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Trial registered on ANZCTR


Registration number
ACTRN12619000832178
Ethics application status
Approved
Date submitted
13/05/2019
Date registered
11/06/2019
Date last updated
11/06/2019
Date data sharing statement initially provided
11/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic effect of different frequency low amplitude vibration on the perception of pain, thermovisual changes and functional status in patients treated for arthritis of the knee joints.
Scientific title
Therapeutic effect of different frequency low amplitude vibration on the perception of pain, thermovisual changes and functional status in patients treated for arthritis of the knee joints - randomized controlled trial.
Secondary ID [1] 298202 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthrosis of knee 312791 0
Condition category
Condition code
Musculoskeletal 311289 311289 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this study is to analyze the effect of variable frequency, low amplitude vibration on the perception of pain, thermovisual changes and functional status in patients treated for osteoarthritis of the knee. All subjects will be divided into two randomized parallel single-blinded groups (intervention and control group). Intervention group will perform 3-weeks series of vibration therapy treatments in a sitting position, with upright legs, with support of the knees. Therapy includes 15 interventions. One intervention lasts 60 minutes. The intervention will be applied once daily (excluding the weekends - 15 days of therapy, 60 minutes per session) with the use of Rehabilitation Massage Device Vitberg+ - RAM Vitberg+ with the Knees Module (Vitberg, Nowy Sacz, Poland). The applied vibration stimulus range from 10.10 Hz to 52.20 Hz, amplitude from 0.01 mm to 0.21 mm and acceleration from 0.01 m/s2 to 13.50 m/s2. Each intervention is the same medical program written by the manufacturer of the medical device, which includes various frequencies and amplitudes that change over time during the intervention. After turning the device on, it turns off automatically when the program is finished. Vibration stimulus will be applied locally to popliteal fossa and thighs and calves simultaneously. The control group will perform the intervention with the devices not producing measurable vibration at application surface only sound of working device. Each volunteer will be qualified by an experienced orthopedic specialist before participation in the study. Before and after the first week and last interventions and after 1 week and 4 weeks thermographic images will be taken and analyzed. Before the beginning, at the end, after 1 week and 4 weeks after the end of the program, measurements of activity assessment by the KOOS - Knee Injury and Osteoarthritis Outcome Score questionnaire) and Time Up and Go test will be performed. The experienced physician will perform the knees joint range of motion (ROM) measurements. The measurements will be carried out by one specialist. The subjects will complete assessment of pain by 3 independent tools (the VAS scale, the Laitinen scale and the McGill Pain Disease sheet. Every session will be followed by attendance checklist for each subject. The follow-up points will be at one week and one month after the treatment. The therapy will take place at Vibrotherapy Vitberg clinic in Nowy Sacz, Poland and will be supervised by the members of Academy of Physical Education in Krakow, Poland.
Intervention code [1] 314446 0
Rehabilitation
Intervention code [2] 314447 0
Treatment: Devices
Comparator / control treatment
3-weeks series with a sham vibration therapy treatments in a sitting position, with upright legs, with support of the knees (the same as intervention group). Therapy includes 15 interventions. One intervention lasts 60 minutes. The intervention will be applied once daily (excluding the weekends - 15 days of therapy, 60 minutes per session) with the use of the sham version of Rehabilitation Massage Device Vitberg+ - RAM Vitberg+ with the Knees Module (Vitberg, Nowy Sacz, Poland). The control group will perform the intervention with the devices not producing measurable, perceptible stimulus at application surface. The device will produce only sound of the working device.
Control group
Placebo

Outcomes
Primary outcome [1] 320039 0
Influence of vibrotherapy treatment on the cutaneous temperature of examined area assessed by thermographic images taken with use of thermal camera.
Timepoint [1] 320039 0
Baseline, 3 weeks (primary endpoint), 4 weeks (post-enrolment), 7 weeks (post-enrolment).
Primary outcome [2] 320040 0
Influence of vibrotherapy treatment on the range of motion of the knee assessed by goniometer.
Timepoint [2] 320040 0
Baseline, 3 weeks (primary endpoint), 4 weeks (post-enrolment), 7 weeks (post-enrolment).
Primary outcome [3] 320041 0
Influence of vibrotherapy treatment on the change in knees pain sensation assessed by visual analog scale (VAS).
Timepoint [3] 320041 0
Baseline, 3 weeks (primary endpoint), 4 weeks (post-enrolment), 7 weeks (post-enrolment).
Secondary outcome [1] 370340 0
Influence of vibrotherapy treatment on the change in knees pain sensation assessed by the Laitinen scale.
Timepoint [1] 370340 0
Baseline, 3 weeks, 4 weeks (post-enrolment), 7 weeks (post-enrolment).
Secondary outcome [2] 370341 0
Influence of vibrotherapy treatment on the change in knees pain sensation assessed by the McGill Pain Disease sheet.
Timepoint [2] 370341 0
Baseline, 3 weeks, 4 weeks (post-enrolment), 7 weeks (post-enrolment).
Secondary outcome [3] 370342 0
Influence of vibrotherapy treatment on the activity assessment by the KOOS - Knee Injury and Osteoarthritis Outcome Score questionnaire).
Timepoint [3] 370342 0
Baseline, 3 weeks, 4 weeks (post-enrolment), 7 weeks (post-enrolment).

Eligibility
Key inclusion criteria
Diagnosed osteoarthritis of the knee (minimum 5 years).
Minimum age
40 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The use of vibro-therapy during the last 6 months.
Weight over 160 kg.
Sensory disturbances in the study area.
Venous thrombotic disease or post-thrombotic syndrome.
Neurological diseases, including hemiparesis.
Diagnosed active cancer disease.
Contraindications to vibrotherapy.

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)
Volunteers are randomly assigned to the groups.
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


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The normality of the variable distribution with Shapiro-Wilk test.
Student's t-test or Wilcoxon's test.
Analysis of variance with repeated measurements.
a = 0.05.

Recruitment
Recruitment status
Recruiting
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] 21474 0
Poland
State/province [1] 21474 0
Lesser Poland

Funding & Sponsors
Funding source category [1] 302745 0
University
Name [1] 302745 0
University of Physical Education in Krakow
Address [1] 302745 0
al. Jana Pawla II 78
31-571 Cracow, Poland
Country [1] 302745 0
Poland
Primary sponsor type
University
Name
University of Physical Education in Krakow
Address
al. Jana Pawla II 78
31-571 Cracow, Poland
Country
Poland
Secondary sponsor category [1] 302677 0
Individual
Name [1] 302677 0
prof. Joanna Golec
Address [1] 302677 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Cracow
Country [1] 302677 0
Poland
Secondary sponsor category [2] 302801 0
Individual
Name [2] 302801 0
M.Eng Alicja Pasterczyk-Szczurek
Address [2] 302801 0
Vitberg Jacek Sikora,
ul. Borelowskiego 29,
33-300 Nowy Sacz
Country [2] 302801 0
Poland
Secondary sponsor category [3] 302802 0
Individual
Name [3] 302802 0
Dr Agata Maslon
Address [3] 302802 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Cracow
Country [3] 302802 0
Poland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303345 0
The Ethical Committee of Regional Medical Chamber in Cracow
Ethics committee address [1] 303345 0
ul. Krupnicza 11a
31-123 Cracow, Poland
Ethics committee country [1] 303345 0
Poland
Date submitted for ethics approval [1] 303345 0
10/07/2018
Approval date [1] 303345 0
20/07/2018
Ethics approval number [1] 303345 0
120/KBL/OIL/2018

Summary
Brief summary
Osteoarthritis (osteoarthrosis, OA) is one of the most frequently registered in clinical practice. The aim for the research is to determine the effect of inconstant frequency and low amplitude vibrations to reduce pain, improve vascular flow and functional status in patients suffering from knee osteoarthritis. The study will be based on subjects from orthopedic trauma surgery clinics. The subjects will participate in a fifteen-day cycle of vibrotherapy procedures, lasting 60 minutes each, once a day, in a semi-recumbent position. The vibrational exposure will be carried out with the use of medical equipment - Rehabilitation Massage Device Vitberg+ (RAM Vitberg+) with the defined by manufacturer therapy program. Recruitment for the study will be performed by the medical specialist.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93354 0
Mrs Alicja Pasterczyk-Szczurek
Address 93354 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Cracow, Poland
Country 93354 0
Poland
Phone 93354 0
+48 18 442 32 21
Fax 93354 0
Email 93354 0
alicja.pasterczyk@vitberg.com
Contact person for public queries
Name 93355 0
Mrs Alicja Pasterczyk-Szczurek
Address 93355 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Cracow, Poland
Country 93355 0
Poland
Phone 93355 0
+48 18 442 32 21
Fax 93355 0
Email 93355 0
alicja.pasterczyk@vitberg.com
Contact person for scientific queries
Name 93356 0
Mrs Alicja Pasterczyk-Szczurek
Address 93356 0
University of Physical Education in Krakow
al. Jana Pawla II 78
31-571 Cracow, Poland
Country 93356 0
Poland
Phone 93356 0
+48 18 442 32 21
Fax 93356 0
Email 93356 0
alicja.pasterczyk@vitberg.com

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
No Results