RCT of IDET

[Guest guest]

So much for the ballyhoo regarding IDET, eh? It sure seemed like it had a

lot of promise at first, but it appears now that nucleoplasty is a better

procedure. So much for 40,000 procedures X $5K per procedure for $200

million in apparently wasted healthcare expenditure.

A Randomized, Double-Blind, Controlled Trial: Intradiscal Electrothermal

Therapy Versus Placebo for the Treatment of Chronic Discogenic Low Back

Pain.

Spine. 30(21):2369-2377, November 1, 2005.

Freeman, J. C. FRCS (Tr & Orth); Fraser, D. MD, FRACS; Cain,

M. J. MD, FRACS; Hall, J. FRACS; Chapple, C. L. MSc,

FRCS (Tr & Orth)

Abstract:

Study Design. A prospective, randomized, double-blind, placebo-controlled

trial of intradiscal electrothermal therapy (IDET) for the treatment of

chronic discogenic low back pain (CDLBP).

Objectives. To test the safety and efficacy of IDET compared with a sham

treatment (placebo).

Summary of Background Data. In North America alone, more than 40,000

intradiscal catheters have been used to treat CDLBP. The evidence for

efficacy of IDET is weak coming from retrospective and prospective cohort

studies providing only Class II and Class III evidence. There is one study

published with Class I evidence. This demonstrates statistically significant

improvements following IDET; however, the clinical significance of these

improvements is questionable.

Methods. Patients with CDLBP who failed to improve following conservative

therapy were considered for this study. Inclusion criteria included the

presence of one- or two-level symptomatic disc degeneration with posterior

or posterolateral anular tears as determined by provocative computed

tomography (CT) discography. Patients were excluded if there was greater

than 50% loss of disc height or previous spinal surgery. Fifty-seven

patients were randomized with a 2:1 ratio: 38 to IDET and 19 to sham

procedure (placebo). In all cases, the IDET catheter was positioned to cover

at least 75% of the annular tear as defined by the CT discography. An

independent technician connected the catheter to the generator and then

either delivered electrothermal energy (active group) or did not (sham

group). Surgeon, patient, and independent outcome assessor were all blinded

to the treatment. All patients followed a standard postprocedural

rehabilitation program. Independent statistical analysis was performed.

Outcome Measures. 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) were measured at baseline

and 6 months. Successful outcome was defined as: no neurologic deficit,

improvement in LBOS of greater then 7 points, and improvement in SF-36

subsets (physical function and bodily pain) of greater than 1 standard

deviation.

Results. Baseline demographic data, initial LBOS, ODI, SF-36, ZDI, and MSPQ

were similar for both groups. No neurologic deficits occurred. No subject in

either arm showed improvement of greater than 7 points in LBOS or greater

than 1 standard deviation in the specified domains of the SF-36. Mean ODI

was 41.42 at baseline and 39.77 at 6 months for the IDET group, compared

with 40.74 at baseline and 41.58 at 6 months for the placebo group. There

was no significant change in ZDI or MSPQ scores for either group.

Conclusions. The IDET procedure appeared safe with no permanent

complications. No subject in either arm met criteria for successful outcome.

Further 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.

D Freeman

Mailing address: 205 Liberty Street NE, Suite B

Salem, OR 97301

503 586-0127

fax 503 586-0192

cell 503 871-0715

drmfreeman@...