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Trial registered on ANZCTR


Registration number
ACTRN12618000258257
Ethics application status
Approved
Date submitted
24/11/2017
Date registered
16/02/2018
Date last updated
3/03/2021
Date data sharing statement initially provided
30/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of monopolar dielectric transmission diathermy in patient recovery after total knee replacement surgery
Scientific title
Efficacy of monopolar dielectric transmission diathermy in patient pain and function recovery after total knee replacement surgery. A placebo-randomised clinical trial
Secondary ID [1] 293434 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain after total knee replacement 305601 0
Function after total knee replacement 305602 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304824 304824 0 0
Physiotherapy
Musculoskeletal 305608 305608 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 305609 305609 0 0
Physiotherapy
Musculoskeletal 305610 305610 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once participants are adequately informed and have signed the informed consent, they will be evaluated face to face by a physiotherapist with more than 10 years of experience on knee replacement rehabilitation. VAS scale for pain, SF-12 questionnaire for quality of life, WOMAC knee function scale, "Five times sit to stand" and "TUG test" for knee function will be used in this evaluation.

After that, patients will be randomized in three groups of treatment:

a) Intervention group: this participants will receive 10 sessions of 20 minutes of monopolar dielectric diathermy with emission of 840kHz modulated in 140Hz, intensity of 30V and pulsed at 70% (device name: DCD®; manufacturer: Biotronic Advance Develops®) and 30 minutes of knee strength exercises, daily from Monday to Friday along two weeks.

b) Placebo group: this participants will receive sham diathermy by using a similar device that turns on the light of the applicator but do not give any emission. In addition, they will also receive 30 minutes of knee strength exercises, both interventions daily from Monday to Friday along two weeks.

c) Control group: this participants will only receive 30 minutes of knee strength exercises daily from Monday to Friday along two weeks.

The knee strength exercises will consist on 10 minutes of active knee flexion and extension until the end of available range of motion without pain, 10 minutes of walking on flat land and 10 minutes of knee extension from sitting with a five kilos dumbbell placed at the foot.

All the interventions will be carried face to face by a different physiotherapist from the one of the evaluations, with also a minimum of ten years of experienced on knee replacement rehabilitation. The intervention will be allocated at the Physiotherapy Room of the Hospital of Jaen.

After the last session of treatment, participants will be re-evaluated by the same first physiotherapist and a follow up will be carried out two weeks after the re-evaluation by using the same questionnaires that at the beginning and the end of treatment evaluation.

All the data will be note down in a registry sheet, which will be encoded to assure the anonymity of the participant. These sheets will be exported to digital archive, useful to its statistical treatment by another investigator different from the physiotherapist that carried out the intervention or evaluation.
Intervention code [1] 299676 0
Treatment: Devices
Comparator / control treatment
The control group will receive only 30 minutes of knee strength exercises daily from Monday to Friday for two weeks.

The placebo group will receive sham diathermy by using a similar device that turns on the light of the applicator but do not give any emission. In addition, they will also receive 30 minutes of knee strength exercises, both interventions daily from Monday to Friday for two weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 304034 0
Pain with VAS scale
Timepoint [1] 304034 0
Before first session of treatment, after last session of treatment and two weeks after last session of treatment
Secondary outcome [1] 340770 0
Functionality by "Five times sit to stand test", TUG test and WOMAC
Timepoint [1] 340770 0
Before the first session of treatment, after the last session of treatment and two weeks after the last session of treatment
Secondary outcome [2] 340771 0
Quality of life by SF-12 questionnaire
Timepoint [2] 340771 0
Before the first session of treatment, after the last session of treatment and two weeks after the last session of treatment

Eligibility
Key inclusion criteria
-Participants that underwent surgery of total knee replacement in one knee in the last two weeks.
-Age: 60 years or more
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Cognitive alterations, cardiovascular disease or metabolic diseased uncontrolled at the moment of study.
-Receiving any other physiotherapy treatment at the moment of the study
-Having or being suffering cancer or any tumor.
-Thermal sensitivity alterations
-Leg deformation or osteomuscular disease

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 procedures (dice-rolling)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
After checking the normal distribution of the variables among groups, a T-test will be carried to calculate the differences between before and after the treatment in each group. Later, the differences of improvement among groups will be valued by one-way-anova and the effect size calculated by Cohen's d.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/02/2018
Actual
2/04/2018
Date of last participant enrolment
Anticipated
6/07/2020
Actual
17/08/2020
Date of last data collection
Anticipated
20/07/2020
Actual
11/09/2020
Sample size
Target
60
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 9391 0
Spain
State/province [1] 9391 0
Jaen

Funding & Sponsors
Funding source category [1] 298063 0
Commercial sector/Industry
Name [1] 298063 0
Biotronic Advance Develops
Country [1] 298063 0
Spain
Primary sponsor type
University
Name
Universidad de Jaén
Address
Departamento de Ciencias de la Salud
Despacho 270, edificio B3
Universidad de Jaén
Paraje de las Lagunillas, s/n
23071 Jaén (Jaén)
Country
Spain
Secondary sponsor category [1] 297138 0
None
Name [1] 297138 0
Address [1] 297138 0
Country [1] 297138 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299080 0
CEI Distrito Hospitalario de Jaen
Ethics committee address [1] 299080 0
Ethics committee country [1] 299080 0
Spain
Date submitted for ethics approval [1] 299080 0
15/11/2017
Approval date [1] 299080 0
30/11/2017
Ethics approval number [1] 299080 0
Ethics committee name [2] 299577 0
Comité de Ética de la Investigación de Centros de Jaén
Ethics committee address [2] 299577 0
Ethics committee country [2] 299577 0
Spain
Date submitted for ethics approval [2] 299577 0
15/11/2017
Approval date [2] 299577 0
30/11/2017
Ethics approval number [2] 299577 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79230 0
Dr Alfonso Ibañez-Vera
Address 79230 0
Universidad de Jaén
Edificio B3, despacho 270, buzon 193
Paraje de las Lagunillas, s/n
23071, Jaén (Jaén)
Country 79230 0
Spain
Phone 79230 0
+34953213519
Fax 79230 0
Email 79230 0
ajibanez@ujaen.es
Contact person for public queries
Name 79231 0
Alfonso Ibañez-Vera
Address 79231 0
Universidad de Jaén
Edificio B3, despacho 270, buzon 193
Paraje de las Lagunillas, s/n
23071, Jaén (Jaén)
Country 79231 0
Spain
Phone 79231 0
+34953213519
Fax 79231 0
Email 79231 0
ajibanez@ujaen.es
Contact person for scientific queries
Name 79232 0
Alfonso Ibañez-Vera
Address 79232 0
Universidad de Jaén
Edificio B3, despacho 270, buzon 193
Paraje de las Lagunillas, s/n
23071, Jaén (Jaén)
Country 79232 0
Spain
Phone 79232 0
+34953213519
Fax 79232 0
Email 79232 0
ajibanez@ujaen.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 don not have permission to share data


What supporting documents are/will be available?

No Supporting Document Provided



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.