APS/AAPM Clinical Guidelines

APS/AAPM Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain

The American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) Opioids Guidelines Panel developed Clinical Guidelines for the Use of Chronic Opioid Therapy (COT) in Chronic Noncancer Pain (2009). These guidelines consist of 25 recommendations; each recommendation is rated by the strength of the recommendation (Strong/Weak) and the quality of the evidence (high/moderate/poor). There are 19 strong recommendations, 4 of which are supported by moderate-quality evidence. None of the recommendations are rated as having high-quality evidence to support it.

For the complete list of recommendations and a discussion of each one, see the full guidelines.

ASIPP Guidelines

Highlights from: Opioids in the Management of Chronic Non-Cancer Pain: An Update of American Society of the Interventional Pain Physicians' (ASIPP) Guidelines (Trescot et al., 2008)

While opioids are widely used in treating chronic pain, prescribing patterns of opioids for chronic pain vary widely and the evidence supporting their use is limited (Trescot et al., 2008). Furthermore, there is significant opioid abuse in conjunction with or without illicit drugs. ASIPP, therefore developed guidelines for opioid prescribing including the following:

• Opioid pharmacology is variable and must be understood.
• Comprehensive evaluation and diagnostic assessment of pain patients are crucial.
• Establishing goals of treatment and using a controlled substance agreement are essential.
• Periodic review of the patient on opioids is essential, using appropriate adjustments, with routine assessment of analgesia, activity, aberrant behavior, and adverse effects.
• Documentation is essential, including accurate and complete medical records to provide proper patient care and meet regulatory and legal requirements
  (Trescot et al., 2008).

The full ASIPP guidelines, provided in the link below, describe use of opioids in chronic pain, pharmacological considerations, terminology of abuse and addiction, clinical effectiveness, adherence monitoring, principles of opioid use, and documentation/medical records. Included are details on the following ten-step algorithm for approaching chronic opioid therapy:

VA/DoDClinical Practice Guideline

The VA/DoD Clinical Practice Guideline for the Management of Opioid Therapy for Chronic Pain was published in March 2003; an update is currently in process. This Guideline follows a flow chart of steps to consider when treating a patient with chronic pain, for example, conducting an assessment, determining if a non-opioid medication would be appropriate, considering if referral is indicated. The Appendices include helpful materials, such as Patient Education Materials, a Sample Treatment Agreement, an Acronym List, and Drug and Dosing Tables.

This Guideline provides a grade for the level of the recommendation as well as the overall quality of the evidence (based on grade of evidence and its relationship to health outcomes)

For the complete list of recommendations and a discussion of each one, see the full guidelines link in Related Resources.

Universal Precautions in Pain Medicine

Universal Precautions in Pain Medicine: A Rational Approach to the Treatment of Chronic Pain

The universal precautions are recommendations developed as a starting point for the treatment of chronic pain patients (Gourlay et al, 2005) . These guidelines brought the clinical consensus guidelines together into one document which can be used to estimate risk and triage patients into different types of ongoing management (Primary Care, Primary Care with Specialist Support, and Specialty Pain Management).

The recommended 10 steps for pain patients:

*The Universal Precautions were supported in the 2009 APS/AAPM guidelines for chronic opioid therapy, however, a written treatment agreement and urine toxicology were considered elective.

Federation of Medical Boards -- Model Policy

The Model Policy for the Use of Controlled Substances for the Treatment of Pain, created by the Federation of State Medical Boards of the U.S., describes criteria for evaluating a physician's treatment of pain, including controlled substances (FSMB, 2004). The policy promotes legitimate medical use of controlled substances for pain management and safeguarding against abuse and diversion. The policy recommends considering "inappropriate treatment, including the under-treatment of pain, a departure from an acceptable standard of practice." The American Academy of Pain Medicine, the Drug Enforcement Administration, the American Pain Society, and the National Association of State Controlled Substances Authorities have all endorsed the guidelines.

Key messages in the Model Policy (FSMB, 2004) include:

• "Appropriate pain management is the treating physician’s responsibility."
• "The Board recognizes that controlled substances including opioid analgesics may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins."
• "Physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not the same as addiction."

Model policy criteria (FSMB, 2004):

1. Evaluation of the patient - medical history and physical exam.
2. Treatment plan - includes objectives that will determine treatment success and other diagnostic tests and treatment modalities
3. Informed consent and agreement for treatment
   • discuss risks vs. benefits
   • receive prescriptions from one physician and one pharmacy
   • use written agreement if there is high risk for substance use problems
4. Periodic review - current state of pain and response to treatment and modify treatment accordingly
5. Consultation - as needed for pain treatment or substance abuse problems
6. Medical records - accurate and complete, include:
   1. the medical history and physical examination
   2. diagnostic, therapeutic and laboratory results
   3. evaluations and consultations
   4. treatment objectives
   5. discussion of risks and benefits
   6. informed consent
   7. treatments
   8. medications (including date, type, dosage and quantity prescribed)
   9. instructions and agreements
   10. periodic reviews
7. Compliance with controlled substances laws and regulations

A link to the complete model policy is available in the Resources section of this page.

The model policy furthermore includes the following definitions of key terms in pain management:

• Acute Pain
• Addiction
• Chronic Pain
• Pain
• Physical Dependence
• Aberrant Behavior Driven by Undertreated Pain
• Substance Abuse
• Tolerance

Cancer Pain Treatment Guidelines

World Health Organization Pain Relief Ladder

The World Health Organization (WHO) developed the following three-step "ladder" that recommends progressively strong treatment for chronic cancer pain until the patient is pain-free (WHO, 1986). It has slipped into usage for all types of chronic pain, however. WHO recommends prompt administration of oral drugs in response to pain, progressing up the ladder until there is no pain. Drugs should be administered by the clock rather than as needed.

1. Mild pain: Non opioid, +/- Adjuvant
2. Moderate pain: Opioid for mild to moderate pain, +/- Non opioid, +/- Adjuvant
3. Severe pain: Opioid for moderate to severe pain, +/- Non opioid, +/- Adjuvant

Examples of the therapies

1. Non opioid: Acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs)
2. Opioid for mild to moderate pain: Tramadol, codeine, dihydrocodeine
3. Opioid for moderate to severe pain: Morphine, fentanyl, buprenorphine, oxycodone, hydromorphone
4. Adjuvant: Antidepressants, anticonvulsants, steroids, muscle relaxants, exercise, psychological counseling, hydrotherapy, acupuncture, etc.

APS Guideline for Management of Cancer Pain

The American Pain Society (APS) practice guideline for treating cancer pain in adults and children made the following recommendations that specifically mention opioids and many others that are relevant to the use of chronic opioid therapy for cancer pain (Miaskowski et al, 2005):

We excerpted the recommendations that include the word "opioids" here; the complete guide is available through the Resources link on this page. "A" indicates the highest quality evidence and "D" the lowest.

• Begin a bowel regimen to prevent constipation when the patient is started on an opioid analgesic. [Evidence strength: B]

• Administer a long-acting opioid on an around-the-clock basis, along with an immediate-release opioid to be used on an as-needed basis, for breakthrough pain once the patient's pain intensity and dose are stabilized. [Evidence strength: A]
• Adjust opioid doses for each patient to achieve pain relief with an acceptable level of side effects. [Evidence strength: A]
• Use optimally titrated doses of opioids and maximal safe and tolerable doses of coanalgesics through other routes of administration before considering spinal analgesics. [Empirical evidence only: Panel consensus]
• Monitor for and prophylactically treat opioid-induced side effects. [Evidence strength: B]
• Titrate naloxone, when in the rare instance it is indicated for the reversal of opioid-induced respiratory depression, by giving incremental doses that improve respiratory function but do not reverse analgesia. [Evidence strength: B]

(Key: A= strongest evidence, D=little or no evidence)

Clincial algorithms. The clinical algorithms section includes algorithms for:

• Rapid Titration with Short-Acting Oral or Intravenous Opioids
• Slow Titration with Short-Acting Oral Opioids

Other Guidelines

There are numerous other guidelines for treating chronic pain in general, as well as for specific conditions and patient populations. The more recent of these other guidelines are listed in the Related Resources below.

Evidence Gaps

Although there is an abundant reservoir of supportive and opposing evidence on chronic opioid therapy (COT), evidence gaps have been identified. This calls attention to the need of studies to address these areas. Currently, there is a paucity of studies regarding certain aspects of opioid use. The controversy and uncertainty surrounding the long term use of opioids to treat chronic non-malignant pain will continue, until more reliable evidence can be obtained.

Areas of COT that contain minimal evidence:

• Reliable prediction of benefits or adverse effects associated with COT
• Best approach to the following:
  • performing risk assessments
  • risk stratification
  • patient monitoring while on COT
  • initiating COT and titrating the dose
• Usefulness of the following:
  • informed consent
  • patient treatment agreements
  • efficacy of opioid rotation
  • benefits and adverse effects for methadone
  • benefits and adverse effects for higher opioid doses
  • treatment of high-risk patients
    (Chou et al., 2009a)
    

Research Gaps:

• the treatment of CNCP with COT in pregnant women.
  • Past focus. Thus far, studies have focused primarily on the use of opioids during childbirth or women in methadone maintenance (Chou et al., 2009b).
• the adverse effects of COT.
  • Past focus. Most trials have been designed to evaluate efficacy and tend to focus on the benefits of opioid use (Chou et al., 2009b).
• the long-term benefits of opioid use.
  • Past focus. Available randomized trials tend to primarily focus on the short-term benefits of opioids versus placebo in highly selected populations (Furlan et al., 2006; Kalso et al., 2004).
• risk for fractures in the elderly when using opioids, with research employing a control for potential confounders.
  • Past focus. Several observational studies suggest older patients may have an increased risk of fractures when on opioids (Takkouche, 2007).
• patient function and quality of life associated with opioid use; few studies have addressed this (Soin et al., 2008; Ballantyne, 2007; Ballantyne and Mao, 2003).
• regulations regarding the prescription and use of COT affect clinical outcomes (Chou et al., 2009a).
• the effectiveness and risks of opioid use for chronic lower back pain (Deshpande et al., 2007).
• the identification of patients who are at-risk for opioid misuse or abuse, before COT is initiated (Turk et al., 2008).

Back Pain

Back pain

• First line treatment.
• For most patients, first-line medication options for low back pain are acetaminophen or nonsteroidal anti-inflammatory drugs (Chou, et al., 2007).
• Tramadol and other opioids and benzodiazepines were found to be supported by moderate quality (grade B evidence) for use in acute (< 4 wks) and chronic low back pain, that is, there is "at least fair-quality evidence of moderate benefit, or small benefit but no significant harms, costs, or burdens." However, in May 2010, the FDA strengthened its warnings regarding tramadol and suicide and overdose risk, so this medication alone or in combination with acetaminophen should be used with caution in patients at risk for suicide or overdose (U.S. FDA, 2010).
• Muscle relaxants were supported by grade B evidence only for acute low back pain.

The American College of Physicians (ACP) and the American Pain Society (APS) developed "Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline" in 2007, which is applicable to primary care (Chou, et al., 2007). Click the following link to expand a summary of the strong recommendations with at least moderate quality evidence from these guidelines:

"Diagnosis and Treatment of Low Back Pain" (ACP/APS, 2007) Strong recommendations/moderate evidence

Strong Recommendations from Diagnosis and Treatment of Low Back Pain: A Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society (Chou, et al., 2007)

For patients with low back pain, strong recommendations with moderate quality evidence in the clinical guidelines say that clinicians should do the following:

Evaluation

Conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories:

• Nonspecific low back pain
• Back pain associated with radiculopathy or spinal stenosis
• Back pain associated with another specific spinal cause

The history should include an assessment of psychosocial risk factors that predict risk for chronic disabling back pain.

Routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain.

Evaluate patients who present with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy. (See 2009 guidelines for a discussion of these interventions)

Assess severity of baseline pain and functional deficits.

Treatment

Provide patients with evidence-based information on low back pain with regard to their expected course

Advise patients to remain active

Provide information about effective self-care options

Consider the use of medications with proven benefits in conjunction with back care information and self-care. For most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs.

Consider potential benefits, risks, and relative lack of long-term efficacy and safety data before initiating therapy.

Other findings

There was also a weak recommendation based on moderate quality evidence (grade B) for adding the following non-pharmacologic treatments for patients with chronic low back pain who do not improve with self care: intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy or progressive relaxation.

Tramadol and other opioids and benzodiazepines were found to be supported by moderate quality (grade B evidence) for use in acute (< 4 wks) and chronic low back pain, which means there is "at least fair-quality evidence of moderate benefit, or small benefit but no significant harms, costs, or burdens." Muscle relaxants were supported by grade B evidence only for acute low back pain.

(Full 2007 guidelines and a guideline applicable to interventions for back pain from 2009 are available at the bottom of this page).




• Use of opioids.
  • Opioids have not been proven to significantly relieve pain or increase function in patients experiencing chronic low back pain (Martell et al., 2007).
  • Opioids are commonly prescribed for chronic back pain and may be efficacious for short-term pain relief. However, long-term efficacy remains unclear (Martell et al., 2007).
  • Substance use disorders are common when patients take opioids for back pain, and aberrant behaviors occurred in 24% of the cases that were reviewed (Martell et al., 2007).
  • Strong opioids may be indicated for chronic low back pain when other pain relief treatments are unsuccessful, according to one study (Allan et al., 2005).

Fibromyalgia

Fibromyalgia

With respect to pain control, the pain in fibromyalgia is thought to be caused by abnormal CNS processing of pain signals, in a complex interaction with stress, patient behavior, neurotransmitters, hormones.

• First line treatment
  • The best treatment approach is employing both medicinal and non-medicinal treatments (Carville et al., 2008), in which evidence suggests the incorporation of patient and family education, medications, massage, exercise, and cognitive behavioral therapy (Goldenberg et al., 2004, Univ of Texas, 2009). For examples of stepwise treatment plans, see articles by Arnold, 2006 and Goldenberg et al., 2004 in the Reference section below.
  • Major recommendations for pharmacologic treatment of fibromyalgia based on high quality evidence include targeting the following (Univ of Texas, 2009):
    • sleep
    • fatigue and depression
    • muscle spasms
    • pain control
  • Specific medicinal treatments:
    • There is strong evidence for the efficacy of tricyclic antidepressant medications, especially amitriptyline and serotonin and norepinephrine reputake inhibitors (SNRIs), for adequate sleep, fatigue, and depression and cyclobenzaprine or low dose benzodiazepines (clonazepam) to treat muscle spasms (Goldenberg et al., 2004; NGC, 2005). Certain anticonvulsants are also effective (Univ of Texas, 2009).
    • There is modest evidence for the efficacy of tramadol and serotonin reuptake inhibitors (Goldenberg et al., 2004). The University of Texas, School of Nursing guidelines from 2009 recommended a dose of 50-100 mg of tramadol every 6 hours for pain control.
    • Opioids are not recommended because evidence for increased benefit from them was not found (NGC, 2005).
    • Non-steroidal anti-inflammatory agents were not recommended because fibromyalgia is not inflammatory (NGC, 2005).
  • Regarding exercise treatment, evidence supports aerobic exercise as effective (Arnold, 2006).




• Use of opioids.The efficacy of COT is rare for fibromyalgia, a condition with psychosocial factors (Chou et al., 2009), and opioids should only be considered when all other medicinal and non-medicinal therapies do not help (Goldenberg et al., 2004).

A link to the complete 2005 Fibromyalgia Treatment Guidelines is available under the Resources section of this page.

Headache

Headache

• Migraine headache:
  • First line treatment. A combination of treatments is the best option (National Pain Foundation, 2009). Various abortive and prophylactic therapies for migraine headache should be used as first line treatments (Chou et al, 2009). A guideline from the National Headache Foundation for acute migraine treatment recommended stratifying treatment according to the patient and even among an individual patient's attacks (NGC/NHF, 2005, updated 2009).
  • Use of opioids. The first line abortive and prophylactic therapies for migraine headache should be used before using COT for migraine headache (Chou et al, 2009). The National Headache Foundation guidelines, however, specify that opioids may be useful for patients who do not respond to the first line treatments and who have moderate to severe pain (NGC/NHF, 2005). Opioids are generally used as rescue medications when other medications fail to provide pain relief or cannot be tolerated or are contraindicated. Opioids should only be used on an "as needed" basis and not regularly when taken for the treatment of migraine headaches (National Pain Foundation, 2009).
• Chronic tension-type headache:
  • First line treatment. OTC analgesics and adjunctive therapy including managing triggering factors, stress reduction, etc are the first line treatments. Regular use of analgesics may lead to chronic daily headache.
  • Use of opioids. A review of treatment for this condition concluded that opioids are not helpful for most people with chronic daily headache and therefore "that COT should be used in rare circumstances for chronic headache patients" (Saper and Lake, 2008). The authors describe a mechanism by which opioids may even contribute to progression of frequency and severity of headaches.

Neuropathic and nociceptive pain

Neuropathic and nociceptive pain

• First line treatment. Only 2 specific neuropathic pain syndromes have US FDA-approved medications for their treatment: carbamazepine for trigeminal neuralgia and gabapentin and the 5% lidocaine patch for post-herpetic neuralgia (Dworkin et al, 2003). Efficacy has been demonstrated for gabapentin, the 5% lidocaine patch, opioid analgesics, tramadol hydrochloride, and tricyclic antidepressants (TCAs) (Dworkin et al, 2003). Other first line treatments for neuropathy were described in guidelines developed by members of the faculty of the Fourth International Conference on the Mechanisms and Treatment of Neuropathic Pain in 2003. (Dworkin et al., 2003). A link to the full guidelines, "Advances in Neuropathic Pain" is provided below.
• Use of opioids.
  • Opioids were deemed unsatisfactory in the long term management of neuropathic and nociceptive pain in at least two studies (Deshpande et al., 2007; Eisenberg et al., 2006).
  • Others concluded that neuropathy and non-neuropathic painconditions respond similarly to COT (Furlan et al., 2006; Kalso et al., 2004; Moore et al., 2005).
  • Kalso et al. (2004) concluded that opioids are effective in the treatment of acute neuropathic and musculoskeletal pain conditions. However, because only a few of these patients received long-term opioid treatment, results regarding long-term effectiveness were inconclusive.
  • Although opioids are not likely to replace "tricyclic antidepressants and anti-epileptic drugs as first-line therapy for neuropathic pain," they remain effective and useful as second- or third-line drugs (Allen, 2008).
• Trigeminal neuralgia:
  • First line treatment.The most commonly used medication is often an anti-convulsant of some sort. The FDA has approved carbamazepine for treatment of trigeminal neuralgia (Dworkin et al, 2003).
  • Use of opioids. Other medications are usually utilized first due to the more serious adverse effects and risks associated with opioids. Opioids often do not provide adequate pain relief. If opioids are decided upon as part of the treatment, they are generally taken alongside other medications (National Pain Foundation, 2009).

Osteoarthritis

Osteoarthritis

• First line treatment. Traditional methods of pain management (eg, acetaminophen, NSAIDs, or tramadol) should be tried first if possible (Seed, 2009). A review of research on effectiveness and safety of analgesics for osteoarthritis, found there was no evidence for greater efficacy of COX-2 selective NSAIDs over nonselective NSAIDs or of any particular medication in these classes over the others. However, important differences were found in terms of potential gastrointestinal and cardiovascular harms. A link to the 2006 AHRQ review, entitled "Comparative Effectiveness and Safety of Analgesics for Osteoarthritis" is provided below in Related Resources.
• Use of opioids.
  • According to the American Academy of Rheumatology, opioids are not considered a first-line treatment option for osteoarthritis and "should be considered only if traditional methods of pain management (eg, acetaminophen, NSAIDs, or tramadol) have been ineffective" or intolerable. Even if opioids are used, they should be done so only at a low dose, especially in elderly patients (Seed, 2009). The decision to use opioids for arthritis treatment should be made on a case by case basis. Specifics such as the severity of the pain, risk for abuse/addiction and side effects, and likely effectiveness and alternative treatments for the particular condition should be considered. As with most other chronic pain conditions, opioids are only part of a comprehensive plan.
  • When other treatments have been ineffective, the use of opioids for osteoarthritic pain "has potentially fewer life-threatening complications associated with it than other more common pharmacotherapeutic approaches to care" when used and monitored appropriately (Goodwin et al., 2009).
  • Opioids are "safe and effective for joint pain including osteoarthritis" if they are used as part of a comprehensive pain treatment plan (Goodwin et al., 2009)
  • For elderly patients, side effects of decreased mobility, decreased cognitivive ability, and increased risk for hip fracture should be considered (Dworkin et al, 2003)
  • "Sustained release oxycodone provided significant analgesia for patients with osteoarthritis" (Roth et al., 2000).
  • Weak evidence exists for the long-term effectiveness of tramadol when treating osteoarthritis (Trescot et al., 2008).

Rheumatoid arthritis

Rheumatoid arthritis

• First line treatment.
  • Treatment of rheumatoid arthritis depends on the patient's age, well-being, medical history, and severity of the condition (Brenman, 2007). Besides rest, exercise, and surgery, there are a number of medications that can be used when treating rheumatoid arthritis. These medications, such as NSAIDs, topical medications, corticosteroids, opioids and disease-modifying antirheumatic drugs (DMARDs), offer relief of certain symptoms.
  • Traditionally, NSAIDs have been used to treat rheumatoid arthritis (Griessinger et al., 2003). NSAIDs can cause "potentially serious gastrointestinal, cardiovascular, and renal adverse effects, especially in the elderly."
• Use of opioids.
  • Because of the potentially serious adverse effects of NSAIDs especially in the elderly, patients, while being closely monitored, have been using opioids to manage the pain associated with rheumatoid arthritis (Griessinger et al., 2003).
  • Pain intensity, functioning, sleep, and overall well-being all improved in patients suffering pain caused by rheumatoid arthritis when transdermal fentanyl became part of the treatment plan. In addition, there was high patient satisfaction regarding such treatment (Berliner et al., 2007).