Contents part 1: Introduction




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ODG hospital length of stay (LOS) guidelines:

Sympathectomy (icd 05.29 -- Other sympathectomy and ganglionectomy)

Actual data -- median 1 day; mean 2.0 days (± 0.4); discharges 540; charges (mean) $24,544

Best practice target (no complications) -- Never recommended

SCS (icd 03.93 Implantation or replacement of spinal neurostimulator leads)

Actual data -- median 1 day; mean 2.3 days (±0.2); discharges 3,998; charges (mean) $68,730

Best practice target (no complications) -- 1 day

Note: About 14% of discharges paid by workers’ compensation.

Intrathecal Pump (icd 86.06 - Insertion of totally implantable infusion pump)

Actual data -- median 3 days; mean 5.4 days (±0.4); discharges 6,995; charges (mean) $62,325

Best practice target (no complications) -- 3 days

Alcohol Detox (icd 94.62 - Alcohol detoxification)

Actual data -- median 3 days; mean 4.2 days (±0.1); discharges 169,797; charges (mean) $13,111

Best practice target (no complications) -- 3 days

Alcohol Rehab/Detox (icd 94.63 - Alcohol rehabilitation and detoxification)

Actual data -- median 5 days; mean 7.0 days (±1.1); discharges 12,586; charges (mean) $12,166

Best practice target (no complications) -- 5 days

Drug Detox (icd 94.65 - Drug detoxification)

Actual data -- median 4 days; mean 4.1 days (±0.2); discharges 78,219; charges (mean) $9,756

Best practice target (no complications) -- 4 days


H-wave stimulation (HWT)

For use recommendations related to the low back, refer to the DWC MTUS chapter on Low Back Complaints.

There is insufficient evidence to recommend the use of H-wave stimulation (HWT) for the treatment of chronic pain as no high-quality studies on this topic were identified. If it is used, HWT is not recommended as an isolated intervention.

H-wave stimulation is a form of electrical stimulation that differs from other forms of electrical stimulation, such as transcutaneous electrical nerve stimulation (TENS), in terms of its waveform. There is no evidence that HWT is more effective as an initial treatment when compared to TENS for analgesic effects. A randomized controlled trial of ischemic pain did not provide convincing evidence for any hypoalgesic effects of H-wave therapy. (McDowell, 1995) In another randomized controlled trial comparing analgesic effects of HWT and transcutaneous electrical nerve stimulation (TENS) on human pain thresholds, both HWT and TENS provided localized hypoalgesia during stimulation and for up to 5 minutes afterwards.  No frequency- or modality-specific differences were found between the groups. (McDowell2, 1999) There is evidence that low-frequency HWT may produce direct localized effects on cutaneous blood flow. (McDowell, 1999)

Uncontrolled studies of HWT in patients with chronic soft tissue injury or neuropathic pain have reported reductions in pain and use of pain medication and improved functional capacity or activity. (Blum, 2006; Blum, 2006a; Blum, 2008A randomized controlled trial, with identified risks of bias, demonstrated improved post-operative range of motion with use of HWT following rotator cuff reconstruction. (Blum 2009) An ongoing double blinded randomized controlled trial with identified risks of bias is currently evaluating HWT in a working-age population with chronic non-specific low back pain. (Thiese, 2013)

The use of HWT may be considered on a trial basis if other noninvasive, conservative modalities for the treatment of chronic pain have failed. Although there are no published studies to guide recommendations for use, a one-month home-based trial of HWT may be considered following a documented face-to-face clinical evaluation and physical examination performed by the recommending physician, who should also document the following in the medical record (refer to the DWC MTUS chapter on Low Back Complaints for issues related to the low back):

(1) The reason the physician believes that HWT may lead to functional improvement and/or reduction in pain for the patient; and

(2) The use of TENS for at least a month has not resulted in functional improvement or reduction in pain; and

(3) PT, home exercise and medications have not resulted in functional improvement or reduction in pain; and

(4) The patient is participating in an evidenced–based functional restoration program without seeing satisfactory reduction in pain or functional improvement.

The one-month initial trial will permit the physician and PT provider to evaluate any effects and benefits. A follow-up evaluation by the physician should take place to document how often the unit was used and any subjective improvement in pain and function. Use of HWT for periods of more than one month should be justified by documentation submitted for periodic review.



Hydrocodone

Refer to the DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids. Hydrocodone is a semi-synthetic opioid which is considered the most potent oral opioid that does not require special documentation for prescribing in some states (not including California). Hydrocodone was reclassified to Schedule II effective October 6, 2014. (FDA 2014). The potency of hydrocodone, an active ingredient of the most commonly prescribed drug (of any type) in the U.S., is greater than morphine, an opioid that is a Schedule II substance. Schedule II drugs can be dispensed only by prescription, and no refills are allowed. Stringent record keeping, reporting, and physical security requirements are also in place for these substances. (FDA, 2013) See also Zohydro.

Hydrocodone/ Acetaminophen (e.g., Vicodin®, Lortab®)

See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for recommendations on the use of opioids. Also see Hydrocodone/Acetaminophen (Anexsia®, Co-Gesic®, Hycet™; Lorcet®, Lortab®; Margesic-H®, Maxidone™; Norco®, Stagesic®, Vicodin®, Xodol®, Zydone®) listing for more information and references. An FDA advisory committee recommended a transition from Schedule III to Schedule II for hydrocodone products (FDA, 2013), but the DEA has yet to make any rules regarding rescheduling and still lists hydrocodone combination products as Schedule III. The Safe Prescribing Act proposed in U.S. Congress would legislatively reclassify hydrocodone combination products without going through the DEA. New York State made this transition to Schedule II in February 2013 as states have authority to upschedule. Now the DEA has officially proposed rescheduling of hydrocodone combination products from CIII to CII. (DEA, 2014) In this ED study, Vicodin failed to provide superior pain relief compared to Tylenol with codeine, and there was no significant difference in side effects. Both Vicodin and Hydrocodone decreased pain scores by approximately 50%, but hydrocodone/acetaminophen (Vicodin [5/500]) failed to provide clinically or statistically superior pain relief compared to codeine/acetaminophen (Tylenol#3 [30/300]). (Chang, 2014)

Hydrocodone/ Ibuprofen (Vicoprofen®)

See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for dosing recommendations.

Also see Hydrocodone/Ibuprofen (Vicoprofen®) listing for more information and references.This combination opioid/NSAID has a low dose of ibuprofen (200mg) that is below the normal adult dose of 400 to 800 mg per dose and total max daily dose of 2400mg. Vicoprofen was approved only based on single dose, post-op pain and is approved to treat acute pain for generally less than 10 days. Prescribing information also stresses that this product is not indicated for treating conditions such as rheumatoid arthritis or osteoarthritis.) In addition, there is also a cost difference between the generic Vicodin (approx $0.35/tab) and generic Vicoprofen ($1.04/tab).



Hydromorphone (Dilaudid®)

See DWC “Guideline for the Use of Opioids to Treat Work-Related Injuries” for dosing recommendations. Also see Hydromorphone (Dilaudid®) listing for more information and references.

Hypnosis

Recommended as a conservative option, depending on the availability of providers with proven outcomes, but the quality of evidence is weak. Hypnosis treatment may have a positive effect on pain and quality of life for patients with chronic muscular pain. (Grøndahl, 2008) The findings of a trial supported greater benefits effects from self-hypnosis training compared to cognitive training on average pain intensity, but the combined hypnosis-cognitive restructuring intervention appeared to have beneficial effects greater than the effects of either cognitive restructuring or hypnosis alone. (Jensen, 2011)

ODG Hypnotherapy Guidelines:

- Initial trial of 4 visits over 2 weeks



- With evidence of objective functional improvement, total of up to 10 visits over 6 weeks (individual sessions)

Hypnotics

See Benzodiazepines. See also Insomnia medications.

Ibuprofen (Motrin®, Advil®)

Recommended as an option. See Anti-inflammatory medications. See also NSAIDs (non-steroidal anti-inflammatory drugs); NSAIDs, GI symptoms & cardiovascular risk; NSAIDs, hypertension and renal function; & NSAIDs, specific drug list & adverse effects for general guidelines, as well as specific Ibuprofen (Motrin®, Advil®) listing for more information and references.

Implantable drug-delivery systems/ Intrathecal drug delivery systems (IDDSs)

There is insufficient evidence to recommend the use of implantable drug-delivery systems (IDDS) for the treatment of chronic pain. There are no high-quality studies on this topic which document that this therapy is safe and effective. Further, significant complications and adverse events have been documented and the data identify a substantial risk to patients. (Washington State Health Care Authority, 2008) Results of studies of opioids for musculoskeletal conditions (as opposed to cancer pain) generally recommend short use of opioids for severe cases, not to exceed 2 weeks, and do not support chronic use (for which a pump would be used). This treatment may be considered relatively late in the treatment continuum, when there is little hope for effective management of chronic intractable pain from other therapies. (Angel, 1998) (Kumar, 2002) (Hassenbusch, 2004) (Boswell, 2005) (Deer, 2009) (Patel, 2009) For most patients, it should be used as part of a program to facilitate restoration of function and return to activity, and not just for pain reduction. The specific criteria in these cases include the failure of at least 6 months of other conservative treatment modalities, intractable pain secondary to a disease state with objective documentation of pathology, further surgical or other intervention is not indicated, there are no contraindications to a trial, psychological evaluation unequivocally states that the individual has realistic expectations and the pain is not psychological in origin, and a temporary trial has been successful prior to permanent implantation as defined by a 50% reduction in pain. (Tutak, 1996) (Yoshida, 1996) (BlueCross, 2005) (United Health Care, 2005) In a study of IDDS in 136 patients with low back pain, after one year 87% of the patients described their quality of life as fair to excellent, and 87% said they would repeat the implant procedure. However, complication rates (i.e., infection, dislodging, and cerebrospinal fluid leak) are likely to rise with time in these procedures and more longitudinal outcome studies need to be conducted. (Deer, 2004) In one survey involving 429 patients with nonmalignant pain treated with intrathecal therapy, physician reports of global pain relief scores were excellent in 52.4% of patients, good in 42.9%, and poor in 4.8%. In another study of 120 patients, the mean pain intensity score had fallen from 93.6 to 30.5 six months after initiation of therapy. In both studies, patients reported significant improvement in activities of daily living, quality of life measures, and satisfaction with the therapy. (Winkelmuller, 1996) (Paice, 1997) One study in patients suffering from chronic low back pain caused by failed back syndrome found a 27% improvement after 5 years for patients in the intrathecal drug therapy group, compared with a 12% improvement in the control group. (Kumar, 2002) Supporting empirical evidence is significantly supplemented and enhanced when combined with the individually based observational evidence gained through an individual trial prior to implant. This individually based observational evidence should be used to demonstrate effectiveness and to determine appropriate subsequent treatment. Generally, use of implantable pumps is FDA approved and indicated for chronic intractable pain. Treatment conditions may include FBSS, CRPS, Arachnoiditis, Diffuse Cancer Pain, Osteoporosis, and Axial Somatic Pain. As we have gained more experience with this therapy, it has become apparent that even intrathecal opioids, when administered in the long term, can be associated with problems such as tolerance and other side effects. Consequently, long-term efficacy has not been convincingly proven. However, it is important to note that there is a distinction between "tolerance" and "addiction", and the levels of drugs administered intrathecally should be significantly below what migh be needed orally in their absence. (Osenbach, 2001) (BlueCross BlueShield, 2005) See also Intrathecal drug delivery systems, medications

Safety Precautions & Warnings: Oral opioid prescribing, use and how to best keep patients as safe as possible have all have been the subject of increasing discussion, in part, due to related accidental deaths. (Phillips, 2008) Use of intrathecal opioids, as for all routes of administration, is not without risk. Constipation, urinary retention, nausea, vomiting, and pruritus are typical early adverse effects of intrathecal morphine and are readily managed symptomatically. Other potential adverse effects include granuloma formation, amenorrhea, loss of libido, edema, respiratory depression, death and pump and catheter malfunctions. (Winkelmuller, 1996) (Paice, 1997) (Washington State Health Care Authority, 2008) Common causes of mortality in implanted pump patients appear to be preventable through adherence to dosing and monitoring information for drugs approved for chronic intrathecal administration. Follow product instructions and dosing recommendations. Failure to comply with all implanted infusion pump product instructions can lead to technical errors or improper use and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant drug underdose or fatal drug overdose. (Medtronic, 2009) The mortality rate in the implanted pump population is higher than some operative benchmarks and similar at approximately 30 days and 1-year post discharge to open spine surgery in the Medicare population. (Coffey, 2009) Patients who receive the implanted device should be monitored in an adequately equipped facility for a sufficient time to monitor drug effects. When using concomitant medications with respiratory or CNS depressant effects, appropriate supervision and monitoring should be provided. (Medtronic, 2009)

Patient selection (in addition to criteria below): Cole (2003) recommends that, after other criteria are met, patients with neuropathic pain are better candidates for spinal cord stimulation (SCS), and patients with nociceptive pain are better candidates for intrathecal drug delivery (IDD). It also recommends psychological evaluation and clearance before any implantation, plus positive response to a trial. (Cole, 2003)
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