Mindfulness-Based Stress Reduction, Cognitive Behavioral Therapy, and Acupuncture in Chronic Low Back Pain: Protocol for Two Linked Randomized Controlled Trials.
chronic low back pain
mind-body therapies
neuroimaging
nonpharmacologic treatments
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
27 Sep 2022
27 Sep 2022
Historique:
received:
10
03
2022
accepted:
06
06
2022
revised:
05
06
2022
entrez:
27
9
2022
pubmed:
28
9
2022
medline:
28
9
2022
Statut:
epublish
Résumé
Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated. In response to these knowledge gaps, the Stanford Center for Low Back Pain-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments. The multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy. Participant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021. This center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments. ClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475. PRR1-10.2196/37823.
Sections du résumé
BACKGROUND
BACKGROUND
Nonpharmacologic mind-body therapies have demonstrated efficacy in low back pain. However, the mechanisms underlying these therapies remain to be fully elucidated.
OBJECTIVE
OBJECTIVE
In response to these knowledge gaps, the Stanford Center for Low Back Pain-a collaborative, National Institutes of Health P01-funded, multidisciplinary research center-was established to investigate the common and distinct biobehavioral mechanisms of three mind-body therapies for chronic low back pain: cognitive behavioral therapy (CBT) that is used to treat pain, mindfulness-based stress reduction (MBSR), and electroacupuncture. Here, we describe the design and implementation of the center structure and the associated randomized controlled trials for characterizing the mechanisms of chronic low back pain treatments.
METHODS
METHODS
The multidisciplinary center is running two randomized controlled trials that share common resources for recruitment, enrollment, study execution, and data acquisition. We expect to recruit over 300 chronic low back pain participants across two projects and across different treatment arms within each project. The first project will examine pain-CBT compared with MBSR and a wait-list control group. The second project will examine real versus sham electroacupuncture. We will use behavioral, psychophysical, physical measure, and neuroimaging techniques to characterize the central pain modulatory and emotion regulatory systems in chronic low back pain at baseline and longitudinally. We will characterize how these interventions impact these systems, characterize the longitudinal treatment effects, and identify predictors of treatment efficacy.
RESULTS
RESULTS
Participant recruitment began on March 17, 2015, and will end in March 2023. Recruitment was halted in March 2020 due to COVID-19 and resumed in December 2021.
CONCLUSIONS
CONCLUSIONS
This center uses a comprehensive approach to study chronic low back pain. Findings are expected to significantly advance our understanding in (1) the baseline and longitudinal mechanisms of chronic low back pain, (2) the common and distinctive mechanisms of three mind-body therapies, and (3) predictors of treatment response, thereby informing future delivery of nonpharmacologic chronic low back pain treatments.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov NCT02503475; https://clinicaltrials.gov/ct2/show/NCT02503475.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
PRR1-10.2196/37823.
Identifiants
pubmed: 36166279
pii: v11i9e37823
doi: 10.2196/37823
pmc: PMC9555327
doi:
Banques de données
ClinicalTrials.gov
['NCT02503475']
Types de publication
Journal Article
Langues
eng
Pagination
e37823Informations de copyright
©Sean Mackey, Gadi Gilam, Beth Darnall, Philippe Goldin, Jiang-Ti Kong, Christine Law, Marissa Heirich, Nicholas Karayannis, Ming-Chih Kao, Lu Tian, Rachel Manber, James Gross. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 27.09.2022.
Références
Lancet. 1998 Aug 1;352(9125):364-5
pubmed: 9717924
Neuroimage Clin. 2014 Jul 23;5:365-76
pubmed: 26958466
J Vis Exp. 2017 Feb 16;(120):
pubmed: 28287532
Psychosom Med. 2002 Jan-Feb;64(1):71-83
pubmed: 11818588
J Biomed Inform. 2009 Apr;42(2):377-81
pubmed: 18929686
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
Neuroimage Clin. 2015 Sep 25;9:430-5
pubmed: 26594625
Cereb Cortex. 2012 Nov;22(11):2692-702
pubmed: 22172578
Cochrane Database Syst Rev. 2012 Nov 14;11:CD007407
pubmed: 23152245
Pain. 2016 Nov;157(11):2434-2444
pubmed: 27257859
Nat Neurosci. 2012 Jul 01;15(8):1117-9
pubmed: 22751038
PLoS One. 2012;7(4):e32960
pubmed: 22496739
Aust J Physiother. 2006;52(2):149
pubmed: 16805041
Pain. 2010 Jun;149(3):435-443
pubmed: 20188472
Pain. 2010 May;149(2):222-228
pubmed: 20236763
J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):340-8
pubmed: 9055514
Cochrane Database Syst Rev. 2015 May 26;(5):CD010664
pubmed: 26006174
Pain. 2012 Jul;153(7):1495-1503
pubmed: 22617632
N Engl J Med. 2010 Jul 29;363(5):454-61
pubmed: 20818865
Nat Neurosci. 2014 Feb;17(2):192-200
pubmed: 24473267
Pain. 2019 Mar;160(3):550-560
pubmed: 30540621
J Pers Soc Psychol. 1988 Jun;54(6):1063-70
pubmed: 3397865
Pain. 2019 Apr;160(4):833-843
pubmed: 30531308
Neuroimage. 2005 Jun;26(2):471-9
pubmed: 15907304
BMC Complement Altern Med. 2012 Sep 25;12:162
pubmed: 23009599
Arthritis Rheum. 2012 Jun;64(6):2028-37
pubmed: 22231424
Rev Saude Publica. 2015;49:
pubmed: 26487293
Pain. 2005 Jan;113(1-2):9-19
pubmed: 15621359
Aust J Physiother. 2008;54(1):77
pubmed: 18567187
Cortex. 2019 Apr;113:255-266
pubmed: 30711854
Trials. 2014 Jun 07;15:211
pubmed: 24906419
JAMA. 2016 Mar 22-29;315(12):1240-9
pubmed: 27002445
Brain Behav. 2016 Feb 16;6(3):e00443
pubmed: 26925304
Arch Phys Med Rehabil. 2001 Feb;82(2):227-31
pubmed: 11239315
J Health Soc Behav. 1983 Dec;24(4):385-96
pubmed: 6668417
J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86
pubmed: 11132119
Ann Intern Med. 2017 Apr 04;166(7):493-505
pubmed: 28192793
Science. 2004 Feb 20;303(5661):1162-7
pubmed: 14976306
J Neurosci. 2006 Nov 22;26(47):12165-73
pubmed: 17122041
Lancet. 2017 Sep 16;390(10100):1211-1259
pubmed: 28919117
Behav Ther. 2011 Dec;42(4):726-39
pubmed: 22036000
Pain. 2011 Feb;152(2):361-369
pubmed: 21146930
J Pers Assess. 1985 Feb;49(1):71-5
pubmed: 16367493
Neuroimage Clin. 2019;24:102042
pubmed: 31670070
Nat Rev Neurosci. 2013 Jul;14(7):502-11
pubmed: 23719569
Curr Opin Neurol. 2013 Aug;26(4):360-7
pubmed: 23823463
Pain. 2016 Sep;157(9):1970-1978
pubmed: 27168362
J Pain. 2018 Aug;19(8):837-851
pubmed: 29578089
Health Psychol. 2007 Jan;26(1):1-9
pubmed: 17209691
Clin J Pain. 2004 Jan-Feb;20(1):27-32
pubmed: 14668653
J Psychosom Res. 2003 Sep;55(3):269-75
pubmed: 12932802
Assessment. 2006 Mar;13(1):27-45
pubmed: 16443717
J Pain. 2014 Jun;15(6):569-85
pubmed: 24787228
Pain. 2007 Feb;127(3):276-286
pubmed: 17071000
Am Psychol. 2014 Feb-Mar;69(2):119-30
pubmed: 24547798
Eur J Pain. 2017 May;21(5):769-786
pubmed: 28146315
Pain. 2019 Jun;160(6):1308-1318
pubmed: 31107712
Spine J. 2008 Jan-Feb;8(1):40-4
pubmed: 18164452
J Pers Soc Psychol. 2007 Apr;92(4):731-44
pubmed: 17469955
Asian J Psychiatr. 2018 Feb;32:79-83
pubmed: 29220782
Clin J Pain. 2010 Jan;26(1):60-9
pubmed: 20026956
Soc Cogn Affect Neurosci. 2013 Aug;8(6):609-16
pubmed: 22446299
Emotion. 2010 Feb;10(1):83-91
pubmed: 20141305
PLoS Biol. 2015 Jan 06;13(1):e1002036
pubmed: 25562688
Ann Intern Med. 2017 Apr 4;166(7):514-530
pubmed: 28192789
J Pers Soc Psychol. 1991 Jul;61(1):115-21
pubmed: 1890582
JAMA. 2008 Feb 13;299(6):656-64
pubmed: 18270354
Arch Intern Med. 2012 Oct 22;172(19):1444-53
pubmed: 22965186
Arch Phys Med Rehabil. 2005 Dec;86(12):2248-55
pubmed: 16344019
Schmerz. 2016 Oct;30(5):412-420
pubmed: 27658393
Pain. 2011 Mar;152(3 Suppl):S41-S48
pubmed: 21078546
Lancet. 2018 Jun 9;391(10137):2356-2367
pubmed: 29573870
Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694
pubmed: 26991822
J Consult Psychol. 1960 Aug;24:349-54
pubmed: 13813058
JAMA. 2017 Feb 14;317(6):642-644
pubmed: 28196244
J Cogn Neurosci. 2012 Jan;24(1):148-58
pubmed: 21861676
JAMA. 2016 Dec 27;316(24):2627-2646
pubmed: 28027366
Eur J Pain. 2006 Jan;10(1):77-88
pubmed: 16291301
Pain. 2008 Oct 15;139(2):467-476
pubmed: 18774224
Pain. 2016 Nov;157(11):2393-2394
pubmed: 27548048
Brain. 2013 Sep;136(Pt 9):2751-68
pubmed: 23983029
Pain. 2006 Jan;120(1-2):69-77
pubmed: 16364548
Biol Psychiatry. 2010 Jun 1;67(11):1083-90
pubmed: 20303069
Ann Intern Med. 2017 Jun 06;166(11):799-807
pubmed: 28437793
Acupunct Med. 2006 Dec;24(4):169-71
pubmed: 17264835
Neurosci Lett. 2004 May 6;361(1-3):258-61
pubmed: 15135942
Pain. 1999 Mar;80(1-2):1-13
pubmed: 10204712
Pain. 2009 Jul;144(1-2):35-42
pubmed: 19356853
Clin Trials. 2012 Dec;9(6):767-76
pubmed: 23169874
Pain. 1994 Sep;58(3):367-375
pubmed: 7838586
Trials. 2018 Mar 6;19(1):165
pubmed: 29510735
Trials. 2018 Dec 13;19(1):685
pubmed: 30541586
J Pain. 2013 Dec;14(12):1573-84
pubmed: 24135432
Anesthesiology. 2018 Jun;128(6):1241-1254
pubmed: 29494401
Pain. 2008 Feb;134(3):310-319
pubmed: 17544212
Med Care. 2007 May;45(5 Suppl 1):S3-S11
pubmed: 17443116
Lancet. 2018 Jun 9;391(10137):2302
pubmed: 29573869
Br J Sports Med. 2011 Apr;45(5):437-40
pubmed: 19553222
J Appl Biobehav Res. 2013 Jun;18(2):82-103
pubmed: 24143062
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24
pubmed: 11124727
Lancet. 2018 Jun 9;391(10137):2368-2383
pubmed: 29573872
J Pers Soc Psychol. 2003 Aug;85(2):348-62
pubmed: 12916575
Pain. 2007 Jun;129(3):332-342
pubmed: 17350169
J Neurosci. 2011 Apr 6;31(14):5540-8
pubmed: 21471390
Spine (Phila Pa 1976). 2006 Apr 15;31(8):853-8
pubmed: 16622371
Pain Med. 2014 Apr;15 Suppl 1:S21-39
pubmed: 24734857
J Altern Complement Med. 2015 Mar;21(3):113-28
pubmed: 25710206
MMWR Morb Mortal Wkly Rep. 2018 Sep 14;67(36):1001-1006
pubmed: 30212442
Neuroimage Clin. 2019;23:101885
pubmed: 31176295
Aust Fam Physician. 2013 Mar;42(3):112-7
pubmed: 23529519
Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Jan;5(1):119-129
pubmed: 31547972
J Psychosom Res. 2010 Jan;68(1):29-36
pubmed: 20004298
Eur J Pain. 2010 Aug;14(7):725-31
pubmed: 20045360
J Abnorm Psychol. 2002 May;111(2):225-36
pubmed: 12003445
Trends Neurosci. 2015 Feb;38(2):86-95
pubmed: 25541287
Behav Res Ther. 1986;24(1):1-8
pubmed: 3947307
J Clin Psychol. 2011 Sep;67(9):942-68
pubmed: 21647882
Eur Arch Psychiatry Clin Neurosci. 2015 Feb;265(1):45-55
pubmed: 24902936
Cereb Cortex. 2014 Apr;24(4):1037-44
pubmed: 23246778
Soc Neurosci. 2007;2(3-4):276-91
pubmed: 18633819
Psychol Med. 2018 May;48(7):1148-1156
pubmed: 28893330