None listed
Conditions
Brief summary
This study evaluates the effects of adding Bodyflow therapy to the standard of care treatment after patients underwent a surgical procedure for total knee replacement (TKR). The Bodyflow treatment will consist of an in-hospital component, as well as a self-administered component after the patient has been discharged. The effect of the treatment on the duration of the post-operative hospital stay will be the primary objective, while its effects on peripheral tissue oedema and patient’s pain scores are evaluated as secondary objectives.
Interventions
Low voltage electrical stimulation of muscles to reduce post-surgery oedema. Therapy is delivered by placing 1 pair of skin electrodes just above the knee, and another pair just below the knee that was operated on. Low voltage (<5V) pulses will slightly stimulate the muscles in thigh and calf which will help reduction of oedema. Treatment is started 2 days post operation with in-hospital treatment, until the day of hospital discharge. From that day on the patient will administer the treatment at
Low voltage electrical stimulation of muscles to reduce post-surgery oedema. Therapy is delivered by placing 1 pair of skin electrodes just above the knee, and another pair just below the knee that was operated on. Low voltage (<5V) pulses will slightly stimulate the muscles in thigh and calf which will help reduction of oedema. Treatment is started 2 days post operation with in-hospital treatment, until the day of hospital discharge. From that day on the patient will administer the treatment at home (using a handheld device) until 2 weeks after operation. Treatments are administered in 3-4 sessions of 20 minutes daily. This treatment is in addition to the standard care.
Sponsors
Bodyflow International PTY LTD
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Candidates for Total Knee Replacement surgery
Exclusion criteria
Patients with a past history of Deep Vein Thrombosis or Thromboembolic event, Patients with an implanted pacemaker or Internal Cardioverter Defibrillator, Pregnant women, Patients suffering from Diabetes type 1, Patients whom have a bleeding disorder such as Haemophilia or associated Coagulopathy
Outcome results
None listed