Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up.

OBJECTIVE: Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain. DESIGN: Prospective, nonrandomized Food and Drug Administration approved pilot study. SETTING: Three centers in the United States. SUBJECTS: Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography. INTERVENTIONS: Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s). OUTCOME MEASURES: Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ). RESULTS: Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product. EFFICACY: Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively. CONCLUSION: Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.

Cadaveric intervertebral disc temperature mapping during disc biacuplasty.

BACKGROUND: Disc Biacuplasty is a procedure for treating discogenic pain through neuron ablation by heating intervertebral disc tissue using cooled, bipolar radiofrequency (RF) technology. This study demonstrates temperature profiles created by disc biacuplasty in human cadavers. OBJECTIVE: To assess temperature profiles created by disc biacuplasty in human cadaver discs. DESIGN: The design of the experiment is a cadaver study with temperature monitoring in the intervertebral disc during disc biacuplasty. METHOD: Seven human cadaver discs were sectioned from 2 cadavers. Each disc was instrumented with 11 [corrected] temperature sensors and 2 cooled radiofrequency probes. Correct placement was verified with the aid of fluoroscopy. The discs were then immersed in a 37 degrees C thermostatic water bath and the treatment protocol was applied. Temperatures were monitored as the discs were heated. RESULTS: At 13 minutes, with the settings used in this study, the posterior longitudinal ligament (PLL) temperature reached 40+/-3 degrees C. The anterior disc reached 41+/-3 degrees C. The outer layer of the posterior annulus fibrosus was heated to 54+/-6 degrees C and the inner two-thirds of the posterior annulus fibrosus reached temperatures of 60+/-6 degrees C. CONCLUSIONS: The anterior disc and PLL remained at safe temperatures below 45 degrees C while temperatures throughout the center posterior and posterolateral disc were all raised above 45 degrees C, sufficient for neural ablation.

Provocative cervical discography symptom mapping.

BACKGROUND CONTEXT: In a small prospective study assessing 10 symptomatic and 10 asymptomatic subjects, Schellhas et al. compared cervical discography to magnetic resonance imaging. Within that study he reported on the distribution of pain for the C3-C4 to C6-C7 levels. Four years later, Grubb and Ellis reported retrospective data from his 12-year experience using cervical discography from C2-C3 to C7-T1 in 173 patients. To date, no large prospective study defining pain referral patterns for each cervical disc has been performed. PURPOSE: To conduct a prospective visual and statistical descriptive study of pain provocation of a cohort of subjects undergoing cervical discography. STUDY DESIGN/SETTING: Prospective multicenter descriptive study. METHODS: Pain referral maps were generated for each disc level from patients undergoing cervical discography with at least two levels assessed. If concordant pain was reproduced in a morphologically abnormal disc, the subject immediately completed a pain diagram. An independent observer interviewed the subject and recorded the location of provoked symptoms. Visual data were compiled using a body sector bit map, which consisted of 48 clinically relevant body regions. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated. RESULTS: A total of 101 symptom provocation maps were recorded during cervical discography on 41 subjects. There were 10 at C2-C3, 19 at C3-C4, 27 at C4-C5, 27 at C5-C6, 16 at C6-C7 and 2 at C7-T1. Predominantly unilateral symptoms were provoked just as often as bilateral symptoms. The C2-C3 disc referred pain to the neck, subocciput and face. The C3-C4 disc referred pain to the neck, subocciput, trapezius, anterior neck, face, shoulder, interscapular and limb. The C4-C5 disc referred pain to the neck, shoulder, interscapular, trapezius, extremity, face, chest and subocciput. The C5-C6 disc referred pain to the neck, trapezius, interscapular, suboccipital, anterior neck, chest and face. The C6-C7 disc referred pain to the neck, interscapular, trapezius, shoulder, extremity and subocciput. At C7-T1 we produced neck and interscapular pain. Visual maps with graduated color codes and frequencies of symptom location at each cervical disc level were generated. CONCLUSIONS: In conclusion, these results confirm the observations of prior investigators that cervical internal disc disruption can elicit axial and peripheral symptoms. The particular patterns of pain generation allow the discographer to preprocedurally anticipate disc levels to assess. With these data, the number of disc punctures that are required can be limited rather than routinely assessing all cervical discs.

Treating radiculopathy with an indwelling epidural catheter and infusion pump.

BACKGROUND: For the purpose of reducing inflammation causing radiculopathy, lumbar transforaminal and interlaminar epidural injections deliver corticosteroid to the vicinity of the spinal nerve, nerve roots, and intervertebral disc. Although acceptable, the efficacy of transforaminal injections is limited and variable. An indwelling epidural catheter offers the distinct advantages of delivering greater concentrations of corticosteroid directly to the site of pathology, over an extended duration. This extended exposure to corticosteroid may benefit the site of pathology. OBJECTIVE: To evaluate the safety and efficacy of corticosteroid administered through a disposable indwelling epidural catheter and infusion pump to treat pain and dysfunction caused by lumbosacral radiculopathy. STUDY DESIGN: A pilot investigation consisting of a prospective consecutive series of 10 patients, conducted in a specialty hospital. METHODS: An indwelling epidural catheter dispensed corticosteroid into the epidural space at the suspect level of pathology. The catheter was attached to an external, lightweight, spring-pressurized, and disposable reservoir pump holding 8.0 mg dexamethasone diluted with bacteriostatic normal saline to a total volume of 72 ml. After each patient's hospital discharge, the medication was administered into the epidural space at a rate of 1 ml per hour over a 72-hour period. Follow-up at six weeks was achieved in 100% of the patients. OUTCOME MEASURES: The outcome measures, recorded at pre-treatment and six weeks post-treatment were assessed using: the Visual Analog Scale (VAS); MOS 36-Item Short-Form Health Survey (SF-36); Pain Symptoms Survey; Oswestry Disability Index; Beck Inventory; Work History Survey; Work Index; Expectations Met Survey; Activities of Daily Living Form; and the Satisfaction With Treatment Form. RESULTS: There was no patient morbidity or mortality associated with this treatment, and patients, on average, experienced decreased pain levels after treatment. Mean delta VAS improvement was 4.1 (SD = 2.6, R =-9.6 to +1.5). The mean percent improvement was 46.7%. CONCLUSIONS: Safe and effective treatment of lower extremity radiculopathy symptoms may be obtained with this new method.

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

BACKGROUND: Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested. PURPOSE: To compare the efficacy of IDET with that of a placebo treatment. STUDY DESIGN/SETTING: Randomized, placebo-controlled, prospective trial. PATIENT SAMPLE: Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features. METHODS: IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients. OUTCOME MEASURES: The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale. RESULTS: Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit. CONCLUSIONS: Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.