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PIRFT | IDET

Modern medical science continues to be completely baffled with regard to how to designing an effective treatment for symptomatic lumbar annular disc tears. But there were hopes: In the late 1990s and early 2000s, researchers invented IDET and later PIRFT in hopes of finding an effective treatment for patients of whom suffered symptomatic annular disc tears.

Unfortunately, as you will see below,it was proof that neither of these treatments worked – much to the chagrin of their inventors.  There can be no question about it, because they were both run through the most powerful investigational study known to mankind: the randomized double-blind placebo controlled trial. (Empirically, I've known this for years).

PIRFT

Kvarstein G, et al. “A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy – a 12 month follow-up.” (2009) Pain Oct;145(3):279-86. Norway.

In 2009, Kvarstein et al published the results of rare, randomized double-blind controlled trial comparing the discTRODE probe (the procedure is called {percutaneous} intra-annular radiofrequency thermal disc therapy [PIRFT]) against a sham treatment.

More specifically, 20 patients with chronic low back pain and one-level pressure-controlled provocation discopathy were randomized to either PIRFT or intra-annular sham treatment (placebo).
At six months status post procedure, a blind assessment was performed on all 20 patients. The six-month analysis did not reveal any statistical trend to favor PIRFT over the sham treatment. That is, there was no difference in pain between the two groups. Because of this poor finding, no further patients were added to the study as planned.

After 12 months there was still no statistical difference between the groups, although "the outcome measures (ODI, SF 36 and VAS) appeared more promising (they were showing some improvement over the sham treatment but not enough to say for sure that it was working).

CONCLUSION

In conclusion, the researchers stated "the study did not finding evidence for a benefit of PIRFT, although a moderate effect cannot be ruled out. Considering the high number, reporting increased pain in our study, we would not recommend intra-annular thermal therapy with discTRODE probe."

IDET:

Freeman BJ, Fraser RD, et al. “A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain." (2005) Nov 1;30(21):2368-77; discussion 2378.

In 2005, Freeman et al published the results of another rare randomized, double-blind, controlled trial that randomly placed 57 chronic low back pain patients in either a intradiscal electrothermal (IDET) group or a sham procedure (placebo). (The respective ratio was 2:1).  All of the patients had either one-or two-level symptomatic disc degeneration with posterior or posterolateral annular tears (as determined by provocative computerized tomography discography). The surgeon, patient, and independent outcome assessor were all blinded to the treatment.
Before the patients underwent the procedure, a battery of outcome evaluation tools were administered. These included the short form 36 questionnaire [SF-36], Oswestry disability index [ODI], Zung Depression Index, Low Back Outcome Score, and the Modified Somatic Perceptions Questionnaire).

RESULTS:

At the six-month time point, not a single outcome tool showed evidence that patients from either group had demonstrated any statistically significant signs of improvement.
For example, the ODI for the IDET procedure was 41.2 at baseline and 39.77 at the six-month time point. For the placebo group, the ODI was 40.74 at baseline and 41.58 at the six-month time point.

CONCLUSION

In conclusion, the authors stated, "No subject in either arm [IDET or placebo] met criteria for successful outcome. This study demonstrates no significant benefit from IDET over placebo."

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