Intrathecal Morphine Microdose Method Sensory Changes
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| ClinicalTrials.gov Identifier: NCT03395275 |
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Recruitment Status :
Recruiting
First Posted : January 10, 2018
Last Update Posted : September 22, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Analgesic Drug Dependence Sensory Disorders Chronic Pain | Behavioral: Quantitative Sensory Tests Behavioral: surveys | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 10 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | The study will be a non-randomized prospective trial. Participants will be selected for microdose intrathecal pump therapy by their pain physicians. Eligible participants will undergo an opioid taper by their physicians, and sensory tests will be carried out in the various stages of the intrathecal microdose treatment process (pre-taper, mid-taper, post-taper and post-implant phase). |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Intrathecal Morphine Microdose Method Sensory Changes: A Pilot Study |
| Actual Study Start Date : | October 8, 2018 |
| Estimated Primary Completion Date : | October 8, 2022 |
| Estimated Study Completion Date : | January 8, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intrathecal Pump Therapy Participants
Patients eligible for intrathecal pump therapy will undergo quantitative sensory tests and surveys during various stages of the treatment process.
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Behavioral: Quantitative Sensory Tests
Three testing modalities will be utilized for this study:
Behavioral: surveys surveys including anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance, self-efficacy, satisfaction roles |
- Heat threshold measurements [ Time Frame: 2 years ]Heat threshold measurements (degrees Celsius) will be obtained using a pen-shaped temperature probe. Tests will be performed on a designated painful and non-painful body surface. Testing will completed when patient reports numeric pain rating of 5 or greater, or at a temperature >49 degrees Celsius.
- Cold threshold measurements [ Time Frame: 2 years ]Cold threshold measurements (degrees Celsius) will be obtained using a pen-shaped temperature probe. Tests will be performed on a designated painful and non-painful body surface. Testing will be completed when patient reports discomfort with cold stimulus, or if probe temperature reaches 0 degrees Celsius.
- Pressure threshold measurements [ Time Frame: 2 years ]Pressure threshold measurements (Newtons) will be obtained using a hand-held algometer. Tests will be performed on a designated painful and non-painful body surface. Testing will be completed when patient reports discomfort with pressure stimulus, or if pressure exceeds 60 Newtons.
- Demographic Evaluation - Pain History [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will do a chart review of one year prior to start of the trial to examine the pain history.
- Demographic Evaluation - Medical History [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will do a chart review of one year prior to start of the trial to examine the medical history.
- Demographic Evaluation - Body Mass Index [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will collect data on body mass index.
- Demographic Evaluation - Gender [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will collect data on gender.
- Demographic Evaluation - Surgical History [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. We will do a chart review of one year prior to start of the trial to examine the surgical history.
- Demographic Evaluation - Age [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will collect data on patient age.
- Demographic Evaluation - Social History [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. We will do a chart review of one year prior to start of the trial to examine the social history.
- Demographic Evaluation - Urine Drug Tests [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. We will do a chart review of one year prior to start of the trial to examine the urine drug tests
- Demographic Evaluation - Numeric Pain Scale Scores [ Time Frame: 2 years ]To describe the patient population and to evaluate patient factors, which predict successful trials. We will do a chart review of one year prior to start of the trial to examine numeric pain scale scores.
- surveys - Anxiety [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on anxiety will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
- surveys - Depression [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on depression will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
- surveys - Pain Behavior [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on pain behavior will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
- surveys - Fatigue [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on fatigue will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
- surveys - Pain Interference [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on pain interference will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
- surveys - Physical Function [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on physical function will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
- surveys - Sleep Disturbance [ Time Frame: 2 years ]Patient-Reported Outcomes Measurement Information System survey on sleep disturbance will be administered at the subject's initial, halfway and end of their evaluations. The results from the surveys will be aggregated and compared to other participants' responses.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395275
| Contact: Denise M Wilkes, MD | 409-772-1221 | dwilkes@utmb.edu | |
| Contact: Andrew M Khoury, MD | amkhoury@utmb.edu |
| United States, Texas | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555 | |
| Contact: Denise Wilkes, MD-PhD 409-772-1221 dwilkes@utmb.edu | |
| Contact: Andrew Khoury, MD 409-772-1221 amkhoury@utmb.edu | |
| Principal Investigator: | Denise M Wilkes, MD | Associate Professor |
| Responsible Party: | The University of Texas Medical Branch, Galveston |
| ClinicalTrials.gov Identifier: | NCT03395275 |
| Other Study ID Numbers: |
17-0245 |
| First Posted: | January 10, 2018 Key Record Dates |
| Last Update Posted: | September 22, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Sensation Disorders Chronic Pain Substance-Related Disorders Pain |
Neurologic Manifestations Chemically-Induced Disorders Mental Disorders Nervous System Diseases |