Treatment Options in Managing Chronic Low Back Pain

Release Date: May 1, 2011

Expiration Date: May 31, 2013

FACULTY:

Amy P. Witte, PharmD
Assistant Professor, Pharmacy Practice
University of the Incarnate Word
Feik School of Pharmacy
San Antonio, Texas

FACULTY DISCLOSURE STATEMENTS:

Dr. Witte has no actual or potential conflicts of interest in relation to this activity.

Postgraduate Healthcare Education, LLC does not view the existence of relationships as an implication of bias or that the value of the material is decreased. The content of the activity was planned to be balanced, objective, and scientifically rigorous. Occasionally, authors may express opinions that represent their own viewpoint. Conclusions drawn by participants should be derived from objective analysis of scientific data.

ACCREDITATION STATEMENT:

Pharmacy
acpePostgraduate Healthcare Education, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
UAN: 0430-0000-11-013-H01-P
Credits: 2.0 hours (0.20 ceu)
Type of Activity: Knowledge

TARGET AUDIENCE:

This accredited activity is targeted to pharmacists. Estimated time to complete this activity is 120 minutes.

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DISCLAIMER:

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

GOAL:

To define chronic low back pain and review the risk factors, clinical evaluation, diagnosis, and pathophysiology associated with this condition, as well as discuss the pharmacologic and nonpharmacologic treatment options.

OBJECTIVES:

After completing this activity, the participant should be able to:

  1. Define chronic low back pain.
  2. Specify the risk factors associated with chronic low back pain.
  3. Review the clinical evaluation, diagnosis, and pathophysiology of chronic low back pain.
  4. Discuss and evaluate pharmacologic and nonpharmacologic options for managing chronic low back pain.
  5. Identify the potential adverse effects associated with the treatment options used for managing chronic low back pain.

In the United States, low back pain is the fifth most common reason for all physician visits and the second most frequent symptomatic reason.1,2 It is the most common cause for chronic or permanent impairment in adults under the age of 65 years and the most prevalent cause of activity limitations in persons under the age of 45.2 Low back pain accounts for a large proportion of health care expenditures. In 1998, total health care expenditures incurred by individuals with back pain in the U.S. were $90.7 billion. In addition, medical treatment for chronic low back pain is estimated to cost $9,000 to $19,000 per patient annually.2

Low back pain can be defined as pain, muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds, with or without leg pain (sciatica), and can be labeled as either specific or nonspecific in nature. Specific low back pain is defined as symptoms caused by red flags. Some of these red flags include spinal fractures, cancer, and infections.3 Sources of low back pain include the intervertebral disks, facet joints, neural structures, muscles, vertebrae, ligaments, and fascia.4

Low back pain is typically classified as acute or chronic. Acute pain is defined as lasting from a few days to weeks, whereas chronic pain is defined as a pain that persists for more than 3 months. The main difference between acute and chronic pain is the duration of the pain. However, there are many differences that exist between these two classifications (TABLE 1).5 Most episodes of low back pain are acute and due to nonspecific musculoskeletal strain.

tbl1

Risk factors associated with the onset of low back pain include individual, psychosocial, or occupational factors. Individual factors include age, gender, smoking, obesity, education level, and occupation. Psychosocial factors consist of anxiety, stress, mood and emotions, cognitive functioning, pain behavior, and depressive disorder. Occupational factors include monotonous tasks, heavy physical work, night shifts, and lifting, bending, twisting, pulling, and pushing while on the job.3

Clinical Evaluation and Diagnosis

Few patients who present for initial evaluation have low back pain caused by a specific disorder such as cancer, spinal infection, compression fracture, or herniated disk. Approximately 85% of patients present with nonspecific back pain.6 Therefore, all patients experiencing low back pain should undergo an evaluation to determine the underlying cause. The evaluation of chronic low back pain consists of taking a complete history and performing a physical examination.

The information that should be assessed during a pain history includes the nature of the pain (onset, duration, location, quality, severity, and associated symptoms), management strategies such as pharmacologic or nonpharmacologic treatments, alternative treatments such as acupuncture and chiropractic medicine, medical family and social history, and the functional impact of pain on work, sleep, and daily activities. Key elements of the physical examination should include inspection of the back and posture, check for sensory loss, muscle weakness and limited range of motion in the feet and legs, palpation of the spine, neurologic assessment, and evaluation of malignancy. The history and physical examination should place the patient into one of three categories: nonspecific low back pain, back pain associated with spinal stenosis, or back pain associated with another specific systemic or spinal cause (TABLE 2).7,8

tbl2

Diagnostic Tests and Imaging

Currently, imaging studies are not frequently needed or recommended in patients with low back pain. Imaging studies are usually limited to those patients whose history or physical examination suggests a specific underlying cause. According to the evidenced-based recommendations from the American College of Physicians (ACP) and the American Pain Society (APS), routine imaging or diagnostic testing should not be obtained in patients with nonspecific low back pain. Clinicians should perform imaging and diagnostic tests only in selected, higher-risk patients who have severe neurologic deficits or the presence of a specific underlying condition. Advanced imaging such as magnetic resonance imaging (MRI) or computerized tomography (CT) should be reserved for those patients who have a suspected serious underlying condition or neurologic deficits, or a suspicion of cancer or infection, or for those who are candidates for invasive interventions. In addition, advanced imaging can be considered in those patients who have experienced low back pain for more than 12 weeks.7,9

Pathophysiology

Commonly, low back pain is caused by disorders of the intervertebral disks. The relationship between intervertebral disk degeneration and low back pain is not clearly understood. It is thought that alterations in the biochemical properties of the disk structure, sensitization of the nerve endings by release of chemical mediators, and neurovascular growth may all contribute to the development of low back pain. Furthermore, cytokines such as matrix metalloproteinases (MMPs), phospholipase A2, nitric oxide, and tumor necrosis factor-alpha (TNFα) play a vital role in the development of low back pain. The main functions of MMPs include degradation of collagen and gelatin and regression of the herniated disk. Another common chemical substance found in the development of low back pain is phospholipase A2. It works by mediating mechanical hyperalgesia. In contrast, nitric oxide inhibits mechanical hyperalgesia and produces thermal hyperalgesia. The final chemical substance present in low back pain is TNFα, which works by promoting matrix degradation.4

Goals of Treatment

The treatment of pain involves both nonpharmacologic and pharmacologic approaches. Unlike acute pain, chronic pain involves a multimodal approach that addresses physical, psychological, and behavioral issues in addition to initiating a treatment regimen. The main goal of therapy is to prevent, reduce, or eliminate the pain, if possible. It is important to remember that most patients who experience chronic pain will not achieve complete resolution. Additional treatment goals include improving quality of life, functional capacity, and ability to regain independence.

Nonpharmacologic Treatment Options

Nonpharmacologic therapies may be used alone or as adjunct therapy to pharmacologic agents to manage low back pain. These therapies include complementary and alternative medicine approaches such as acupuncture, chiropractic medicine, and herbal and dietary supplements. Psychological interventions can also play an important role in the management of low back pain. These interventions include biofeedback, cognitive behavior therapy, and psychotherapy.

Acupuncture is an intervention that consists of inserting needles at specific predetermined acupuncture points to reduce pain or induce anesthesia. It is widely used for numerous conditions such as low back pain; however, there is limited evidence to support its efficacy. According to the ACP and the APS clinical practice guidelines, clinicians should consider acupuncture as a possible treatment option for patients with chronic low back pain who do not respond to self-care.2,10 Most patients will incorporate acupuncture into a multidisciplinary approach to the management of chronic low back pain. Patients with chronic low back pain should undergo a diagnostic evaluation before participating in acupuncture therapy. In addition, patients with cancer or current infection are not appropriate candidates for acupuncture. Contraindications to acupuncture therapy include clotting or bleeding disorders, current warfarin use, severe psychiatric conditions, and local skin infections or trauma to the skin. Common adverse effects include needle-site pain, nausea, vomiting, dizziness, or fainting. Acupuncture appears to be extremely safe, and the risk of infection is minimal when single-use needles are used.11 Further studies are needed to determine the efficacy of acupuncture therapy in patients with chronic low back pain, and the current recommendations may change as these new studies become available.

Chiropractic medicine involves the application of high velocity, low-amplitude thrusts to joints, including the spine. The goal of chiropractic medicine is to relieve pain and improve the body’s physical function. It has been used for years to treat back pain, headaches, nerve inflammation, muscle spasms, and injuries. Adverse events associated with chiropractic manipulation are extremely rare. However, a potential complication of low back pain manipulation is cauda equina syndrome, a condition in which nerves in the lower part of the spinal cord become compressed. This condition results in pain, weakness, and loss of feeling in one or both legs.12

Currently, most supporting evidence for the use of chiropractic medicine exists in patients with acute low back pain. Like acupuncture, chiropractic manipulation is recommended in patients who do not respond to self-care.12

Herbal and dietary supplements have been used for years to manage pain and treat other underlying conditions. Some of the common dietary supplements used in the management of pain include SAM-e, devil’s claw, ginger, cat’s claw, magnesium, and alpha-lipoic acid.13 The major concern with the use of herbal and dietary supplements is that they are not required to be regulated for safety and efficacy by the FDA. Herbal products carry the potential for significant drug interactions and the possibility that the product may not contain the amount of each ingredient listed on the label. Patients should be counseled on the safety concerns and potential interactions of these products and reminded that just because a product is “natural” does not mean it is safe.

Biofeedback is commonly used in the management of different types of pain. It appears to be most effective for headache, low back pain, and myofascial pain.14 In biofeedback, the patient is educated to exercise control of physiologic activities such as heart beat, muscle tension, and skin temperature. The goal is to teach the patient to mentally control physiologic responses to pain.

Cognitive therapy can also be used to help patients modify their perception of pain, increase their sense of control, and decrease maladaptive behaviors. During cognitive therapy, patients are taught to monitor negative thoughts and manage their pain and stress.15

Psychotherapy is most useful in patients with chronic pain accompanied by psychological comorbidities or maladaptive behaviors. In addition, it may be helpful for patients with malignant disease to assist them in coping with fear of disability and death.15

Physical therapy, including cryotherapy, aqua therapy, stretching, and electric nerve stimulation, is an important component of the pain management process. These different types of therapy are typically used in addition to other treatments. Physical therapy can both decrease pain and improve functioning.15

Pharmacologic Treatment Options

In addition to complementary and alternative medicine approaches, numerous pharmacologic agents are prescribed for low back pain. According to one study, 80% of patients with low back pain were prescribed at least one medication at their initial office visit and more than one-third were prescribed two or more.14 OTC medications such as acetaminophen, aspirin, and certain nonsteroidal anti-inflammatory drugs (NSAIDs) are generally used prior to prescription therapy. However, the most commonly prescribed medications for low back pain include NSAIDs, tramadol, skeletal muscle relaxants, and opioid analgesics. Other medications used in the treatment of low back pain are antidepressants, antiepileptic drugs, benzodiazepines, and systemic corticosteroids (TABLE 3).1 Choosing a pharmacologic agent depends on several factors, including duration of symptoms, prior response to medications, adverse effect profile, and presence of other comorbid conditions.

tbl3

The World Health Organization (WHO) has a developed a stepwise approach to pain management which is referred to as the “analgesic ladder.”15 This ladder provides a general guideline for pain medication selection of varying intensities. The WHO guidelines were developed for the treatment of cancer pain; however, they are applicable to other types of pain. Mildto-moderate pain is often managed with analgesics such as aspirin, acetaminophen, NSAIDs, or cyclooxygenase-2 (COX-2) inhibitors. Opioids can be used to treat mildto-moderate pain that is persistent or has increased on nonopioid therapy; however, they remain the mainstay of therapy for patients with moderate-to-severe pain. Combination therapy, which usually consists of opioids with acetaminophen and/or NSAIDs, is reserved for patients with moderate-to-severe pain.15

Acetaminophen

Acetaminophen exhibits both analgesic and antipyretic properties, but unlike aspirin, has few anti-inflammatory properties. It is widely used for the management of mild-to-moderate pain and is recommended by the ACP and the APS as a first-line agent for both acute and chronic low back pain and osteoarthritis.8 Acetaminophen works by inhibition of prostaglandin synthesis in the central nervous system (CNS). The recommended dosage is 500 to 1,000 mg every 4 to 6 hours with a maximum dose of 4 g per day (TABLE 3).15 Acetaminophen is generally safe at the recommended dose. Dosages exceeding 4 grams per day may result in elevated liver enzymes. Acetaminophen should be avoided in patients with pre-existing liver disease and in patients with heavy alcohol use. There are no clinical drug interactions associated with acetaminophen use.7,15

In January 2011, the FDA announced that drug manufacturers must begin to limit the strength of acetaminophen in prescription products to 325 mg per tablet, capsule, or other dosage form.16 This limit will prevent acetaminophen overdose, severe liver injury, and the potential for allergic reactions. In addition, a boxed warning highlighting the potential for severe liver injury and allergic reactions has been added to the label of all prescription products that contain acetaminophen. Currently, OTC products containing acetaminophen are not affected by this action.

NSAIDs

NSAIDs are the most commonly prescribed analgesics in the U.S.17 They are also recommended as a first-line treatment option for either acute or chronic low back pain.2 According to the American Geriatrics Society guideline, the use of NSAIDs is not recommended in patients >75 years of age for chronic pain due to increased gastrointestinal (GI) and cardiovascular risk.18 In addition, the American Heart Association recommends avoiding the use of NSAIDs for chronic pain in persons with cardiovascular disease or in patients at higher cardiovascular risk.19

NSAIDs have analgesic, antipyretic, and anti-inflammatory properties. These agents work by inhibiting COX-1 and COX-2 enzymes, which results in a decreased production of prostaglandins from arachidonic acid. The recommended dosage for aspirin therapy is 500 to 1,000 mg every 4 to 6 hours, not to exceed 4 g per day (TABLE 3).15 Aspirin, the most potent COX-1 inhibitor, is associated with the most GI adverse effects. Higher doses of NSAIDs and long-term use can lead to potentially fatal GI adverse effects such as perforation, ulceration, and bleeding. The risk of bleeding can be reduced with lower dosages and shorter duration of therapy. Enteric-coated formulations may also be used to reduce the risk of gastric irritation. Patients who require chronic use of NSAIDs may consider adding a proton pump inhibitor, an H2-receptor antagonist, misoprostol, or switching to a COX-2 inhibitor such as celecoxib to reduce the risk of GI-associated adverse effects.7,8,15

Other adverse effects seen with NSAID use include hepatic dysfunction, renal insufficiency or failure, and hypersensitivity reactions such as respiratory problems, urticaria, and angioedema. Blood pressure, weight, and serum creatinine should be closely monitored in patients with underlying renal disease, hypertension, and congestive heart failure. Aspirin is contraindicated in patients with bleeding disorders and in children less than 12 years of age due to the risk of Reye’s syndrome. Aspirin must be used with caution in patients with impaired renal function, gastritis, peptic ulcer disease, and gout.7,8,15

The recommended dosage for ibuprofen is 400 to 800 mg every 6 to 8 hours, with a maximum daily dose of 2,400 mg.15 The recommended dosage for naproxen is 250 to 500 mg every 8 to 12 hours, not to exceed 1,500 mg daily.15 The adverse effect profile for ibuprofen and naproxen is similar to that of aspirin (TABLE 3).7

Opioids

The use of opioids for managing low back pain remains controversial. Opioids are the agents of choice for managing severe acute pain and chronic pain associated with cancer. However, they are commonly prescribed for acute and chronic low back pain. Based on the WHO analgesic ladder, opioids are the mainstay of therapy for moderate-to-severe pain.15 They work by binding to opiate receptors, mimicking the action of endogenous endorphins by stimulating inhibitory descending pathways, which results in analgesia. Short-acting opioids are recommended initially for treating low back pain. These include codeine, hydrocodone, and oxycodone. However, if opioid treatment is required for more than a few days, the patient should be transitioned to a controlled-release or long-acting preparation.15

The recommended dosage for codeine alone or in combination with acetaminophen is 30 to 60 mg every 4 hours as needed; hydrocodone alone or in combination with acetaminophen, aspirin, or ibuprofen is 5 to 10 mg every 4 hours as needed; and oxycodone alone or in combination with acetaminophen is 5 to 10 mg every 4 hours as needed (TABLE 3).7,8 The most common adverse effects associated with opioids include constipation, nausea, vomiting, sedation, and pruritus. Less common side effects are dry mouth, mental confusion, urinary retention, and respiratory depression at higher doses. In addition, the potential for addiction has been associated with long-term use of opioids.7,8,15 Several factors affect the selection of opioid treatment. These include pain intensity, pharmacologic factors, co-existing conditions, and economic factors. Opioid selection should be patient specific and guided by the intensity and duration of pain as well as tolerance and safety considerations.15

Tramadol

Due to limited evidence, tramadol is not recommended as a first-line treatment option in patients with low back pain. There are no clinical trials available that compare tramadol with first-line analgesics in patients with low back pain. Tramadol is appropriate for moderate pain and can be used in combination with or instead of acetaminophen or NSAIDs.2 Tramadol is a synthetic centrally active analgesic with a dual mechanism of action. It is a weak mu-opioid receptor and an inhibitor of norepinephrine and serotonin reuptake. The recommended dosage for tramadol is 50 to 100 mg every 4 to 6 hours with a maximum daily dose of 400 mg, with doses <200 mg/day recommended in the elderly (TABLE 3).7,8 Common adverse effects include constipation, somnolence, dizziness, nausea, vomiting, and pruritus. Tramadol use has been associated with the risk of addition, physical dependence, and tolerance. It should be used with caution in patients concomitantly taking certain antidepressants due to the associated risk of serotonin syndrome.7,8

Skeletal Muscle Relaxants

Skeletal muscle relaxants (SMRs) may be considered a treatment option for patients with low back pain. Like opioids, SMRs should be considered adjunct therapy in patients with low back pain who do not respond to first-line analgesics. SMRs are utilized as adjunctive agents in combination with opioid and nonopioid analgesics.7 These agents work by interrupting the pain-spasm cycle without affecting muscle function. In the U.S., skeletal muscle relaxants approved for the treatment of spasticity include baclofen, dantrolene, and tizanidine. Dantrolene currently carries a black box warning for potentially fatal hepatotoxicity and should not be used to treat low back pain. Tizanidine has been associated with hepatotoxicity; however, it is usually not serious and can be reversible. Those approved for the treatment of musculoskeletal conditions are carisoprodol, cyclobenzaprine, and methocarbamol.8 However, the skeletal muscle relaxants commonly used for the treatment of low back pain include baclofen and cyclobenzaprine. The recommended dosage for baclofen is 5 mg three times daily initially, and then increased slowly to a maximum daily dose of 80 mg administered in three to four divided doses (TABLE 3).7,8 Cyclobenzaprine is typically dosed 5 mg three times daily.7,8

Muscle relaxants are commonly associated with CNS adverse effects.8 These include drowsiness, dizziness, light-headedness, fatigue, and sedation. There is no current evidence to support increased efficacy of carisoprodol over other SMRs. Therefore, due to the potential harms such as abuse and addiction, carisoprodol should be avoided in patients with low back pain.8

Benzodiazepines

There are limited data on the effectiveness of benzodiazepines (BZs) for acute and chronic low back pain. In chronic pain, BZs may produce analgesic effects by reducing the anxiety, insomnia, and muscle tension that contribute to pain. These agents may cause cognitive impairment and worsen pre-existing depression. If BZs are chosen to treat chronic low back pain, a short course of therapy is recommended to minimize the potential for abuse, addiction, or physical dependence. Clonazepam is the preferred agent due to once-daily dosing at bedtime.15

Antiepileptic Drugs

Antiepileptics, such as gabapentin, pregabalin, and carbamazepine, are often used for the treatment of neuropathic pain. Carbamazepine is commonly used for the treatment of trigeminal neuralgia. Occasionally, these agents are used to treat other types of pain, such as low back pain. The recommended dosage for gabapentin is 300 to 900 mg three times daily, titrated to a maximum dose of 3,600 mg daily; pregabalin is 50 to 300 mg daily in two or three divided doses, and carbamazepine is 200 to 600 mg two times daily (TABLE 3).7,8

The most common adverse effects associated with this class of drugs are sedation, mental confusion, dizziness, and nausea.7,15 Like gabapentin, the most common adverse effects associated with pregabalin use are dizziness, somnolence, and peripheral edema. However, somnolence and dizziness are more profound with gabapentin use. Pregabalin is classified as a schedule V controlled substance by the Drug Enforcement Agency (DEA). Abrupt or rapid discontinuation of pregabalin has been associated with insomnia, headache, and diarrhea, which are all symptoms that could be associated with physical dependence.20 The evidence to support their effectiveness in the management of low back pain is lacking, and these agents should be considered adjunctive therapy in patients who do not respond to first-line or other recommended agents.

Antidepressants

Antidepressants, particularly tricyclic antidepressants (TCAs), have been used for years to treat various pain conditions. The role of antidepressants in treating chronic low back pain in patients with depression is unknown. There are no current trials evaluating the use of TCAs for acute low back pain; therefore, they should not be used to treat in these patients. In addition, TCAs have been associated with a higher incidence of adverse effects such as drowsiness, dry mouth, constipation, and dizziness. TCAs work by inhibiting both serotonin and norepinephrine reuptake. Due to their mechanism of action, it is thought that TCAs may improve symptoms in patients with chronic low back pain.21 TCAs commonly prescribed in the management of chronic low back pain are amitriptyline, desipramine, and nortriptyline. Dosages used to treat low back pain are typically much lower than those used for depression. The dose should start low and gradually increase as needed. The recommended dosage of amitriptyline is 10 to 150 mg once daily, preferably at bedtime because of drowsiness (TABLE 3).7,8

Serotonin norepinephrine reuptake inhibitors (SSRIs) such as duloxetine and milnacipran are used to treat certain types of pain with or without a neuropathic component. Duloxetine has not been studied for low back pain but now has FDA approval for musculoskeletal pain. Milnacipran is currently under investigation for the treatment of chronic low back pain.8

Conclusion

Chronic low back pain can be defined as pain, muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds, with or without leg pain (sciatica) lasting longer than 3 months. Optimal management of low back pain usually requires a multimodal approach that combines both nonpharmacologic and pharmacologic treatment. The treatment plan for each patient should be individualized based on the presence of risk factors, concomitant medication use, severity of pain, duration of symptoms, and cost, and should always involve discussion of potential benefits and risks.

REFERENCES

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