drugset / Trial / NCT04034004
Chronic Low Back Pain and Meditation
Phase 0
Completed
88 enrolled
University of California, San Diego
National Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedCrossoverTriple-blindBasic science
Summary
The purpose of this research study is to see if and how mindfulness meditation affects pain. Specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (IV) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.
Timeline
- Start
- 2021-01-01
- Primary completion
- 2022-12-22
- Completion
- 2022-12-22
Publications
- Background Anderson WS, Sheth RN, Bencherif B, Frost JJ, Campbell JN. Naloxone increases pain induced by topical capsaicin in healthy human volunteers. Pain. 2002 Sep;99(1-2):207-16. doi: 10.1016/s0304-3959(02)00103-3.
- Background Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.
- Background Apkarian AV, Krauss BR, Fredrickson BE, Szeverenyi NM. Imaging the pain of low back pain: functional magnetic resonance imaging in combination with monitoring subjective pain perception allows the study of clinical pain states. Neurosci Lett. 2001 Feb 16;299(1-2):57-60. doi: 10.1016/s0304-3940(01)01504-x.
- Background Bencherif B, Fuchs PN, Sheth R, Dannals RF, Campbell JN, Frost JJ. Pain activation of human supraspinal opioid pathways as demonstrated by [11C]-carfentanil and positron emission tomography (PET). Pain. 2002 Oct;99(3):589-598. doi: 10.1016/S0304-3959(02)00266-X.
- Background Brown CA, Matthews J, Fairclough M, McMahon A, Barnett E, Al-Kaysi A, El-Deredy W, Jones AKP. Striatal opioid receptor availability is related to acute and chronic pain perception in arthritis: does opioid adaptation increase resilience to chronic pain? Pain. 2015 Nov;156(11):2267-2275. doi: 10.1097/j.pain.0000000000000299.
- Background Bruehl S, Burns JW, Passik SD, Gupta R, Buvanendran A, Chont M, Schuster E, Orlowska D, France CR. The Contribution of Differential Opioid Responsiveness to Identification of Opioid Risk in Chronic Pain Patients. J Pain. 2015 Jul;16(7):666-75. doi: 10.1016/j.jpain.2015.04.001. Epub 2015 Apr 16.
- Background Bruehl S, Chung OY. Parental history of chronic pain may be associated with impairments in endogenous opioid analgesic systems. Pain. 2006 Oct;124(3):287-294. doi: 10.1016/j.pain.2006.04.018. Epub 2006 May 24.
- Background Bruehl S, Chung OY, Burns JW, Biridepalli S. The association between anger expression and chronic pain intensity: evidence for partial mediation by endogenous opioid dysfunction. Pain. 2003 Dec;106(3):317-324. doi: 10.1016/S0304-3959(03)00319-1.
- Background Bruehl S, Chung OY, Burns JW, Diedrich L. Trait anger expressiveness and pain-induced beta-endorphin release: support for the opioid dysfunction hypothesis. Pain. 2007 Aug;130(3):208-215. doi: 10.1016/j.pain.2006.11.013. Epub 2007 Jan 2.
- Background Bruno PA, Millar DP, Goertzen DA. Inter-rater agreement, sensitivity, and specificity of the prone hip extension test and active straight leg raise test. Chiropr Man Therap. 2014 Jun 16;22:23. doi: 10.1186/2045-709X-22-23. eCollection 2014.
- Background Burns JW, Bruehl S, France CR, Schuster E, Orlowska D, Chont M, Gupta RK, Buvanendran A. Endogenous Opioid Function and Responses to Morphine: The Moderating Effects of Anger Expressiveness. J Pain. 2017 Aug;18(8):923-932. doi: 10.1016/j.jpain.2017.02.439. Epub 2017 Mar 30.
- Background Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, Goertz C, Khalsa P, Loeser J, Mackey S, Panagis J, Rainville J, Tosteson T, Turk D, Von Korff M, Weiner DK. Report of the NIH Task Force on Research Standards for Chronic Low Back Pain. Int J Ther Massage Bodywork. 2015 Sep 1;8(3):16-33. doi: 10.3822/ijtmb.v8i3.295. eCollection 2015 Sep.
- Background Deyo RA, Mirza SK, Turner JA, Martin BI. Overtreating chronic back pain: time to back off? J Am Board Fam Med. 2009 Jan-Feb;22(1):62-8. doi: 10.3122/jabfm.2009.01.080102.
- Background DosSantos MF, Martikainen IK, Nascimento TD, Love TM, Deboer MD, Maslowski EC, Monteiro AA, Vincent MB, Zubieta JK, DaSilva AF. Reduced basal ganglia mu-opioid receptor availability in trigeminal neuropathic pain: a pilot study. Mol Pain. 2012 Sep 24;8:74. doi: 10.1186/1744-8069-8-74.
- Background Fardon DF. Nomenclature and classification of lumbar disc pathology. Spine (Phila Pa 1976). 2001 Mar 1;26(5):461-2. doi: 10.1097/00007632-200103010-00007. No abstract available.
- Background Fardon DF, Williams AL, Dohring EJ, Murtagh FR, Gabriel Rothman SL, Sze GK. Lumbar disc nomenclature: version 2.0: Recommendations of the combined task forces of the North American Spine Society, the American Society of Spine Radiology and the American Society of Neuroradiology. Spine J. 2014 Nov 1;14(11):2525-45. doi: 10.1016/j.spinee.2014.04.022. Epub 2014 Apr 24.
- Background Han B, Compton WM, Jones CM, Cai R. Nonmedical Prescription Opioid Use and Use Disorders Among Adults Aged 18 Through 64 Years in the United States, 2003-2013. JAMA. 2015 Oct 13;314(14):1468-78. doi: 10.1001/jama.2015.11859.
- Background Harris RE, Clauw DJ, Scott DJ, McLean SA, Gracely RH, Zubieta JK. Decreased central mu-opioid receptor availability in fibromyalgia. J Neurosci. 2007 Sep 12;27(37):10000-6. doi: 10.1523/JNEUROSCI.2849-07.2007.
- Background Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9.
- Background Institute of Medicine (US) Committee on Advancing Pain Research, Care, and Education. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington (DC): National Academies Press (US); 2011. Available from http://www.ncbi.nlm.nih.gov/books/NBK91497/
- Background Jacob JA. As Opioid Prescribing Guidelines Tighten, Mindfulness Meditation Holds Promise for Pain Relief. JAMA. 2016 Jun 14;315(22):2385-7. doi: 10.1001/jama.2016.4875. No abstract available.
- Background Jamison RN, Ross EL, Michna E, Chen LQ, Holcomb C, Wasan AD. Substance misuse treatment for high-risk chronic pain patients on opioid therapy: a randomized trial. Pain. 2010 Sep;150(3):390-400. doi: 10.1016/j.pain.2010.02.033. Epub 2010 Mar 23.
- Background Jones AK, Cunningham VJ, Ha-Kawa S, Fujiwara T, Luthra SK, Silva S, Derbyshire S, Jones T. Changes in central opioid receptor binding in relation to inflammation and pain in patients with rheumatoid arthritis. Br J Rheumatol. 1994 Oct;33(10):909-16. doi: 10.1093/rheumatology/33.10.909.
- Background Jones AK, Kitchen ND, Watabe H, Cunningham VJ, Jones T, Luthra SK, Thomas DG. Measurement of changes in opioid receptor binding in vivo during trigeminal neuralgic pain using [11C] diprenorphine and positron emission tomography. J Cereb Blood Flow Metab. 1999 Jul;19(7):803-8. doi: 10.1097/00004647-199907000-00011.
- Background Jones AK, Watabe H, Cunningham VJ, Jones T. Cerebral decreases in opioid receptor binding in patients with central neuropathic pain measured by [11C]diprenorphine binding and PET. Eur J Pain. 2004 Oct;8(5):479-85. doi: 10.1016/j.ejpain.2003.11.017.
- Background Klega A, Eberle T, Buchholz HG, Maus S, Maihofner C, Schreckenberger M, Birklein F. Central opioidergic neurotransmission in complex regional pain syndrome. Neurology. 2010 Jul 13;75(2):129-36. doi: 10.1212/WNL.0b013e3181e7ca2e.
- Background Kwong EH, Virani N, Robert M, Gerry K, Harding A, Rose MS, Dukelow SP, Barton PM. Inter-rater reliability of the Active Straight-Leg Raise and One-Leg Standing tests in non-pregnant women. J Rehabil Med. 2013 Nov;45(10):1058-64. doi: 10.2340/16501977-1213.
- Background Loggia ML, Kim J, Gollub RL, Vangel MG, Kirsch I, Kong J, Wasan AD, Napadow V. Default mode network connectivity encodes clinical pain: an arterial spin labeling study. Pain. 2013 Jan;154(1):24-33. doi: 10.1016/j.pain.2012.07.029. Epub 2012 Oct 27.
- Background Maarrawi J, Peyron R, Mertens P, Costes N, Magnin M, Sindou M, Laurent B, Garcia-Larrea L. Differential brain opioid receptor availability in central and peripheral neuropathic pain. Pain. 2007 Jan;127(1-2):183-94. doi: 10.1016/j.pain.2006.10.013. Epub 2006 Nov 29.
- Background Martikainen IK, Pecina M, Love TM, Nuechterlein EB, Cummiford CM, Green CR, Harris RE, Stohler CS, Zubieta JK. Alterations in endogenous opioid functional measures in chronic back pain. J Neurosci. 2013 Sep 11;33(37):14729-37. doi: 10.1523/JNEUROSCI.1400-13.2013.
- Background May LM, Kosek P, Zeidan F, Berkman ET. Enhancement of Meditation Analgesia by Opioid Antagonist in Experienced Meditators. Psychosom Med. 2018 Nov/Dec;80(9):807-813. doi: 10.1097/PSY.0000000000000580.
- Background Mens JM, Vleeming A, Snijders CJ, Stam HJ, Ginai AZ. The active straight leg raising test and mobility of the pelvic joints. Eur Spine J. 1999;8(6):468-73. doi: 10.1007/s005860050206.
- Background Nelson LS, Juurlink DN, Perrone J. Addressing the Opioid Epidemic. JAMA. 2015 Oct 13;314(14):1453-4. doi: 10.1001/jama.2015.12397. No abstract available.
- Background Ngai SH, Berkowitz BA, Yang JC, Hempstead J, Spector S. Pharmacokinetics of naloxone in rats and in man: basis for its potency and short duration of action. Anesthesiology. 1976 May;44(5):398-401. doi: 10.1097/00000542-197605000-00008.
- Background Rebain R, Baxter GD, McDonough S. A systematic review of the passive straight leg raising test as a diagnostic aid for low back pain (1989 to 2000). Spine (Phila Pa 1976). 2002 Sep 1;27(17):E388-95. doi: 10.1097/00007632-200209010-00025.
- Background Roussel NA, Nijs J, Truijen S, Smeuninx L, Stassijns G. Low back pain: clinimetric properties of the Trendelenburg test, active straight leg raise test, and breathing pattern during active straight leg raising. J Manipulative Physiol Ther. 2007 May;30(4):270-8. doi: 10.1016/j.jmpt.2007.03.001.
- Background Saloner B, Karthikeyan S. Changes in Substance Abuse Treatment Use Among Individuals With Opioid Use Disorders in the United States, 2004-2013. JAMA. 2015 Oct 13;314(14):1515-7. doi: 10.1001/jama.2015.10345. No abstract available.
- Background Sharma HA, Gupta R, Olivero W. fMRI in patients with lumbar disc disease: a paradigm to study patients over time. J Pain Res. 2011;4:401-5. doi: 10.2147/JPR.S24393. Epub 2011 Dec 7.
- Background Steglitz J, Buscemi J, Ferguson MJ. The future of pain research, education, and treatment: a summary of the IOM report "Relieving pain in America: a blueprint for transforming prevention, care, education, and research". Transl Behav Med. 2012 Mar;2(1):6-8. doi: 10.1007/s13142-012-0110-2.
- Background Summers B, Malhan K, Cassar-Pullicino V. Low back pain on passive straight leg raising: the anterior theca as a source of pain. Spine (Phila Pa 1976). 2005 Feb 1;30(3):342-5. doi: 10.1097/01.brs.0000152378.93868.c8.
- Background Thompson SJ, Pitcher MH, Stone LS, Tarum F, Niu G, Chen X, Kiesewetter DO, Schweinhardt P, Bushnell MC. Chronic neuropathic pain reduces opioid receptor availability with associated anhedonia in rat. Pain. 2018 Sep;159(9):1856-1866. doi: 10.1097/j.pain.0000000000001282.
- Background Wasan AD, Davar G, Jamison R. The association between negative affect and opioid analgesia in patients with discogenic low back pain. Pain. 2005 Oct;117(3):450-461. doi: 10.1016/j.pain.2005.08.006.
- Background Wasan AD, Loggia ML, Chen LQ, Napadow V, Kong J, Gollub RL. Neural correlates of chronic low back pain measured by arterial spin labeling. Anesthesiology. 2011 Aug;115(2):364-74. doi: 10.1097/ALN.0b013e318220e880.
- Background Zeidan F, Adler-Neal AL, Wells RE, Stagnaro E, May LM, Eisenach JC, McHaffie JG, Coghill RC. Mindfulness-Meditation-Based Pain Relief Is Not Mediated by Endogenous Opioids. J Neurosci. 2016 Mar 16;36(11):3391-7. doi: 10.1523/JNEUROSCI.4328-15.2016.
- Background Zeidan F, Emerson NM, Farris SR, Ray JN, Jung Y, McHaffie JG, Coghill RC. Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia. J Neurosci. 2015 Nov 18;35(46):15307-25. doi: 10.1523/JNEUROSCI.2542-15.2015.
- Background Zeidan F, Gordon NS, Merchant J, Goolkasian P. The effects of brief mindfulness meditation training on experimentally induced pain. J Pain. 2010 Mar;11(3):199-209. doi: 10.1016/j.jpain.2009.07.015. Epub 2009 Oct 22.
- Background Zeidan F, Grant JA, Brown CA, McHaffie JG, Coghill RC. Mindfulness meditation-related pain relief: evidence for unique brain mechanisms in the regulation of pain. Neurosci Lett. 2012 Jun 29;520(2):165-73. doi: 10.1016/j.neulet.2012.03.082. Epub 2012 Apr 6.
- Background Zeidan F, Johnson SK, Diamond BJ, David Z, Goolkasian P. Mindfulness meditation improves cognition: evidence of brief mental training. Conscious Cogn. 2010 Jun;19(2):597-605. doi: 10.1016/j.concog.2010.03.014. Epub 2010 Apr 3.
- Background Zeidan F, Johnson SK, Gordon NS, Goolkasian P. Effects of brief and sham mindfulness meditation on mood and cardiovascular variables. J Altern Complement Med. 2010 Aug;16(8):867-73. doi: 10.1089/acm.2009.0321.
- Background Zeidan F, Lobanov OV, Kraft RA, Coghill RC. Brain mechanisms supporting violated expectations of pain. Pain. 2015 Sep;156(9):1772-1785. doi: 10.1097/j.pain.0000000000000231.
- Background Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.
- Background Zeidan F, Martucci KT, Kraft RA, McHaffie JG, Coghill RC. Neural correlates of mindfulness meditation-related anxiety relief. Soc Cogn Affect Neurosci. 2014 Jun;9(6):751-9. doi: 10.1093/scan/nst041. Epub 2013 Apr 24.
- Background Zubieta JK, Smith YR, Bueller JA, Xu Y, Kilbourn MR, Jewett DM, Meyer CR, Koeppe RA, Stohler CS. Regional mu opioid receptor regulation of sensory and affective dimensions of pain. Science. 2001 Jul 13;293(5528):311-5. doi: 10.1126/science.1060952.
- Background Zubieta JK, Smith YR, Bueller JA, Xu Y, Kilbourn MR, Jewett DM, Meyer CR, Koeppe RA, Stohler CS. mu-opioid receptor-mediated antinociceptive responses differ in men and women. J Neurosci. 2002 Jun 15;22(12):5100-7. doi: 10.1523/JNEUROSCI.22-12-05100.2002.
- Khatib L, Dean JG, Oliva V, Riegner G, Gonzalez NE, Birenbaum J, Cruanes GF, Miller J, Patterson M, Kim HC, Chakravarthy K, Zeidan F. The role of endogenous opioids in mindfulness and sham mindfulness-meditation for the direct alleviation of evoked chronic low back pain: a randomized clinical trial. Neuropsychopharmacology. 2024 Jun;49(7):1069-1077. doi: 10.1038/s41386-023-01766-2. Epub 2023 Nov 20.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxone | Small molecule | 0.1 mg/kg | Intravenous |
Indications
No indication recorded.