Frequently Asked Questions
- What is the Spinal-Stim® Bone Growth Stimulator, and how will it help me?
- How does Spinal-Stim work?
- Is Spinal-Stim safe?
- Can I wear Spinal-Stim with a TENS unit or cardiac pacemaker?
- What will Spinal-Stim treatment feel like? How will it affect my daily activities?
- What is my daily treatment time?
- Do I need to wear Spinal-Stim at the same time each day?
- Can I wear Spinal-Stim over a brace?
- How long will it take to heal with Spinal-Stim?
- Will my insurance company pay for the device?
- Does Orthofix pre-authorize the bone growth stimulator with my insurance company?
- What happens if my insurance company denies the claim?
- Who do I call if I have questions?
What is the Spinal-Stim® Bone Growth Stimulator, and how will it help me?
The Spinal-Stim spinal fusion system is a safe, nonsurgical treatment your doctor has prescribed to aid the healing of your spinal fusion. Spinal-Stim is a bone growth stimulator which uses a very low-strength pulsed electromagnetic field (PEMF) to activate the body’s natural healing process.
Electrical currents have been used to heal bones since the mid-1800’s. However, it wasn’t until the 1950’s that scientists made an important discovery. When human bone is bent or broken, it generates an electrical field. This low-level electrical field activates the body’s internal repair mechanism which, in turn, stimulates bone healing.
Bone growth stimulation therapy was initially used to stimulate the natural healing process in long bone fractures. The treatment proved so successful that scientists studied its effectiveness in healing spinal fusions. The results showed that, when Spinal-Stim is used following spine surgery, fusion success can be increased when compared to surgery without Spinal-Stim treatment.1
How does Spinal-Stim work?
Using electricity, Spinal-Stim generates a low-level magnetic signal at the fusion site. This signal stimulates your own normal bone healing process which may be impaired or absent.
Is Spinal-Stim safe?
A: Yes. Spinal-Stim produces a signal at the fusion site like the one your own body generates to induce normal bone healing. The PEMF therapy emitted by Spinal-Stim was specially designed with your safety in mind, and is similar in strength to what you’re exposed to naturally from the magnetic field of the earth.
Well over 265,000 Orthofix patients have worn our spine stimulators to increase the probability of fusion success. Spinal-Stim may be safely used with surgical hardware. You should not wear the device if you have an implanted cardiac pacemaker. The effect of PEMF treatment during pregnancy or nursing has not been studied. Therefore, you should consult with your doctor if you suspect you may be pregnant. For full prescribing information,see the manual that came with your device or visit www.spinestimulation.com.
Can I wear Spinal-Stim with a TENS unit or cardiac pacemaker?
Spinal-Stim can be used with a TENS unit; however, use of the device with an implanted cardiac pacemaker is contraindicated.
What will Spinal-Stim treatment feel like? How will it affect my daily activities?
You won’t feel the PEMF therapy, and the Spinal-Stim unit is lightweight and adjustable for a comfortable fit. It may be worn alone or over a back brace. It is powered with a rechargeable battery, which allows the unit to be portable. You can sit, stand, sleep, walk, recline, and drive while using Spinal-Stim. With your doctor’s approval, you can resume a normal activity level.
What is my daily treatment time?
Spinal-Stim treatment is based on a daily therapy schedule. Your doctor will prescribe the device for a certain number of hours each day, based on your needs. The minimum daily treatment time is two hours per day.
Do I need to wear Spinal-Stim at the same time each day?
No. You have the flexibility to receive your treatment at any time during the day. The device has a built - in 24 hour clock which allows for treatment each day between the hours of 12:00 a.m. through 11:59 p.m. (Central Time, unless adjusted for your time zone.) Additionally, you may choose to break your total daily prescribed treatment into a number of shorter sessions lasting at least one hour each, in accordance with your doctor’s instructions.
Can I wear Spinal-Stim over a brace?
Yes, it can be worn over an orthopedic brace or clothing without affecting the PEMF signal as it travels through the body to the fusion site.our unit in on your follow-up visits to check your compliance. Most patients wear the device between three and nine months.
How long will it take to heal with Spinal-Stim?
The healing process itself determines the duration of the treatment, and your doctor will closely monitor your progress. Your individual risk factors (such as smoking, multi-level fusion, and graft type) and your compliance in wearing Spinal-Stim will factor into the duration of your treatment. To promote your healing, it is very important that you wear Spinal-Stim daily as prescribed. Your doctor may require that you bring the unit in on your follow-up visits to check your compliance. Most patients wear the device between three and nine months.
Will my insurance company pay for the device?
Insurance policies are different depending on the plan you have chosen. If guidelines are met, the bone growth stimulator is accepted and approved by the majority of private and public health plans, including Medicare, Medicaid and workers’ compensation plans.
Does Orthofix pre-authorize the bone growth stimulator with my insurance company?
Yes, Orthofix will pre-authorize the device with your health plan.
What happens if my insurance company denies the claim?
If this happens, the claim will be pursued by our appeals processing department on your behalf. If all appeals are exhausted and your contracted provider has denied medical necessity, you may receive a claim. If you have not already made prior payment arrangements and you receive a claim, please contact Customer Service at 1-800-535-4492 to discuss payment options and/or arrangements.
Who do I call if I have questions?
Customers may call the Orthofix Customer Service line: 1-800-535-4492.