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Patient Satisfaction Following Intrathecal Targeted Drug Delivery for Benign Chronic Pain: Results of a Single-Center Survey Study.

ABSTRACT: OBJECTIVES:Targeted Drug Delivery (TDD) is commonly used for the management of patients with intractable pain. Past studies have proven efficacy in pain relief and reduction in opioid use and cost-effectiveness in long-term pain management. There are few studies investigating satisfaction among patients with implanted pain pumps that are managed with targeted intrathecal medications. MATERIAL AND METHODS:Patients in a single medical practice implanted with pain pumps for relief of intractable pain were identified and extracted from the electronic health record (EHR). Six hundred and ten active TDD patients were identified and an anonymous 18-question survey was administered to determine satisfaction with TDD therapy. During an 18-month period from May 2018 to August 2019, patients were invited to take a satisfaction survey. Both primary and secondary outcomes were reported as proportions; P

SUBMITTER: Schultz DM

PROVIDER: S-EPMC7687151 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Patient Satisfaction Following Intrathecal Targeted Drug Delivery for Benign Chronic Pain: Results of a Single-Center Survey Study.

Schultz David M DM Orhurhu Vwaire V Khan Faizan F Hagedorn Jonathan M JM Abd-Elsayed Alaa A

Neuromodulation : journal of the International Neuromodulation Society 20200506 7

<h4>Objectives</h4>Targeted Drug Delivery (TDD) is commonly used for the management of patients with intractable pain. Past studies have proven efficacy in pain relief and reduction in opioid use and cost-effectiveness in long-term pain management. There are few studies investigating satisfaction among patients with implanted pain pumps that are managed with targeted intrathecal medications.<h4>Material and methods</h4>Patients in a single medical practice implanted with pain pumps for relief of ...[more]

PMID: 32378289

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Project description:Resiniferatoxin (RTX) is a potent agonist of TRPV1, which possesses unique properties that can be utilized to treat certain modalities of pain. In the present study, systemic intraperitoneal (i.p.) administration of RTX resulted in a significant decrease in acute thermal pain sensitivity, whereas localized intrathecal (i.t.) administration had no effect on acute thermal pain sensitivity. Both i.p. and i.t. administration of RTX prevented TRPV1-induced nocifensive behavior and inflammatory thermal hypersensitivity. There were no alterations in mechanical sensitivity either by i.p. or i.t. administration of RTX. In spinal dorsal horn (L4-L6), TRPV1 and substance P immunoreactivity were abolished following i.p. and i.t. administration of RTX. In dorsal root ganglia (DRG), TRPV1 immunoreactivity was diminished following i.p. administration, but was unaffected following i.t. administration of RTX. Following i.p. administration, basal and evoked calcitonin gene-related peptide release were reduced both in the spinal cord and peripheral tissues. However, following i.t. administration, basal and evoked calcitonin gene-related peptide release were reduced in spinal cord (L4-L6), but were unaffected in peripheral tissues. Both i.p. and i.t. RTX administration lowered the body temperature acutely, but this effect reversed with time. Targeting TRPV1-expressing nerve terminals at the spinal cord can selectively abolish inflammatory thermal hypersensitivity without affecting acute thermal sensitivity and can preserve the efferent functions of DRG neurons at the peripheral nerve terminals. I.t. administration of RTX can be considered as a strategy for treating certain chronic and debilitating pain conditions.Localized administration of RTX in spinal cord could be a useful strategy to treat chronic debilitating pain arising from certain conditions such as cancer and at the same time could maintain normal physiological peripheral efferent functions mediated by TRPV1.

Project description:BACKGROUND:The safety and efficacy of intrathecal drug delivery systems (IDDSs) for the treatment of cancer-related pain have been demonstrated in randomized controlled clinical trials (RCTs). Despite positive evidence for this therapy, IDDS remains underutilized to treat cancer pain. Real-world registry data augment existing safety and effectiveness data and are presented here to broaden awareness of this therapeutic option, needed for adequate cancer-related pain treatment, and as a viable tool addressing concerns with systemic opioid use. METHODS:This prospective, long-term, multicenter (United States, Western Europe, and Latin America) registry started in 2003 to monitor the performance of SynchroMed Infusion Systems. Patient-reported outcomes were added in 2013. Before data acquisition, all sites obtained Ethics Committee/Institutional Review Board approval and written patient consent. The study was registered (NCT01524276 at clinicaltrials.gov) before patients were enrolled. Patients who provided informed consent were enrolled in the registry at initial IDDS implant or replacement. RESULTS:Through July 2017, 1403 patients with cancer pain were enrolled and implanted. The average (minimum/maximum) age of patients was 59 years (13/93 years), with 56.6% female. The most frequent cancer types were lung, breast, colon/rectal, pancreatic, and prostate. The majority of patients whose registry follow-up ended (87%; 1141/1311) were followed through death, with 4.3% (n = 57) exiting due to device explant or therapy discontinuation; the remaining 113 (8.6%) discontinued for reasons such as transfer of care, lost to follow-up, and site closure. Pain scores within the cohort of patients providing baseline and follow-up data improved significantly at 6 (P = .0007; n = 103) and 12 (P = .0026; n = 55) months compared to baseline, with EuroQol with 5 dimensions (EuroQol-5D) scores showing significant improvement at 6 months (P = .0016; n = 41). Infection requiring surgical intervention (IDDS explant, replacement, pocket revision, irrigation and debridement, etc) was reported in 3.2% of patients. CONCLUSIONS:Adequate and improved pain control in patients with cancer, even in advanced stages, with concurrent quality of life maintenance is attainable. Results from this large-scale, multicenter, single-group cohort supplement existing RCT data that support IDDS as a safe and effective therapeutic option with a positive benefit-risk ratio in the treatment of cancer pain.

Dataset Information

Patient Satisfaction Following Intrathecal Targeted Drug Delivery for Benign Chronic Pain: Results of a Single-Center Survey Study.

Publications

Patient Satisfaction Following Intrathecal Targeted Drug Delivery for Benign Chronic Pain: Results of a Single-Center Survey Study.

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