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

NCT03375216 | Completed

• 1 other identifier: 17-0195
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesic Drug Dependence; Sensory Deficit

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• PROMIS surveys

  2 years

Study Arms (5)

taper

ACTIVE COMPARATOR

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); Behavioral: Promis Survey

non taper systemic <90

PLACEBO COMPARATOR

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

Behavioral: sensory testing (Heat, cold, and pressure); Behavioral: Promis Survey

non taper systemic >90

PLACEBO COMPARATOR

participants on systemic opioids \> 90 MEDD and no taper

Behavioral: sensory testing (Heat, cold, and pressure); Behavioral: Promis Survey

non taper intrathecal

PLACEBO COMPARATOR

Participants on intrathecal therapy and no taper

Behavioral: sensory testing (Heat, cold, and pressure); Behavioral: Promis Survey

non opioids

SHAM COMPARATOR

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

Behavioral: sensory testing (Heat, cold, and pressure); Behavioral: Promis Survey

Interventions

sensory testing (Heat, cold, and pressure) BEHAVIORAL

sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure

non opioids; non taper intrathecal; non taper systemic <90; non taper systemic >90; taper

Promis Survey BEHAVIORAL

PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy

non opioids; non taper intrathecal; non taper systemic <90; non taper systemic >90; taper

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (15)

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  PMID: 21029354 RESULT

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  PMID: 25437498 RESULT

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  PMID: 21412369 RESULT

• 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.

  PMID: 27993558 RESULT

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  PMID: 16229972 RESULT

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  PMID: 22570562 RESULT

• 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.

  PMID: 27908840 RESULT

• 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.

  PMID: 23340535 RESULT

• 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.

  PMID: 26469365 RESULT

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  PMID: 26685018 RESULT

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  PMID: 28402092 RESULT

• 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.

  PMID: 27898461 RESULT

Related Links

• MMWR Recomm Rep 2016

MeSH Terms

Interventions

Hot Temperature; Cold Temperature; Pressure

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Mechanical Phenomena

Study Officials

• Denise Wilkes, MD-PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 15, 2017
• Study Start: December 22, 2017
• Primary Completion: November 18, 2023
• Study Completion: November 18, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)