Pain quality of life as measured by utilities.

OBJECTIVE: Utilities are values of health-related quality of life (HRQoL) based on patient preference for a health status. The purpose of this study was to compare indirect measures to a directly elicited utility. DESIGN: Cross-sectional study. SETTING AND PATIENTS: Emory Spine Center and the Emory Center for Chronic Pain at Crawford Long Hospital. Patients at least 18 years of age with chronic pain, defined as pain that persists beyond the normal time of healing, usually beyond 6 months. MEASURES: Chronic pain subjects completed a paper-based, self-administered time trade-off (TTO) survey, EQ-5D survey, and a face-to-face (FTF) TTO interview. Current pain severity was graded using the Numeric Rating Scale-11, subsequently stratified into no (0), mild (1-3), moderate (4-6), and severe (7-10) pain. RESULTS: Paired t test comparing FTF TTO and proxy utility measures stratified by severity revealed FTF TTO utility values significantly higher than EQ-5D utility values for all pain severities (overall mean difference 0.18, standard deviation [SD] 0.30, P < 0.001; Pearson's correlation 0.34, P < 0.0001); FTF TTO utility values were lower than paper TTO utility values, reaching statistical significance for mild and moderate pain (overall mean difference 0.09, SD 0.29, P = 0.0006; Pearson's correlation 0.38, P < 0.0001). CONCLUSIONS: This study demonstrates that the EQ-5D overestimates, whereas the paper version of TTO underestimates, the impact of pain on HRQoL compared with the directly elicited FTF TTO utility. Our findings provide preliminary evidence that utilities vary by method, and directly elicited utility values differ from indirectly elicited measures.

A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up.

STUDY DESIGN: Randomized, controlled, prospective (AAOS therapeutic level I) trial conducted under Food and Drug Administration Investigational Device Exemption hypothesized noninferiority of a novel bioactive composite material to polymethylmethacrylate (PMMA). OBJECTIVE: To determine the safety and efficacy of a new, nonresorbable bioactive composite (Cortoss) compared with PMMA, the standard treatment of vertebral compression fractures (VCFs). SUMMARY OF BACKGROUND DATA: Vertebroplasty with PMMA, the widely adopted treatment for VCFs nonresponsive to conservative care, provides effective, immediate pain relief, but the material has received criticism for its properties. A new bioactive composite material designed specifically for vertebroplasty showed promising results in animals and nonrandomized clinical studies and was subsequently compared with PMMA in a randomized study. This study represents the first prospective study evaluating vertebroplasty comparing PMMA with another material with 24-month follow-up. METHODS: Using 2:1 randomization, vertebroplasty was performed with Cortoss on 162 patients and PMMA on 94 patients. Inclusion criteria were painful osteoporotic VCFs with a visual analogue scale pain score of at least 50 mm on a 100-mm scale and at least 30% disability as measured by the Oswestry Disability Index. Evaluations at pretreatment, treatment day, and 7 posttreatment intervals out to 24 months included pain, disability, neurological status, adverse events, quality of life, patient satisfaction, analgesic use, and independently reviewed radiographs. RESULTS: Noninferiority of Cortoss relative to PMMA was observed, with Cortoss-treated patients experiencing significant pain relief at 3 months (P = 0.0395) and better maintenance or improvement in function at 24 months (P = 0.0299). Incidence of serious device-related adverse events was 4.3% in both groups; none were life threatening. CONCLUSION: Vertebroplasty using either Cortoss or PMMA provides effective, immediate, and lasting pain relief and prevents further loss of function. Both materials performed comparably at most time points; Cortoss demonstrated better results for pain reduction at 3 months and for function at 24 months.

Adverse events of conscious sedation in ambulatory spine procedures.

BACKGROUND CONTEXT: Interventional spine procedures are commonly performed in the ambulatory surgical setting, often using conscious sedation. The rate of adverse events with conscious sedation has not been previously assessed in the interventional spine procedure setting. PURPOSE: The goal of this study was to determine the rate of adverse events when using conscious sedation in the ambulatory interventional spine setting. STUDY DESIGN: A retrospective cohort chart review analysis was performed on all interventional spine procedures performed during one calendar year at a university-affiliated ambulatory surgery center by six nonanesthesia-trained spine interventionalists. PATIENT SAMPLE: Of the 3,342 procedures performed that year, 2,494 charts (74.6%) were available for review. OUTCOME MEASURES: Adverse events were documented immediately after the procedure and at a maximum 3-day follow-up phone call. METHODS: The rate and type of adverse events were analyzed and compared between those who received conscious sedation with local anesthesia and those who received local anesthesia alone. RESULTS: Of the 2,494 cases reviewed, 1,228 spine procedures were performed with local anesthesia and conscious sedation, and 1,266 procedures were performed with local anesthesia alone. Of these cases, 66 immediate adverse events (5.12%) were documented in the conscious sedation group, and 61 immediate adverse events (4.82%) were documented in the local anesthesia alone group. At maximum 3-day follow-up, 670 patients of the conscious sedation group were available for contact, and 699 patients were available from the local anesthesia group. Thirty-two adverse events (4.77%) were noted in the conscious sedation group, and 28 adverse events (4.00%) were noted in the local anesthesia group. Comparison of these rates found no significant statistical difference. However, patients in the local anesthesia group had a significantly higher rate of postoperative hypertension. Adverse events reported both immediately and at follow-up were determined to be mild, with no serious adverse events reported. CONCLUSION: The findings of this study suggest that mild to moderate conscious sedation in interventional spine procedures is associated with low rates of adverse events when established protocols are followed.

Interlaminar versus transforaminal epidural steroid injections for the treatment of symptomatic lumbar spinal stenosis.

BACKGROUND: Lumbar spinal stenosis is a common condition that causes axial low back pain, radicular pain, and neurogenic claudication. Epidural steroid injections are commonly used for the treatment of radicular symptoms and neurogenic claudication associated with symptomatic lumbar spinal stenosis. No prior study has evaluated whether transforaminal or interlaminar epidural steroid injections produce better clinical outcomes. DESIGN: Retrospective case control study. METHODS: For each technique, 19 patients were retrospectively identified who received their first fluoroscopically guided epidural steroid injection for radicular and neurogenic claudication symptoms caused by lumbar spinal stenosis over a 12-month interval. All patients had corresponding MRI findings and had failed previous non-invasive therapies. Outcomes included the visual analog scale (VAS, 0-10 scale) immediately before the injection, immediately after the injection, and upon follow up at 4-6 weeks. Surgery rates and number of repeat injections over a 3 year period were also analyzed. The patient groups were matched for age and level of stenosis on MRI. RESULTS: There was no statistically significant difference between the two groups in pre injection to follow up VAS scores (P=0.919). The difference between number of repeat injections between the interlaminar and transforaminal groups was not statistically significant (0.91-mean 2.47 and 2.58, respectively). Both the interlaminar and transforaminal groups experienced statistically significant improvement in VAS scores from before the injection to after the injection, and on follow up. Low numbers underwent surgery (11% in the interlaminar group vs 15% in the transforaminal group, not significant, P=0.63). CONCLUSIONS: In the current study, neither transforaminal nor interlaminar steroid injections resulted in superior short term pain improvement or fewer long term surgical interventions or repeat injections when compared with each other.

Single level lumbar disc herniations resulting in radicular pain: pain and functional outcomes after treatment with targeted disc decompression.

STUDY DESIGN: Single-arm prospective clinical trial. OBJECTIVE: To determine the treatment effect and MRI changes of targeted disc decompression using an intradiscal catheter for focal heating of symptomatic lumbar disc protrusions resulting in radicular pain. SUMMARY OF BACKGROUND DATA: Percutaneous methods for treatment of lumbar disc herniations are potentially attractive alternatives to open surgical discetomies. The effects of a newly designed, percutaneous electrothermal intradiscal catheter were evaluated. METHODS: Twenty-two subjects with MRI confirmed, single-level contained lumbar disc protrusions, a minimum of 8 weeks of radicular pain (average 63 weeks) and failed nonsurgical treatment were invited. Nineteen patients underwent the decompression procedure. Follow-up was performed by physical exam and pain severity visual analog scale (VAS), SF-36 bodily pain (BP)/physical functioning (PF) scores for 12 months post-procedure. MRIs were obtained prior to treatment and at 3 months post-procedure. RESULTS: Eighty-four percent of treated patients were available for follow-up at 12 months. The mean reduction in leg pain VAS scores was 2.6 points (40.6%, 95% CI 1.0-4.1). The mean reduction in back pain VAS scores was 2.4 points (44.4%, 95% CI 0.8-4.0). SF-36 BP scores improved 28.8 points (95% CI 17.5-40.0) and SF-36 PF scores improved 25.4 points (95% CI 13.0-37.7) on average. Effect sizes were small for VAS scores and moderate for SF-36 scores. Fifty-four percent of disc herniations were improved or resolved on MRI. No device-related or intraoperative complications were observed. CONCLUSIONS: Targeted disc decompression provided moderate improvement in leg pain and function in the majority of patients with chronic radicular pain.

Interlaminar versus transforaminal epidural injections for the treatment of symptomatic lumbar intervertebral disc herniations.

BACKGROUND: Epidural steroid injections are commonly used for the treatment of radicular symptoms associated with symptomatic lumbar intervertebral disc herniations. Transforaminal epidural injections are believed to produce better clinical outcomes than interlaminar epidural injections. OBJECTIVE: To determine a difference in short-term pain improvement and longterm surgical rates between interlaminar and transforaminal injection techniques. DESIGN: Case Control Study. METHODS: For each technique, 20 patients were retrospectively identified who received their first fluoroscopically guided epidural steroid injection for radicular symptoms caused by a lumbar intravertebral disc herniation over an 18 months interval. All patients had corresponding MRI findings and failed previous non-invasive therapies. The Verbal Numerical Rating Scale (VNRS, 0-10 scale) before the treatment, within one hour after the treatment and upon follow-up (average 17.1 days) were analyzed, along with the need for repeat injections and surgical interventions over a 1-year follow-up interval. The patient groups were matched for symptom duration, MRI findings and pre-injection VNRS scores. RESULTS: In the transforaminal group, there was a statistically significant improvement in the VNRS scores from before the injection (VNRS mean 5.9) to immediately after the injection (VNRS mean 2.9, p<0.01), and upon follow-up (VNRS mean 3.2, p<0.01, mean 18.7 days). Nine patients (45%) required 1 or 2 repeated injections, 2 patients (10%) underwent surgery. In the interlaminar group, there was a statistically significant improvement in the VNRS scores from before the injection (VNRS mean 7.3) to immediately after the injection (VNRS mean 3.1, p<0.01), and upon follow-up (VNRS mean 5.9, p<0.01, mean 15.6 days). Eight patients (40%) required 1 or 2 repeated injection, 5 patients (25%) underwent surgery. Fourteen patients (70%) had an improvement of 2 points or more on the VNRS scale in the transforaminal group, compared to 9 (45%) in the interlaminar group. CONCLUSIONS: In the current study, transforaminal epidural steroid injections for the treatment of symptomatic lumbar disc herniation resulted in better short-term pain improvement and fewer long-term surgical interventions than interlaminar epidural steroid injection.

Physical function measurements in neck pain.

The literature on physical and functional measurements for the cervical spine is more limited than for the lumbar spine. Most of the studies so far have dealt with the methods for range-of-motion measurements in the cervical spine. These studies indicate that newer computer-guided, three-dimensional measurements systems may provide more precise and reliable data than inclinometer-based techniques and visual estimation methods. The research available also shows a correlation between training and strength improvement in the cervical spine. In addition to physical measurements, several tests have been developed to measure pain level, psychologic factors, disability from neck pain, and generic health, which can assist the clinician in choosing the most appropriate treatment for patients with neck pain. Furthermore, functional measurement systems, such as FCEs, have been developed to describe the functional limitations that a patient may have as a result of a spinal injury. Except for the range-of-motion measurement methods, much more research is required to determine which measurement systems provide the optimal balance between reliability and validity and pragmatic considerations such as time and expense.

Outcome research in patients with chronic low back pain.

Outcome research in chronic low-back pain is entering a new phase. In the past several years, several outcome measures have been evaluated for their psychometric properties, and databases for patients with low-back pain exist for some of them. A set of recommended and standardized outcome measures and questionnaires is now available for the different outcome domains. The use of computerized versions of these questionnaires will allow simplified data collection and analyses, which will not only help to formulate a more uniform design of research trials, but can be useful for clinicians interested in documenting multi-dimensional outcomes in their patient population.