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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.

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000832178
Enrollment
86
Registered
2019-06-11
Start date
2019-04-30
Completion date
2021-01-04
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Physical Education in Krakow
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
40 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Diagnosed osteoarthritis of the knee (minimum 5 years).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026