A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain

Pauza, Kevin; Howell, Susan; Dreyfuss, Paul; Peloza, John; Dawson, Keith; Bogduk, Nikolai

doi:10.1016/j.spinee.2003.07.001

Cited by 310 publications

(276 citation statements)

References 24 publications

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“…This might be true for the testing of new drugs (where the design of RCTs originated), but it is questionable in the surgical field and perhaps explains why some randomised prospective trials in spine surgery have delivered such contradictory results. For example, the introduction of intradiscal electrothermal therapy (IDET) treatment was launched with a RCT [41] that indicated the positive effect of the procedure. However, a few years later, another RCT [18,19] compared the new procedure with placebo treatment and found absolutely no clinically relevant benefit of IDET compared with the control.…”

Section: Discussionmentioning

confidence: 99%

A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects

et al. 2009

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Randomised controlled trials (RCTs) of cervical disc arthroplasty vs fusion generally show slightly more favourable results for arthroplasty. However, RCTs in surgery often have limited external validity, since they involve a select group of patients who fit very rigid admission criteria and who are prepared to subject themselves to randomisation. The aim of this study was to examine whether the findings of RCTs are verified by observational data recorded in our Spine Center in association with the Spine Society of Europe Spine Tango surgical registry. Patients undergoing fusion/stabilisation or disc arthroplasty for degenerative cervical spinal disease were selected for inclusion. They completed a questionnaire pre-operatively and at 12 and 24 months follow-up (FU). The questionnaire comprised the multidimensional Core Outcome Measures Index (COMI; 0-10 scale) and, at FU, questions on global outcome and satisfaction with treatment (5-point scales, dichotomised to ''good'' and ''poor''), re-operation and patient-rated complications. The surgeon completed a Spine Tango Surgery form. The outcome data from 266 (208 fusion, 58 arthroplasty) out of 284 eligible patients who had reached 12 months FU, and 169 (139 fusion, 30 arthroplasty) out of 178 who had reached 24 months FU, were included. Patients with cervical disc arthroplasty were younger [46 (SD 8) years vs 56 (SD 11) years for fusion; P \ 0.05], had less comorbidity (P \ 0.05), more often had only mono-segmental pathology (69% arthroplasty, 47% fusion) and only one type of degenerative pathology (69% arthroplasty, 46% fusion). Surgical complication rates were similar in each group (arthroplasty, 1.5%; fusion, 2.6%). The reduction in the COMI score was significantly greater in the arthroplasty group (at 12 months, 4.8 (SD 3.0) vs 3.7 (SD 2.9) points for fusion, and at 24 months 5.1 (SD 2.8) vs 3.8 (SD 2.9) points; each P \ 0.05). In the arthroplasty group, a ''good'' global outcome was recorded in 90% patients (at 12 months) and 93% (at 24 months); in the fusion group the figures were 80 and 82%, respectively (group differences at each timepoint, P [ 0.09). Satisfaction with treatment was similar in both groups (89-93%), at each timepoint. In multiple regression analysis, treatment group was of borderline significance as a unique predictor of the change in COMI at FU (P = 0.059 at 12 months, P = 0.055 at 24 months) in a model in which known confounders (age, comorbidity, number of affected levels) were controlled for. Being in the arthroplasty group was associated with an approximately 1-point greater reduction in the COMI score at FU. The results of this observational study appear to support those of the RCTs and suggest that, in patients with degenerative pathology of the cervical spine, disc arthroplasty is associated with a slightly better outcome than fusion. However, given the small size of the difference, its clinical relevance is questionable, especially in view of the a priori more favourable outcome expected in the arthroplasty group due to ...

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Section: Discussionmentioning

confidence: 99%

A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects

et al. 2009

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“…The other RCT compared the effects of intradiscal electrothermal therapy (IDET) (N=37 patients) with sham IDET (same procedure without heating) (N=27 patients) (Pauza et al 2004). Patients in both groups exhibited improvements in VAS pain, Oswestry disability and quality of life (SF-36); improvements in pain and disability were slightly but significantly better in the IDET group.…”

Section: Effectiveness Of Irft or Idet Vs A Sham Proceduresmentioning

confidence: 99%

“…A second, randomized, double blind, placebo controlled trial (with a similar design to that described above (Pauza et al 2004)) was recently published in the form of a peer-reviewed abstract (Freeman et al 2003b) after presentation at the Annual Conference of the Spine Society of Europe. The study reported no difference between IDET and sham IDET with respect to the number of patients showing a clinically relevant improvement in pain or disability (no significant improvements in either group).…”

Section: Commentsmentioning

confidence: 99%

Chapter 4 European guidelines for the management of chronic nonspecific low back pain

Airaksinen¹,

Brox²,

Cedraschi³

et al. 2006

Eur Spine J

2,236

1,673

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“…Interventional treatment often requires additional procedures, such as diagnostic scans or medication to prevent infection 43, 56, 62 , blood clots 40 , transplant rejection 63 , or epileptic fits 35 . For example, in the trial by Freed and colleagues, both groups received identical preoperative evaluation, intraoperative sedation and pain control, underwent two PET scans and a MRI scan, and received phenytoin 35 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain

Cited by 310 publications

References 24 publications

A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects

A comparison of outcomes of cervical disc arthroplasty and fusion in everyday clinical practice: surgical and methodological aspects

Chapter 4 European guidelines for the management of chronic nonspecific low back pain

Blinding in trials of interventional procedures is possible and worthwhile

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