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CME / CE

Herniated Disk Improves With Either Surgical or Nonsurgical Treatment

  • Authors: News Author: Laurie Barclay, MD
    CME Author: Charles Vega, MD, FAAFP
  • CME / CE Released: 11/21/2006; Reviewed and Renewed: 11/21/2007
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 11/21/2008
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Target Audience and Goal Statement

This article is intended for primary care clinicians, pain medicine specialists, orthopedists, and other specialists who care for patients with radicular pain and lumbar disk herniation.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  • Identify outcomes of a nonrandomized trial of diskectomy vs nonoperative care for radicular back pain.
  • Compare diskectomy vs nonoperative care in a randomized trial of patients with radicular pain.

 


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Medscape, LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.


Author(s)

  • Laurie Barclay, MD

    Laurie Barclay, MD is a freelance reviewer and writer for Medscape.

    Disclosures

    Disclosure: Laurie Barclay, MD, has disclosed no relevant financial relationships.

CME Author(s)

  • Charles P Vega, MD

    Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine

    Disclosures

    Disclosure: Charles Vega, MD, FAAFP, has disclosed that he has received grants for educational activities from Pfizer.


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CME / CE

Herniated Disk Improves With Either Surgical or Nonsurgical Treatment

Authors: News Author: Laurie Barclay, MD CME Author: Charles Vega, MD, FAAFPFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME / CE Released: 11/21/2006; Reviewed and Renewed: 11/21/2007

Valid for credit through: 11/21/2008

processing....

November 21, 2006 — Patients with herniated disks had improved outcomes during 2 years whether treated surgically or nonsurgically, according to the results of a randomized trial with an accompanying observational cohort reported in the November 22/29 issue of JAMA.

"Lumbar diskectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to nonoperative care remains controversial," write James N. Weinstein, DO, MSc, of the Dartmouth Medical School in Hanover, New Hampshire, and colleagues from the Spine Patient Outcomes Research Trial (SPORT).

Between March 2000 and November 2004, SPORT enrolled 501 surgical candidates from 13 multidisciplinary spine clinics in 11 US states and randomized them to standard open diskectomy vs individualized nonoperative treatment. Mean age was 42 years, and 42% were women. All patients had imaging-confirmed lumbar intervertebral disk herniation and persistent signs and symptoms of radiculopathy for at least 6 weeks.

The main endpoints were changes from baseline for the Medical Outcomes Study 36-item Short-Form Health Survey bodily pain and physical function scales and the modified Oswestry Disability Index (American Academy of Orthopaedic Surgeons MODEMS version) at 6 weeks, 3 months, 6 months, and 1 and 2 years from enrollment. Secondary endpoints included sciatica severity on the Sciatica Bothersomeness Index, satisfaction with symptoms, self-reported improvement, and employment status.

There was considerable crossover between groups and limited adherence to assigned treatment: 50% of patients assigned to surgery received surgery within 3 months of enrollment, whereas 30% of those assigned to nonoperative treatment also received surgery during the same period. Based on intent-to-treat analyses, both treatment groups had substantial improvements for all primary and secondary outcomes. Between-group differences in improvements were consistently in favor of surgery, but these were small and not statistically significant for the main endpoints.

"Patients in both the surgery and the nonoperative treatment groups improved substantially over a 2-year period," the authors write. "Because of the large numbers of patients who crossed over in both directions, conclusions about the superiority or equivalence of the treatments are not warranted based on the intent-to-treat analysis."

Other study limitations include strict eligibility criteria limiting generalizability, lack of masking through the use of sham procedures, and choice of nonoperative treatments at the discretion of the treating clinician and patient.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, and the US Centers for Disease Control and Prevention funded this study. Some of the authors have disclosed various financial relationships with Spine, United Health Care, the Foundation for Informed Medical Decision Making, St. Francis Medical Technologies, American Board of Orthopaedic Surgery, Ortho-MacNeil Pharmaceuticals, the Robert Graham Center of the American Academy of Family Practice, Centocor, Myexpertdoctor.com, Pacific Business Group on Health, National Spine Network, Medtronic, and/or Synthes.

The second report describes outcomes in the observational cohort of patients who met the SPORT eligibility criteria but declined randomization between March 2000 and March 2003. Of the 743 patients enrolled, 528 patients received surgery, and 191 received usual nonoperative treatment.

At 3 months, patients who opted for surgery had greater improvement in the primary outcome measures of bodily pain (mean change: surgery, 40.9 vs nonoperative care, 26.0; treatment effect, 14.8; 95% confidence interval [CI], 10.8 - 18.9), physical function (mean change: surgery, 40.7 vs nonoperative care, 25.3; treatment effect, 15.4; 95% CI, 11.6 - 19.2), and Oswestry Disability Index (mean change: surgery, -36.1 vs nonoperative care, -20.9; treatment effect, -15.2; 95% CI, -18.5. to -11.8). These differences were less pronounced at 2 years.

"Patients with persistent sciatica from lumbar disk herniation improved in both operated and usual care groups," the authors write. "Those who chose operative intervention reported greater improvements than patients who elected nonoperative care. However, nonrandomized comparisons of self-reported outcomes are subject to potential confounding and must be interpreted cautiously."

In an accompanying editorial, Eugene Carragee, MD, of the Stanford University Medical Center in California, notes that "these findings suggest that in most cases there is no clear reason to advocate strongly for surgery apart from patient preference. For the patient with emotional, family, and economic resources to handle mild or moderate sciatica, surgery may have little to offer."

Dr. Carragee has disclosed receiving support from the US Department of the Army for research in this field, and he is an officer in the Medical Corps, USAR.

A second editorial, by David R. Flum, MD, MPH, of the University of Washington in Seattle, describes the difficulty in interpreting surgical trials with subjective outcomes.

"Because of limitations in design and study operation, the proper role and benefits of these competing interventions are still unclear," Dr. Flum concludes. "Given the large number of patients potentially exposed to the risks of these strategies, a sham surgical trial may be the only effective and ethical next step."

Dr. Flum has disclosed no relevant financial relationships.

JAMA. 2006;296:2441-2450, 2451-2459, 2483-2485, 2485-2487.

Clinical Context

SPORT is a study comparing early operative vs nonoperative approaches for patients with radicular pain and confirmed intervertebral lumbar disk herniation. In the nonrandomized component of SPORT, reported in another study in the current issue of JAMA by Weinstein and colleagues, patients with radicular pain who chose surgery instead of nonoperative care tended to be younger, receive some form of disability compensation, and have more severe symptoms. This open trial found that, while both the operative and nonoperative cohorts improved with time, diskectomy was associated with improved outcomes in terms of pain, physical function, and disability at 3 months and 2 years after treatment selection.

The results of the randomized group of SPORT are summarized in the "Study Highlights."

Study Highlights

  • Patients eligible for study participation were at least 18 years old and had radicular pain present for at least 6 weeks. All subjects had undergone advanced vertebral imaging demonstrating disk herniation. Patients with prior lumbar surgery or significant scoliosis were excluded from study participation.
  • Participants were randomized to a surgery or nonoperative care group. Surgery was performed according to a standard protocol at 13 centers. Nonoperative care consisted of physical therapy, home exercises, and nonsteroidal anti-inflammatory drugs.
  • The main study outcomes were measures of bodily pain, physical function, and disability. These results were assessed between 6 weeks and 2 years after randomization. Patient self-reports of improvement and satisfaction with care were also followed. Analyses were performed by intent-to-treat.
  • 472 subjects had data available for analysis. The mean age of participants was 42 years, and 41% of subjects were female. The most common disk herniation was at L5-S1.
  • Surgery was successful for the majority of patients, with only 5% of subjects experiencing postoperative complications. Rates of reoperation at 1 year were 4%.
  • Nonadherence to randomized therapy was a significant issue in this study. 50% of subjects assigned to surgery had not received diskectomy at 3 months. Conversely, 30% of the nonoperative treatment group had surgery during this same period. Characteristics favoring crossover into receiving surgery included lower income and greater disability while subjects who deferred surgery were more likely to be older and have an upper lumbar disk herniation.
  • Both treatment groups improved significantly in the main study outcomes of pain, physical function, and disability. The rate of improvement was marked during the first 6 months of the trial and flattened between 6 months and 2 years. While surgery was associated with numerically superior values at all time points, the difference between the operative and nonoperative groups was not statistically significant.
  • Patients self-reports of symptom improvement were significantly superior in the surgery cohort vs the nonoperative group. Both randomized groups reported high levels of satisfaction with care.
  • As-treated analyses demonstrated superiority for surgery vs nonoperative treatment in all main study outcomes.

Pearls for Practice

  • The open trial of operative vs nonoperative care for radicular back pain in SPORT demonstrated that patients choosing surgery tended to be younger and more likely to receive disability compensation. Patients receiving surgery reported better outcomes in terms of pain, disability, and physical function at 3 months and 2 years.
  • The randomized component of SPORT was limited by significant treatment crossover by study subjects. Only results of patient self-reports of symptom improvement were different between the diskectomy and nonoperative care groups, and this result favored the diskectomy cohort.

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