undergo a program of supervised physical therapeutic exercise. And the subjects of the control group will follow the medical-pharmacological treatment and the ergonomic recommendations according to the established protocol.

The target population will be all patients diagnosed with patellofemoral pain syndrome (PFPS) unilaterally or bilaterally, from the health area of La Rinconada while the eligible population will be composed of all those patients residing in or around Seville who can and wish to be part of it. of the study and that they meet the inclusion and exclusion criteria..
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (EPIDAR versión 3.1)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
* Student t-test.

* ANOVAS.

* D. of Cohen.

* Wilcoxon signed-rank test

* Mann-Whitney test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21530 0
Spain
State/province [1] 21530 0
Seville

Funding & Sponsors
Funding source category [1] 302881 0
University
Name [1] 302881 0
University of Seville
Address [1] 302881 0
Calle San Fernando, 4, 41004 Sevilla
Country [1] 302881 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Calle San Fernando, 4, 41004 Sevilla
Country
Spain
Secondary sponsor category [1] 302837 0
None
Name [1] 302837 0
Address [1] 302837 0
Country [1] 302837 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303457 0
CEI de los Hospitales Universitarios Virgen Macarena-Virgen del Rocio
Ethics committee address [1] 303457 0
Hospital Virgen del Rocio
Avda. Manuel Siurot, s/n
41013 - SEVILLA
Ethics committee country [1] 303457 0
Spain
Date submitted for ethics approval [1] 303457 0
26/10/2018
Approval date [1] 303457 0
06/04/2019
Ethics approval number [1] 303457 0
41255cfc9ab78019f9a8501bb354b0ba4b15a804

Summary
Brief summary
The present study aims to promote research in the field of Physiotherapy, focusing on a health problem of maximum relevance, such as patellofemoral pain syndrome (Crossley et al 2016, Andersen et al., 1999).

Although these treatments seem to be based on theoretical reasoning, the evidence for the efficacy of these interventions is not well established (Logan et al., 2017).
Therefore, we select from among all the therapeutic tools available in physiotherapy, a procedure of therapeutic physical exercise.

Main objectives:
To know the efficacy of a therapeutic physical exercise protocol in the reduction of pain and the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS).

Secondary objectives:
- Quantify the reduction of pain in the anterior aspect of the knee in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.
- To evaluate the improvement of functional disability in patients with patellofemoral pain syndrome (PFPS), after treatment with monopolar capacitive diathermy by radiofrequency.

Study hypothesis:
The treatment of patellofemoral pain syndrome (PFPS) with a therapeutic physical exercise protocol produces statistically significant changes in the reduction of pain and functional disability and the normalization of the anthropometric values of the joint balance of the knee
Trial website
Trial related presentations / publications
Public notes
This ethics approval was solicited on 26/10/2018 and we obtained a provisional permission to initiate enrolling patients finally it was finally emitted by the ethics comitte on 06/04/2019.

Contacts
Principal investigator
Name 93722 0
Dr Cristo Jesus Barrios Quinta
Address 93722 0
Cristo Jesus Barrios Quinta.
Physiotherapist of Los Carteros Primary Care Center
Servicio Andaluz de Salud.
Calle / Los Carteros Sin numero,
CP. 41300 San Jose de la Rinconada. La Rinconada. Sevilla, Espana
Country 93722 0
Spain
Phone 93722 0
+34669121747
Fax 93722 0
Email 93722 0
cristo.barrios@gmail.com
Contact person for public queries
Name 93723 0
Dr Cristo Jesus Barrios Quinta
Address 93723 0
Cristo Jesus Barrios Quinta.
Physiotherapist of Los Carteros Primary Care Center
Servicio Andaluz de Salud.
Calle / Los Carteros Sin numero,
CP. 41300 San Jose de la Rinconada. La Rinconada. Sevilla, Espana
Country 93723 0
Spain
Phone 93723 0
+34669121747
Fax 93723 0
Email 93723 0
cristoj.barrios.sspa@juntadeandalucia.es
Contact person for scientific queries
Name 93724 0
Dr Manuel Albornoz Cabello
Address 93724 0
Dr. Manuel Albornoz Cabello
Facultad De Enfemeria, Fisioterapia y Podologia
Universidad de Sevilla.
Direccion:
Calle AVICENA. Sin numero
C.P: 41009 (SEVILLA) ESPANA
Country 93724 0
Spain
Phone 93724 0
+34954486502
Fax 93724 0
Email 93724 0
malbornoz@us.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary