SPINE Volume 30, Number 21, pp 2369 –2377
©2005, Lippincott Williams & Wilkins, Inc.
A Randomized, Double-Blind, Controlled Trial
Intradiscal Electrothermal Therapy Versus Placebo for the
Treatment of Chronic Discogenic Low Back Pain
Brian J. C. Freeman, FRCS (Tr & Orth), Robert D. Fraser, MD, FRACS,
Christopher M. J. Cain, MD, FRACS, David J. Hall, FRACS,
and David C. L. Chapple, MSc, FRCS (Tr & Orth)
Study Design. A prospective, randomized, double-
blind, placebo-controlled trial of intradiscal electrother-
mal therapy (IDET) for the treatment of chronic discogenic
low back pain (CDLBP).
Objectives. To test the safety and efficacy of IDET com-
pared 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 fol-
lowing 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 provoca-
tive 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 techni-
cian 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 rehabilita-
tion program. Independent statistical analysis was per-
formed.
Outcome Measures. Low Back Outcome Score (LBOS),
Oswestry Disability Index (ODI), Short Form 36 question-
From the Spinal Unit, Department of Orthopaedics and Trauma, Royal
Adelaide Hospital, Adelaide, South Australia.
Acknowledgment date: August 18, 2004. First revision date: December
11, 2004. Acceptance date: December 13, 2004.
Supported in part by grants from Oratec Interventions, Menlo Park,
CA; DePuy AcroMed, Raynham, MA; and Smith and Nephew Inc.,
Andover MA.
The device(s)/drug(s) is/are FDA-approved or approved by correspond-
ing national agency for this indication.
Corporate/Industry funds were received in support of this work. Al-
though one or more of the authors(s) has/have received or will receive
benefits for personal or professional use from a commercial party re-
lated directly or indirectly to the subject of this manuscript, benefits
will be directed solely to a research fund, foundation, educational in-
stitution, or other nonprofit organization which the author(s) has/have
been associated.
Address correspondence and reprint requests to Brian J. C. Freeman,
FRCS (Tr & Orth), Centre for Spinal Studies and Surgery, University
Hospital, Queens Medical Centre, Nottingham, NG7 2UH, United
Kingdom; E-mail: brian.freeman@qmc.nhs.uk
naire (SF-36), Zung Depression Index (ZDI), and Modified
Somatic Perceptions Questionnaire (MSPQ) were mea-
sured 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 stan-
dard 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 do-
mains 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 anal-
yses showed no significant change in outcome measures
in either group at 6 months. This study demonstrates no
significant benefit from IDET over placebo.
Key words: intradiscal electrothermal therapy, chronic
discogenic low back pain, randomized double-blind con-
trolled trial, clinical outcome. Spine 2005;30:2369 –2377
The treatment of chronic discogenic low back pain (CDLBP)
remains challenging for the spinal specialist. Failed conserva-
tive treatment traditionally has been followed by spinal fusion.
However, clinical outcome following spinal fusion remains
variable with reported satisfactory clinical results varying be-
tween 46% and 82%.1,2
Saal and Saal introduced an alternative method for the
treatment of CDLBP using controlled thermal energy de-
livered via an intradiscal catheter.3 Early studies on in-
tradiscal electrothermal therapy (IDET) were promising,
offering patients an option other than chronic pain man-
agement or spinal fusion.4
There has been much written about the proposed
mechanism of action of IDET. Targeted thermal energy
has been shown to coagulate neural tissue5 and shrink
collagen fibrils.6 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.3 For these
events to occur, tissue temperatures need to reach 45 C
and 60 C, respectively, but doubt has been cast on the
ability of both radiofrequency and thermal-resistive coil
heating to achieve these temperatures.7,8 Shah et al
2369
2370 Spine • Volume 30 • Number 21 • 2005
showed sufficient temperatures to induce collagen dena-
turation and coalescence in human cadaveric lumbar
discs.9 Freeman et al also showed adequate temperatures
in an in vivo model to theoretically perform both coag-
ulation of nociceptors and contraction of collagen.10
However, Freeman et al subsequently were unable to
show denervation of a posterior annular lesion in sheep
following IDET.11 Lee et al demonstrated no significant
difference in the stability of cadaveric lumbar spine be-
fore and after treatment with IDET.12 Similarly, Klein-
stueck et al concluded that IDET failed to cause stiffening
of the disc.13 It is clear that further studies in basic sci-
ence are required to explain the mechanism of action of
IDET.
A comprehensive systematic review of the clinical out-
come following IDET has not been published. Literature
reviews cite few clinical reports and suggest that early
results are conflicting.14 Saal and Saal reported statisti-
cally significant improvements in visual analogue scores
(VAS), sitting time, and physical function and bodily
pain subsets of the SF-36 in a prospective cohort of pa-
tients undergoing IDET.15,16 Other authors have re-
ported similar results from similar studies.17–19 Subse-
quent reports from prospective and retrospective cohort
studies have shown IDET to be much less effective.20 –23
Two randomized controlled trials of IDET have been
performed.24,25 The Pauza et al study was further pre-
sented and has subsequently been published.26,27 This
was a randomized, placebo-controlled, prospective trial
of IDET. Of 1360 individuals who were prepared to
submit to randomization, only 64 were regarded as eli-
gible for inclusion in the study (4.7%). Patients in both
the IDET group and the placebo group exhibited im-
provement, but improvements in pain, disability, and
depression were significantly greater for the IDET group.
The Freeman et al study has been presented25 and forms
the basis for this paper.
Many authors attest to the safety of IDET, but cathe-
ter breakage,14 vertebral osteonecrosis,28 and cauda
equina syndrome29,30 have all been reported following
IDET, suggesting that the procedure is not entirely with-
out risk. Konno et al have shown tissue temperatures as
low as 70 C resulting in complete block of adjacent nerve
root function. 31 Inappropriate catheter placement
clearly has the potential to cause such an injury.
The aim of our study was to assess the efficacy and
safety of IDET for the management of internal disc dis-
ruption in the lumbar spine. The null hypothesis states
that IDET is no more effective than placebo for the treat-
ment of CDLBP.
Materials and Methods
This study is a prospective, randomized, double-blind, placebo-
controlled trial with crossover offered to the placebo subjects
when unblinding occurred at 6 months. Ethics committee ap-
proval was obtained from the ethics committee of St. Andrew’s
Hospital, Adelaide, South Australia. All subjects provided
signed informed consent.
Table 1. Inclusion Criteria
1. Candidate for IDET procedure at one or two levels
2. Symptoms of degenerative lumbar disc disease of at least 3 mo
duration
3. Failure to improve with a minimum of 6 wk of conservative
treatment (including pain medication and physical therapy)
4. Present with marked functional limitation
5. Sitting intolerance greater than standing intolerance
6. Present with predominant low back pain with or without referred
leg pain
7. Negative straight leg raise and normal neurologic examination
8. The presence of degenerative disc disease on magnetic resonance
scan with global disc degeneration or posterior or posterolateral
annular tear evident
9. The presence of one- or two-level symptomatic disc degeneration
as determined by provocative lumbar discography at L3–L4, L4–L5,
L5–S1 and with an adjacent asymptomatic control disc
10. At the target level, the discogram and subsequent computed
tomography scan should demonstrate contrast spreading to the
outer annulus or beyond the confines of the disc (Figure 2A, B)
11. Minimum age 18 yr
12. Must be willing to comply with follow-up as per the protocol
A total of 57 subjects were enrolled during the period No-
vember 13, 1999 to December 16, 2001 (25 months) without
inducement according to the inclusion and exclusion criteria
listed in Tables 1 and 2. Study participants were selected from
consecutive patients from the routine practices of three consul-
tant spinal surgeons in a large city providing they satisfied the
inclusion/exclusion criteria. All subjects had CDLBP, marked
functional disability, and evidence of degenerative disc disease
on magnetic resonance scan (Figure 1) and subsequently failed
conservative management. To successfully enroll, all subjects
had one- or two-level symptomatic disc degeneration as deter-
mined by provocative lumbar discography (Figure 2) followed
by postdiscography computed tomography to delineate the in-
ternal disc disruption (Figure 3).
The study adopted a 2:1 (IDET:placebo) randomization
schedule. From the total of 57 subjects, 38 were randomized to
IDET and 19 to placebo (sham treatment). All procedures were
carried out under light neuroleptic anesthesia and local anes-
thesia. One gram of intravenous cefazolin was administered at
the start of proceedings. A 17– gauge introducer needle was
used, employing a standard posterolateral approach to the
symptomatic disc under multiplane fluoroscopic guidance. The
intradiscal catheter was navigated to cover at least 75% of the
posterior (interpedicular) annulus (Figure 4) or at least 75% of
Table 2. Exclusion Criteria
1. Evidence of a large contained or sequestered herniation (small
contained herniation is allowed)
2. Loss of more than 50% disc height at the target level
3. Severely disrupted disc (sufficient annular tissue is required for safe
catheter placement)
4. Neurogenic claudication due to spinal stenosis
5. Three or more symptomatic lumbar disc levels
6. Previous back surgery at any level of the lumbar spine
7. Spondylolisthesis at a symptomatic disc level
8. Psychological disorders that may impact treatment outcome
(e.g., severe depression, drug addiction)
9. Medical condition that could interfere with follow-up care or
evaluation
10. Current injury litigation
11. Pregnant women (risk of exposure to radiation)
12. Failure to understand informed consent form
13. Participation in other studies of any kind
 Randomized Double-Blind Controlled Trial for IDET • Freeman et al 2371
Figure 1. T2-weighted sagittal magnetic resonance image lumbar
spine. Note loss of signal in the L4 –L5 disc with high intensity zone
posteriorly.
the anular tear as defined by the postdiscography CT scan.
Once a satisfactory position was obtained in the anteroposte-
rior, lateral, and Ferguson views, the catheter was connected to
a lead and passed to an independent technician. The technician
then opened a sealed envelope to ascertain the randomization
schedule and covertly either connected the catheter to the gen-
erator (active IDET group) or did not (sham placebo group).
Critically, both surgeon and subject were blinded to this step.
The generator was switched on and the standard heating pro-
tocol commenced at 65 C rising over 12.5 minutes to 90 C and
held for 4 minutes. The catheter was removed and 100 mg of
cefazolin was inserted into the disc via the introducer needle.
The needle was removed; the subject recovered before under-
going a detailed neurologic examination. All subjects followed
a common rehabilitation program including Pilates-based
exercises.
Subjects were reviewed at 6 weeks and 6 months by an
independent third party to minimize investigator bias. Out-
come measures recorded at baseline and 6 months included the
Visual Analogue Score for back pain (VAS),32 the Low Back
Pain Outcome Score (LBOS),33 the Oswestry Disability Index
(ODI),34 the Short-Form 36 General Health questionnaire
(Australian version) (SF-36),35 the Zung Depression Index
(ZDI),36 the Modified Somatic Perception Questionnaire
(MSPQ),37 sitting tolerance, work tolerance, medication, and
the presence of any neurologic deficit.
Successful outcome was defined as one demonstrating all the
following: no neurologic deficit resulting from the procedure, an
improvement in the LBOS of 7 or more points, and an improve-
ment in the SF-36 subscales of bodily pain and physical function-
ing of greater than 1 standard deviation from the mean.
Statistical Methods. The mean clinically important difference
in primary and secondary outcome measures was set at 7 points
for the Low Back Outcome Score, 1 standard deviation from
Figure 2. Anteroposterior (A) and lateral (B) provocative lumbar
discograms L4 –L5 and L5–S1. Note midline posterior anular tear at
L4 –L5.
the mean for each respective subset of the SF-36 (bodily pain
and physical function), 2 points for the VAS for back pain,38 10
points for the ODI, and 8 points for the ZDI.39
Sample size was determined before the study using statisti-
cal analysis. Using the 2:1 allocation for active and control
treatment in order to have 80% power, the study required 50
patients to be treated with IDET and 25 with the sham
treatment.
A ␹2 test was planned for the analysis of primary outcome,
although this proved unnecessary. Secondary comparisons be-
tween treatments of the change in continuous outcome mea-
sures from baseline to 6 months used t tests for unadjusted
analyses and analysis of covariance (ANCOVA) for analyses
adjusted for the relevant baseline measure. Treatment group by
baseline measure interactions were tested for, and if significant,
were included in the ANCOVA models. All tests were two-
tailed at the 0.05 level of significance.
Results
Enrollment of subjects was slower than anticipated, with
only 57 patients enrolled after 25 months. A request by
the sponsoring company was made to pool our results
2372 Spine • Volume 30 • Number 21 • 2005

Figure 3. Axial (A) and sagittal (B) computed tomogram postdis-

cography. Note midline posterior anular tear with concentric
spread of contrast into the mid and right posterior anulus at L4 –L5.

with a U.S. randomized controlled trial on IDET that had

been set up using a modified version of our protocol. This
offer was declined because the studies were dissimilar.40
Following advice from the ethics committee, the study
was halted and an independent statistical analysis car-
ried out.
Figure 4. Anteroposterior (A), lateral (B), and Ferguson (C) (max-
imal caudal tilt of radiograph beam). Note final position of intra-
Baseline Demographics discal catheter at L4 –L5.
The 2:1 (IDET: Placebo) randomization produced two
groups (38 IDET; 19 placebo) with well-matched LBOS,
ODI, SF-36, ZDI, and MSPQ scores. Table 3 shows a Protocol Violations
summary of the baseline characteristics for both the After treatment, two subjects (both from the IDET
IDET and the placebo group. Table 4 shows the subjects group) from 57 (3.5%) violated the prescribed protocol
by occupation. mandating their rejection from analysis. One was con-
 Randomized Double-Blind Controlled Trial for IDET • Freeman et al 2373

Table 3. Summary of Baseline Characteristics Table 3. Continued

Treatment Group Treatment Group

IDET Placebo IDET Placebo

Characteristic (n ⫽ 38) (n ⫽ 19) Characteristic (n ⫽ 38) (n ⫽ 19)

Demographic Mental Component Summary

Age (yr) Mean 40.34 44.77
Mean 37.49 40.20 SD 12.76 8.29
SD 7.82 8.38 Physical Component Summary
Minimum 20.38 27.13 Mean 32.58 26.90
Maximum 54.68 54.13 SD 8.07 5.74
Gender (male:female) 25:13 17:2 Zung
Current back history
Mean 41.03 40.42
Main complaint*
SD 6.13 10.04
Lumbar back pain 37 (97.4%) 19 (100%)
MSPQ
Leg pain 4 (10.5%) 0 (0.0%)
Mean 8.22 6.84
Other 1 (2.6%) 0 (0.0%)
SD 5.16 5.88
Duration of symptom (mo)
Patient self-reported
Mean 41.54 66.07
questionnaire
SD 39.41 76.04
Currently working
Minimum 6 8
Yes 19 (50.0%) 12 (63.2%)
Maximum 180 240
No
Conservative therapy*
Back pain related 6 (15.8%) 2 (10.5%)
Physical therapy 11 (29.0%) 5 (26.3%)
Not back pain related 13 (34.2%) 5 (23.3%)
Narcotics 8 (21.1%) 2 (10.5%)
Workers’ Compensation† 21 (55.3%) 11 (57.9%)
Injections 6 (15.8%) 4 (21.1%)
On disability† 4 (10.5%) 0 (0.0%)
Bed rest 10 (26.3%) 4 (21.1%)
Work tolerance (hr/day)
Anti-inflammatory 11 (29.0%) 4 (21.1%)
Mean 6.21 6.27
Exercise program 11 (29.0%) 5 (26.3%)
SD 3.23 3.49
Other 1 (2.6%) 2 (10.5%)
Spine physical examination Sitting tolerance (min)
Motor assessment (abnormal) Mean 40.74 39.56
Right 1 (2.6%) 0 (0.0%) SD 40.85 52.68
Left 1 (2.6%) 0 (0.0%) *Multiple outcomes were possible in each study participant. Patients were
Sensation (abnormal) excluded if they had signs of nerve root tension. The patients had reduced
Right 2 (5.3%) 1 (5.3%) SLR by LBP but did not have positive nerve root tension, i.e., did not have
Left 6 (15.8%) 2 (10.5%) clinical evidence of a disc protrusion. This is an important distinction as
Reflexes (abnormal) abnormal SLR was an exclusion.
Right 32 (84.2%) 17 (89.5%) †IDET no. of subjects (n ⫽ 37).
Left 33 (86.8%) 17 (89.5%)
Range of motion (abnormal)
Flexion 34 (89.5%) 17 (89.5%)
Extension 36 (94.7%) 19 (100%) sidered a technical failure and was withdrawn from the
Waddell signs (positive) 5 (13.2%) 1 (5.3%) study at the 6-week follow-up. The second subject expe-
Low Back Outcome Score rienced increased low back pain and chose to withdraw
Mean 39.51 36.71
SD 5.25 3.00 from the study at 3 months and subsequently underwent
Oswestry Disability Index Score a spinal fusion.
Mean 41.42 40.74
SD 14.80 11.84
Physical Functioning
Mean 41.86 35.00
Table 4. Subjects by Occupation
SD 23.01 15.37
Social Functioning Treatment Group
Mean 41.12 44.08 Occupation: Australian Standard
SD 27.86 19.71 Classification of Occupations IDET Placebo
Mental Health Index (ASCO) Code (n ⫽ 38) (n ⫽ 19)
Mean 55.89 64.00
SD 21.30 13.86 1. Managers and administrators 1 (2.6%) 1 (5.3%)
Pain Index 2. Professionals 5 (13.2%) 3 (15.8%)
Mean 33.13 24.42 3. Associate professionals 6 (15.8%) 0 (0.0%)
SD 15.97 13.45 4. Tradespersons and related 4 (10.5%) 7 (36.8%)
Role-Physical workers
Mean 13.82 5.26 5. Advanced clerical and 2 (5.3%) 1 (5.3%)
SD 30.03 10.47 service workers
SF-36 Health Survey 6. Intermediate clerical, sales, 2 (5.3%) 0 (0.0%)
Role-Emotional and service workers
Mean 46.49 46.30 7. Intermediate production and 4 (10.5%) 3 (15.8%)
SD 42.83 42.99 transport workers
Vitality 8. Elementary clerical, sales, 3 (7.9%) 2 (10.5%)
Mean 38.86 45.53 and service workers
SD 21.69 16.32 9. Laborers and related workers 4 (10.5%) 1 (5.3%)
General Health Perception 10. Unemployed, housewives, 7 (18.4%) 1 (5.3%)
Mean 65.29 60.33 students, and unknown
SD 19.21 17.79 occupation status
2374 Spine • Volume 30 • Number 21 • 2005

Table 5. Comparison of Scores at Baseline and at 6 Months

Baseline 6 mo

IDET (n ⫽ 38) Placebo (n ⫽ 19) IDET (n ⫽ 36) Placebo (n ⫽ 19)

Characteristic Mean SD Mean SD Mean SD Mean SD

Low Back Outcome Score* 39.51 5.25 36.71 3.00 38.31 3.61 37.45 1.60
Oswestry Disability Index† 41.42 14.80 40.74 11.84 39.77 16.28 41.58 11.29
Zung Depression Index‡ 41.03 6.13 40.42 10.04 41.39 4.46 40.82 7.72
MSPQ§ 8.22 5.16 6.84 5.88 8.67 6.09 8.67 4.37
SF-36㛳
Physical Functioning 41.86 23.01 35.00 15.37 44.72 24.20 36.58 20.14
Role-Physical 13.82 30.03 5.26 10.47 20.83 34.59 13.89 23.04
Pain Index 33.13 15.97 24.42 13.45 38.28 21.37 31.47 15.29
General Health Perceptions 65.29 19.21 60.33 17.79 61.44 22.68 64.16 19.29
Vitality 38.86 21.69 45.53 16.32 37.08 25.22 45.79 21.16
Social Functioning 41.12 27.86 44.08 19.71 45.14 30.80 43.42 20.14
Role-Emotional 46.49 42.83 46.30 42.99 42.59 44.09 38.89 36.60
Mental Health Index 55.89 21.30 64.00 13.68 52.22 23.11 61.26 19.42
Standard Physical Component Scale 32.58 8.07 26.90 5.74 35.10 8.70 30.40 6.15
Standard Mental Component Scale 40.34 12.76 44.77 8.29 38.16 13.29 43.05 11.07
*The higher the score, the better the outcome.
†The higher the score, the worse the outcome.
‡The higher the score, the greater the degree of depression.
§The higher the score, the worse the outcome.
㛳The higher the score, the better the outcome.

Six-Month Outcome Scores
The summary of scores at baseline and at 6 months is
shown in Table 5. The mean LBOS for the IDET group
was 39.51 at baseline and 38.31 at 6 months. The mean
LBOS for the placebo group was 36.71 at baseline and
37.45 at 6 months. The mean ODI for the IDET group
was 41.42 at baseline and 39.77 at 6 months. The mean
ODI for the placebo group was 40.74 at baseline and
41.58 at 6 months. No subject reached the set mean
clinically important difference previously defined.
The primary determinants of a successful outcome at
6 months were defined in the protocol. For a successful
outcome, the subject had to demonstrate all of the fol-
lowing: no neurologic deficit resulting from the proce-
dure, an improvement in the LBOS of 7 or more points,
and an improvement in the SF-36 subscales of bodily
pain and physical function of greater than 1 standard
deviation from the mean. Table 6 shows the distribution
of these improvement criteria. It can be seen that no
subject in either treatment arm met the joint criteria for
Table 6. Distribution of Improvement Criteria
Study Participants
IDET
Outcome (n ⫽ 36)
No neurologic deficit 36 (100.0%)
LBOS improvement (ⱖ7 points) 0 (0.0%)
SF-36 Subscales Improvement
⌬(Physical Functioning) and ⌬(Bodily 9 (25.0%)
Pain Index) ⬎0
⌬(Physical Functioning) and ⌬(Bodily 3 (8.3%)
Pain Index) ⱖ1 SD*
*One standard deviation within respective treatment arm.
“success.” Hence, the specified primary analysis showed
no difference between the treatments.
Secondary outcomes were compared at baseline and 6
months. These included comparisons of change at 6
months in LBOS, ODI, ZDI, MSPQ, and SF-36 scores
for the following subgroups as requested by the sponsor-
ing company Oratec:
1. The entire study population (Table 7).
2. Males only (the placebo group showed a prepon-
derance of males) (Table 8, available for viewing
online through ArticlePlus only).
3. Restricted to those with “adequate treatment of
the tear” as assessed by Dr. Saal (Table 9, available
for viewing online through ArticlePlus only).
4. Restricted to those with psychological impairment
(Table 10, available for viewing online through
ArticlePlus only).
5. Excluding subjects taking narcotic medication at
baseline (Table 11, available for viewing online
through ArticlePlus only).
6. Excluding subjects taking 8 or more Pana-
deine Forte tabs per day at baseline (Table 12,
available for viewing online through ArticlePlus
only).
Placebo
(n ⫽ 19) 7. Restricted to those with single-level treatment for
an anulus tear without global degeneration (Ta-
19 (100.0%) ble 13, available for viewing online through
0 (0.0%)
ArticlePlus only).
4 (21.1%) 8. Restricted to those with single-level treatment for an
anulus tear without global degeneration, taking no
3 (15.8%)
analgesics at baseline and with “adequate treatment
of tear” as assessed by Dr. Saal (Table 14, available
for viewing online through ArticlePlus only).
 Randomized Double-Blind Controlled Trial for IDET • Freeman et al 2375

Table 7. Comparison of Changes in Scores in the Entire Study Population (6 Months ⴚ Baseline) Between Treatments
(IDET ⴚ Placebo)
Treatment Group Difference

IDET (n ⫽ 36) Placebo (n ⫽ 19)

Difference of
Variable Mean* 95% CI Mean* 95% CI Means† 95% CI Pr ⬎ 兩t兩

Low Back Outcome ⫺0.971 ⫺2.337, 0.394 0.737 ⫺0.765, 2.238 ⫺1.708 ⫺3.824, 0.408 0.111
Oswestry ⫺1.314 ⫺4.171, 1.543 0.842 ⫺6.149, 7.833 ⫺2.156 ⫺8.369, 4.056 0.489
Zung ⫺0.167 ⫺2.481, 2.148 0.706 ⫺3.834, 5.246 ⫺0.873 ⫺5.302, 3.557 0.693
MSPQ 0.286 ⫺1.533, 2.104 0.177 2.733, 3.086 0.109 ⫺3.036, 3.254 0.945
SF-36
Physical Functioning 2.624 ⫺2.675, 7.922 1.579 ⫺6.416, 9.574 1.044 ⫺8.045, 10.134 0.819
Bodily Pain Index 5.056 ⫺0.799, 10.910 7.053 0.963, 13.142 ⫺1.997 ⫺11.020, 7.031 0.659
*As a measure of direction of change (response to treatment), positive mean changes in Low Back Outcome Score and SF-36 indices, and negative mean changes
in Oswestry, Zung, and MSPQ Outcomes indicate “improvement” at 6 months, respectively.
†Difference in means of response: a negative value suggests worse outcome with IDET than with placebo for Low Back Pain and SF-36 indices, and the converse
is true for Oswestry, Zung, and MSPQ Outcomes.

These detailed secondary analyses showed no statisti-
cally significant or clinically important differences in the
measured study outcomes for either treatment. This was
true irrespective of whether the comparison was further
adjusted for the baseline measure. A further stratified
analysis by surgeons (R.D.F., C.M.J.C., D.J.H.) conduct-
ing the IDET procedure was carried out. No significant
difference in secondary endpoints between treatment
arms was identified for any surgeon.
Safety Data
There were no serious adverse events in either arm of the
study. Transient radiculopathy (⬍6 weeks) was reported
in 4 study participants who underwent IDET and in 1
study participant who underwent the sham procedure.
Discussion
Saal and Saal reported on IDET for CDLBP in a prospec-
tive outcome study with a minimum of 2-year follow-
up.16 A total of 1116 patients were treated with a com-
prehensive nonoperative program, including back
education, activity modification, progressive intensive
exercise, at least one fluoroscopically guided epidural
corticosteroid injection, physical therapy, and anti-
inflammatory medication. Sixty-two patients (5.5%)
failed to improve and underwent lumbar discography
that proved to be positive in all cases. Patients were sub-
sequently offered chronic pain management, interbody
fusion, or IDET. All chose IDET. Of 62 patients that had
IDET, 4 patients were lost to follow-up. The baseline
demographics with a mean age of 40.5 years, male pre-
ponderance and long mean duration of pain (60.7
months) very closely matched the cohort presented in
our series. The study participants of the Saal and Saal
study16 were 65.5% private pay patients and 34.5%
Workers’ Compensation patients.
Saal and Saal16 reported impressive results over 24
months. The mean VAS dropped from 6.57 to 3.41, an
improvement of 3.16 points. The sitting time increased
on average by 52.7 minutes. The mean physical function
score of the SF-36 improved 31.33 points, and the mean
bodily pain score improved 21.87 points; 81% of pa-
tients showed at least a 7 point improvement in physical
function and 78% improved at least 7 points in bodily
pain; 72% of patients improved their VAS by at least 2
points. Also striking was that the improvement contin-
ued over 2 years and seemed to be comparable in one-,
two-, or three-level treated disease.
Derby et al reported their first 32 consecutive cases of
IDET.17 All patients were initially assessed by an orthope-
dic surgeon and told either they were not suitable for spine
surgery or were offered surgery and declined. Outcome
measures included the Roland Morris Disability Question-
naire, the VAS, a patient satisfaction index, and a question-
naire related to activities of daily living. The mean age of
participants was 42 years, with only 4 Workers’ Compen-
sation cases. Seven patients had previous surgery. Derby et
al17 treated both discrete annular fissures and global disc
degeneration; the patients in this study showed no signifi-
cant difference in outcome measures at 6 months and at 12
months. The mean improvement in VAS was 1.84 (SD ⫾
2.38). The mean improvement in Roland Morris was 4.03
(SD ⫾ 4.82). Overall, 62.5% had a favorable outcome,
25% no change, and 12.5% had a nonfavorable outcome.
One patient underwent a spine fusion due to persistent dis-
cogenic back pain.
Karasek and Bogduk reported their 12-month follow-up
of a controlled trial of IDET for back pain due to internal
disc disruption.18 From 110 patients undergoing CT dis-
cography, 53 satisfied the criteria for internal disc disrup-
tion at one or two levels. Authority to undergo IDET was
sought from the insurance carriers of these patients. Au-
thority was granted in 36 and denied in 17. The 36 patients
constituted the index treatment group and underwent
IDET followed by rehabilitation. The 17 patients consti-
tuted a “convenience sample control group” and under-
went rehabilitation. Outcome measures included the VAS,
return to work, use of opioid analgesics, and ODI in some
patients. The control group was followed for 3 months: the
2376 Spine • Volume 30 • Number 21 • 2005

median VAS was 8 (range, 5– 8) before rehabilitation and 8
(range, 7– 8) at 3 months. The IDET group had a median
VAS of 8 (range, 7–9) before treatment reducing to 3
(range, 1–7) at 12 months. Some patients returned to work
and reduced their opioid intake. Bogduk and Karesek sub-
sequently reported on the 24-month follow-up in the IDET
group: 54% of patients reduced their pain by half, with 1 in
5 patients achieving complete relief of pain.19 The use of
patients who had been denied treatment as a control group
has contributed to serious methodologic flaws in this paper,
and one should regard the results with caution.
Pauza et al reported a randomized placebo-controlled
trial of IDET for the treatment of CDLBP.24,26 Of 1360
individuals who were prepared to submit to randomiza-
tion, 260 (19.1%) were found potentially eligible after
clinical examination and 64 became eligible after discog-
raphy (4.7%). Inclusion criteria listed failure to improve
after 6 weeks of nonoperative care, low back pain exac-
erbated by sitting or standing, less than 20% loss of disc
height on plain radiographs, and the presence of a pos-
terior tear of the annulus fibrosis on CT discography.
They excluded those with Worker’s Compensation and
those with diffuse changes on CT discography. Random-
ization used a 3:2 ratio (3 IDET: 2 sham) (total 64). The
sham treatment consisted on introduction of a 17-gauge
needle to contact the outer annulus fibrosis, but not to
breech this. No intradiscal catheter was inserted. Out-
come was assessed using VAS, SF-36, and ODI pretreat-
ment and at 6 months. The initial study planned to re-
cruit 40 patients to IDET and 27 to sham (total 67
patients). The study recruited 64 patients in total (37
were allocated to IDET and 27 to sham) with 8 (12.5%)
excluded for protocol violation or loss to follow-up.
Measurement of baseline outcomes reported a mean
VAS of 6.5, mean bodily pain score of 35, mean physical
function score of 51, and mean ODI of 32 points. The
mean improvement in VAS for the IDET group was 2.4
points (SD ⫾ 2.3) and for the sham group was 1.2 points
(SD ⫾ 2.7), a difference of 1.2 points when comparing
groups. The mean improvement in ODI for the IDET
group was 10.9 points (SD ⫾ 11.2) compared with 5.2
points (SD ⫾ 12.0) in the sham group, a difference of 5.7
points when comparing groups.24 However, these results
are reported slightly differently in the paper with a dif-
ference of 1.3 points on the VAS and 7 points on the ODI
in favor of IDET.27 There was no significant difference
between the improvements in bodily pain and physical
function when comparing the two groups. Pauza et al
concluded that IDET is not a universally successful treat-
ment. 24 Only 40% of patients treated with IDET
achieved 50% relief of pain. Some 50% of patients did
not benefit appreciably or at all. The reported improve-
ments following IDET fall well below the established
mean clinically important differences38,39; moreover, the
reported large standard deviations would suggest the
95% tolerance intervals may not have been achieved.
How can two similarly sized randomized controlled
trials reach such different conclusions? Pauza et al con-
cluded IDET to be an effective treatment for discogenic
low back pain.24 On the contrary, Freeman et al showed
no significant benefit from IDET over placebo.25 There
are important differences between the two studies (Table
15). The study participants of Freeman et al25 had higher
levels of disability as measured by ODI and worse SF-36
physical function scores when compared with the Pauza
et al subjects.24 There are other differences relating to the
inclusion criteria, study populations, how the sham pro-
cedures were performed, the blinding procedure, and
how success and the mean clinically important differ-
ences were defined. Pauza et al24 may well have shown

Table 15. Comparison of the Freeman et al 41 and the Pauza et al 26 Studies

Characteristic Freeman et al 41 Pauza et al 26

Start date of trial November 1999 September 2000

Finish date of trial December 2001 April 2002
Study total n 57 64
Withdrawn or loss to follow-up 2 (3.5%) 8 (12.5%)
Mean age (yr) IDET 37.5 IDET 42
Placebo 40.2 Placebo 40
Disc height Up to 50% loss Up to 20% loss
Disc morphology Discrete annular tear or global degeneration Posterior annular tear only
Workers Compensation (% in each group) IDET 55.3 Excluded from study
Placebo 57.9
Duration of symptoms (mo) IDET 41 IDET 78% ⬎ 24
Placebo 66 Placebo 74% ⬎ 24
ODI baseline IDET 41.4 IDET 32
Placebo 40.7 Placebo 33
SF-36 PF baseline IDET 41.8 IDET 54
Placebo 35.0 Placebo 48
SF-36 BP baseline IDET 33.1 IDET 35
Placebo 24.4 Placebo 35
Definition of success No neurologic deficit Comparison of mean
LBOS ⬎ 7.0 Categorical outcomes
SF-36 PF ⬎ 1 SD
SF-36 BP ⬎ 1 SD
PF ⫽ Physical Function subset of SF-36; BP ⫽ Bodily Pain subset of SF-36.
 Randomized Double-Blind Controlled Trial for IDET • Freeman et al 2377
statistical significance between their two groups, but
Freeman et al would argue that this does not necessarily
equate to clinical significance.41,42 One thing is clear
from the literature: that highly selected groups of pa-
tients are required to show only marginal benefit from
the procedure and that IDET is not beneficial for the vast
majority of patients with CDLBP.
Key Points
● A randomized, double-blind, controlled trial of
IDET versus placebo for the treatment of chronic
discogenic low back pain is presented.
● The IDET procedure appeared safe with no per-
manent complications.
● No subject in either arm showed clinically signif-
icant improvements 6 months following treatment.
● IDET is no more effective than placebo for the
treatment of chronic discogenic low back pain.
Acknowledgments
The authors thank Associate Professor Philip Ryan, Dr.
Freddie Mpelasoka, and Ms. Liddy Griffith for carrying
out the independent statistical analysis as well as Dr. J. S.
Saal and Dr. J. A. Saal for their advice and criticism.
References
1. Wetzel FT, LaRocca SH, Lowery GL. The treatment of lumbar spinal pain syn-
dromes diagnosed by discography: lumbar arthrodesis. Spine 1994;19:792–800.
2. Thomsen K, Christensen FB, Eiskjaer SP, et al. 1997 Volvo award winner in
clinical studies. The effect of pedicle screw insertion on functional outcome
and fusion rates in posterolateral lumbar spinal fusion: a prospective ran-
domised clinical study. Spine 1997;22:2813–22.
3. Saal JS, Saal JA. Management of chronic discogenic low back pain with a
thermal intradiscal catheter: a preliminary report. Spine 2000;25:382– 8
4. Saal JA, Saal JS. Intradiscal electrothermal therapy for the treatment of
chronic discogenic low back pain. Operative Tech Orthop 2000;10:271– 81.
5. Letcher F, Goldring S. The effect of radiofrequency current and heat on
peripheral nerve action potential in the cat. J Neurosurg 1968;29:42–7.
6. Hayashi K, Thabit G, Bogdanske JJ, et al. The effect of non-ablative laser energy
on the ultrastructure of joint capsular collagen. Arthroscopy 1996;12:471– 81.
7. Houpt JC, Conner ES, McFarland EW. Experimental study of temperature
distributions and thermal transport during radiofrequency current therapy
of the intervertebral disc. Spine 1996;21:1808 –13.
8. Kleinstueck FS, Diederich CJ, Nau WH, et al. Temperature and thermal dose
distributions during intradiscal electrothermal therapy in the cadaveric lum-
bar spine. Spine 2003;28:1700 – 8.
9. Shah RV, Lutz GE, Lee J, et al. Intradiskal electrothermal therapy: a prelim-
inary histological study. Arch Phys Med Rehabil 2001;82:1230 –7.
10. Freeman BJ, Walters R, Moore RJ, et al. In-vivo measurement of peak pos-
terior annular and nuclear temperatures obtained during Intradiscal Electro-
thermal Therapy (IDET) in sheep. 28th Annual Meeting of the International
Society for the Study of the Lumbar Spine. Edinburgh, Scotland, 2001.
11. Freeman BJC, Walters RM, Moore RJ, et al. Does Intradiscal Electrothermal
Therapy denervate and repair experimentally induced posterolateral annular
tears in an animal model? Spine 2003;28:2602– 8.
12. Lee J, Lutz GE, Campbell D, et al. Stability of the lumbar spine after Intra-
discal Electrothermal Therapy. Arch Phys Med Rehabil 2001;82:120 –2.
13. Kleinstueck FS, Diederich CJ, Nau WH, et al. Acute biomechanical and
histological effects of Intradiscal Electrothermal Therapy on human lumbar
discs. Spine 2001;26:2198 –207.
14. Biyani A, Andersson GBJ, Chaudhary H, et al. Intradiscal Electrothermal
Therapy: a treatment option in patients with internal disc disruption. Spine
2003;28(suppl):8 –14.
15. Saal JA, Saal JS. Intradiscal Electrothermal Treatment for chronic discogenic
low back pain: a prospective outcome study with a minimum 1 year follow
up. Spine 2000;25:2622–7.
16. Saal JA, Saal JS. Intradiscal Electrothermal Treatment for chronic discogenic
low back pain: prospective outcome study with a minimum 2-year follow up.
Spine 2002;27:966 –74.
17. Derby R, Eek B, Chen Y, et al. Intradiscal Electrothermal Annuloplasty
(IDET): a novel approach for treating chronic discogenic back pain. Neuro-
modulation 2000;3:5–9.
18. Karasek M, Bogduk N. Twelve month follow-up of a controlled trial of
intra-discal thermal anuloplasty for back pain due to internal disc disruption.
Spine 2000;25:2601–7.
19. Bogduk M, Karesek M. Two-year follow-up of a controlled trial of intradis-
cal electrothermal annuloplasty for chronic low back pain resulting from
internal disc disruption. Spine J 2002;2:343–50.
20. Cohen SP, Larkin T, Abdi S, et al. Risk factors for failure and complications
of intradiscal electrothermal therapy: a pilot study. Spine 2003;28:1142–7.
21. Spruit M, Jacobs WCH. Pain and function after intradiscal electrothermal
treatment (IDET) for symptomatic lumbar disc degeneration. Eur Spine J
2002;11:589 –93.
22. Freedman BA, Cohen SP, Kuklo TR, et al. Intradiscal electrothermal therapy
(IDET) for chronic low back pain in active-duty soldiers: two-year follow-up.
Spine J 2003;3:502–9.
23. Webster BS, Verma S, Pransky GS. Outcomes of Workers’ compensation
claimants with low back pain undergoing intradiscal electrothermal therapy.
Spine 2004;29:435– 41.
24. Pauza KJ, Howell S, Dreyfuss P, et al. A randomised, double blind, placebo-
controlled trial evaluating the efficacy of intradiscal electrothermal anulo-
plasty (IDET) for the treatment of chronic discogenic low back pain: 6
months outcomes. Presented at the International Spinal Injection Society
10th Annual Meeting, Austin, TX, 2002.
25. Freeman BJC, Fraser RDF, Cain CMJ, et al. A randomised double blind efficacy
study: intradiscal electrothermal therapy (IDET) versus placebo. Presented at
the 30th Annual Meeting of the International Society for the Study of the Lum-
bar Spine, Vancouver, British Columbia, Canada, 2003.
26. Pauza K, Howell S, Dreyfuss P, et al. A randomised, double blind, placebo
controlled trial evaluating intradiscal electrothermal annuloplasty (IDET).
Presented at the 30th Annual Meeting of the International Society for the
Study of the Lumbar Spine, Vancouver, British Columbia, Canada, 2003.
27. Pauza KJ, Howell S, Dreyfuss P, et al. A randomised, placebo-controlled trial
of intradiscal electrothermal therapy for the treatment of discogenic low
back pain. Spine J 2004;4:27–35.
28. Djurasovic M, Glassman SD, Dimar JR, et al. Vertebral osteonecrosis asso-
ciated with the use of intradiscal electrothermal therapy: a case report. Spine
2002;27:E325– 8.
29. Hsui A, Isaac K, Katz J. Cauda equina syndrome from intradiscal electro-
thermal therapy. Neurology 2000;55:320.
30. Wetzel FT. Cauda equina syndrome from intradiscal electrothermal therapy.
Neurology 2001;56:1607.
31. Konno S, Olmarker K, Byrod G, et al. Acute thermal nerve root injury: the
European Spine Society AcroMed Prize 1994. Eur Spine J 1994;3:6:299 –302.
32. Huskisson EC. Measurement of pain. Lancet 1974;2:1127–31.
33. Greenough CG, Fraser RD. Assessment of outcome in patients with low back
pain. Spine 1992;17:36 – 41.
34. Fairbank JCT, Cooper J, Davies JB, et al. The Oswestry low back pain
questionnaire. Physiotherapy 1980;66:271–3.
35. McCallum J. The SF-36 in an Australian sample: validating a new, generic
health status measure. Aust J Public Health 1995;19:160 – 6.
36. Zung WWK. A self-rating depression scale. Arch Gen Psychiatry 1965;12:63–70.
37. Main CJ. The modified somatic perception questionnaire (MSPQ). J Psycho-
som Res 1983;27:503–14.
38. Farrar JT, Portenoy RK, Berlin JA, et al. Defining the clinically important
difference in pain outcome measures. Pain 2000;88:287–94.
39. Hagg O, Fritzell P, Nordwall A. The clinical importance of changes in outcomes
scores after treatment for chronic low back pain. Eur Spine J 2003;12:12–20.
40. Fraser RD. Research, companies and conflict of interest. Aust Orthop Assoc
Bull 2004;25:16 –7.
41. Freeman BJC, Fraser RDF, Cain CMJ, et al. A randomised double blind
efficacy study: intradiscal electrothermal therapy (IDET) versus placebo.
Synthes Ltd 2003 Spine Society of Europe Best Podium Presentation Award.
Presented at EuroSpine 2003 Prague, Czech Republic, 2003 [Abstract].
Eur Spine J 2003;12(suppl):23.
42. Freeman BJC, Fraser RDF, Cain CMJ, et al. A randomised double-blind
controlled efficacy study: intradiscal electrothermal therapy (IDET) versus
placebo for the treatment of chronic discogenic low back pain. Lyman Smith
MD Award for the Best Podium. Presented at the International Intradiscal
Therapy Society 17th Annual Meeting, Munich, Germany, 2004.