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

Primary Purpose

Analgesic Drug Dependence, Sensory Deficit

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
sensory testing (Heat, cold, and pressure)
Promis Survey
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Analgesic Drug Dependence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Placebo Comparator

Placebo Comparator

Sham Comparator

Arm Label

taper

non taper systemic <90

non taper systemic >90

non taper intrathecal

non opioids

Arm Description

participants undergoing a taper as directed by their pain physician. Interventions include sensory testing ( heat, cold, and pressure) and PROMIS surveys.

participants on systemic opioids < 90 MEDD (morphine equivalent daily dose) and no taper

participants on systemic opioids > 90 MEDD and no taper

Participants on intrathecal therapy and no taper

Participants on non-opioid therapy will undergo behavioral tests and PROMIS surveys

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

PROMIS surveys
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.

Full Information

First Posted
December 5, 2017
Last Updated
March 3, 2023
Sponsor
The University of Texas Medical Branch, Galveston
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1. Study Identification

Unique Protocol Identification Number
NCT03375216
Brief Title
Quantitative Sensory Testing in Chronic Pain Patients Undergoing Opioid Treatment and Opioid Tapering
Official Title
Quantitative Sensory Testing in Chronic Pain Patients Undergoing Opioid Treatment and Opioid Tapering
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
December 18, 2025 (Anticipated)
Study Completion Date
December 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesic Drug Dependence, Sensory Deficit

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
taper
Arm Type
Active Comparator
Arm Description
participants undergoing a taper as directed by their pain physician. Interventions include sensory testing ( heat, cold, and pressure) and PROMIS surveys.
Arm Title
non taper systemic <90
Arm Type
Placebo Comparator
Arm Description
participants on systemic opioids < 90 MEDD (morphine equivalent daily dose) and no taper
Arm Title
non taper systemic >90
Arm Type
Placebo Comparator
Arm Description
participants on systemic opioids > 90 MEDD and no taper
Arm Title
non taper intrathecal
Arm Type
Placebo Comparator
Arm Description
Participants on intrathecal therapy and no taper
Arm Title
non opioids
Arm Type
Sham Comparator
Arm Description
Participants on non-opioid therapy will undergo behavioral tests and PROMIS surveys
Intervention Type
Behavioral
Intervention Name(s)
sensory testing (Heat, cold, and pressure)
Intervention Description
sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
Intervention Type
Behavioral
Intervention Name(s)
Promis Survey
Intervention Description
PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy
Primary Outcome Measure Information:
Title
Heat threshold measurements
Description
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.
Time Frame
2 years
Title
Cold threshold measurements
Description
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.
Time Frame
2 years
Title
Pressure threshold measurements
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PROMIS surveys
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Wilkes, MD-PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan
Citations:
PubMed Identifier
22704854
Citation
Chu LF, D'Arcy N, Brady C, Zamora AK, Young CA, Kim JE, Clemenson AM, Angst MS, Clark DJ. Analgesic tolerance without demonstrable opioid-induced hyperalgesia: a double-blinded, randomized, placebo-controlled trial of sustained-release morphine for treatment of chronic nonradicular low-back pain. Pain. 2012 Aug;153(8):1583-1592. doi: 10.1016/j.pain.2012.02.028. Epub 2012 Jun 16.
Results Reference
result
PubMed Identifier
18989788
Citation
Dumas EO, Pollack GM. Opioid tolerance development: a pharmacokinetic/pharmacodynamic perspective. AAPS J. 2008 Dec;10(4):537-51. doi: 10.1208/s12248-008-9056-1. Epub 2008 Nov 7.
Results Reference
result
PubMed Identifier
8815179
Citation
Dyck PJ, Zimmerman IR, Johnson DM, Gillen D, Hokanson JL, Karnes JL, Gruener G, O'Brien PC. A standard test of heat-pain responses using CASE IV. J Neurol Sci. 1996 Mar;136(1-2):54-63. doi: 10.1016/0022-510x(95)00277-9.
Results Reference
result
PubMed Identifier
21029354
Citation
Hooten WM, Mantilla CB, Sandroni P, Townsend CO. Associations between heat pain perception and opioid dose among patients with chronic pain undergoing opioid tapering. Pain Med. 2010 Nov;11(11):1587-98. doi: 10.1111/j.1526-4637.2010.00962.x. Epub 2010 Oct 1.
Results Reference
result
PubMed Identifier
25437498
Citation
Katz NP, Paillard FC, Edwards RR. Review of the performance of quantitative sensory testing methods to detect hyperalgesia in chronic pain patients on long-term opioids. Anesthesiology. 2015 Mar;122(3):677-85. doi: 10.1097/ALN.0000000000000530.
Results Reference
result
PubMed Identifier
21412369
Citation
Lee M, Silverman SM, Hansen H, Patel VB, Manchikanti L. A comprehensive review of opioid-induced hyperalgesia. Pain Physician. 2011 Mar-Apr;14(2):145-61.
Results Reference
result
PubMed Identifier
27993558
Citation
Morasco BJ, Yarborough BJ, Smith NX, Dobscha SK, Deyo RA, Perrin NA, Green CA. Higher Prescription Opioid Dose is Associated With Worse Patient-Reported Pain Outcomes and More Health Care Utilization. J Pain. 2017 Apr;18(4):437-445. doi: 10.1016/j.jpain.2016.12.004. Epub 2016 Dec 18.
Results Reference
result
PubMed Identifier
16229972
Citation
Pud D, Cohen D, Lawental E, Eisenberg E. Opioids and abnormal pain perception: New evidence from a study of chronic opioid addicts and healthy subjects. Drug Alcohol Depend. 2006 May 20;82(3):218-23. doi: 10.1016/j.drugalcdep.2005.09.007. Epub 2005 Oct 17.
Results Reference
result
PubMed Identifier
22570562
Citation
Krishnan S, Salter A, Sullivan T, Gentgall M, White J, Rolan P. Comparison of pain models to detect opioid-induced hyperalgesia. J Pain Res. 2012;5:99-106. doi: 10.2147/JPR.S27738. Epub 2012 Apr 27.
Results Reference
result
PubMed Identifier
27908840
Citation
Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28.
Results Reference
result
PubMed Identifier
23340535
Citation
Suzan E, Eisenberg E, Treister R, Haddad M, Pud D. A negative correlation between hyperalgesia and analgesia in patients with chronic radicular pain: is hydromorphone therapy a double-edged sword? Pain Physician. 2013 Jan;16(1):65-76.
Results Reference
result
PubMed Identifier
26469365
Citation
Wasserman RA, Hassett AL, Harte SE, Goesling J, Malinoff HL, Berland DW, Zollars J, Moser SE, Brummett CM. Pressure Pain Sensitivity in Patients With Suspected Opioid-Induced Hyperalgesia. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):687-93. doi: 10.1097/AAP.0000000000000315.
Results Reference
result
PubMed Identifier
26685018
Citation
Weimer MB, Hartung DM, Ahmed S, Nicolaidis C. A chronic opioid therapy dose reduction policy in primary care. Subst Abus. 2016;37(1):141-7. doi: 10.1080/08897077.2015.1129526.
Results Reference
result
PubMed Identifier
28402092
Citation
Wilkes D, Martinello C, Medeiros FA, Babazade R, Hurwitz E, Khanjee N, Iyer PS, Leary P, Vadhera RB. Ultrasound-determined landmarks decrease pressure pain at epidural insertion site in immediate post-partum period. Minerva Anestesiol. 2017 Oct;83(10):1034-1041. doi: 10.23736/S0375-9393.17.11782-7. Epub 2017 Apr 11.
Results Reference
result
PubMed Identifier
27898461
Citation
Wright A, Benson HAE, Will R, Moss P. Cold Pain Threshold Identifies a Subgroup of Individuals With Knee Osteoarthritis That Present With Multimodality Hyperalgesia and Elevated Pain Levels. Clin J Pain. 2017 Sep;33(9):793-803. doi: 10.1097/AJP.0000000000000458.
Results Reference
result
Links:
URL
http://dx.doi.org/10.15585/mmwr.rr6501e1
Description
MMWR Recomm Rep 2016
URL
http://www.hhs.gov/sites/default/files/Factsheet-opioids-061516.pdf
Description
the opioid epidemic by numbers

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

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