Precise management system for chronic intractable pain patients implanted with spinal cord stimulation based on a remote programming platform: study protocol for a randomized controlled trial (PreMaSy study).
Chronic intractable pain
Mobile health
Precision medicine
Randomized controlled trial
Remote programming
Spinal cord stimulation
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Sep 2023
11 Sep 2023
Historique:
received:
12
04
2023
accepted:
18
08
2023
medline:
12
9
2023
pubmed:
11
9
2023
entrez:
10
9
2023
Statut:
epublish
Résumé
Spinal cord stimulation (SCS) is a surgical technique used in patients with chronic intractable pain, and its effectiveness and safety have been validated by multiple studies. However, to maintain an optimal and steady long-term effect is still challenging. Here, we report a new management paradigm integrating smartphone application and remote programming. Chronic pain patients with SCS implants can monitor their pain status on the phone and change stimulation parameters accordingly. The PreMaSy study is a randomized controlled trial to evaluate the clinical effectiveness and safety of this precise management system. Patients with chronic intractable pain will be screened for eligibility, and 82 participants are anticipated to be enrolled in this trial. After the electrode implantation, the stimulation effectiveness will be tested. Participants with a reduction of more than 50% in the visual analog scale (VAS) will receive implantation of an implantable pulse generator and randomized (1:1) into the experimental group or control group. All participants will be asked to take online follow-ups and complete assessments using a smartphone application. Daily pain characteristic assessments and monthly quality of life questionnaires are integrated into the App, and participants will be required to complete these assessments. The daily VAS for pain intensity will be monitored and a threshold will be set based on baseline VAS score. The interventional appointment will be scheduled once the threshold is reached. The primary outcome is the health condition and quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). Utility values of EQ-5D-5L will be assessed at baseline and 1, 3, and 6 months post-operative. The PreMaSy study aims to evaluate the effectiveness and safety of a novel App-based, patient-centered, self-assessment management system for chronic intractable pain. A randomized controlled trial is designed to test the non-inferiority of this precise management system compared to the monthly online follow-ups. It is also expected to yield valuable experiences regarding precision medicine. ClinicalTrials.gov NCT05761392. Registered on March 07, 2023.
Sections du résumé
BACKGROUND
BACKGROUND
Spinal cord stimulation (SCS) is a surgical technique used in patients with chronic intractable pain, and its effectiveness and safety have been validated by multiple studies. However, to maintain an optimal and steady long-term effect is still challenging. Here, we report a new management paradigm integrating smartphone application and remote programming. Chronic pain patients with SCS implants can monitor their pain status on the phone and change stimulation parameters accordingly. The PreMaSy study is a randomized controlled trial to evaluate the clinical effectiveness and safety of this precise management system.
METHODS
METHODS
Patients with chronic intractable pain will be screened for eligibility, and 82 participants are anticipated to be enrolled in this trial. After the electrode implantation, the stimulation effectiveness will be tested. Participants with a reduction of more than 50% in the visual analog scale (VAS) will receive implantation of an implantable pulse generator and randomized (1:1) into the experimental group or control group. All participants will be asked to take online follow-ups and complete assessments using a smartphone application. Daily pain characteristic assessments and monthly quality of life questionnaires are integrated into the App, and participants will be required to complete these assessments. The daily VAS for pain intensity will be monitored and a threshold will be set based on baseline VAS score. The interventional appointment will be scheduled once the threshold is reached. The primary outcome is the health condition and quality of life assessed by the five-level EuroQol five-dimensional questionnaire (EQ-5D-5L). Utility values of EQ-5D-5L will be assessed at baseline and 1, 3, and 6 months post-operative.
DISCUSSION
CONCLUSIONS
The PreMaSy study aims to evaluate the effectiveness and safety of a novel App-based, patient-centered, self-assessment management system for chronic intractable pain. A randomized controlled trial is designed to test the non-inferiority of this precise management system compared to the monthly online follow-ups. It is also expected to yield valuable experiences regarding precision medicine.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT05761392. Registered on March 07, 2023.
Identifiants
pubmed: 37691092
doi: 10.1186/s13063-023-07595-4
pii: 10.1186/s13063-023-07595-4
pmc: PMC10494385
doi:
Banques de données
ClinicalTrials.gov
['NCT05761392']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
580Subventions
Organisme : Beijing Nova Program
ID : Z211100002121050
Organisme : Beijing Nova Program
ID : 20220484216
Organisme : Tsinghua University
ID : LC201906
Informations de copyright
© 2023. BioMed Central Ltd., part of Springer Nature.
Références
Sci Data. 2016 Mar 03;3:160011
pubmed: 26938265
Neuromodulation. 2021 Apr;24(3):441-447
pubmed: 33751731
Neuromodulation. 2021 Apr;24(3):556-565
pubmed: 33296127
JMIR Cancer. 2022 Jan 17;8(1):e29485
pubmed: 35037883
Pain Res Manag. 2011 Sep-Oct;16(5):337-51
pubmed: 22059206
Nat Biotechnol. 2017 Apr;35(4):354-362
pubmed: 28288104
Neurosurgery. 2007 Aug;61(2):361-8; discussion 368-9
pubmed: 17762749
Trials. 2020 Oct 7;21(1):834
pubmed: 33028415
Front Neurosci. 2020 Dec 08;14:594696
pubmed: 33363453
J Pain Res. 2016 Jun 28;9:457-67
pubmed: 27418853
Neuromodulation. 2021 Jan;24(1):3-12
pubmed: 32881257
Lancet Neurol. 2020 Feb;19(2):123-134
pubmed: 31870766
Psychiatry Res. 1989 May;28(2):193-213
pubmed: 2748771
Neurosurgery. 2013 Jan;72(1):99-108; discussion 108
pubmed: 23096417
Eur J Pain. 2019 Jul;23(6):1117-1128
pubmed: 30793414
J Clin Med. 2021 Sep 10;10(18):
pubmed: 34575196
Biomed Eng Online. 2011 Apr 05;10:24
pubmed: 21466669
Emerg Med J. 2001 May;18(3):205-7
pubmed: 11354213
JMIR Form Res. 2022 Mar 2;6(3):e30052
pubmed: 35234654
Pain. 2015 Aug;156(8):1382-1395
pubmed: 25985142
Value Health. 2017 Apr;20(4):662-669
pubmed: 28408009
Biomedicines. 2021 Jun 04;9(6):
pubmed: 34200097
J Med Internet Res. 2022 May 11;24(5):e36114
pubmed: 35373776
J Telemed Telecare. 2011;17(6):308-12
pubmed: 21844177
Spine (Phila Pa 1976). 2005 Jan 1;30(1):152-60
pubmed: 15626996
Qual Life Res. 2011 Dec;20(10):1727-36
pubmed: 21479777
Pain. 2017 Apr;158(4):669-681
pubmed: 28030470
Popul Health Metr. 2022 Nov 4;20(1):20
pubmed: 36333770
Anesth Analg. 1967 Jul-Aug;46(4):489-91
pubmed: 4952225
JAMA Neurol. 2021 Jun 1;78(6):687-698
pubmed: 33818600
Pain. 2017 May;158(5):771-774
pubmed: 28106667
N Engl J Med. 2020 Jun 4;382(23):e82
pubmed: 32240581
Appl Ergon. 2021 Nov;97:103521
pubmed: 34214756
Neuromodulation. 2016 Jun;19(4):398-405
pubmed: 27139915
Trials. 2020 Jan 15;21(1):87
pubmed: 31941531
Health Technol Assess. 2009 Mar;13(17):iii, ix-x, 1-154
pubmed: 19331797
Neuromodulation. 2014 Aug;17(6):599-615; discussion 615
pubmed: 25112892
Psychiatry (Edgmont). 2007 Jul;4(7):28-37
pubmed: 20526405
J Telemed Telecare. 2005;11(1):3-9
pubmed: 15829036
Neuromodulation. 2022 Oct;25(7):947-955
pubmed: 35690508
Pediatrics. 2004 Jan;113(1 Pt 1):1-6
pubmed: 14702439
Neuromodulation. 2021 Jan;24(1):142-149
pubmed: 32940398
Libyan J Med. 2020 Dec;15(1):1730550
pubmed: 32066339
Neurosurgery. 2005;56(1):98-106; discussion 106-7
pubmed: 15617591
SAGE Open Med. 2020 Aug 20;8:2050312120951369
pubmed: 32913650
Neurosurgery. 2016 Nov;79(5):667-677
pubmed: 27584814
J Clin Med. 2021 May 25;10(11):
pubmed: 34070601
J Pain. 2012 Aug;13(8):715-24
pubmed: 22607834
CNS Neurosci Ther. 2020 Apr;26(4):403-415
pubmed: 32087613
MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006
pubmed: 30212442
Neuromodulation. 2018 Jan;21(1):56-66
pubmed: 28961366
Am J Med. 2017 Dec;130(12):1388-1396.e6
pubmed: 28847546
Neurosurgery. 2008 Oct;63(4):762-70; discussion 770
pubmed: 18981888