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Intrathecal Morphine Microdose Method Sensory Changes

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ClinicalTrials.gov Identifier: NCT03395275
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

Study Description
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Brief Summary:
Following the retrospective study ont he effectiveness of the microdose method of IT 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 IT 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.

Condition or disease Intervention/treatment Phase
Analgesic Drug Dependence Sensory Disorders Chronic Pain Behavioral: Quantitative Sensory Tests Behavioral: PROMIS surveys Not Applicable

Detailed Description:

The use of intrathecal (IT) 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 (UTMB) 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Study Start Date : October 8, 2018
Estimated Primary Completion Date : October 8, 2019
Estimated Study Completion Date : January 8, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intrathecal Pump Therapy Participants
Patients eligible for intrathecal pump therapy will undergo quantitative sensory tests and PROMIS surveys during various stages of the treatment process.
 Behavioral: Quantitative Sensory Tests

Three testing modalities will be utilized for this study:

  1. Hot threshold test: The hot threshold method we will be utilizing has been described in the literature with good reproducibility and reliability. [Dyck 1996] We will be using a similar system and have reproduced the program using a non-invasive device.
  2. Cold threshold test: the same non-invasive device will be used to test cold detection and pain threshold levels. This method is previously described. [Wright 2017]
  3. Pressure threshold: Mechanical testing (pressure pain threshold) will be assessed utilizing an algometer. We have used this method in a previous study and published results. [Wilkes 2017]

Behavioral: PROMIS surveys
PROMIS surveys including anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance, self-efficacy, satisfaction roles


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. PROMIS surveys - Anxiety [ Time Frame: 2 years ]
    PROMIS (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.

  11. PROMIS surveys - Depression [ Time Frame: 2 years ]
    PROMIS (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.

  12. PROMIS surveys - Pain Behavior [ Time Frame: 2 years ]
    PROMIS (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.

  13. PROMIS surveys - Fatigue [ Time Frame: 2 years ]
    PROMIS (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.

  14. PROMIS surveys - Pain Interference [ Time Frame: 2 years ]
    PROMIS (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.

  15. PROMIS surveys - Physical Function [ Time Frame: 2 years ]
    PROMIS (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.

  16. PROMIS surveys - Sleep Disturbance [ Time Frame: 2 years ]
    PROMIS (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.


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Age between 18 and 75
  • Selected for microdose IT 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 IT therapy and/or with multiple IT drugs (such as other opioids, local anesthetics, muscle relaxants)
  • Medical conditions (myocardial infarction within the last year, uncontrolled diabetes with a hemoglobin A1C of greater than 10, autoimmune disease
  • Recent history of alcohol or substance abuse in the last 5 years
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Denise M Wilkes, MD 409-772-1221 dwilkes@utmb.edu
Contact: Andrew M Khoury, MD amkhoury@utmb.edu

Locations
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   
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Principal Investigator: Denise M Wilkes, MD Associate Professor
More Information
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Publications:

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03395275     History of Changes
Other Study ID Numbers: 17-0245
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: January 2018
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

Additional relevant MeSH terms:
Chronic Pain
Substance-Related Disorders
Sensation Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders
 Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents