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Key Paper Summaries IDD

Non-Malignant Pain

Roberts LJ, Finch PM, Goucke CR, Price LM
Outcome of intrathecal opioids in chronic non-cancer pain. European Journal of Pain 2001; 5: 353-361
Methods
  • Intrathecal or epidural opioid demonstration has an established role in the management of cancer pain. The role of intraspinal opioids in chronic non-cancer pain is less well-defined and there is debate about the long-term efficacy of therapy and potential for adverse effects and technical complications.

  • The aims of this study were threefold:
    • 1. To evaluate outcome in all patients treated >6 months with intrathecal opioids administered by totally implanted drug administrations systems (DASs) at two centers since 1989
    • 2. To examine DAS-related complications in all patients implanted with DASs
    • 3. To investigate the patterns of opioid dosage during long-term therapy

  • 88 patients who had experienced chronic non-cancer pain for an average of 9.8 years were evaluated following treatment with intrathecal opioids for an average duration of 36.2 months. The most frequent diagnosis was lumbar spine or radicular pain after failed spinal surgery (63% of patients).

  • 85 patients were implanted with SynchroMed (Medtronic) and 3 with Infusaid (Arrow)

  • Outcome measures included global pain relief, physical activity levels, medication consumption, work status, intrathecal opioid side effects, proportion of patients ceasing therapy and patient satisfaction.
Results
  • From the time of commencement of intrathecal opioids to the time of follow-up:

    Positive


    • 82% of patients reported overall pain relief of 50% or greater. Mean pain relief was 60%.
    • 74% of patients reported increased activity levels.
    • Oral medication intake was significantly reduced.
    • Patient satisfaction with treatment was high with 88% of patients reporting satisfaction.

Less positive/complication

    • There was no significant change in work status.
    • There were frequent reports of opioid side effects including sexual dysfunction and menstrual disturbances.
    • Technical complications occurred in 40% of patients, most often catheter related.
    • 93% of patients were initially treated with morphine. Mean morphine dosage increased from 9.95 ± 1.49 mg/day at 6 months to 15.26 ± 2.52 mg/day at 36 months.
    • Drug administration systems were permanently removed in 6% of patients,
Discussion/conclusion
  • In this group of patients with chronic intractable non-cancer pain for an average of 12 years, infusion of opioids via an implanted DAS for a mean duration of >3 years was associated with improved analgesia, self-reported activity levels, reduction in medication intake and high levels of patient satisfaction.

  • In line with other studies of intrathecal opioids, there was no significant change in work status associated with treatment. It has previously been suggested that successful return to work may not be a realistic outcome in patients with very severe non-cancer pain and high levels of disability and dysfunction.

  • Therapy does not seem to be significantly inhibited by the development of tolerance.

  • Intrathecal opioid therapy using implanted drug administration systems appears to have a place in the management of chronic non-cancer pain.
Portenoy RK, Savage SR
Clinical Realities and Economic Considerations: Special Therapeutic Issues in Intrathecal Therapy - Tolerance and Addiction. Journal of Pain and Symptom Management 1997; 14: S27-S35
Discussion/conclusion
  • Opioids have a demonstrated use in treating chronic pain. However there are many myths about the use of these drugs, which limit or preclude their use by many physicians, particularly in non-cancer patients.

  • Historically, the need to increase the dose of opioid has usually been attributed to the development of tolerance. However, this may well have other origins, such as disease progression, changes in affective state or underdosing.

  • Clinical data suggest that the need for dose increases rarely compromises effective therapy, and is no more of a problem in intrathecal than during systemic therapy. Thus, concerns about the possible development of tolerance should not be the basis for withholding opioid therapy.

  • Patients requiring dose escalation because of increasing pain should be investigated for the source of this increase, which may be a change in disease state, psychological state or a problem with the drug-delivery system. If a dose increase is warranted, this should be made, although at high doses the potential for hyperalgesia should be recognised.

  • Addiction to opioid medications used in pain therapy is rare in individuals with no history of addictive disorders. Moreover, it seems possible that the likelihood of addition would be even smaller when using intrathecal than oral systemic therapy, as systemic exposure to the opioids is much smaller.

  • Opioids are stigmatised drugs and their underuse, and therefore undertreatment, is a significant problem. To address this, education is needed at all levels: clinicians, policy makers and patients.
Portenoy RK
Clinical Realities and Economic Considerations: Introduction. Journal of Pain and Symptom Management 1997; 14: S1-S2
Discussion/conclusion
  • This is an introduction to a supplement on this subject.
    In an effort to explore the evolving clinical consensus and ongoing disagreements that characterise the controversy of the use of intrathecal therapy in non-cancer patients, a closed roundtable meeting of pain specialists was convened. The supplement reports on that meeting.
Tutak U, Doleys DM
Intrathecal Infusion Systems for Treatment of Chronic Low Back and Leg Pain of Noncancer Origin. Southern Medical Journal 1996; 89: 295-300
Methods
  • The aim of the study was to assess the effects of continuous intrathecally administered opiate, primarily morphine, via a programmable infusion pump (SynchroMed Infusion System).

  • Patients were referred for treatment of intractable, chronic, non-cancer pain. They were fully evaluated for treatment response and possible psychological origins of pain before being fitted with a pump.
Results
  • A total of 26 patients were followed up for an average of 23 months (range 16-17 months).

  • Average pain rating decreased from 8.9 (out of 10) before treatment to 5.5 at 6 months and 4.9 at 12 months. The average subjective rating of improvement in pain was 59%.

  • The average functional level was 4.0 (out of 6) before surgery and decreased (improved) to 2.8 afterwards. Average improvement in daily functioning was 50%.
Discussion/conclusion
  • The data support a growing number of reports indicating the effectiveness of intrathecally-administered morphine in the management of non-cancer pain.
Winkelmüller M, Winkelmüller W
Long-Term Effects of Continuous Intrathecal Opioid Treatment in Chronic Pain of Nonmalignant Etiology. Journal of Neurosurgery 1996; 85: 458-467
Methods
  • This was a retrospective study designed to investigate therapeutic effects, side-effects and the development of tolerance and dependency, in patients with non-cancer pain receiving continuous intrathecal opioid therapy.

  • Data were collected for 120 patients, followed up for a period of between 6 months and 5.7 years.
Results
  • Pain was reduced from a mean of 93.6 (maximum 100) to 30.5 on a visual analogue scale after 6 months. This was accompanied by a marked reduction in patients' social withdrawal, and improvements in their mood and quality of life. 92% of the patients were satisfied with the therapy and 81% reported an improvement of their quality of life.

  • The dose of opiate required generally increased throughout the treatment period. Tolerance developed in seven patients, which was managed by drug holidays in four patients, but required explantation of the pump in the other three.

  • Most common side-effects could be managed pharmacologically, and decreased as treatment continued. A total of 25 pumps had to be removed for various reasons.
Discussion/conclusion
  • Results showed that 74% of the patients who were treated profited from the intrathecal morphine therapy, in a follow-up period lasting for nearly 5 years.

  • Thus, a good therapeutic effect can be maintained in the long term, provided patients are carefully selected and followed up.


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