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One-year outcomes of surgical versus nonsurgical treatments for discogenic back pain: a community-based prospective cohort study.

ABSTRACT: The clinical entity "discogenic back pain" remains controversial at fundamental levels, including its pathophysiology, diagnostic criteria, and optimal treatment. This is true despite availability of four randomized trials comparing the efficacy of surgical and nonsurgical treatments. One trial showed benefit for lumbar fusion compared with unstructured nonoperative care, and three others showed roughly similar results for lumbar surgery and structured rehabilitation.To compare outcomes of community-based surgical and nonsurgical treatments for patients with chronic back pain attributed to degeneration at one or two lumbar disc levels.Prospective observational cohort study.Patients presenting with axial back pain to academic and private practice orthopedic surgeons and neurosurgeons in a large metropolitan area.Roland-Morris back disability score (primary outcome), current rating of overall pain severity on a numerical scale, back and leg pain bothersomeness measures, the physical function scale of the short-form 36 version 2 questionnaire, use of medications for pain, work status, emergency department visits, hospitalizations, and further surgery.Patients receiving spine surgery within 6 months of enrollment were designated as the "surgical treatment" group and the remainder as "nonsurgical treatment." Outcomes were assessed at 3, 6, 9, and 12 months after enrollment.We enrolled 495 patients with discogenic back pain presenting for initial surgical consultation in offices of 16 surgeons. Eighty-six patients (17%) had surgery within 6 months of enrollment. Surgery consisted of instrumented fusion (79%), disc replacement (12%), laminectomy, or discectomy (9%). Surgical patients reported more severe pain and physical disability at baseline and were more likely to have had prior surgery. Adjusting for baseline differences among groups, surgery showed a limited benefit over nonsurgical treatment of 5.4 points on the modified (23-point) Roland disability questionnaire (primary outcome) 1 year after enrollment. Using a composite definition of success incorporating 30% improvement in the Roland score, 30% improvement in pain, no opioid pain medication use, and working (if relevant), the 1-year success rate was 33% for surgery and 15% for nonsurgical treatment. The rate of reoperation was 11% in the surgical group; the rate of surgery after treatment designation in the nonsurgical group was 6% at 12 months after enrollment.The surgical group showed greater improvement at 1 year compared with the nonsurgical group, although the composite success rate for both treatment groups was only fair. The results should be interpreted cautiously because outcomes are short term, and treatment was not randomly assigned. Only 5% of nonsurgical patients received cognitive behavior therapy. Nonsurgical treatment that patients received was variable and mostly not compliant with major guidelines.

SUBMITTER: Mirza SK

PROVIDER: S-EPMC4699569 | biostudies-other | 2013 Nov

REPOSITORIES: biostudies-other

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One-year outcomes of surgical versus nonsurgical treatments for discogenic back pain: a community-based prospective cohort study.

Mirza Sohail K SK Deyo Richard A RA Heagerty Patrick J PJ Turner Judith A JA Martin Brook I BI Comstock Bryan A BA

The spine journal : official journal of the North American Spine Society 20130723 11

<h4>Background context</h4>The clinical entity "discogenic back pain" remains controversial at fundamental levels, including its pathophysiology, diagnostic criteria, and optimal treatment. This is true despite availability of four randomized trials comparing the efficacy of surgical and nonsurgical treatments. One trial showed benefit for lumbar fusion compared with unstructured nonoperative care, and three others showed roughly similar results for lumbar surgery and structured rehabilitation.< ...[more]

PMID: 23890947

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Project description:BackgroundThoracic trauma (TT) is common among people with multiple traumatic injuries. One of the injuries caused by TT is the loss of thoracic stability resulting from multiple fractures of the rib cage, otherwise known as flail chest (FC). A person with FC can be treated conservatively with orotracheal intubation and mechanical ventilation (internal pneumatic stabilization) but may also undergo surgery to fix the costal fractures.ObjectivesTo evaluate the effectiveness and safety of surgical stabilization compared with clinical management for people with FC.Search methodsWe ran the search on the 12 May 2014. We searched the Cochrane Injuries Group's Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), MEDLINE (OvidSP), EMBASE Classic and EMBASE (OvidSP), CINAHL Plus (EBSCO), ISI WOS (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), and clinical trials registers. We also screened reference lists and contacted experts.Selection criteriaRandomized controlled trials of surgical versus nonsurgical treatment for people diagnosed with FC.Data collection and analysisTwo review authors selected relevant trials, assessed their risk of bias, and extracted data.Main resultsWe included three studies that involved 123 people. The methods used for blinding the participants and researchers to the treatment group were not reported, but as the comparison is surgical treatment with medical treatment this bias is hard to avoid. There was no description of concealment of the randomization sequence in two studies.All three studies reported on mortality, and deaths occurred in two studies. There was no clear evidence of a difference in mortality between treatment groups (risk ratio (RR) 0.56, 95% confidence interval (CI) 0.13 to 2.42); however, the analysis was underpowered to detect a difference between groups. Out of the 123 people randomized and treated, six people died; the causes of death were pneumonia, pulmonary embolism, mediastinitis, and septic shock.Among people randomized to surgery, there were reductions in pneumonia (RR 0.36, 95% 0.15 to 0.85; three studies, 123 participants), chest deformity (RR 0.13, 95% CI 0.03 to 0.67; two studies, 86 participants), and tracheostomy (RR 0.38, 95% CI 0.14 to 1.02; two studies, 83 participants). Duration of mechanical ventilation, length of intensive care unit stay (ICU), and length of hospital stay were measured in the three studies. Due to differences in reporting, we could not combine the results and have listed them separately. Chest pain, chest tightness, bodily pain, and adverse effects were each measured in one study.Authors' conclusionsThere was some evidence from three small studies that showed surgical treatment was preferable to nonsurgical management in reducing pneumonia, chest deformity, tracheostomy, duration of mechanical ventilation, and length of ICU stay. Further well-designed studies with a sufficient sample size are required to confirm these results and to detect possible surgical effects on mortality.

Project description:BackgroundManagement of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.MethodsSurgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.ResultsWe enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.ConclusionsIn nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).

Project description:A previous study has suggested that it is uncommon for patients with chronic bothersome low back pain (LBP), who consult the secondary health care sector, to report at least four consecutive weeks without such bothersome pain in 1 year. It is not yet known, however, how many days of the week they experience pain throughout the year.The current study analyzed data collected in two randomized clinical studies conducted in 2007-9 on patients with back pain (Study 1 and 2). Study participants were patients with LBP for more than 2 months, one group with MRI-defined Modic changes (Study 1) and the other without any pathological explanation for the pain (Study 2). In both studies, participants were followed over 1 year with weekly automated text messages (SMS-Track). Each week they reported the number of days they had experienced bothersome LBP (0-7 days). The number of weeks with 7 days of bothersome LBP was calculated for both study groups. As baseline and outcome characteristics were similar between the intervention and control groups in each study, the data from treatment and control groups in each study were analyzed together, regardless of treatment allocation and the results compared between the two study samples.The proportion of patients reporting bothersome LBP all days of the week ranged from 0 to 100 %, with the findings arranged in a U-shaped curve. The pain frequency patterns were remarkably similar for the two study samples. At one extreme, 31 % of participants reported 0-10 % of weeks with daily LBP. At the other extreme, 25 % of participants reported 91-100 % of weeks with daily LBP. The distribution between these values was also very similar for the two groups.This study revealed there to be considerable variation in weekly persistence of symptoms during 1 year in patients from the secondary care sector with chronic LBP. The results range from bothersome pain each day of the week, every week of the year, to no weeks at all with 7 days of pain. Interestingly, this pattern is near-identical in the two study samples; those with non-specific LBP and those with LBP and Modic changes. This heterogeneic pain profile in patients with chronic LBP deserves to be further investigated.

Project description:BackgroundIn order to define the onset of a new episode of low back pain (LBP), the definition of a "non-episode" must be clear. De Vet et al reviewed the scientific literature but found no evidence-based definitions of episodes or non-episodes of LBP. However, they suggested that pain-based episodes should be preceded and followed by a period of at least one month without LBP. As LBP is an episodic disease, it is not clear whether a sufficient number of patients with LBP will be LBP-free for at least one month ("non-episode") to justify the use of this duration in the definition of pain free episode.ObjectivesTwo clinical populations were followed weekly over one year making it possible 1) to determine the maximum numbers in a row of weeks without LBP, 2) to determine the prevalence of non-episodes throughout a one-year period, and 3) to find the prevalence of patients who reported to be in a non-episode of LBP at the end of the study.MethodsSecondary data were used from two recent clinical studies, in which weekly automated text messages (SMSes) had been collected on the number of days with LBP in the preceding week for one year. Weeks with 0 days of LBP were defined as "zero-weeks" and four zero-weeks in a row were defined as a period without LBP (a"non-episode") according to de Vet et al's suggestion. The study participants, all from the secondary care sector, consisted of: study 1) patients with LBP and Magnetic Resonance Imaging-identified Modic changes and study 2) patients without obvious acute disc problems, Modic changes or other pathologies, who therefore were assumed to have non-specific LBP. Both studies were two-armed intervention studies without a significant difference in outcome between intervention groups. The number of zero-weeks was identified in each participant. Thereafter the numbers of participants who reported at least one non-episode during the study period were identified. Finally, the numbers of participants who had a non-episode at the end of the study were counted. Estimates are reported with their 95% confidence intervals.ResultsThe numbers of participants included in the analyses were 80 and 209. Most commonly, no zero weeks were reported, by 65% (55-75) and 56% (49-63) of patients, respectively. The percentages of study participants with at least one non-episode at some time during the course of the study were 20% (11-29) and 18% (15-21. The percentages of participants who were identified as being in a non-episode at the time of the last week of the study were, 5% (95% CI: 0-10) and 4% (1-7) respectively.ConclusionsThe vast majority of these secondary care sector patients had a profile of more or less constant LBP. The estimates for non-episodes during the study period and at the end of the study were very similar for participants with LBP who also had Modic changes and those with non-specific LBP. It is possible that a definition of pain-free periods is pointless in patients seeking care in the secondary care sector.

Project description:OBJECTIVES:The purpose of the international multicenter prospective single arm clinical trial was to evaluate restorative neurostimulation eliciting episodic contraction of the lumbar multifidus for treatment of chronic mechanical low back pain (CMLBP) in patients who have failed conventional therapy and are not candidates for surgery or spinal cord stimulation (SCS). MATERIALS AND METHODS:Fifty-three subjects were implanted with a neurostimulator (ReActiv8, Mainstay Medical Limited, Dublin, Ireland). Leads were positioned bilaterally with electrodes close to the medial branch of the L2 dorsal ramus nerve. The primary outcome measure was low back pain evaluated on a 10-Point Numerical Rating Scale (NRS). Responders were defined as subjects with an improvement of at least the Minimal Clinically Important Difference (MCID) of ?2-point in low back pain NRS without a clinically meaningful increase in LBP medications at 90 days. Secondary outcome measures included Oswestry Disability Index (ODI) and Quality of Life (QoL; EQ-5D). RESULTS:For 53 subjects with an average duration of CLBP of 14 years and average NRS of 7 and for whom no other therapies had provided satisfactory pain relief, the responder rate was 58%. The percentage of subjects at 90 days, six months, and one year with ?MCID improvement in single day NRS was 63%, 61%, and 57%, respectively. Percentage of subjects with ?MCID improvement in ODI was 52%, 57%, and 60% while those with ?MCID improvement in EQ-5D was 88%, 82%, and 81%. There were no unanticipated adverse events (AEs) or serious AEs related to the device, procedure, or therapy. The initial surgical approach led to a risk of lead fracture, which was mitigated by a modification to the surgical approach. CONCLUSIONS:Electrical stimulation to elicit episodic lumbar multifidus contraction is a new treatment option for CMLBP. Results demonstrate clinically important, statistically significant, and lasting improvement in pain, disability, and QoL.

Dataset Information

One-year outcomes of surgical versus nonsurgical treatments for discogenic back pain: a community-based prospective cohort study.

Publications

One-year outcomes of surgical versus nonsurgical treatments for discogenic back pain: a community-based prospective cohort study.

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