Treatment of chronic discogenic low back pain with intradiskal electrothermal therapy.

The treatment of chronic, nonradicular, discogenic low back pain remains controversial. The posterior anulus fibrosus appears to be a potential site of origin of the pain, which is mediated by nociceptors in the inner layers of the anulus. Diagnosis requires a thorough history, physical examination, and imaging protocol; provocative diskography is key. Nonsurgical treatment options have been limited to physical therapy and pharmacotherapy. Success rates of spinal fusion range from 39% to 96%. Reported therapeutic success rates of intradiskal electrothermal therapy, a possible intermediate treatment, range from 60% to 80%. Despite this apparent therapeutic effect, however, a more precise quantification of clinical benefits remains to be proved in randomized prospective trials.

Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: new directions and interventions.

STUDY DESIGN: Retrospective literature review. OBJECTIVES: To review the data on the clinical efficacy of intradiscal electrothermal annuloplasty found at this writing in the peer-reviewed literature to date, to discuss the methodologic strengths and flaws of the studies, to discuss the pitfalls of clinical study designs, to emphasize the need for prospective randomized studies and for increased basic science investigation. SUMMARY OF BACKGROUND DATA: Studies published or presented at peer-reviewed societies concerning the clinical efficacy of intradiscal electrothermal annuloplasty are reviewed, including background studies on deafferentation and application of thermal energy to alter biomechanical and structural properties. A proposal for future investigations is presented. METHODS: Background data from intracapsular annuloplasty highlighting the safety and efficacy of intradiscal electrothermal annuloplasty are presented. Current studies on this procedure, including those in the National Registry are reviewed. All the studies share a common study design: prospective cohort with historical or noninterventional groups used as controls. The patients reviewed are similar. All have nonradicular low back pain of at least 3 months duration, failed conservative care, normal neurologic examination, and MRI showing only nondegenerative disc disease and positive concordant discography. All the patients underwent intradiscal electrothermal annuloplasty lesion at one or two levels according to standard protocols. Follow-up evaluation was performed at various intervals up to 2 years. All the studies used data from a visual analog scale, with most using the Short Form 36 (SF-36) as outcome instruments. RESULTS: The reported follow-up periods for the studies ranged from 6 months to 2 years. Three published studies, one with a 6-month follow-up period and two with a 1-year follow-up period, were published in the peer-reviewed literature. Two recent reports presented to the North American Spine Society were reviewed: a study of patients on a manufacturer-sponsored registry with a 1-year follow-up period and a multicenter prospective cohort study of 75 patients in an intent-to-treat group, with a 1-year follow-up period. Using the 7-point criteria of Deyo et al, all the studies suggested a positive effect of treatment, with a decrease in visual analog scale ratings and improvement in SF-36 scales, particularly those for physical function and bodily pain. CONCLUSIONS: The studies published so far suggest that the pain resulting from lumbar disc disease may be diminished by intradiscal electrothermal annuloplasty. All these studies project a positive therapeutic effect. However, all the studies suffer from the same methodologic flaws. A prospective cohort design or a nonrandomized prospective design is used with a biased control. The scientific validity of various study designs is discussed, and a randomized prospective study is recommended. Additionally, more investigation into the basic science of the action of intradiscal electrothermal annuloplasty is required.

The strength of distal fixation of flexor digitorum profundus tendon grafts in human cadavers.

Early active motion limits adhesion formation and thus improves functional performance after tendon grafting. The early strength of distal fixation is critical to successful tendon grafting. We describe a new Y-tunnel technique of distal fixation and compare it with 2 established methods, the Pulvertaft transverse tunnel and the Bunnell button over the fingernail techniques, in a human cadaver model to determine which is the strongest method. Hands with a grafted tendon were rigidly mounted on an anatomic tensiometer testing apparatus and loaded to failure. Mean load to failure (newtons +/- 95% confidence intervals) of the Y-tunnel technique (155.2 +/- 29.4) was greater than those for the Pulvertaft (100.2 +/- 13.2) and Bunnell (57.1 +/- 4.7) techniques. Two-way analysis of variance showed significant differences, and the Bonferroni multiple pairwise comparison test showed that all 3 intergroup comparisons were statistically significant. These results indicate marked improvement in immediate strength with the Y-tunnel technique and lay the groundwork for further studies using a healing tendon model.