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Thermal annuloplasty PDF Print E-mail

Introduction to Thermal annuloplasty
(also called: IDETT, IDET, PIRFT, Intra-Discal Electro-Thermal Therapy)

THERMAL ANNULOPLASTY is an FDA approved minimally invasive spine procedure to treat mid and lower back pain. THERMAL ANNULOPLASTY is for people who have moderate to severe back pain that interferes with their lives and which does not get enough better with physical therapy and medications.    As with all interventional procedures, this procedure is only for patients who havea good understanding of the various options available to them and the risksand benefits of each.  Thermal annuloplasty is not a substitute for intensive multidisciplinary rehabilitation of the type offered through the Integrative Pain Center -  in fact, in  most cases this procedure is offered as an adjunct to our multidisciplinary program, when the patient's back pain is severely limiting and psychosocial factors do not appear to be prominent; and provided the patient's health insurance plan will support a multidisciplinary approach to pain treatment.    
  • It is not for the leg pain (sciatica) that goes with a herniated or slipped disc, or with spinal stenosis.
  • Thermal annuloplasty is therefore not an alternative to surgical procedures for leg pain/sciatica (including discectomy, foraminotomy,laminectomy, laser decompression, and others)
There are two variations of the thermal annuloplasty procedure.  Allmost all of the research has studies the first generation procedure introduced in mid1990, yet at IPCA 80% of the thermal annuloplasty procedures are done using a very different generation II technique, introduced in about 2002.  Both techniques involve heating the outer covering of a painful intervertebral disc, but they use different methods - and we think that this makes a big difference in results.  The generation II technique includes taking actual temperature measurements in the outer disc, for example.
                      
Here are our results as of 2008 for lumbar discs, Generation II technique:

 

 

 

At IPCA we continue to offer thermal annuloplasty because

 

 

  • We see patients whose back pain is fairly debilitating yet they have not responded adequately to conservative care up to and including our multidisciplinary rehabilitation program - the back pain is often identified as interfering significantly with their progress in this program.
  • We see patients whose persistent back pain seems likely to have an organic cause based on history, physical exam, and advanced testing.  
  • We are seeing good results about 70% of the time (good results means at least 50% pain reduction that lasts).
  • We are not seeing complications at anywhere near the severity or frequency that we see with surgical procedures for back pain such as fusion or disc replacement.
  • The procedure is far less costly (especially when done in the office) and has much shorter recovery time than the surgical procedures.
  • If thermal annuloplasty works, a patient may avoid a bigger surgical procedure.
  • If thermal annuloplasty does not work, the door is still open for a surgical procedure - but if a patient has a surgical procedure, the door is shut to thermal annuloplasty in the future.

Here is a typical patient report of the long term results of generation II thermal annuloplasty, this is typical of what the 70% who do well say, and is helpful in understanding what to expect:

 

 

 

 

 

From: Kathy Malone [
Sent: Wednesday, August 27, 2008 12:01 PM
To: This e-mail address is being protected from spambots. You need JavaScript enabled to view it
Subject: IDET info

 

 

Dr. Davis,

 

 

    Just to give you an update on my condition, it’s now been 25 months since my procedure (July 2006) and I consider it very successful. Although I had to give up running for exercise (I had to give it up before the procedure - and the procedure did not get me back to running), I am able to walk several miles at a time at a fast pace, use an elliptical trainer several times a week, lift light weights and do core strengthening exercises without pain. My lower back muscles do get tight, but I’ve found that some massage and stretching make that manageable.  

 

 

 The biggest difference for me is that I can now sit for long periods of time without severe pain, which I was unable to do prior to the IDET. I am very pleased with the outcome of my IDET procedure and have absolutely no regrets (even though I had to pay for it myself and fly to AZ!) because it allowed me to avoid major surgery. J   

 

 

 If it is still possible to post comments on a website, please let me know. I would be happy to do so.

 

 

Thanks again!

 

 

Kathy Malone, MA, ATC

 

 

Urban Outreach Coordinator

 

 

Methodist Sports Medicine / The Orthopedic Specialist

 

 

Indianapolis, IN

 

 

 

 

 

 

 

 

Patient Education Handout: Thermal Annuloplasty 

What is the purpose of THERMAL ANNULOPLASTY?
To decrease back pain and improve tolerance of activity (sit longer, stand longer, sleep better, etc.).

 

 

 

 

 

How does THERMAL ANNULOPLASTY work?

 

 

With age or injury, discs may degenerate (cracks, tears, or fissures develop). This is a situation similar to “torn cartilage” in the in the knee. Torn knee cartilage causes knee pain and there is evidence that torn disc cartilage causes back pain. THERMAL ANNULOPLASTY is used to apply heat to the tears in the covering of disc, called the “annulus fibrosis”, contracting and thickening the protein, and raising the temperature of the small nerve endings which destroys them. The heat may result in contraction of fissures (cracks) and innactivation of pain sensing nerves in the disc tear. The first THERMAL ANNULOPLASTY’s were performed in 1995 and the procedure was formally approved by the FDA in 1998. Most studies have shown that 60 - 70% of patients have at least some improvement in low back pain after the THERMAL ANNULOPLASTY procedure. There has recently been a placebo1 controlled study published that shows that the procedure is more effective than placebo . All these studies have been done using the original generation I technique and we use the newer Radionics technique (sometimes called PIRFT) for most lumbar THERMAL ANNULOPLASTY procedures and we are finding better results because this new technique more directly heats the tear in the disc, and we can control the temperature or the tear better.

Prior to the THERMAL ANNULOPLASTY procedure, the patient undergoes a discogram. This is a test used to confirm the diagnosis of a painful tear in a disc. If the discogram reveals a degenerated and painful disc or two, that patient may be a candidate for the THERMAL ANNULOPLASTY procedure

1 Pauza A Spine 2004 Jan-Feb; 4 (1):27-35.

 

 

  

 

 

Who might benefit from it?

 

 

 

People with moderate to severe upper or lower back pain that has not gotten better with physical therapy, which interferes a lot with quality of life, and which has been bad for at least 4 months.

 

 

 

 

 

Who should not have thermal annuloplasty?

 

 

• Patients whose back pain is not from a disc tear • Patients whose x-rays show very severely degenerated discs • Patients who are very overweight • Patients who have been diagnosed with spinal instability or severe spinal stenosis • Patients with pressure on nerves that is causing severe weakness, numbness, or changes in bowel or bladder control. Patients with these symptoms need urgent medical evaluation for possible surgery. • People with active infections. • Pregnant women. • Patients taking blood thinning medication who cannot stop the medication for a week.

 

               

 

How is it actually performed?

 

 

 

  
Generation I technique: one heating catheter, no temperature monitoring in the outer disc
   
THERMAL ANNULOPLASTY is an outpatient procedure. Patients will go home the same day. The patient is given a mild sedative/pain killer to reduce the discomfort during the procedure. The patient is awake so that you can give valuable feedback to the physician during the insertion of the needle into the discs and the heating of the catheter that follows. The patient is on their stomach during the procedure and the back is “numbed” with a local anesthetic. With the guidance of x-ray images, a needle is inserted into the disc and a catheter is passed through the needle. Once the catheter is in the appropriate position, it is heated for about 10-15 minutes. After heating is completed, the needle and catheter are removed. A band-aid is placed over the needle insertion site and a back brace is applied. Patients are discharged home with a friend or family member.
     

Will I be “put out” for this procedure?

 

 

 

No – a nurse or an anesthesiologist will be with you, but you are awake enough so you can give the physician valuable input during the procedure.

 

 

  

 

 

 

 

Will the procedure hurt?

 

 

 

The procedure involves inserting a needle through the skin and underlying tissue into the disc, so some discomfort is involved. However, we will numb the skin around the injection area with a local anesthetic using a very thin needle before inserting the procedure needles.

 

 

 

 

 

 

 

What are the risks and side effects?

 

 

This procedure is very low risk compared to major back surgery procedures. However, as with any procedure, there are risks, side effects and the possibility of complications. The most common side effect is pain at the site of the needle insertion, which is temporary. The other risk factors involve bleeding, infection, damage to nerves and injection into blood vessels and surrounding nerves. Fortunately, serious side effects and complications are uncommon. A rare complication of this procedure is an infection in the disc, which is referred to as discitis. The procedure has not been in use long enough to know if there are delayed problems that might occur 15 or more years after, but there is no sound reason to suspect that there will be problems late after the procedure.

Will my insurance cover THERMAL ANNULOPLASTY?
Some insurers do and some do not.  Blue Cross Blue Shield covers the procedure and has published their reasons.  Other insurers look at the same information yet they decide not to cover the procedure. That is unfortunate, because it is the patient and their medical team that should be making these decisions!

 

 



What should I expect after the procedure?
Discomfort from the disc heating may take several days up to 3 weeks to subside.  The benefit from the procedure can be felt early in some cases, but sometimes it can take several weeks  to see improvement.

 

 

The following are things you can do for pain control:
FOR PAIN

 

 

 

• Apply ice 1 to 3 times a day • If your physician has prescribed an anti-inflammatory medication, take this as prescribed for pain. • If your physician has prescribed a pain medication, take this as prescribed for pain. • If your physician has prescribed a TENS unit, use this as directed for pain control.
  

  

Activity Restrictions: Thermal Annuloplasty 

DOs AND DON'Ts FOR THE FIRST SIX WEEKS

• Wear your back brace as much as you can for the first six weeks. You may take it off at night.
• Rest the first three days after the THERMAL ANNULOPLASTY procedure. You are not restricted to bedrest, but no bending, lifting, standing or   
  sitting for more than 30 minutes at a time.
• After the first three days: > You may begin walking for exercise.
    > Do not sit longer than 30 minutes at a time.
    > You may return to light activity and light duty work, as you are able to tolerate without increasing pain or fatigue.
    > Avoid sudden or frequent bending or twisting
    > Do not lift anything over 10 pounds
    > You may drive after three days if your pain level is mild. If it is still moderate to severe at 3 days post-procedure, wait to drive until it becomes 
       mild.
• If pain increases in intensity or is severe, wait until your pain level has decreased enough to work with reasonable comfort. The same is true for driving. Use good sense: if a particular activity increases your pain, wait a few more days before resuming that activity.
• After one week, you may begin light housework. You may lift up to 15 pounds.
   You may resume gentle pool exercises if you had been doing these before surgery. Do not swim laps for exercise.  No sittups.

 

 


SECOND SIX WEEKS

 

 

• You may discontinue using the back brace.
• You will have a “check up with your doctor and the physical therapist.
• Increase your exercise routine, involving upper body, leg strengthening and lumbar stabilization exercised on a daily basis as instructed by your physical therapist.
• You may begin swimming laps for exercise.  No sittups.  20 pound lifting limit.
• You may begin riding the exercise bike. Again, use good sense: if a particular activity increases your pain, wait a few more days before resuming that activity. If you feel stiffness in your back, this is normal. It is part of the healing process.

 

 

TWELVE TO SIXTEEN WEEKS POST PROCEDURE

 

 

• You may return to unrestricted work guided by your pain level. Again, use good sense: if a particular activity increases your pain, wait a few more days before resuming that activity. • Avoid heavy exercise and athletics such as tennis, competitive running, weight lifting, snow or water skiing and similar activities.No sittups.  50 pound lifting limit

 

SIXTEEN WEEKS POST PROCEDURE

 

 

• You may resume your accustomed activities/pursuits and physical training
  

  

Pre-procedure Instructions: Thermal Annuloplasty 


If your Pain Management physician has ordered a THERMAL ANNULOPLASTY procedure for you, please follow these instructions:  As soon as you have received a call from the Pain Clinic with a date for your THERMAL ANNULOPLASTY procedure, please call the physical therapy provider to set up two (2) appointments. You need to see a physical therapist who has been trained in our rehabilitation protocol before the procedure.  Our schedulers can assist you with finding the right therapist. One appointment should take place one to two weeks before your procedure. The second appointment should be scheduled for six (6) weeks after your procedure. It is important that you use these time frames because of a sixty day limit your insurance may impose.

 

 

 

 

 

You will also need to obtain the THERMAL ANNULOPLASTY back brace that has been prescribed. You will receive a prescription as part of the scheduling process for the procedure. You will need to obtain this brace before your procedure because you will need to wear it home the day of your procedure. The brace can be obtained from the physical therapist or Hangar Orthopedic and Tucson Limb and Brace. PLEASE BRING THIS BRACE WITH YOU TO YOUR THERMAL ANNULOPLASTY PROCEDURE.

 

 

 

 

 

You may take your usual pain and other medications the day of your procedure, except for blood thinners and diabetic medications. If you take either of these medications you will be given specific instructions as to how to handle those, seperately.

 

 

 

 

 

You will be given instructions for how long to fast by the IPCA scheduler.

 

 

 

 

 

 You will be given instructions on pre-op medications by the scheduler or at your pre-procedure visit. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tuesday, 14 April 2009 01:05
Last Updated on Friday, 11 June 2010 20:17
 
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