Doctor Q&A
What are the various clinical indications that have been treated with the Calmare® Pain Therapy Treatment (“Calmare®”) technology?

Various types of neuropathic, oncologic and visceral pain. Severe pain non-responsive to pharmaceutical treatment, TENS or implanted devices.

Describe the treatment protocol for the various indications.
Mixed or neuropathic pain
10/12 consecutive treatments of 30 or 45 minutes; once a day for five days a week.
Oncologic Pain:
initial treatment program consisting of 10/12 consecutive treatments of 45 minutes, once a day, and every time the pain reappears. Analgesia on patient request.
What is the mean treatment protocol?

10/12 consecutive treatments once a day, and booster cycles when needed.

What is the mean VAS score for patient selection?

All VAS are potentially responsive to the Calmare® treatment, but studies focused on a mean VAS >7 on a 0 to 10 standard scale.

What is the mean result per clinical indication?

In the follow up to a cure cycle, 10/12 applications, the biggest difference in results is not found in neuropathic pain types, but between monoradicular and pluriradicular neuropathies. The effects of a treatment cycle on monoradicular neuropathies can be extended to greater than three months. For pluriradicular neuropathies the effects on a treatment cycle can be extended from one to three months, according to the damage severity.

Have there been treatment results with "no pain" periods of seven days, or longer?

After a 10/12-treatment cycle "no pain" is the most likely expected response.

What is the longest recorded "no pain" result between treatments?

No relapse during the check-up after one year.

What is the mean recorded "no pain" result between treatments?

From one to three months for VAS <2 on a 0 to 10 scale.

What clinical indications favor longer "no pain" periods?

Neuropathies where tissue damage is stabilized and not sensitive to new inflammation, or damage triggered by movement or other pathologies. In these cases, the complete therapy cycle can be decisive. This is often witnessed in sciatica where the operation is successful, yet the pain remains. In these cases, a complete treatment cycle of 10/12 treatments after the operation seems to completely solve the problem.

What known clinical indications are not receptive to treatment with the MC-5A device?

Determining clinical indications that are and are not receptive to treatment with the Calmare® device is ongoing and specific to the underlying causes to a particular patient’s pain. It is important to note that “Not Receptive” refers only to patients who do not have benefits after a treatment cycle, or where it is not possible to identify the correct area or dermatomes to treat. This is highly dependent on the clinician/technician skills and ability to correctly identify the correct area(s) for placement of the electrodes. A rapid pain relapse after the treatment cycle occurs in an evolutionary pathology, or in the presence of mechanic or inflammatory causes that continuously damage the nervous tissue. In these cases, the therapy should be carried out continuously every time the pain appears, since a single cycle is not sufficient to adequately treat an unstable situation of nervous tissue damage. It has also been noticed that anticonvulsant drugs reduce the medium – long-term efficacy retention, while analgesics, such as anti-inflammatory or paracetamols have proven to be synergistic.

What is unique about treating oncologic neuropathies?

It is critical to the success of the treatment for the clinician to place the electrodes at the proper nerve zones to produce the best analgesia. The duration of the analgesic affect will depend upon how many zones were successfully engaged during the treatments. The type of cancer or the advanced stage of cancer does not allow long pauses of "no pain" periods. Similar to drug protocols, the patient is treated whenever the patient has pain present. The key to successful treatment is the proper training of the clinician.