Intrathecal Morphine Microdose Method Sensory Changes
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 11/11/2018 |
| Start Date: | October 8, 2018 |
| End Date: | January 8, 2020 |
| Contact: | Denise M Wilkes, MD |
| Email: | dwilkes@utmb.edu |
| Phone: | 409-772-1221 |
Intrathecal Morphine Microdose Method Sensory Changes: A Pilot Study
Following the retrospective study on the effectiveness of the microdose method of intrathecal
morphine therapy, the investigators are interested in measuring the sensory changes at 4 time
points during the microdose method. The microdose method involves weaning the patient off
oral opioids and maintaining an opioid-free period prior to initiating a very low opioid dose
in intrathecal therapy. The microdose method is a standard of care. The study involves
measuring sensory changes to hot, cold, and pressure. Data collection will be performed at
regularly scheduled clinic visits, examining range of doses, pain scores,dose escalations,
quantifiable psychosocial factors ( not captured in previous retrospective study), and
changes in sensory thresholds.
morphine therapy, the investigators are interested in measuring the sensory changes at 4 time
points during the microdose method. The microdose method involves weaning the patient off
oral opioids and maintaining an opioid-free period prior to initiating a very low opioid dose
in intrathecal therapy. The microdose method is a standard of care. The study involves
measuring sensory changes to hot, cold, and pressure. Data collection will be performed at
regularly scheduled clinic visits, examining range of doses, pain scores,dose escalations,
quantifiable psychosocial factors ( not captured in previous retrospective study), and
changes in sensory thresholds.
The use of intrathecal drug delivery systems for the management of chronic non-cancer pain
has been in practice for over 30 years. A recently published study from the University of
Texas Medical Branch performed a retrospective review on the morphine microdose method in
community-based clinics. The goal of the study was to examine the morphine microdose method
in an outpatient setting and assess success of therapy, pain scores and dose escalation.
Patients were successfully weaned off their systemic opioids, maintained in an opioid-free
period for 4-6 weeks, and then underwent a microdose trial and implantation. The majority of
patients were successfully managed on morphine monotherapy, with a significant reduction in
pain scores, and dose escalations comparable to prior studies. No prospective studies have
examined the microdose method in correlation with changes in pain sensitivity.
Several studies have looked at the use of various pain testing models to investigate the
effects of chronic opioid therapy and changes in pain perception. A systematic review of the
literature identified clinical studies incorporating measures of hyperalgesia in patients on
chronic opioid therapy. This review was aimed at finding the optimal testing modality to
evaluate pain threshold and tolerance to external stimuli, including mechanical (pressure,
touch, injection), thermal (cold/heat), and electrical. Although the results did not reveal
any one method with sufficient power, several prospective studies evaluating hyperalgesia
with heat pain ratings have shown some promising results; two studies revealing significant
changes in heat responses for opioid treatment groups, and one study demonstrating lower heat
pain perception values following an opioid taper. The latter study of research pertaining to
pain sensitivity changes following an opioid taper is lacking, and only recently was a study
performed investigating changes in pressure threshold following transition from full mu
agonist to buprenorphine. Little is known at this juncture how pain thresholds change due to
opioid dose changes and/or route of delivery changes such as oral to intrathecal routes.
has been in practice for over 30 years. A recently published study from the University of
Texas Medical Branch performed a retrospective review on the morphine microdose method in
community-based clinics. The goal of the study was to examine the morphine microdose method
in an outpatient setting and assess success of therapy, pain scores and dose escalation.
Patients were successfully weaned off their systemic opioids, maintained in an opioid-free
period for 4-6 weeks, and then underwent a microdose trial and implantation. The majority of
patients were successfully managed on morphine monotherapy, with a significant reduction in
pain scores, and dose escalations comparable to prior studies. No prospective studies have
examined the microdose method in correlation with changes in pain sensitivity.
Several studies have looked at the use of various pain testing models to investigate the
effects of chronic opioid therapy and changes in pain perception. A systematic review of the
literature identified clinical studies incorporating measures of hyperalgesia in patients on
chronic opioid therapy. This review was aimed at finding the optimal testing modality to
evaluate pain threshold and tolerance to external stimuli, including mechanical (pressure,
touch, injection), thermal (cold/heat), and electrical. Although the results did not reveal
any one method with sufficient power, several prospective studies evaluating hyperalgesia
with heat pain ratings have shown some promising results; two studies revealing significant
changes in heat responses for opioid treatment groups, and one study demonstrating lower heat
pain perception values following an opioid taper. The latter study of research pertaining to
pain sensitivity changes following an opioid taper is lacking, and only recently was a study
performed investigating changes in pressure threshold following transition from full mu
agonist to buprenorphine. Little is known at this juncture how pain thresholds change due to
opioid dose changes and/or route of delivery changes such as oral to intrathecal routes.
Inclusion Criteria:
- Age between 18 and 75
- Selected for microdose Intrathecal pump therapy by their pain physician
- Chronic pain for at least 3 months
- Willing to cooperate with all study procedures
Exclusion Criteria:
- Presence of cancer
- Age less than 18 years old or greater than 75
- Current intrathecal therapy and/or with multiple intrathecal drugs (such as other
opioids, local anesthetics, muscle relaxants)
- Medical conditions (myocardial infarction within the last year, uncontrolled diabetes,
autoimmune disease
- Recent history of alcohol or substance abuse in the last 5 years
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Phone: 409-772-1221
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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