Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2018-10-08
2023-02-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Intrathecal Pump Therapy Participants
Patients eligible for intrathecal pump therapy will undergo quantitative sensory tests and surveys during various stages of the treatment process.
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.
surveys
surveys including anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance, self-efficacy, satisfaction roles
Interventions
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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.
surveys
surveys including anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance, self-efficacy, satisfaction roles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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The University of Texas Medical Branch, Galveston
OTHER
Responsible Party
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Principal Investigators
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Denise M Wilkes, MD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
References
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Wallace M, Yaksh TL. Long-term spinal analgesic delivery: a review of the preclinical and clinical literature. Reg Anesth Pain Med. 2000 Mar-Apr;25(2):117-57. doi: 10.1053/rapm.2000.0250117. No abstract available.
Wilkes DM, Orillosa SJ, Hustak EC, Williams CG, Doulatram GR, Solanki DR, Garcia EA, Huang LM. Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics. Pain Med. 2018 Sep 1;19(9):1782-1789. doi: 10.1093/pm/pnx132.
Hamza M, Doleys D, Wells M, Weisbein J, Hoff J, Martin M, Soteropoulos C, Barreto J, Deschner S, Ketchum J. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.
Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug;14(4):343-51.
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.
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.
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.
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.
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.
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.
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.
Wasserman RA, Hassett AL, Harte SE, Goesling J, Malinoff HL, Berland DW, Zollars J, Moser SE, Brummett CM. Pressure sensitivity and phenotypic changes in patients with suspected opioid-induced hyperalgesia being withdrawn from full mu agonists. J Nat Sci. 2017 Feb;3(2):e319.
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.
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.
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.
Other Identifiers
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17-0245
Identifier Type: -
Identifier Source: org_study_id
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