Intrathecal Morphine Microdose Method Sensory Changes

March 3, 2023 updated by: The University of Texas Medical Branch, Galveston

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Galveston, Texas, United States, 77555
        • Recruiting
        • University of Texas Medical Branch
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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. 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.
  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.
Behavioral: surveys
surveys including anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance, self-efficacy, satisfaction roles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Principal Investigator: Denise M Wilkes, MD, Associate Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2018

Primary Completion (Actual)

February 3, 2023

Study Completion (Actual)

February 3, 2023

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-0245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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