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Trial registered on ANZCTR


Registration number
ACTRN12618001259235
Ethics application status
Approved
Date submitted
5/07/2018
Date registered
25/07/2018
Date last updated
15/03/2019
Date data sharing statement initially provided
4/02/2019
Date results information initially provided
4/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Analysis of the efficacy of dielectric radiofrequency diathermy in patelofemoral pain syndrome

Scientific title
Analysis of the efficacy of dielectric radiofrequency diathermy in patelofemoral pain syndrome
Secondary ID [1] 295396 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patelofemoral pain 308625 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307572 307572 0 0
Physiotherapy
Physical Medicine / Rehabilitation 307573 307573 0 0
Other physical medicine / rehabilitation
Musculoskeletal 307574 307574 0 0
Osteoarthritis
Musculoskeletal 307575 307575 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group will receive 10 sessions of 12 minutes of radiofrequency along three weeks: first week from Monday to Friday, second week on Monday, Wednesday and Friday, third week on Tuesday and Thursday.

The treatment will be applied by a Physiotherapist with over 10 years of experience with a 600-800kHz pulsed emission radio frequency device. A dose of 30 volts will be used applied on a 100cm2 at the participant knee.

Treatment will be delivered in a ambulatory facility under health and clinic conditions required by current legislation
Intervention code [1] 301734 0
Treatment: Devices
Intervention code [2] 301735 0
Rehabilitation
Comparator / control treatment
Control treatment will consist on 10 sessions of 12 minutes of non-emission radiofrequency along three weeks: first week from Monday to Friday, second week on Monday, Wednesday and Friday, third week on Tuesday and Thursday.

The applicator will turn on the light but will not emit any electromagnetic signal.
Control group
Placebo

Outcomes
Primary outcome [1] 306585 0
Patelofemoral pain with Visual analogue scale
Timepoint [1] 306585 0
Before and after every treatment session with the 1st session being the primary timepoint
Primary outcome [2] 306586 0
DN4 (neuropathic pain questionnaire)
Timepoint [2] 306586 0
Before and after every treatment session with the 1st session being the primary timepoint
Primary outcome [3] 306587 0
Knee function with Kujala score
Timepoint [3] 306587 0
Before the first session of treatment and after the last one with the 1st session being the primary timepoint
Secondary outcome [1] 348948 0
Knee temperature with infra-red thermometer
Timepoint [1] 348948 0
Before and after every treatment session
Secondary outcome [2] 348949 0
Jump function with "My Jump 2" validated app
Timepoint [2] 348949 0
Before the first session of treatment and after the last one
Secondary outcome [3] 348950 0
Knee range of motion with digital goniometer
Timepoint [3] 348950 0
Before and after every treatment session
Secondary outcome [4] 348951 0
State of mood with Personal Psychological Aprehension Scale in its spanish adaptation
Timepoint [4] 348951 0
Before the first session of treatment and after the last one
Secondary outcome [5] 348953 0
Ultrasound study of patellar tendon (tendon tear) echogeneicity

Timepoint [5] 348953 0
Before the first session of treatment and after the last one
Secondary outcome [6] 349966 0
Knee function with Lower Extremity Functional Scale
Timepoint [6] 349966 0
Before the first session of treatment and after the last one with the 1st session being the primary timepoint

Eligibility
Key inclusion criteria
Participants between 18 and 60 years old and diagnosed of patelofemoral syndrome with over 6 months of evolution
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Under antitumoral treatment
-People with pacemaker
-Undergone knee surgery in last six 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)
Sealed opaque envelopes
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 receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We will use a total sample of 56 subjects diagnosed with unilateral or bilateral patellofemoral pain syndrome (PFPS), assuming a maximum loss or reduction of 15%. The calculation of the sample size was carried out with the G-Power 3.1 computer program, assuming a difference between means of two independent samples (Student's t-test) and a tail, for an alpha value or statistical significance of 0.05 or 95 %, a statistical power at 90% and a large effect size or clinical significance (d = 0.8). Resulting in a minimum size of 28 subjects for each group (experimental or intervention and control)

Kolmogorov-Smirnov test will be performed to analyse the normality of the continuous variables. Afterwards, between-groups differences in change scores will be analyzed using the t-test for independent samples or anova of repeated measures. To measure effect size, Cohen’s d will be calculated as the difference of means between groups divided by the combined standard deviation. Spearman correlation test will be held to study the possible relations among outcomes.

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] 10613 0
Spain
State/province [1] 10613 0
Seville

Funding & Sponsors
Funding source category [1] 299986 0
Commercial sector/Industry
Name [1] 299986 0
Biotronic Advace Develops
Address [1] 299986 0
Horno de Abad, 12
18002, Granada, SPAIN
Country [1] 299986 0
Spain
Primary sponsor type
Commercial sector/Industry
Name
Biotronic Advance Develops
Address
Horno de Abad, 12
18002, Granada, SPAIN
Country
Spain
Secondary sponsor category [1] 299367 0
University
Name [1] 299367 0
University of Seville
Address [1] 299367 0
Avicena, s/n
41009, Sevilla, SPAIN
Country [1] 299367 0
Spain
Secondary sponsor category [2] 299400 0
University
Name [2] 299400 0
University of Jaen
Address [2] 299400 0
Paraje de las Lagunillas, s/n
18071, Jaén, SPAIN
Country [2] 299400 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300842 0
CEI de los Hospitales Universitarios Virgen Macarena y Virgen del Rocío
Ethics committee address [1] 300842 0
Avda. Dr. Fedriani, 3 - Unidad de Investigación 2a planta Sevilla 41071 Sevilla España
Ethics committee country [1] 300842 0
Spain
Date submitted for ethics approval [1] 300842 0
Approval date [1] 300842 0
29/01/2018
Ethics approval number [1] 300842 0
1696-N-17

Summary
Brief summary
Patellofemoral pain syndrome (PFPS) is a common musculoskeletal problem more known as "knee pain", characterized by pain in the anterior aspect of the knee that tends to become chronic. Non-operative treatments are frequent, and physiotherapy is a commonly used intervention. Therefore, we will use an electrotherapy procedure consisting of the application of monopolar dielectric diathermy by radiofrequency. This type of therapy is well known in the field of physiotherapy; although, there are hardly any relevant studies as far as their application is concerned with the PFPS.

The aim of this study is to analyze the effectiveness of monopolar dielectric diathermy by radiofrequency in the reduction of knee pain, functional disability and degree of psychological apprehension of patients with the syndrome of patellofemoral pain.

Participants will receive either 10 sessions of 12 minutes of monopolar dielectric diathermy or 10 sessions of 12 minutes of non-emission treatment. Several outcomes will be assessed: pain, knee function, range of motion and temperature.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2854 2854 0 0

Contacts
Principal investigator
Name 84998 0
Prof Manuel Albornoz Cabello
Address 84998 0
Calle Avenzoar, 6
Universidad de Sevilla
Facultad de Fisioterapia, Enfermería y Podología
41009, Sevilla (SPAIN)
Country 84998 0
Spain
Phone 84998 0
+34954486502
Fax 84998 0
Email 84998 0
malbornoz@us.es
Contact person for public queries
Name 84999 0
Prof Manuel Albornoz Cabello
Address 84999 0
Calle Avenzoar, 6
Universidad de Sevilla
Facultad de Fisioterapia, Enfermería y Podología
41009, Sevilla (SPAIN)
Country 84999 0
Spain
Phone 84999 0
+34954486502
Fax 84999 0
Email 84999 0
malbornoz@us.es
Contact person for scientific queries
Name 85000 0
Prof Manuel Albornoz Cabello
Address 85000 0
Calle Avenzoar, 6
Universidad de Sevilla
Facultad de Fisioterapia, Enfermería y Podología
41009, Sevilla (SPAIN)
Country 85000 0
Spain
Phone 85000 0
+34954486502
Fax 85000 0
Email 85000 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
We do not have participants permission to share the data
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 – plain English summary