Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001717145
Ethics application status
Approved
Date submitted
23/10/2019
Date registered
5/12/2019
Date last updated
11/12/2019
Date data sharing statement initially provided
5/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the effectiveness of conventional physiotherapy treatment supplemented with a protocol for strengthening the gluteus maximus in patients with femoral patellar syndrome.
Scientific title
Study of the effectiveness of gluteus maximus strengthening in femoro-patellar syndrome. Randomized clinical trial.
Secondary ID [1] 299572 0
Nill known
Universal Trial Number (UTN)
U1111-1241-7686
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Femoro-patellar syndrome. 314848 0
Condition category
Condition code
Musculoskeletal 313187 313187 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 313683 313683 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study of the effectiveness of gluteus maximus strengthening in femoro-patellar syndrome.

The sample (74 subjects) is randomly divided into two groups. In both groups, a physiotherapeutic treatment based on masotherapy, patella mobilizations, isometric quadriceps exercises, and Transcutaneous electrical nerve stimulation (TENS) will be carried out. Compex 3.0 ® will be used by applying the “smart TENS” analgesic function. The impulse form is biphasic and pulsed, the frequency is 80Hz, the amplitude is 125 msec and finally, the intensity depends on the patient, because each of them has a different pain tolerance. The sessions will be carried out every 2 weeks, and in each of them the TENS will be applied for 15 minutes. In group 2 or intervention, you will also add some home exercises to strengthen the gluteus maximus.

It will work with five variables, obtained by different tests: Y-Balance Test, Triple single-leg jump, Q angle measurement, measurement of gluteus maximus strength using a dynamometer, and questionnaire "Kujala Knee Pain".

The study will be carried out by both of the physiotherapists in charge of the study. One of them will be responsible for making the measurements to be evaluated unaware of neither which group each subject belongs to, nor the results obtained in previous measurements; while the other physiotherapist will carry out the measurement of the gluteus maximus as well as the treatments, aware of which group each subject belongs to.

Measurements of the different variables will be made once every 3 months. Treatment sessions will be every two weeks, each one of them lasting approximately 30 minutes. The whole study will be undergone in two physiotherapy clinics in Vigo, Spain.

The intensity of the protocol will be hard (6 -7 Borg RPE Scale) and the total duration of the intervention will be 6 months. The frecuency of the sessions at home will be 10 minute sessions a day, 4 days a week. Also, the physiotherapist will send a reminder via text message to ensure that all patients complete the exercises.

The gluteus maximus protocol exercises will be "Buttock Bridge", "walk sideways with miniband", "Hip extension with 90º knee flexion from standing with the ventral aspect of the trunk resting on the stretcher", "External hip rotation from quadruped" and "Clam".
Intervention code [1] 315829 0
Rehabilitation
Intervention code [2] 316245 0
Treatment: Other
Comparator / control treatment
- Treatment will be started by doing therapeutic massage on the quadriceps, since it has been demonstrated that the relaxation of the musculature involved has a very important role in the treatment of femoropatelar syndrome. This technique will last approximately 15 minutes.
- Exercises of quadriceps contraction will be included, during which both the intensity as well as the repetition number will be tailor made to each patient. After the third month, this exercise will be complemented with electrostimulation of the medial vastus. This technique will be used because it has been demonstrated that it helps improve the patella mobilization.
- TENS will be used as an analgesic technique. TENS will be applied for 15 minutes on an intensity in which the patient does not feel pain.
- Lastly, the McConnell taping technique will be used in order to attempt to correct the patella anormal position.

Control group
Active

Outcomes
Primary outcome [1] 321700 0
Measurement of the gluteus maximus strength by dynamometer.
Timepoint [1] 321700 0
Timepoint: baseline, 3 months (primary timepoint) and 6 months after intervention commencement.
Secondary outcome [1] 375945 0
Measurement of knee pain using the "Kujala Knee Pain" questionnaire.
Timepoint [1] 375945 0
Timepoint: baseline, 3 months and 6 months after intervention commencement.

Eligibility
Key inclusion criteria
- People between 18 and 65 years old.
- People with femoropatellar syndrome of at least 6 months, diagnosed by a specialist doctor.
- People who understand and are able to do the protocol exercises correctly.
- People who have enough commitment to do the exercises proposed during the study.
- People who are able to maintain standing or walking completely autonomously.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- People with hip and / or ankle pathology.
- People with a cardiac pathology which has been diagnosed either at the beginning of the study or as during it.
- People who are pregnant.
- People who have undergone surgery or knee infiltration.
- People who show strong knee mobility limitations.
- People who are currently undergoing rehabilitation related to knee pain.

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)
A computer program is used to randomize both groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The sample is divided into two groups:
1. Conventional treatment.
2. Conventional treatment + exercise protocol.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To carry out this study, a sample size of 74 subjects (37 in each group) will be considered. This value has been calculated using the GPower 3.1.9.4 ® assuming an error of 0.05, with a study power of 80% and an effect size of 0.69 obtained from a previous reference study. Hence, by using this program, a sample of 68 subjects is estimated, which will extend up to 74 to take into account a 10% margin due to the possible losses that may take place.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/12/2019
Actual
Date of last participant enrolment
Anticipated
7/01/2020
Actual
Date of last data collection
Anticipated
9/07/2020
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment outside Australia
Country [1] 21929 0
Spain
State/province [1] 21929 0
Galicia

Funding & Sponsors
Funding source category [1] 304056 0
Self funded/Unfunded
Name [1] 304056 0
There aren’t any sponsor or external funding.
Country [1] 304056 0
Primary sponsor type
University
Name
University of Alcala de Henares
Address
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country
Spain
Secondary sponsor category [1] 304250 0
None
Name [1] 304250 0
Address [1] 304250 0
Country [1] 304250 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304548 0
Comité de Ética de la Investigación y Experimentación Animal de la Universidad de Álcala de Henares
Ethics committee address [1] 304548 0
Colegio de León c/ Libreros, 21 28801 Alcalá de Henares (Madrid)
Ethics committee country [1] 304548 0
Spain
Date submitted for ethics approval [1] 304548 0
Approval date [1] 304548 0
05/09/2019
Ethics approval number [1] 304548 0
CEIM/HU/201920

Summary
Brief summary
The hypothesis is that an increase in gluteus maximus strength is a protective factor of the femoropatelar syndrome, that is to say, the symptomatology of the femoropatellar syndrome decreases when the strength of the gluteus maximus is higher.

The main objective is to verify the effectiveness of a gluteus maximization strengthening protocol as a treatment of femoral patellar syndrome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97342 0
Miss Cristina Ruano Jiménez
Address 97342 0
University of Alcala de Henares.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 97342 0
Spain
Phone 97342 0
+34 691524139
Fax 97342 0
Email 97342 0
[email protected]
Contact person for public queries
Name 97343 0
Miss Cristina Ruano Jiménez
Address 97343 0
University of Alcala de Henares
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 97343 0
Spain
Phone 97343 0
+34 691524139
Fax 97343 0
Email 97343 0
[email protected]
Contact person for scientific queries
Name 97344 0
Miss Cristina Ruano Jiménez
Address 97344 0
University of Alcala de Henares.
Av. de León, 3A, 28805 Alcalá de Henares, Madrid
Country 97344 0
Spain
Phone 97344 0
+34 691524139
Fax 97344 0
Email 97344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The data of the subjects related to the results of the study, not their personal data.
When will data be available (start and end dates)?
The article will be available indefinitely from its publication.
Available to whom?
The article will be available to everyone looking for studies of this type.
Available for what types of analyses?
The article will be available for different purposes, not just for a specific type of study.
How or where can data be obtained?
The data can be obtained through a web page when the article is published.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5365Informed consent form  [email protected] 378571-(Uploaded-22-10-2019-17-24-13)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.