Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy.

STUDY DESIGN: Prospective, randomized, blinded clinical trial. OBJECTIVE: To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy. SUMMARY OF BACKGROUND DATA: Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy. METHODS: Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations. RESULTS: There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6). CONCLUSION: These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.

The Lumbar Spine Outcomes Questionnaire: its development and psychometric properties.

BACKGROUND CONTENT: There are currently a number of generic and disease-specific instruments for assessing complaints of low back pain (LBP). None provide the comprehensive coverage of the wide range of factors that are considered essential in evaluating treatment outcomes. PURPOSE: To develop and evaluate the psychometric properties of a comprehensive, disease-specific questionnaire for characterizing complaints of LBP and evaluating the outcomes of treatments for these complaints. STUDY DESIGN: A clinical-cohort study of a large, convenience sample of LBP patients. METHODS: We have developed a comprehensive, disease-specific questionnaire for characterizing complaints of LBP and evaluating the outcomes of treatments for these complaints. A large group of patients who sought treatment for LBP (n=2539) completed the Lumbar Spine Outcomes Questionnaire (LSOQ) before treatment, and at 12 and 24 months after treatment. For each subject and for each evaluation period, scores on six composite measures were derived from the subjects' responses to the questionnaire: a LBP severity score, a leg pain severity score, a functional disability score, a psychological distress score, a physical symptoms score, and a health-care utilization score. These scores were used to evaluate the reliability, validity, and responsiveness of the questionnaire. RESULTS: Test-retest reliability of the LSOQ was evaluated by correlating the subject's 12-month scores on each composite measure with the corresponding 24-month scores. Intraclass coefficients of correlation were used. The obtained coefficients of correlation [(a) LBP severity, 0.87; (b) leg pain severity, 0.85; (c) functional disability, 0.87; (d) psychological distress, 0.88; (e) physical symptoms other than pain, 0.82; and (f) health-care utilization, 0.76] indicate good test-retest reliability for the LSOQ. Construct validity was evaluated by correlating scores on the composite measures derived from the LSOQ with scores on measures of the same constructs derived from the Oswestry Low Back Pain Disability Questionnaire and the Short Form 36-Item Health Survey. The coefficients of correlation were relatively high (mostly between .7 and .9), indicating good construct validity. Construct validity was also evaluated by comparing the scores of groups of subjects who were known to differ or not to differ on the composite measures, using multivariate analyses of variance. Significant multivariate and univariate differences were obtained between groups who were expected to differ (ie, surgically and nonsurgically treated patients). No significant differences were found for groups who were not expected to differ (ie, patients with similar diagnosis, but different surgical treatments). Responsiveness was assessed by evaluating differences in the 24-month change scores between improved and unimproved subjects. Large and significant differences were obtained between improved and unimproved subjects for all composite measures derived from the LSOQ. The observed effect sizes ranged from .68 to 1.17 indicating that the LSOQ is highly responsive. CONCLUSION: The LSOQ appears to be acceptable to patients, easy to administer, highly reliable, valid, and responsive. It provides information on demographics, pain severity, functional disability, psychological distress, physical symptoms, health-care utilization, and satisfaction. It should be considered for use in both clinical and research applications as well as regulatory review involving patients with LBP complaints.

Reduction of leg pain and lower-extremity weakness for 1 year with Oxiplex/SP gel following laminectomy, laminotomy, and discectomy.

OBJECT: Although good surgical technique is effective in reducing postoperative epidural fibrosis, compression or tethering of the nerve root may cause recurrent radicular pain and physical impairment. The implantation of a bioresorbable gel on the dura may further decrease the amount of scar formation after surgery and thus improve the patient's ability to perform activities of daily living (ADL). This study is a 12-month evaluation of the safety and effectiveness of Oxiplex/SP Gel (FzioMed, Inc., San Luis Obispo, CA) in the reduction of pain and radiculopathy after lumbar discectomy. METHODS: A pilot randomized single-blind multicenter clinical trial was conducted to evaluate the performance of Oxiplex/SP Gel in patients who underwent surgery for unilateral herniation of the lumbar disc at L4-5 or L5-S1. Eighteen patients with severe leg pain and lower-extremity weakness (11 women and seven men) were randomly assigned intraoperatively to receive the gel at the conclusion of surgery (treatment group) or to undergo surgery alone (control group). Self-assessment questionnaires (Lumbar Spine Outcomes Questionnaire) to assess pain, symptoms, and ADL were completed preoperatively and at scheduled postoperative intervals (30 days, 90 days, 6 months, and 12 months). The authors examined the spine and lower extremities of patients scheduled for discectomy to assess neurological function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 ml) to coat the nerve root and fill the epidural space. Postoperative clinical evaluations were performed at 30 and 90 days. Patients completed the self-assessment questionnaires at baseline and were contacted by telephone or mail for the completion of the postoperative self-assessment questionnaires. Surgical procedures were well tolerated; no device-related adverse events and no clinically significant laboratory results were reported. The 11 patients with severe leg pain and lower-extremity weakness who were treated with Oxiplex/SP Gel had a reduction in those symptoms at 30 days, 90 days, 6 months, and 12 months after discectomy, compared with the seven control patients who underwent surgery only. CONCLUSIONS: Oxiplex/SP Gel was easy to use and safe in patients who underwent unilateral discectomy. A greater benefit in clinical outcome measures was seen over the 12-month follow-up period in gel-treated patients.

Reduction of radiculopathy and pain with Oxiplex/SP gel after laminectomy, laminotomy, and discectomy: a pilot clinical study.

STUDY DESIGN: Safety using Oxiplex/SP Gel during single-level discectomy for reduction of symptoms associated with unilateral herniation of the lumbar disc was investigated by self-assessment questionnaire and magnetic resonance imaging. OBJECTIVE: To evaluate the safety and assess the efficacy parameters of Oxiplex/SP Gel. SUMMARY OF BACKGROUND DATA: Animal studies demonstrated that Oxiplex/SP Gel (CMC/PEO) reduced epidural fibrosis after lumbar surgery. METHODS: Surgeons examined spine and lower extremities of patients scheduled for discectomy to assess neurologic function and pain. Treated patients received sufficient Oxiplex/SP Gel (1-3 mL) to coat the nerve root and fill the epidural space. The control condition was surgery alone. At baseline, then 30 days, 90 days, and 6 months after surgery, patients completed self-assessment questionnaires concerning leg pain, lower extremity weakness, functional disability, daily living activities, symptoms, and radiculopathy. Magnetic resonance imaging was performed at baseline and 90 days after surgery. At 30 and 90 days after surgery, patients underwent physical examination, wound inspection, and laboratory tests. RESULTS: The surgical procedures were well tolerated by the 23 patients treated with Oxiplex/SP Gel and the 11 control patients. There were no unanticipated adverse events, no clinically significant laboratory results, and no significant differences detected by magnetic resonance imaging. Treated patients had greater reduction in outcome measures at 30 days. The differences in scores were attenuated at 90 days and 6 months. A subgroup, the patients with significant leg pain and weakness at baseline (11 patients treated with Oxiplex/SP Gel and 7 control patients), had greater reduction in outcome measures than the control patients throughout the study. CONCLUSIONS: Oxiplex/SP Gel was easy to use and safe for patients undergoing unilateral discectomy. Greater benefit in clinical outcome measures was seen in gel-treated patients, especially those with severe leg pain and weakness at baseline.

Cervical spine outcomes questionnaire: its development and psychometric properties.

STUDY DESIGN: A cross-sectional study was conducted to analyze a convenience sample of patients seeking treatment for cervical spine conditions. OBJECTIVE: To develop and evaluate the psychometric properties of a comprehensive, disease-specific questionnaire for characterizing complaints of neck pain and evaluating the outcomes of treatments for these complaints. SUMMARY OF BACKGROUND DATA: There currently are a number of generic and disease-specific instruments for assessing complaints of neck pain. None comprehensively cover the wide range of factors considered essential in evaluating treatment outcomes. METHODS: The authors developed a comprehensive, disease-specific questionnaire for characterizing complaints of neck pain and evaluating the outcomes of treatments for these complaints. In this study, 216 patients who underwent surgery for cervical spine disorders completed the Cervical Spine Outcomes Questionnaire before treatment, then at 3 and 6 months after treatment. The data were used to evaluate the reliability, validity, and responsiveness of the questionnaire. RESULTS: The authors have shown that the Cervical Spine Outcomes Questionnaire has high test-retest reliability, good construct validity, and responsiveness to change after treatment. CONCLUSIONS: The Cervical Spine Outcomes Questionnaire is a comprehensive, disease-specific instrument for assessing complaints of neck pain and evaluating the outcomes of treatments for these complaints. It provides information on demographics, pain severity, functional disability, psychological distress, physical symptoms, health care utilization, and satisfaction. It appears to be acceptable to patients, easy to administer, highly reliable, valid, and responsive. It should be considered for use in monitoring patients with cervical spine conditions and in studies of cervical spine disorders and their treatments.

Persistent low back pain and sciatica in the United States: treatment outcomes.

Patients with persistent low back pain (LBP) appear to be different in several important ways from patients who have traditionally been classified as patients with acute or chronic LBP, and data on the effectiveness of the treatments prescribed for them are lacking. The aim of the current study was to evaluate the short- and long-term effectiveness of the treatments currently prescribed for these patients. The data reported in this article were gathered as part of a multicenter, prospective, cross-sectional study of patients who were treated for persistent LBP by neurologic and orthopedic surgeons who are recognized specialists in spinal disorders. At enrollment, patients completed a baseline evaluation, and their physicians recorded relevant clinical and treatment data on standardized study forms. At 3, 6, 12, and 24 months after treatment, patients completed follow-up evaluations. Patients were divided into five treatment groups, and effectiveness was evaluated separately for each group using five patient-reported measures of outcome: pain severity, functional disability, psychologic distress, physical symptoms, and health care use. The data revealed that at the 2-year follow-up, the typical patient of the no-treatment group had improved slightly in terms of pain severity and health care use, but had experienced little or no improvement in functional disability, physical symptoms, and psychologic distress. The average patient in the conservative care group reported small improvements in pain severity, functional disability, physical symptoms, and health care use, with no change in psychologic distress. These small improvements occurred within the first 3 months after enrollment, with essentially no change thereafter. The average patient in the immediate surgical care group showed substantial improvement on all of the outcome measures. The observed improvements were evident shortly after treatment and were maintained for the duration of the study. Patients in the delayed surgical care group had outcomes that were less dramatic than those observed in the immediate surgery care group, but greater than those observed in the conservative care group. The patients who were treated surgically by physicians outside the study, outside surgical care group, did not improve over time. Patients with persistent LBP who received no treatment showed no spontaneous recovery. Conservative care treatments prescribed by surgeons who specialize in spinal disorders, did not appear to be any more effective than no treatment. The outcome of surgery for persistent LBP varied from dramatic for one subgroup of surgical patients, to poor for another subgroup of patients. Patients who were selected immediately for surgical treatment improved substantially. Those treated surgically later by study physicians or by physicians not associated with the study fared less well.

A validated, practical classification procedure for many persistent low back pain patients.

We have developed a simple procedure for assigning persistent low back pain patients to one of four mutually exclusive, hierarchically organized classes. The procedure relies on the spatial distribution of a patient's pain and the results of straight leg raise tests to make the assignment. We have applied the procedure to a large group of patients who sought treatment for persistent LBP at several university affiliated tertiary care clinics, and found that the resulting four classes of patients were significantly different from one another in their presentation, and in the way they were evaluated and treated by physicians. We concluded that the procedure may have practical research and clinical applications.