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Quantitative Sensory Testing in Chronic Pain Patients Undergoing Opioid Treatment and Opioid Tapering

This study is currently recruiting participants.
Verified December 2017 by Denise Wilkes, The University of Texas Medical Branch, Galveston
Sponsor:
ClinicalTrials.gov Identifier:
NCT03375216
First Posted: December 15, 2017
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Denise Wilkes, The University of Texas Medical Branch, Galveston
  Purpose
Few studies have used quantitative sensory tests to study the effect of chronic opioid treatment on sensation. The investigators will test chronic pain patients who are on different MEDDs, normal volunteers, and patients undergoing an opioid taper. This will be the first study to perform sensory testing on patients while undergoing an opioid taper on an outpatient basis.

Condition Intervention
Analgesic Drug Dependence Sensory Deficit Behavioral: sensory testing (Heat, cold, and pressure) Behavioral: Promis Survey

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Sensory Testing in Chronic Pain Patients Undergoing Opioid Treatment and Opioid Tapering

Resource links provided by NLM:


Further study details as provided by Denise Wilkes, The University of Texas Medical Branch, Galveston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • PROMIS surveys [ Time Frame: 2 years ]
    PROMIS (Patient-Reported Outcomes Measurement Information System) surveys will be administered at the subject's initial, halfway and end of their evaluations. These measures include topics on anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance. The results from the surveys will be aggregated and compared to other participants' responses.


Estimated Enrollment: 90
Anticipated Study Start Date: December 18, 2017
Estimated Study Completion Date: December 18, 2020
Estimated Primary Completion Date: December 18, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: taper
participants undergoing a taper as directed by their pain physician. Interventions include sensory testing ( heat, cold, and pressure) and PROMIS surveys.
Behavioral: sensory testing (Heat, cold, and pressure)
sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
Behavioral: Promis Survey
PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy
Placebo Comparator: non taper systemic <90
participants on systemic opioids < 90 MEDD (morphine equivalent daily dose) and no taper
Behavioral: sensory testing (Heat, cold, and pressure)
sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
Behavioral: Promis Survey
PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy
Placebo Comparator: non taper systemic >90
participants on systemic opioids > 90 MEDD and no taper
Behavioral: sensory testing (Heat, cold, and pressure)
sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
Behavioral: Promis Survey
PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy
Placebo Comparator: non taper intrathecal
Participants on intrathecal therapy and no taper
Behavioral: sensory testing (Heat, cold, and pressure)
sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
Behavioral: Promis Survey
PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy
Sham Comparator: non opioids
Participants on non-opioid therapy will undergo behavioral tests and PROMIS surveys
Behavioral: sensory testing (Heat, cold, and pressure)
sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
Behavioral: Promis Survey
PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy

Detailed Description:

Death from drug overdoses reached a record high in 2014, with the majority involving an opioid. The United States government has labeled this an epidemic due to the progressive rise in opioid-involved deaths. In 2015, the Centers for Disease Control and Prevention determined that, on average, 650,000 opioid prescriptions are dispensed daily in the United States alone. It is well-documented and observed in clinical practice that patients on chronic opioid therapy will commonly require an escalation in opioid dose over time to maintain analgesia. The consequence of such escalations is the development of tolerance to opioids, along with other known adverse effects of opioids including respiratory depression, constipation, and potential for addiction. The drastic increase in opioid doses over the years has urged the CDC to release a report for primary care clinicians treating patients with chronic pain. This report provides a risk assessment and recommendations for prescribing opioids for non-cancer chronic pain. The guidelines state that careful reassessment of individual benefits must be considered when increasing doses to ≥50 morphine milligram equivalents (MME)/day, and that increases to ≥90 MME/day must be avoided, with recommendations for consultation with a specialist. Avoiding high opioid doses will also minimize the development of opioid-induced hyperalgesia, which is a paradoxical response to increases in opioid doses; these patients become increasingly sensitized to painful stimuli. While the precise mechanism of this condition remains to be elucidated, treatment includes reducing and tapering opioids. Interestingly, an article on patient-reported outcomes surveyed a group of 517 patients that revealed the higher opioid dose group to have greater pain intensity, poorer self-efficacy for managing pain, and more impairment in functioning and quality of life.

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 was performed to identify 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 is unique in that research pertaining to changes in pain sensitivity on patients following an opioid taper is lacking. Little is known at this juncture how pain thresholds change to opioid dose reductions and following completion of a taper.

The purpose of the study is to objectively measure pain threshold levels in patients without opioids, low dose opioids, high dose opioids and patients undergoing a taper from long-term opioid therapy. This study utilizes taper techniques that are commonly employed in a pain medicine practice. The innovation involves use of quantitative measures of sensitivity to evaluate patients on differing opioid doses and undergoing current taper practices.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient age between 18 and 75
  • History of chronic pain for at least 3 months
  • Patients may have been selected for opioid taper by their pain physicians.
  • Patients may or may not be on opioid therapy.
  • They must have the ability to understand the protocol and provide voluntary, written, informed consent.

Exclusion Criteria:

  • Cancer pain
  • Unstable medical conditions (including but not limited to history of myocardial infarction within the past year, autoimmune diseases, uncontrolled diabetes with hemoglobin A1C of greater than 10)
  • Pregnancy
  • Inability to adequately answer surveys
  • History of substance abuse within 5 years
  • Surgery within the past month
  • Surgery planned during the next six months
  • Use of systemic steroids.
  Contacts and Locations
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): NCT03375216


Contacts
Contact: Denise Wilkes, MD-PhD 409-772-1221 dwilkes@utmb.edu
Contact: Meredith Hamilton 409-772-1221 melhamil@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 Wilkes, MD-PhD University of Texas
  More Information

Additional Information:
Publications:

Responsible Party: Denise Wilkes, Associate Professor, The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03375216     History of Changes
Other Study ID Numbers: 17-0195
First Submitted: December 5, 2017
First Posted: December 15, 2017
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan

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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents