Research Review By Dr. Joshua Plener©

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Date Posted:

September 2020

Study Title:

An Assessment of Nonoperative Management Strategies in a Herniated Lumbar Disc Population: Successes Versus Failures

Authors:

Lilly D, Davison M, Eldridge C et al.

Author's Affiliations:

Cleveland Clinic, Cleveland OH, USA; University of Texas Southwestern Medical Center, Dallas, Texas, USA

Publication Information:

Global Spine Journal 2020 (In Press). https://doi.org/10.1177/2192568220936217

Background Information:

Intervertebral disc disorders are a common cause of low back pain, with disc herniations affecting 2-3% of the population at any given time (remember, many more will have discogenic pain arising from some form of disc pathology without frank herniation!) (1-3). Current evidence has demonstrated that first-line conservative management such as analgesic medications, steroid injections and physical/manual therapy, within 12 weeks of symptom onset, results in symptomatic relief in over 90% of patients (3-6) – most of these patients improve! However, the cost of prolonged use of nonoperative treatments in patients not experiencing early clinical improvement is unclear (4, 7-9).

The aim of this large, cross-sectional cohort study was to compare the utilization of conservative treatments used in lumbar intervertebral disc herniation patients who were successfully treated nonoperatively versus patients who were unsuccessfully treated nonoperatively, resulting in elective microdiscectomy surgery.

Pertinent Results:

The studied population consisted of 277 941 adult patients diagnosed with a lumbar disc herniation. Of this population, 56.6% were female and 70.8% of individuals identified as white. Prevalent comorbidities that were present in these patients included 35% suffering from diabetes, 25.5% who were obese and 16.3% who smoke.

A whopping 97% of the studied population was treated successfully with nonoperative management, while only 3% of the studied population failed conservative management and subsequently opted for surgery. When examining the failed management interventions, patients utilizing muscle relaxants had a 4% failure rate, those utilizing lumbar epidural steroid injection had a 4.5% failure rate and if a patient presented to the emergency department for back pain or radiculopathy there was a 21.5% failure rate (the latter statistic may relate to the severity of the individual’s condition, versus any failing of management at the ER). All other nonoperative therapies had a failure rate between 3% to 4.5%. For example, 15.6% of the patients (n = 43 460) visited a chiropractor, with a 4.1% failure rate. Furthermore, higher nonoperative failure rates were present in males, smokers and patients with a history of myocardial infarction – each factor had approximately a 3% failure rate.

The cost analysis demonstrated that during the 2-year surveillance window, patients who failed nonoperative management billed approximately double in conservative therapies compared to successfully treated patients. This was calculated to be $1718 vs $906. The greatest contributors to the increased cost in the failed nonoperative cohort included lumbar spine imaging and lumbar epidural steroid injections (it may also mean they tried various types of conservative treatment with no benefit?).

The multivariate regression analysis demonstrated that the following factors predicted failing nonoperative therapy: male gender (which had an odds ratio of 1.49) and opioid utilization during conservative treatment (which had an odds ratio of 2.72). Furthermore, compared to patients aged 50 to 54, individuals aged 70 to 74 were the most likely age group to fail conservative management, with an odds ratio of 2.24.

Clinical Application & Conclusions:

Research has demonstrated that conservative therapies can play an important and successful role in the first-line management of lumbar disc herniation patients. This paper demonstrated that 97% of patients can successfully be treated with nonoperative management, which supports past research and this premise (3-6).

Furthermore, this paper provides an understanding of the costs associated with responders and non-responders to conservative therapy. This is important, as patients who fail nonoperative treatments result in a high economic burden as compared to successfully treated patients. Despite this paper demonstrating that male gender and opioid utilization during nonoperative treatment were independent predictors of failed conservative management, further research is required. Advancing the clinical utility of this research will potentially help to streamline patient care and allow patients to receive care that will be most effective.

Reviewers note: The aim of this study, which was to compare the use of nonoperative treatment for lumbar disc herniation patients, was achieved. It is certainly positive to see that the failure rates associated with each nonoperative treatment were all relatively low. However, as a result of the 2-year surveillance window, further research needs to occur to determine if the improvements seen were mostly due to natural history, or if in fact all treatments provided were (approximately) equally effective. Future studies controlling for these variables can help answer these questions.

Study Methods:

The population studied was extracted from the Humana Ortho (HORTHO) insurance database. The included patients were at least 19 years old with a primary diagnosis of lumbar disc herniation (Editor’s note: it is worth mentioning that the authors were not forthcoming in the body of this paper regarding their specific diagnostic criteria for a lumbar disc herniation. However, in an included Appendix, they did reference the specific ICD-9 and ICD-10 diagnosis and procedure codes that were applied in their analysis to include or exclude subjects. This results in a possible inaccuracy in this regard. We should keep this in mind when assessing their results, but I don’t consider this a fatal flaw for this paper and would presume the peer reviewers would have taken issue with this at that stage of publication if it were of major concern). Patients were divided into a successful conservative therapy management cohort and a failed nonoperative management cohort who opted for surgery. For the successfully treated cohort, included patients were continuously active within the insurance company for at least two years following their primary diagnosis of a lumbar disc herniation, and for the failed treatment cohort patients were continuously active within the insurance system for at least two years prior to their microdiscectomy operation.

Exclusion criteria:
  • Previous cervical or lumbar fusion surgery
  • Diagnosis of lumbosacral spinal fracture or malignancy
Nonoperative treatments that were provided to patients included:
  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Muscle relaxants
  • Lumbar epidural steroid injections
  • Physical therapy and occupational therapy sessions
  • Chiropractic treatments
  • Prescription opioids which included Oxycodone, hydrochloride, hydrocodone/acetaminophen, and oxycodone/acetaminophen
Emergency department visits, x-rays, CT scans and MRI studies for the primary compliant of a lumbar disc herniation were also collected.

The average dollars spent, average number of documented prescriptions and average number of units billed were collected. A “unit” consisted of an individual pill, injection, therapy visit, emergency department visit or imaging study.

Data Analysis:
Statistics used to compare categorical parameters were X2 tests, with p values < 0.05 considered statistically significant. Independent predictors of conservative management failure were determined through a multivariate, logistic regression analysis.

Study Strengths / Weaknesses:

Strengths:
  • This paper adds to the knowledge gap regarding the nonoperative management of lumbar disc herniation patients – a topic that has not been studied thoroughly in the literature.
  • This paper had a large (huge!) data set which helps increase the strength of the results.
Weakness:
  • The population studied was derived from an insurance database in the USA, therefore it may not be transferrable to other populations and other countries.
  • As a result of using the insurance database, no investigation into the individual diagnostic information was possible, such as baseline symptom characteristics of patients who failed conservative therapy and opted for surgery. This sort of data may have been helpful for explaining why conservative care did not help those patients.
  • The studied population had a number of comorbidities present such as obesity and diabetes. These comorbidities can lead to increased risk of infection, and therefore these patients may not have been offered operative management and may have been less likely to benefit from operative management.
  • Some nonoperative treatments did not specify what interventions were performed. For example, the study looked at “chiropractor treatments” but no context was provided as to what the treatment consisted of.

Additional References:

  1. Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among adults with back and neck problems. JAMA 2008; 299: 656-664.
  2. Vialle LR, Vialle EN, Suarez Henao JE, et al. Lumbar disc herniation. Rev Bras Orthop 2010; 45: 17-22.
  3. Amin RM, Andrade NS, Neuman BJ. Lumbar disc herniation. Curr Rev Musculoskelet Med 2017; 10: 507-516.
  4. Alentado VJ, Lubelski D, Steinmetz MP, et al. Optimal duration of conservative management prior to surgery for cervical and lumbar radiculopathy: a literature review. Global Spine J 2014; 4: 279-286.
  5. Gugliotta M, da Costa BR, Dabis E, et al. Surgical versus conservative treatment for lumbar disc herniation: a prospective cohort study. BMJ Open 2016; 6: e012938.
  6. Shamim MS, Parekh MA, Bari ME, et al. Microdiscectomy for lumbosacral disc herniation and frequency of failed disc surgery. World Neurosurg 2010; 74: 611-616.
  7. Parker SL, Godil SS, Mendenhall SK, et al. Two-year comprehensive medical management of degenerative lumbar spine disease (lumbar spondylolisthesis, stenosis, or disc herniation): a value analysis of cost, pain, disability, and quality of life: clinical article. J Neurosurg Spine 2014; 21: 143-149.
  8. Tosteson AN, Skinner JS, Tosteson TD, et al. The cost effectiveness of surgical versus nonoperative treatment for lumbar disc herniation over two years: evidence from the Spine Patient Outcomes Research Trial (SPORT). Spine 2008; 33: 2108-2115.
  9. Daffner SD, Hymanson HJ, Wang JC. Cost and use of conservative management of lumbar disc herniation before surgical discectomy. Spine J 2010; 10: 463-468.