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Nov. 14, 2005 Intradiscal electrothermal therapy (IDET) is not better than sham for chronic discogenic low back pain, (CDLBP) according to the results of a randomized, double-blind trial reported in the Nov. 1 issue of Spine.

"Early studies on IDET were promising, offering patients an option other than chronic pain management or spinal fusion," write Brian J. C. Freeman, FRCS, from Royal Adelaide Hospital in South Australia, and colleagues. "It has been suggested that IDET may coagulate annular nociceptors and lead to contraction of collagen, thereby addressing both the nociceptive and mechanical components of discogenic pain."

Inclusion criteria were patients with CDLBP who failed to improve following conservative therapy, with one- or two-level symptomatic disc degeneration with posterior or posterolateral annular tears determined by provocative computed tomography discography. Patients with greater than 50% loss of disc height or previous spinal surgery were excluded.

Of 57 patients who were randomized, 38 (66%) received IDET and 19 (33%) received a sham procedure (placebo). For all patients, the IDET catheter covered at least 75% of the annular tear as demonstrated on computed tomography discography. An independent technician connected the catheter to the generator and then delivered either electrothermal energy (active group) or did not (sham group), allowing blinding of the surgeon, patient, and independent outcome assessor. All patients received standard postprocedural rehabilitation.

Both groups had similar baseline demographic data, initial Low Back Outcome Score (LBOS), Oswestry Disability Index (ODI), Short-Form 36 questionnaire (SF-36), Zung Depression Index (ZDI), and Modified Somatic Perceptions Questionnaire (MSPQ).

No subject in either group met criteria for successful outcome, defined as no neurologic deficit, LBOS improvement greater then seven points, and improvement in SF-36 subsets (physical function and bodily pain) greater than one SD.

No subject in either group had a neurologic deficit or showed improvement of greater than seven points in LBOS or greater than one SD in the specified domains of the SF-36. For the IDET group, mean ODI was 41.42 at baseline and 39.77 at six months. For the placebo group, mean ODI was 40.74 and 41.58, respectively. Neither group had a significant change in ZDI or MSPQ scores.

"The IDET procedure appeared safe with no permanent complications," the authors write. "Detailed analyses showed no significant change in outcome measures in either group at 6 months. This study demonstrates no significant benefit from IDET over placebo."

Oratec Interventions, DePuy AcroMed, and Smith and Nephew, Inc., have disclosed that they supported this study. The device is approved by the U.S Food and Drug Administration or approved by another national agency for this indication. Although one or more of the authors have disclosed that they have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article, benefits will be directed solely to a research fund, foundation, educational institution, or other nonprofit organization.

Spine. 2005;30:2369-2377

Clinical Context
According to the authors, the treatment of CDLBP remains a challenge for the spinal specialist after failure of conservative treatment or spinal fusion. However, outcomes following spinal fusion remain variable with satisfactory results in 46% to 82% of cases. The IDET procedure was introduced as an alternative to spinal surgery and uses controlled thermal energy delivered through an intradiscal catheter to address the nociceptive and mechanical components of pain. However, the efficacy of the method is uncertain and studies have reported conflicting results for control of pain and disability, according to the authors.

The current study is a randomized, double-blind prospective, sham-controlled trial comparing six-month outcomes with the use of IDET vs sham procedure for the treatment of CDLBP. Patients were enrolled from the practices of three consultant spinal surgeons in a large city.

Study Highlights
Inclusion criteria were age older than 18 years with marked functional disability, failure to improve with 6 weeks of conservative therapy, including medication and physical therapy, degenerative disc disease on magnetic resonance imaging with global disc degeneration or posterior or posterolateral annular tear, presence of 1- or 2-level symptomatic disc disease determined by provocative lumbar discography, and sitting intolerance greater than standing intolerance.
Exclusion criteria were large contained or sequestered herniation, severely disrupted disc not permitting catheter placement, 3 or more lumbar disc levels, neurogenic disc claudication due to spinal stenosis, psychological condition or medication interfering with outcomes, current injury litigation, and pregnancy.
Three surgeons performed all the procedures.
The procedure was carried out under neuroleptic and local anesthesia with 1 g of cefazolin administered before and after. Surgeons used the posterolateral approach under fluoroscopic guidance with a 17-gauge introducer needle.
The catheter was navigated to cover at least 75% of the posterior annulus.
Once the catheter was in place, either IDET or no treatment was applied by a technician. Both surgeon and patient were blinded to treatment assignment.
IDET was delivered using a standard heating protocol starting at 65C rising for 12.5 minutes to 90C and held for 4 minutes.
All patients underwent a standard rehabilitation program using Pilates-based exercises.
Primary outcome was success defined as no neurologic deficit, improvement in the PBOS of 7 or more points, and improvement in the SF-36 physical functioning and bodily pain subscales of at least 1 SD.
Secondary outcomes were change in Visual Analog Scale (VAS) score for LBP, the ODI, ZDI, the MSPQ score, sitting tolerance, standing tolerance, medication use, and presence of any neurologic deficit.
Enrollment was below the calculated number required to meet predetermined power calculations (50 in the IDET and 25 in the sham group), and the study was prematurely halted at an enrollment of 57 patients.
38 patients were randomized to IDET and 19 to placebo sham treatment.
3 patients were excluded from analysis due to protocol violations.
Mean age was 38 years, there were more men than women, and the main complaint was low back pain. 89% to 100% had abnormal range of flexion or extension.
Mean duration of symptoms was 41 to 66 months, and one quarter to one third had undergone physical therapy, bed rest, anti-inflammatory treatment, and/or exercise programs.
No patient in either group reached the criteria for successful outcome.
Secondary outcomes at 6 months were similar for both groups for all measures.
There were no differences in secondary outcomes when analyzed by the surgeon performing the procedure.
There were no serious adverse events in either group. Transient radiculopathy of less than 6 weeks was reported in 4 of the IDET patients and one of the sham patients.
Pearls for Practice
The IDET procedure uses controlled thermal energy delivered through an intradiscal catheter to address the nociceptive and mechanical components of pain in CDLBP.
Use of the IDET procedure in patients with CDLBP unresponsive to conservative treatment is not associated with significant improvements in pain or function at six months.

All these different types of back surgeries, sure can make a person think. One thing you are NEVER told with fusion, is what it can do to the disc above or below. The pressure from the fusion, can cause the other discs to blow out. That is what is happening in my case. Referred to as the "domino effect". Then of course there is always the chance of scar tissue and bony overgrowths, etc. Gets to pressing on nerves and causes lot of problems. I think I am better in some ways but worse in others, if that makes sense. I am not sorry I had the fusions because I couldn't have stood it the way it was. It has all made me old before my time!!
Elaine

Ken,
I think I must have missed this post. Wow, it is almost a month old.(Wish I was)
I have never tried Methadone. My main pain reliever is Oxycontin, with Vicodin for breakthrough. Doctor started me out on 10mg. of Oxycontin(2xday) which did absolutely nothing. I have been on 20mg. twice a day for about a year. I am increasing to three times a day now, as it just doesn't seem to be doing much of anything. That is what scares me. We seem to become immune to the current dosage and need more. It seems like a lot to me, but to some people, it is nothing compared to what they have to take.
Fusion is a very scary thing to go through. I won't even tell you how bad it hurts to get out of bed the first time. It would scare the @@@@ out of you. Probably no worse than the rib surgery though.
I need to be scheduling a myelogram, but after having had one of them, I am not too keen on the idea. The doctor said it would be no picnic, but he thought they had improved since I had my last one. I ended up with one of the famous spinal headaches, that lasted three days.
I agree with your doctor. Deal with it, until you can't stand it. I am not sorry I had the surgery because I was getting electrocuted everytime I moved wrong. Until the disc would heal over, I walked stooped over because I couldn't straighten up. Now I deal with more discs going because of pressure from the fusion. It is such a mess. I have such a spinal history that doesn't even makes sense to me.(Neither do the doctors) Three opinions and no one agrees to anything. Who do you believe? Your gut instinct, I guess. I am getting to the point, I need to do something. Just not sure what.
Elaine