What is OsteoSpine® therapy?
OsteoSpine® therapy (Mod: Osteospine) is biophysical therapy for patients with spine pathologies.
OsteoSpine® therapy controls the inflammatory process and favours bone healing.
OsteoSpine® therapy remedies the acute and chronic pain of osteoporotic vertebral fractures, favours the reabsorption of edema, improves quality of life and allows the patient to resume normal daily activities.
When OsteoSpine® therapy indicated?
Osteoporotic vertebral fractures are associated with a considerable reduction in quality of life, morbidity, and mortality.
The management of patients with vertebral fractures should include treatment for osteoporosis and appropriate measures to reduce pain and improve mobility.
OsteoSpine® therapy remedies the acute and chronic pain associated with osteoporotic vertebral fractures, favours the reabsorption of edema, favours bone healing and allows the patient to resume normal daily activities.
How does OsteoSpine® therapy work?
OsteoSpine® therapy is a capacity coupling electrical stimulator with osteogenetic and anti-inflammatory activities.
The treatment efficay depends of the physical parameters of the signal: pulse train signal with frequency 12,5 Hz and duty cycle of 50%. Every single pulse train is made up of a sinusoidal signal of 60 kHz (patented).
More precisely OsteoSpine® therapy biophysical signal acts on the cell mambrane favouring the release of calcium ions from the endoplasmic reticulum.
The localised increase in calcium triggers the bone repair process.
How do you know if OsteoSpine® therapy is working properly?
Switch on the OsteoSpine® therapy, by moving the switch to position "I". A yellow and red indicators will illuminate, and the buzzer will emit a short buzz indicating that the system is switched on.
The device will then take a few seconds in order to check that the electrodes are present and correctly applied to the body (continuous yellow indicator light on) and once this test is completed the treatment commences (flashing yellow light).
The correct operating procedure is indicated by the flashing yellow LED. The flashing yellow light indicates the correct mode for therapy.
Once the treatment session is compleate, the patient should switch off the generator by moving the switch to the "O" position (all the indicator lights will be off).
Is OsteoSpine® therapy safe?
Yes. Its biological and electrical safety are widely documented.
Thousands of patients have successfully used OsteoSpine® therapy in the absence of negative side effects.
OsteoSpine® therapy is manufactured in compliance with the IEC 60601-1 standards, meets the requirements of directive 93/42/EEC and it is CE0051 marked.
What does OsteoSpine® therapy feel like and what effect does it have on daily activities?
The patient does not feel the presence of the electric field generated by OsteoSpine® therapy.
The treatment does not interfere with daily activities.
To guarantee the effectiveness of the therapy, the treatment parameters (in compliance with the CEI EN 60601-1-11 standard) are preset and can not be changed, even accidentally, by the patient.
How long does daily treatment last?
Daily treatment with OsteoSpine® therapy must be at least 8 hours (not necessarily consecutive).
The attending physician will specify the total duration of therapy in accordance with the pathology being treated.
Should OsteoSpine® therapy be used at the same time every day?
No, treatment can be carried out at any time of day.
Daily treatment may be split into several shorter sessions, provided they are at least 2 hours per session.
What happens if I miss a treatment session?
It is advised to recommence the treatment program as soon as possible.
How long does healing take with OsteoSpine® therapy?
Treatment length depends on the severity of and length of time since fracture.
The doctor prescribes the duration of the therapy based on his experience and on the results of clinical trials.
Before discontinuing therapy, even if there are clear signs of improvement, it is always necessary to firstly consult your doctor.
The constant daily use of OsteoSpine® therapy and the continuity of treatment until recovery is essential to promote the healing process.
Can OsteoSpine® therapy be used by patients with a pace-maker?
Yes, however coils should be positioned at least 50 cm away from pace-maker.
In this situation, Cardiologist advice is recommended.
Can OsteoSpine® therapy be used during pregnancy?
The effects of an electric field in pregnancy or while breastfeeding have not been investigated and, therefore, Physician advice is recommended.
Does OsteoSpine® therapy need special care or specific maintenance?
OsteoSpine® therapy is prepared and shipped to patients ready for use. No intervention or maintenance is required.
To guarantee the reliability of the performance, OsteoSpine® therapy should be subjected to ordinary maintenance procedures and a control of the operating parameters (to be performed by the IGEA Service Centre) every 24 months of use (Guide IEC 62-122).
Does OsteoSpine® therapy have contraindications or side effects?
OsteoSpine® therapy has no contraindications or side effects.
The experience gained in treating thousand of patients guarantees the safety of all the IGEA therapies.
I am a cancer patient, can I use OsteoSpine® therapy?
In patients with oncological diseases the use of OsteoSpine® therapy is not contraindicated.
However, we would advise you to consult your doctor.