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Original Nomination

Draft Key Questions:
These questions were available for public comment from Dec. 17, 2013–Jan. 17, 2014

Noninvasive Treatments for Low Back Pain

Draft Key Questions

Question 1
What are the comparative benefits and harms of different pharmacological therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? (Including NSAIDs, acetaminophen, opioids, muscle relaxants, antiseizure medications, antidepressants, corticosteroids and topicals/patch-delivered medications)
Question 2
What are the comparative benefits and harms of different nonpharmacological, noninvasive therapies for acute or chronic nonradicular low back pain, radicular low back pain, or spinal stenosis? (Including but not limited to interdisciplinary rehabilitation, exercise (various types), physical modalities (ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Interferential Therapy (IFT), heat (various forms), ice), traction tables/devices, back supports/bracing, spinal manipulation, various psychological therapies, acupuncture, massage therapy (various types), yoga, magnets and low level lasers)

Draft Analytic Framework

Figure 1 depicts the key questions within the context of the PICOTS described in the previous section. In general, the figure illustrates how the use of pharmaceutical therapies (drugs) or other nonpharmaceutical, noninvasive treatments used alone or in combination may result in improvements in outcomes of low back pain, such as pain, physical function, health-related quality of life (HRQoL), global improvement (pain + function) and reduction in work disability along with satisfaction with care. The figure also shows that patient characteristics prior to the onset of low back pain can impact the experience and recovery from low back pain. Adverse events may also occur at any point after the treatment (pharmaceutical or nonpharmaceutical) is initiated.

Background

Low back pain affects more than 34 million Americans annually and is a leading cause of disability in the United States.1 Low back pain costs Americans more than $50 billion annually in terms of treatment, lost work productivity, and extended disability1-5 and spine-related health care expenditures have increased dramatically in the last two decades.2 Most Americans experience low back pain at some time in their lives1,6 and nearly one-third of adults experience low back pain over a 3-month period.2,7

Numerous factors contribute to low back pain including, but not limited to, general health status, age, lifestyle choices, work routines, avocational activities, psychological issues, habits, genetics, job dissatisfaction, and secondary gain interests.1,8,9 Many episodes of low back pain have an insidious onset but acute injuries from lifting, bending, accidents, and sports can also result in low back pain.

Most acute low back pain episodes are self-limiting and tend to improve over time.5,8-10 The vast majority of low back pain is labeled as nonspecific because providers do not know or seek to know, for several reasons, the dominant pain generator during flare ups.5 The anatomic source of uncomplicated low back pain often does not drive early treatment recommendations in the absence of concerning neurologic findings. Moreover, advanced imaging, such as magnetic resonance imaging (MRI), may not help to identify the main source of low back pain because many individuals without low back pain also have extensive age-related and other changes in the discs and vertebrae on MRI.5,11 Additionally, perceptions of pain vary widely between patients and the magnitude of low back pain reported by patients often does not reflect the magnitude of age-related changes or pathology seen on MRI or related studies.11 Therefore, low back pain treatment guidelines do not support the routine or initial use of advanced diagnostic imaging such as MRI based on pain complaints alone, unless the history and clinical exam indicate the potential for a more serious spine problem, such as severe neurologic compromise.5

Since patients with differing low back conditions may have similar clinical presentations, low back pain is commonly classified by the location of symptoms and the duration of pain.12 Subclassifications of low back pain by pain patterns, pain duration, and by specific diagnoses are common. Low back pain can be centrally located in the low back region, can occur primarily in the buttocks, groin, or leg(s) as radicular or referred pain, or can be a combination of back and leg pain. Radicular pain follows the course of a nerve root and is often labeled as leg pain distal to the knee. Referred pain relates to hip and upper leg pain that does not follow the distribution of a nerve root and does not extend distal to the knee. An additional and unique category of leg symptoms from a low back condition comes from spinal stenosis. Patients with spinal stenosis can have back and leg symptoms, but the classic symptoms of spinal stenosis include pain or symptoms in the legs while walking that is relieved by sitting (neurogenic claudication). The definitive diagnosis of spinal stenosis is made with advanced diagnostic imaging, such as MRI, not clinical exam.

The duration of low back pain is generally classified in the literature as acute (typically up to 4-6 weeks12,13) or chronic (12 weeks or longer), and some providers classify a subacute phase as 6 to 12 weeks.12,13 Many patients labeled as chronic have flare ups but are asymptomatic between episodes. Patients with chronic low back pain may also experience stiffness or low-grade pain over time but have frequent flare ups, rather than constant higher-level pain. However, since no universal definition of chronic low back pain exists, clinical studies tend to define acute or chronic patient inclusion by the duration of symptoms, history and timing of prior back pain episodes, and, if available, by dominant MRI findings. Yet, these literature classifications do not accurately reflect the natural history of low back pain as a life-long, typically recurrent disorder.

The intensity of low back pain ranges from mild or bothersome to incapacitating. Low back pain is usually not static in intensity, tends to wax and wane over time, and recurrences are common.4 Recurrent back pain episodes may differ in intensity and frequency and treatment needs for symptomatic relief in affected individuals can change over time. Up to one-third of patients experience chronic or recurrent low back complaints up to a year after an acute low back pain episode.14

Therapy for acute low back pain is typically aimed at mitigating pain and preventing further exacerbation through activity modification until the problematic symptoms abate. Preventing acute back pain from becoming chronic is an overarching but implicit treatment goal. The goals for treating chronic low back pain patients are to reduce the frequency and severity of flare-ups, improve self-efficacy in the self-management of symptoms, and improve spine fitness and general endurance. However, back pain patients often pose a clinical dilemma to primary care physicians due to their heterogeneity in terms of reported pain intensity, pain tolerance, objective and perceived disability, treatment preferences and motivation for treatment surrounding acute or chronic low back pain management.

Affected individuals often seek symptomatic relief from acute low back pain through self-directed measures and provider-directed therapies.10 No one treatment approach works well in all individuals with low back pain, even if they appear to be clinically similar. Therefore, a wide variety of treatment approaches exist from self-care activities such as heat, ice, exercise and/or anti-inflammatory medications (NSAIDs) to provider-delivered therapies such as spinal manipulation, acupuncture or massage, and other machine-and-provider-delivered treatments like ultrasound, electrical muscle stimulation, and traction, all with varying degrees of success.

Primary care, nonoperative specialists and complementary and allied health providers face ongoing challenges in matching treatments to patients5,15 for which the large body of synthesized evidence and original research on low back pain treatments through 2006 are not particularly helpful.5,12,16 Given substantial new information on low back pain treatments since 2006, an updated systematic review can provide current and potentially better information for practicing physicians who evaluate, treat, and refer patients with low back pain.

Population(s)

  • Adults with low back pain, with or without accompanying leg pain, spinal stenosis, or symptoms of neurogenic claudication.

Interventions

KQ1: Noninjectable pharmacologic therapies: alone or in combination (such as skeletal muscle relaxant plus analgesic)

  • Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naproxen, celecoxib, acetylsalicylic acid (aspirin)
  • Nonopioid analgesics, such as acetaminophen
  • Opioid analgesics, such as oxycodone, hydrocodone, hydromorphone, morphine, fentanyl
  • Antidepressants, such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), and selective serotonin-reuptake inhibitors (SSRIs), or serotonin antagonist and reuptake inhibitors (SARIs)
  • Skeletal muscle relaxants (benzodiazepines)
  • Oral corticosteroids, such as prednisone or prednisolone
  • Anti-epileptic drugs, such as gabapentin
  • Topicals/patch-delivered medications, such as steroids, fentanyl, or capsaicin

KQ2: Noninvasive, nonpharmacological therapies (or combinations thereof)

  • Interdisciplinary or multicomponent rehabilitation
  • Exercise, including the MedX™ Lumbar Extension Machine
  • Spinal manipulation
  • Passive physical modalities: heat, ice, ultrasound, electrical muscle stimulation (such as Transcutaneous Electrical Nerve Stimulation (TENS), Electrical Muscle Stimulation (EMS), Interferential Therapy (IFT), traction
  • Yoga
  • Acupuncture
  • Massage therapy
  • Lumbar supports/braces
  • Psychological therapies, such as Cognitive Behavioral Therapy
  • Back schools
  • Low level laser therapy
  • Other noninvasive treatments, such as taping

Comparators

All other noninvasive, nonsurgical treatment options, alone or in combination within each class of treatments (nonpharmaceutical, pharmaceutical). Other possible comparators include placebo (drug trials), sham (functionally-inert) treatments or no treatment.12,17

Outcomes
  • Final health outcomes
    • Reduction or elimination of low back pain, including related leg symptoms
    • Improvement in back-specific and overall function
    • Improvement in health-related quality of life (HRQoL)
    • Reduction in work disability
    • Patient satisfaction
    • Global improvement
  • Adverse effects of intervention(s)
    • Pharmaceutical: serious (anaphylaxis, death) and nonserious (mild allergic or untoward) drug reactions or effects; opioid addiction
    • Nonpharmaceutical: serious (death, cauda equine syndrome, fracture, local skin burns, etc.) and nonserious (mild transient local or general soreness, stiffness, aching; local skin irritation, etc.)
Timing

Duration of followup: short term (up to 6 months) and long term (at least 1 year)

Setting

Any nonhospital inpatient setting

References

  1. Strine TW, Hootman JM. US national prevalence and correlates of low back and neck pain among adults. Arthritis Rheum. 2007 May 15;57(4):656-65. PMID 17471542.
  2. Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among adults with back and neck problems. JAMA. 2008 Feb 13;299(6):656-64. PMID 18270354.
  3. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine Journal: Official Journal of the North American Spine Society. 2008 Jan-Feb;8(1):8-20. PMID 18164449.
  4. Ricci JA, Stewart WF, Chee E, et al. Back pain exacerbations and lost productive time costs in United States workers. Spine (Phila Pa 1976). 2006 Dec 15;31(26):3052-60. PMID 17173003.
  5. Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007 Oct 2;147(7):478-91. PMID 17909209.
  6. Kelsey JL, White AA, 3rd. Epidemiology and impact of low-back pain. Spine (Phila Pa 1976). 1980 Mar-Apr;5(2):133-42. PMID 6446158.
  7. Schiller J, Lucas J, Ward B, et al. Summary Health Statstics for U.S. Adults: National Health Interview Survey, 2010. National Center for Health Statstics (NCHS). 2012.
  8. Dunn KM, Croft PR. Epidemiology and natural history of low back pain. Eura Medicophys. 2004 Mar;40(1):9-13. PMID 16030488.
  9. Boos N, Semmer N, Elfering A, et al. Natural history of individuals with asymptomatic disc abnormalities in magnetic resonance imaging: predictors of low back pain-related medical consultation and work incapacity. Spine (Phila Pa 1976). 2000 Jun 15;25(12):1484-92. PMID 10851096.
  10. Carey TS, Evans AT, Hadler NM, et al. Acute severe low back pain. A population-based study of prevalence and care-seeking. Spine (Phila Pa 1976). 1996 Feb 1;21(3):339-44. PMID 8742211.
  11. Jensen MC, Brant-Zawadzki MN, Obuchowski N, et al. Magnetic resonance imaging of the lumbar spine in people without back pain. N Engl J Med. 1994 Jul 14;331(2):69-73. PMID 8208267.
  12. Chou R, Huffman LH, American Pain S, et al. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2007 Oct 2;147(7):492-504. PMID 17909210.
  13. Goertz M, Thorson D, Bonsell J, et al. Health Care Guidellines: Adult Acute and Subacute Low Back Pain. Institute for Clinical Systems Improvement (ICSI). Updated November 2012. https://www.icsi.org/_asset/bjvqrj/LBP.pdf.
  14. Von Korff M, Saunders K. The course of back pain in primary care. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2833-7; discussion 8-9. PMID 9112707.
  15. Slater SL, Ford JJ, Richards MC, et al. The effectiveness of sub-group specific manual therapy for low back pain: a systematic review. Manual Therapy. 2012 Jun;17(3):201-12. PMID 22386046.
  16. Chou R, Huffman LH, American Pain S, et al. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Annals of Internal Medicine. 2007 Oct 2;147(7):505-14. PMID 17909211.
  17. Puhl AA, Reinhart CJ, Rok ER, et al. An examination of the observed placebo effect associated with the treatment of low back pain - a systematic review. Pain Res Manag. 2011 Jan-Feb;16(1):45-52. PMID 21369541.