FAQ’S

Patients don’t have to discontinue NSAIDS prior to the procedure. They can stay on them pre-and post treatment. However, it’s preferred to wean them off NSAIDS 2 weeks after the treatment.

NOTE: Patients who are taking medications that may prolong bleeding (such as aspirin), should consult their physician regarding temporary discontinuation.

Patients should discontinue meds which prolong bleeding 5-7 days prior to the procedure. They may resume these meds the following day after treatment. You can check the coagulation blood work prior to surgery if it is of any concern.

Normal activity can be resumed immediately.

Strenuous activity should be delayed for approximately 2 weeks post treatment. Especially if the patient has an increase in pain from baseline….which often happens.

Heat or Ice does not need to be applied post treatment…..however the doctor can use his discretion for the application of either.

Patients may resume NSAIDS immediately post-op.

Orthotic use should be used post-op to decrease the risk of reoccurrence. Furthermore, the patient should continue a stretching program to allow for elongation of the plantar fascia. Steroid injections aren’t necessary, and should have been exhausted at this point. If the patient has increased pain, ensure them that this is part of the reparative process, and provide them palliative care (i.e. ultrasound and strappings).

Although the Medispec device obtained FDA approval without the use of anesthetic, A Posterior Tibial Nerve block in adjunct with a sural nerve block allows for greater patient comfort. This also allows for the device to be placed at a higher level for a greater amount of shocks….which should increase clinical efficacy.

For patients taking anticoagulant therapy such as Coumadin, it is suggested that the patient come off the therapy 7 days prior to treatment and then can start back on the therapy immediately post treatment. An I.N.R. assessment is suggested to gauge the blood’s coagulation.

In our study of 172 treated, 72% of Orthospec patients (115 patients) showed a decrease in pain (measured by the VAS pain scale) of 3 cm or more. 86% of Orthospec patients showed a decrease of pain by 1 or more cm. At enrollment patients had to have 5 cm or more on the VAS scale. Physicians find that an improvement in pain of 2 or 3 cm is highly significant.

During the Orthospec clinical investigation of a total of 172 treated patients, NO sedation or any form of analgesic was used on participating subjects. None was provided before, during or after the treatment procedure in either the active group (Orthospec) or the sham group.

Each additional treatmet provides the same improvement rate respectively. Overseas usage of the Orthospec suggests that multiple treatments result in greater improvement in pain level.

According to overseas studies and current usage of the Orthospec, usually physicians do not exceed more than 4 treatments (4 separate visits). The treating physicianshould use his / her own discretion.

Usual healing time is 3 weeks. We recommend patients come back around 3 weeks after being treated to be assessed again. At this time the doctor can prescribe an additional treatment. We want to leave this up to the physician; depending on the severity of the patients’ condition and the treatment outcome. We recommend a period of roughly 3 weeks to administer another treatment. This period gives the treated area time to heal itself.

We recommend 3 weeks. Again, it is up to the physician’s discretion. We don’t recommend multiple treatments in one visit.

The Orthospec™ provides symptomatic relief of the chronic pain caused by PPF. Plantar Fasciitis occurs when the long ligament or fascia tissue at the bottom of the foot becomes inflamed. What this treatment does is break down or injure the tissue (ligament) as to heal itself, thus reducing the pain. After awhile, the tissue can become inflamed again and the severe pain could come back. Our study looked at the effectiveness out to 3 months post treatment. 86% of patients had reduced their pain level by 1 or cm on the VAS scale out to 3 months, therefore demonstrating that after one treatment, pain can be greatly reduced and the reduction can last out to 3 months. In other Orthospec™ experience, pain reduction or elimination has lasted out to 4 to 6 months.

We are not risking anything not using imaging. Imaging is used to focus the shock wave (F2) onto the affected area of the foot. The reason the competitor uses an additional imaging apparatus is to assist in the focus of their F2. With the Orthospec, our enlarged therapy zone (focal zone) eliminates the need for additional targeting. The yellow marker or target enables the center of the shock wave to be directed to the effected area. However, because the enlarged therapy zone disperses the energy over a wider area, this reduces the pain to the patient. The Orthospec is designed to directly target a wider area of the affected foot without causing damage to surrounding tissues.

Because our therapy zone is larger, the energy is dispersed over a wider area for treatment. Because this energy is not directed to a small area (pinpoint) this reduces the pain of the patient. Thus eliminates the requirement for anesthesia. This does not mean, however, this treatment is not uncomfortable or painful. It means that it is less painful than other devices. All actively treated patients in the study were not given any type of anesthesia or analgesic and they were able to reach energy levels well over 4.

Heidi and Leticia can provide information from various clinical websites. In addition, I can provide you with presentation materials that discuss some foot anatomy. Below I’ve included a couple of diagrams for your review.

We recommend the procedure be carried out by qualified trained medical personnel under a physician’s supervision. The procedure should be supervised by the physician, whether in the room or on the premises.

As far as we know, the permanent code should be out by January 2006. We will look into this further and let you know the current status.

Please discuss this with your managers.

Since our therapy zone is larger than the other devices, it allows the reduction of pain during treatment. The main benefit is to patients who are more able to tolerate higher energy levels without sedation. And for the physicians, this eliminates the need for additional imaging and the extra cost for anesthesiologist.

The Orthospec™ reduces and in some cases temporarily subside pain for more than a one month period and even longer depending on the severity of the case. In terms of safety, we found that over a 12 month period patients experienced 0 adverse events, therefore treatment is deemed safe over a long period of time.