Chronic Pain Clinical Trial
Official title:
Intrathecal Morphine Microdose Method Sensory Changes: A Pilot Study
Verified date | March 2023 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 3, 2023 |
Est. primary completion date | February 3, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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The University of Texas Medical Branch, Galveston |
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Heat threshold measurements | 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 | |
Primary | Cold threshold measurements | 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 | |
Primary | Pressure threshold measurements | 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 | Demographic Evaluation - Pain History | 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 | |
Secondary | Demographic Evaluation - Medical History | 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 | |
Secondary | Demographic Evaluation - Body Mass Index | 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 | |
Secondary | Demographic Evaluation - Gender | To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will collect data on gender. | 2 years | |
Secondary | Demographic Evaluation - Surgical History | 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 | |
Secondary | Demographic Evaluation - Age | To describe the patient population and to evaluate patient factors, which predict successful trials. The investigators will collect data on patient age. | 2 years | |
Secondary | Demographic Evaluation - Social History | 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 | |
Secondary | Demographic Evaluation - Urine Drug Tests | 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 | |
Secondary | Demographic Evaluation - Numeric Pain Scale Scores | 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 | |
Secondary | surveys - Anxiety | 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 | |
Secondary | surveys - Depression | 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 | |
Secondary | surveys - Pain Behavior | 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 | |
Secondary | surveys - Fatigue | 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 | |
Secondary | surveys - Pain Interference | 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 | |
Secondary | surveys - Physical Function | 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 | |
Secondary | surveys - Sleep Disturbance | 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 |
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