The Science. The Research.
Disclosures: This study was sponsored by Spinal Restoration, Inc. Drs. Yin, Pauza, and Olan are members of the Clinical Advisory Board and have been granted options, own stock or receive consulting fees from Spinal Restoration. Jeff Doerzbacher is Director of Regulatory and Clinical Affairs, and Dr. Thorne is Director of Scientific Affairs for the sponsor.
Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.
Prospective, nonrandomized Food and Drug Administration approved pilot study.
Three centers in the United States.
Fifteen adults with chronic, single, or contiguous two‐level lumbar discogenic pain confirmed through meticulous provocation discography.
Volume‐ and pressure‐controlled intradiscal delivery of BIOSTAT BIOLOGX® Fibrin Sealant with the Biostat® Delivery Device into symptomatic lumbar disc(s).
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).
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.
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.
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.
Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.
To compare the efficacy of IDET with that of a placebo treatment.
Randomized, placebo-controlled, prospective trial.
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.
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.
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.
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.
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.
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.
To conduct a prospective visual and statistical descriptive study of pain provocation of a cohort of subjects undergoing cervical discography.
Prospective multicenter descriptive study.
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.
A total of 101 symptom provocation maps were recorded during cervical discography on 41 subjects. There were10 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.
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.
To evaluate relationships among ROM and self-reported clinical outcomes ins ingle or multilevel ProDisc-L patients.
USE-FDA IDE trial, one site
Randomized (RCT, n-59), Pilot (P, n=6), Continued Access (CA, n=147) and Compassionate Use (CU, n=37).
Oswestry Disability Index (ODI), Visual Analogue Scale for pain (VAS).
ROM was maintained throughout follow-up in Pro-Disc-L, patients. Importantly, greater ROM was strongly associated with greater functional ability, less pain, and greated satisfaction. This is the first report of these associations.
This prospective study evaluated the diagnostic utility of historically accepted sacroiliac joint tests. A multidisciplinary expert panel recommended 12 of the “best” sacroiliac joint tests to be evaluated against a criterion standard of unequivocal gain relief after an intra-articular injection of local anesthetic into the sacroiliac joint.
To identify a single sacroiliac joint test or ensemble of test that are sufficiently useful in diagnosing sacroiliac joint disorders to be clinically valuable.
SUMMARY OF BACKGROUND DATA:
No previous research has been done to evaluate any physical test of sacroiliac joint pain against an accepted criterion standard.
Historical data was obtained, and the 12 tests were performed by two examiners on 85 patients who subsequently underwent sacroiliac joint blocks. Ninety percent or more relief was considered a positive response, and less then 90% relief was considered a negative response.
There were 45 positive and 40 negative responses. No historical feature, none of the 12 sacroiliac joint tests, and no ensemble of these 12 tests demonstrated worthwhile diagnostic value.
Sacroiliac joint pain is resistant to identification by the historical and physical examination data from tests evaluated in this study.