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  • ACOEM Comments on DWC 2008 Proposed Chronic Pain Medical Treatment Guidelines

    Introduction 

    These comments are a representative sampling of reviews from several individuals with expertise in treatment of chronic pain and evidence-based medicine. They are meant to provide the DWC with both editorial and clinical perspectives.  Due to limited time available for review and the length of the document, these comments should not be interpreted as a comprehensive review. General comments represent ACOEM’s impressions and important recommendations missing from the draft. Specific comments are specific examples and additional items of actionable change due to erroneous or ambiguous text that DWC may also wish to consider.

    General Comments 

    1. The proposed Chronic Pain Medical Treatment Guidelines lack specificity in expressing recommendations.  There is a high degree of variability in explanatory detail.  There is frequently contradictory and confusing text that would result in inconsistent interpretation at the provider level, difficulty in assessing appropriateness of care and the risk of restricting high quality health care to injured California workers. 
    2. The scope of this draft document is unclear. A careful reading of the document shows that it includes far too many clinical situations that are inconsistent with Part 1 of the proposal that they “…apply to patients who fail to recover from and continue to have persistent complaints without definitive treatment, such as surgical options.” (page 1, par 1).  Many of the recommendations are largely, or completely irrelevant to occupational chronic pain; e.g., acute pain [Appendix 1], post-mastectomy (DWC pages 12, 22), central pain (DWC pages 13, 14), post-stroke pain (DWC pages 12, 14, 17), most headache disorder (pages 19, 21, 53, 79, 80) and cervical dystonia/torticollosis (DWC page 21).  
    3. Although chronic pain is now almost universally accepted as a biopsychosocial condition, there is very little guidance useful to a provider in the draft guidelines.  While the draft document notes that pain has a psychological component in the introduction (DWC page 5), and out of date psychological assessments are mentioned in several places as being recommended, the biopsychosocial model is never very well addressed without mention of fear avoidance. The draft does not address the multiple biopsychosocial concerns that occur with chronic pain, but rather notes that potential psychological concerns are recognized as occurring with chronic pain. It does not provide any information about potential psychosocial concerns, such as fear of re-injury, poor pain coping strategies or includes them in any treatment recommendations. There is a considerable literature on these issues, which could have provided actual guidance for the practitioner; but the proposed text does not review or address it.
    4. The lack of treatment algorithms in the proposed guidelines is of concern.  Algorithms provide further guidance about the sequence of treatment.  Good algorithms include branches to offer guidance in cases with different progressions, circumstances, or outcomes. They also often include integration with time frames indicating when tests or treatments are appropriate in the course of a case.  They assist in the development of treatment plans.  They provide quick, accurate guidance for busy clinicians, who otherwise might use multiple guideline recommendations in no particular order, without a suggested preferential hierarchy for sequencing of treatments.  The lack of preferential sequencing of treatment interventions may increase variance and duration of pain and disability.
    5. Work Hardening and Work Conditioning Programs are an example of a serious omission.  They are not mentioned at all in the draft, but are well established and often accredited. Their absence implies not recommending, contradicting other guidelines leading to potentially unnecessary confusion. An effective ban on these programs would unfairly restrict a valuable treatment option to injured California workers.
    6. The draft provides a summary of different treatment options with an inconsistent amount of supporting detail.  The document utilizes both open and proprietary evidence rating systems, which are quite different (e.g. DWC page 1), one of which appears at best difficult to reproduce. While some of the summarizations of different treatments may be of interest, the draft does very little to help the practitioner to identify clear treatment options that may or may not make meaningful changes in the patient with chronic pain. Instead, this is simply a summarization of particular treatments identified as being helpful.

    Specific Comments   

    1. Medications for subacute and chronic pain.  The section’s (DWC page 41) first sentence states that “there are few studies of the use of medications in the sub acute ….. or chronic pain periods. There are over 50 RCTs in this area that should be the foundation for quality evidence-based guidelines for injured workers in California
    2. Medications for subacute and chronic pain. (DWC page 41) Links generalized recommendations for osteoarthritis medications to chronic pain conditions, refers to a section. “There are multiple medication choices in the Procedure summary” that does not exist within the document. The paragraph also lists medication choices implying recommendation for chronic pain, several of which are explicitly not recommended elsewhere in the document (Appendix 2).
    3. Intrathecal Clonidine. The recommendations for CRPS intrathecal clonidine are potentially misapplied from evidence from spinal cord patients. While possibly appropriate in some patients, the proposed guidelines give the impression of standard of care, when clearly it should be more conservative:  “generally not recommended, although …. may be indicated in patients who have failed multiple trials of different oral medications and have undergone independent psychological consultation including psychometric testing that does not reveal a contraindication.” (DWC page 38, page 25 par 1)
    4. Intravenous Regional Sympathetic Blocks.  This discussion section uses the term “RSD” which is a discarded term by over 10 years.  It states these blocks are not commonly done for RSD, which is incorrect.  It does not state the diagnosis to which the recommendation applies (it seems to infer it only applies to CRPS patients, but that is unclear, and as noted previously is a major systematic issue).  It states that there is “no scientific evidence to support this treatment, it is recommended as an option.” However there are six (6) quality randomized controlled trials and four (4) (67.7%) of these appear to have been omitted from the California draft document (Livingstone 02; Jadad 95; Ramamarthy 95; Blanchard 90; Hord 92; Taskaynatan 04], that would result in a more appropriate “recommended as indicated below”. (DWC page 38, par 4)
    5. Ketamine.  The statement included in the draft is that “There are no quality studies that support the use of ketamine for chronic pain [sic].” In fact, there are two (2) high quality randomized controlled trials on Ketamine (Kvarnstrom 03 & 04).  (DWC Page 38, par 5)
    6. Optional Psychological Interventions with Opioids for Chronic Pain - recommended. There is no quality evidence to suggest that psychological interventions used with opioids “improve effectiveness of opioids for chronic pain”. Such interventions should be considered for clinically significant symptoms of addiction or during weaning.  (DWC Page 58, par 4)
    7. Antidepressants. The draft suggests that SSRIs are efficacious, that the evidence is strongest for use of anti-depressants for neuropathic pain, much less evidence for non-neuropathic pain and that disorders generally respond equally to these agents. However, there is robust evidence from numerous moderate and high quality studies that SSRI antidepressants are uniformly ineffective for treatment of chronic painful conditions with the sole exception of fibromyalgia.(Dickens 00, Atkinston 99, Atkinson 07) ( DWC Page 11, par 60)
    8. CRPS, Medications. The section on CRPS Regional inflammatory reaction, groups DMSO creams, IV administration and oral corticosteroids with the statement that there is “little likelihood for harm [sic]” is contrary to accepted clinical training – any IV administration needs to be considered at higher risk than topical administration. (DWC Page 25, par 6)
    9. CRPS Bisphosphonates. The section ends with bisphosphonates which appear to produce the largest magnitude reductions in pain ratings for CRPS patients and most of the relevant trials were not cited (also note that this was not mentioned for pain management on page 28).  The document’s stated assumption that the effects of bisphosphonates are due to effects on bone resorption demonstrate that the literature on this subject was not comprehensively reviewed, as the effects are thought to potentially involve avenues other than inhibition of bone resorption. (Manicourt 04, Varenna 00, Adami 97, Robinson 04) (DWC Page 25, par 6)
    10. CRPS Outcome Measures. (DWC page 29) Three of the outcomes measures listed (McGill Pain Questionnaire-Short Form, the Pain Disability Index and Treatment Outcomes in Pain Survey) do not meet the APA standards for standardized test in clinical use (American Education Research Association 1999).
    11. Calcitonin is suggested to have “Mixed results.”  However, there are 3 quality RCTs, and both of the higher rated studies show benefits (Bickerstaff 91, Gobelet 92) with one lower quality exception (Sahin 06).  (DWC Page 24, par 2)
    12. Spinal cord stimulation efficacy differs across time in all quality studies with at least one year of follow-up.  This is a potentially major and limiting aspect of this therapy, beyond the paralysis and other adverse complications.  Major complications of interventions have to be discussed to give a balanced view of the condition.  The implications that spinal cord stimulation is not effective at 3 years (Kemler) must be highlighted and that limitation along with complications discussed so that patients are adequately prepared for the risks and benefits of the procedure. (DWC Page 68)
    13. Arthritis Treatment is not properly addressed in the draft (DWC page 41). The few places it is addressed, it is handled erroneously (e.g., DWC page 34, Glucosamine). There are now at least two quality RCTs showing delayed progression of destructive joints with this intervention. (Pavelká 02, Reginster 03)
    14. Methadone is a dangerous drug.  The section on this topic appears to mute the dangers.  It is highly questionable whether this is an appropriate intervention in employed individuals.  There is no discussion in this section or in the document about safety sensitive positions, suggesting a lack of sensitivity towards the potential for an impaired individual to injure a co-worker. There is also the risk to the public when a methadone treated injured worker operates a motor vehicle. (DWC Page 42)
    15. The NSAIDs section persists in the belief that acetaminophen (or the analog paracetamol) may be as effective as NSAIDs for acute LBP.  Yet, quality evidence suggests inferiority to Diflunisal, mefenamic acid, indomethacin, and aspirin (Hickey 82; Evans 80). (DWC Page 44, par 9)
    16. Trigger point injections. This section appears to note that they may include an anesthetic or corticosteroid.  This guidance is not evidence-based.  There is quality evidence that trigger point injections with corticosteroids are not helpful, yet it has potential adverse consequences.(Garvey 89, Porta 00) (DWC page 79, par 6)
    17. Psychological Assessments. The draft incorporates listings of common psychological assessments (DWC Page 65) from the Colorado Div of Workers Compensation from 2002 which includes the Millon Behavioral Health Inventory (MBHI) and the Millon Behavioral Medical Diagnostic (MBMD) tests. Unfortunately, as was noted in the 2002 Colorado document, the MBMD replaced the archaic MBHI test. By simply listing the MBHI in the California guidelines, without the attached information supplied in the original documents seems to overstate the value of this test.  Furthermore, it is an ethical violation for a psychologist to use a psychological test that is far out of date, when a newer and improved model is available. From the APA: 

      9.08 Obsolete Tests and Outdated Test Results(a) Psychologists do not base their assessment or intervention decisions or recommendations on data or test results that are outdated for the current purpose.

      (b) Psychologists do not base such decisions or recommendations on tests and measures that are obsolete and not useful for the current purpose. 
       
    18. Psychological Assessments (cont). Similarly, for the Battery for Health Improvement (BHI). The original source lists BHI 2, which is the newer, more appropriate test, that unless the audience is very familiar with the clinical area could again apply sub-standard care. A further possibility could result from a payer incorrectly inferring that the BHI 2 test was experimental.  (DWC Page 65)
    19. Biofeedback. The draft uses, in part, references which are not high or moderate quality studies.  It uses proprietary sponsored guidelines which are potentially not relevant to the working population.  It is confusing, equivocating biofeedback and psychotherapy, seemingly randomly. (DWC page 20)
    20. Milnacipran (Ixel®) is listed under medications for Acute and Chronic Pain (DWC page 41), yet under its description it is designated as not recommended, not approved by the FDA and not available in the US.  Currently under an NDA, the DWC should be wary about predicting the outcome of a FDA drug evaluation for marketing in the US determination and also de novo including such a recommendation without any evidence of efficacy in injured workers comp chronic pain. (DWC Page 43, par3)
    21. Off label recommendations. Several instances of off label indications are documented in the text including Venlafaxine. In its description Venlafaxine is recommended as a first line treatment option for neuropathic pain despite not having FDA approval for this indication, only a reference for hepatic and renal consideration is listed.  (DWC page 80, par 6) 

    Appendix 1 Acute Treatments Recommendations in the MTUS Chronic Pain Proposed Guideline 

    p. 14          AEDs not recommended for Acute Pain

    p. 15          Gabapentin use in acute pain

    p. 40          Manipulation for acute conditions

    p. 40          Medications for acute pain (analgesics)


    Appendix 2 Listing of Contradictory Medication Choices (DWC page 41-42) 

     

    See Anticonvulsants for chronic pain;

     

     

     

     

    Antidepressants for chronic pain;

     

     

     

     

    Antidepressants for neuropathic pain;

     

     

     

     

    Antidepressants for non-neuropathic pain;

     

     

     

     

    Anti-Inflammatories;

     

     

     

     

    Benzodiazepines;

    Not Recommended (DWC page 19)

    Boswellia Serrata Resin (Frankincense);

    Not Recommended  (DWC page 20)

    Cannabinoids;

    Not Recommended  (DWC Page 21)

     

     

    Capsaicin;

     

     

     

     

    Cod liver oil;

    Not Recommended  (DWC page 25)

    Curcumin (Turmeric);

    Not Recommended (DWC page 32)

    Cyclobenzaprine (Flexeril®);

     

     

     

     

    Duloxetine (Cymbalta®);

     

     

     

     

    Gabapentin (Neurontin®); 

     

     

     

     

    Glucosamine (and Chondroitin Sulfate);

    Not Recommended (DWC page 34)

    Green tea;

    Not Recommended (DWC page 34)

    Herbal medicines;

     

     

     

     

    Implantable drug-delivery systems (IDDSs);

     

     

     

     

    Injection with anaesthetics and/or steroids;

     

     

     

     

    Intrathecal drug delivery systems, medications;

     

     

     

     

    Intravenous regional sympathetic blocks (for RSD, nerve blocks);

    Not Recommended (DWC page 49)

    Ketamine;

    Not Recommended (DWC page 50)

    Methadone;

     

     

     

     

    Milnacipran (Ixel®);

    Not Recommended (DWC page 43)

    Muscle relaxants;

     

     

     

     

    Nonprescription medications;

     

     

     

     

    NSAIDs (non-steroidal anti-inflammatory drugs); 

      

      

      

      

    NSAIDs, GI symptoms & cardiovascular risk;

     

     

     

     

    Opioids (with links to multiple topics on opioids);

     

     

     

     

    Pycnogenol (maritime pine bark);

    Not Recommended (DWC page 86)

    Salicylate topicals;

     

     

     

     

    Topical analgesics;

     

     

     

     

    Uncaria Tomentosa (Cat's Claw);

    Not Recommended (DWC page 80)

    Venlafaxine (Effexor®);

     

     

     

     

    White willow bark;

    Not Recommended (DWC page 81)

    Ziconotide (Prialt®).

     

     

     

     

     

    Appendix 3 References   

    Livingstone JA, Atkins RM. Intravenous regional guanethidine blockade in the treatment of post-traumatic complex regional pain syndrome type 1 (algodystrophy) of the hand. J Bone Joint Surg Br. 2002;84(3):380-6.  

    Jadad AR, Carroll D, Glynn CJ, McQuay HJ. Intravenous regional sympathetic blockade for pain relief in reflex sympathetic dystrophy: a systematic review and a randomized, double-blind crossover study. J Pain Symptom Manage. 1995;10(1):13-20.  

    Ramamurthy S, Hoffman J; Guanethidine Study Group. Intravenous regional guanethidine in the treatment of reflex sympathetic dystrophy/causalgia: a randomized, double-blind study. Anesth Analg. 1995;81:718-23. 

    Blanchard J, Ramamurthy S, Walsh N, et al. Intravenous regional sympatholysis: a double-blind comparison of guanethidine, reserpine, and normal saline. J Pain Symptom Manage. 1990;5(6):357-61. 

    Hord AH, Rooks MD, Stephens BO, Rogers HG, Fleming LL. Intravenous regional bretylium and lidocaine for treatment of reflex sympathetic dystrophy: a randomized, double-blind study. Anesth Analg. 1992;74(6):818-21. 

    Taskaynatan MA, Ozgul A, Tan AK, et al. Bier block with methylprednisolone and lidocaine in CRPS Type I: a randomized, double-blinded, placebo-controlled study. Regional Anesth Pain Med. 2004;29(5):408-12. 

    Kvarnström A, Karlsten R, Quiding H, Emanuelsson BM, Gordh T. The effectiveness of intravenous ketamine and lidocaine on peripheral neuropathic pain. Acta Anaesthesiol Scand. 2003;47(7):868-77. 

    Kvarnström A, Karlsten R, Quiding H, Gordh T. The analgesic effect of intravenous ketamine and lidocaine on pain after spinal cord injury. Acta Anaesthesiol Scand. 2004;48(4):498-506. 

    Dickens C, Jayson M, Sutton C, et al. The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychomatics. 2000;41(5):490-9. 

    Atkinson JH, Slater MA, Wahlgren DR, et al. Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain. 1999;83:137-45. 

    Atkinson JH, Slater MA, Capparelli EV, et al. Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial. J Clin Psychopharmacol. 2007;27(2):135-42.  

    Manicourt DH, Brasseur JP, Boutsen Y, Depreseux G, Devogelaer JP. Role of alendronate in therapy for posttraumatic complex regional pain syndrome type I of the lower extremity. Arthritis Rheum. 2004;50(11):3690-7. 

    Varenna M, Zucchi F, Ghiringhelli D, et al. Intravenous clodronate in the treatment of reflex sympathetic dystrophy syndrome. A randomized, double blind, placebo controlled study. J Rheumatol. 2000;27(6):1477-83. 

    Adami S, Fossaluzza V, Gatti D, et al. Bisphosphonate therapy of reflex sympathetic dystrophy syndrome. Ann Rheum Dis. 1997;56(3):201-4. 

    Robinson JN, Sandom J, Chapman PT. Efficacy of pamidronate in complex regional pain syndrome type I. Pain Med. 2004;5(3):276-80.

    American Educational Research Association, American Psychological Association, et al. Standards for educational and psychological testing. Washington, DC, American Educational Research Association. 1999

    Bickerstaff DR, Kanis JA. The use of nasal calcitonin in the treatment of post-traumatic algodystrophy. Br J Rheumatol. 1991;30(4):291-4. 

    Gobelet C, Waldburger M, Meier JL. The effect of adding calcitonin to physical treatment on reflex sympathetic dystrophy. Pain. 1992;48:171-5. 

    Sahin F, Yilmaz F, Kotevoglu N, Kuran B. Efficacy of salmon calcitonin in complex regional pain syndrome (type 1) in addition to physical therapy. Clin Rheumatol. 2006;25(2):143-8. 

    Pavelká K, Gatterová J, Olejarová M, Machacek S, Giacovelli G, Rovati LC. Glucosamine sulfate use and delay of progression of knee osteoarthritis: a 3-year, randomized, placebo-controlled, double-blind study. Arch Intern Med. 2002;162(18):2113-23. 

    Reginster JY, Deroisy R, Rovati LC, Lee RL, Lejeune E, Bruyere O, et al. Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomized, placebo-controlled clinical trial. Lancet. 2001;357:251-6. 

    Hickey RF. Chronic low back pain: a comparison of diflunisal with paracetamol. NZ Med J. 1982 12;95(707):312-4.  

    Evans DP, Burke MS, Newcombe RG. Medicines of choice in low back pain. Curr Med Res Opin. 1980;6(8):540-7. 

    Garvey TA, Marks MR, Wiesel SW. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. Spine. 1989;14(9):962-4.  

    Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 2000;85(1-2):101-5.