Effects of pain neuroscience education combined with neuromuscular exercises on pain, functional disability and psychological factors in chronic low back pain: A study protocol for a single-blind randomized controlled trial.

Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

Original Publication: San Francisco, CA : Public Library of Science

Chronic Pain*/therapy ; Chronic Pain*/psychology ; Exercise Therapy*/methods ; Low Back Pain*/therapy ; Low Back Pain*/psychology; Adult ; Female ; Humans ; Male ; Middle Aged ; Neurosciences/education ; Pain Management/methods ; Pain Measurement ; Patient Education as Topic/methods ; Single-Blind Method ; Treatment Outcome ; Randomized Controlled Trials as Topic

Objective: Chronic low back pain (CLBP) is a prevalent health condition worldwide. Several therapeutic interventions aim to improve CLBP. Pain Neuroscience Education (PNE) helps patients better understand their pain from biological and physiological perspectives, which clinicians use to reduce pain and disability in patients with chronic musculoskeletal conditions. Neuromuscular exercises (NMS) are also treatments adopted in CLBP. This study will investigate whether PNE combined with an NMS program improves pain, functional and psychological outcomes more than NMS alone in patients with CLBP.
Methods: In this single-blind randomized controlled trial, 60 patients (male and female; age range, 30-60 years) diagnosed with CLBP will be randomly assigned to one of the following groups: (1) PNE plus NMS (n = 30; 24 sessions of PNE plus NMS in a total of 8 weeks, 3 each week), and (2) NMS alone (n = 30; 24 sessions of NMS sessions in a total of 8 weeks, 3 each week). Outcome assessors will be blinded to the group allocation. The primary outcome will be pain. Secondary outcomes will be disability, fear-avoidance beliefs about work and physical activity, self-efficacy, exercise anxiety, and kinesiophobia. Outcomes will be assessed at baseline, after 8 weeks of intervention, and 6 months post-intervention.
Discussion: The findings of this RCT will help shed light on new treatment strategies to address the biopsychosocial dimensions of CLBP. The study protocol will be conducted in a clinical setting, offering the opportunity for future implementation in healthcare systems. Moreover, it will help clarify whether a combined treatment (PNE with NMS) is more effective than NMS alone for improving pain, functional and psychological outcomes in CLBP.
Trial Registration: Study registration: The study was prospectively registered in the Iranian Registry of Clinical Trials-IRCT20190427043384N2 (https://www.irct.ir/trial/69146). Registered on March 17, 2023.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 Alvani et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

BMC Musculoskelet Disord. 2019 Jul 13;20(1):328. (PMID: 31301741)
PLoS One. 2018 Sep 21;13(9):e0204091. (PMID: 30240417)
Pain Rep. 2022 Aug 05;7(5):1025. (PMID: 36203647)
Sci Rep. 2024 Apr 22;14(1):9176. (PMID: 38649771)
Man Ther. 2003 Aug;8(3):130-40. (PMID: 12909433)
Eur J Phys Rehabil Med. 2020 Oct;56(5):600-606. (PMID: 32420712)
J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. (PMID: 21350618)
Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. (PMID: 16778675)
Complement Ther Clin Pract. 2021 Aug;44:101439. (PMID: 34246129)
Pain Pract. 2021 Mar;21(3):333-342. (PMID: 33135286)
Eur Spine J. 2016 Sep;25(9):2882-8. (PMID: 27356516)
Spine (Phila Pa 1976). 2008 Jan 1;33(1):90-4. (PMID: 18165753)
BMJ Open. 2023 Apr 25;13(4):e064119. (PMID: 37185180)
Patient Educ Couns. 2024 Jun;123:108201. (PMID: 38387389)
Pain Med. 2009 May-Jun;10(4):619-32. (PMID: 19453954)
JMIR Mhealth Uhealth. 2019 Oct 18;7(10):e14619. (PMID: 31628786)
PLoS One. 2013 Jun 27;8(6):e67779. (PMID: 23826339)
J Orthop Sports Phys Ther. 2024 May;54(5):350-359. (PMID: 38497906)
Spine (Phila Pa 1976). 2013 Mar 1;38(5):375-84. (PMID: 22941095)
J Pain. 2016 Jun;17(6):707-18. (PMID: 26975193)
Pain. 2024 Jun 1;165(6):1196-1206. (PMID: 38047772)
Br J Sports Med. 2017 Jan;51(2):126-132. (PMID: 27343238)
Gait Posture. 2023 Feb;100:114-119. (PMID: 36516645)
Physiother Theory Pract. 2016 Jul;32(5):332-55. (PMID: 27351541)
Phys Ther. 2017 May 01;97(5):561-570. (PMID: 28340202)
Med Sci Monit. 2020 Mar 17;26:e921295. (PMID: 32182226)
BMC Public Health. 2018 Dec 17;18(1):1376. (PMID: 30558592)
Pain Med. 2016 Apr;17(4):781-9. (PMID: 26814242)
J Orthop Sports Phys Ther. 2021 Apr;51(4):188-195. (PMID: 33789433)
Musculoskeletal Care. 2023 Mar;21(1):78-96. (PMID: 36912214)
J Pain Res. 2022 Sep 01;15:2629-2639. (PMID: 36072909)
Pilot Feasibility Stud. 2023 Jan 24;9(1):15. (PMID: 36694217)
Man Ther. 2011 Oct;16(5):413-8. (PMID: 21632273)
PLoS Med. 2020 Sep 21;17(9):e1003294. (PMID: 32956344)
BMJ Open. 2023 May 12;13(5):e070336. (PMID: 37173101)
Int J Environ Res Public Health. 2022 Feb 25;19(5):. (PMID: 35270384)
Spine (Phila Pa 1976). 2000 Nov 1;25(21):2784-96. (PMID: 11064524)
J Orthop Sports Phys Ther. 2021 Dec;51(12):562-565. (PMID: 34783262)
J Altern Complement Med. 2005 Apr;11(2):333-42. (PMID: 15865501)
Nephrology (Carlton). 2020 Jul;25(7):513-517. (PMID: 32147926)
Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. (PMID: 11074683)
Med Sci Sports Exerc. 2020 Nov;52(11):2373-2379. (PMID: 32366799)
J Orthop Sports Phys Ther. 2016 Mar;46(3):131-4. (PMID: 26928735)
BMJ. 2014 Mar 07;348:g1687. (PMID: 24609605)
Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):108-115. (PMID: 28967357)
Clin J Pain. 2018 Jan;34(1):44-52. (PMID: 28514231)
J Can Chiropr Assoc. 2021 Aug;65(2):193-206. (PMID: 34658391)
J Electromyogr Kinesiol. 2019 Oct;48:84-93. (PMID: 31252284)
J Back Musculoskelet Rehabil. 2014;27(2):213-21. (PMID: 24254494)
JAMA. 2013 Nov 27;310(20):2191-4. (PMID: 24141714)
BMJ Open Sport Exerc Med. 2016 Mar 03;2(1):e000098. (PMID: 27900169)
Lancet. 2018 Jun 9;391(10137):2356-2367. (PMID: 29573870)
BMJ. 2013 Jan 08;346:e7586. (PMID: 23303884)
Pain. 2022 Jan 1;163(1):e20-e30. (PMID: 33863860)
Br J Sports Med. 2020 Jul;54(13):782-789. (PMID: 31630089)
J Orthop Sports Phys Ther. 2021 Nov;51(11):CPG1-CPG60. (PMID: 34719942)
Spine J. 2008 Nov-Dec;8(6):968-74. (PMID: 18201937)
Spine (Phila Pa 1976). 2016 Aug 15;41(16):1284-1295. (PMID: 27128390)
Front Neurosci. 2023 Nov 24;17:1272068. (PMID: 38075271)
JAMA Neurol. 2018 Jul 1;75(7):808-817. (PMID: 29710099)
Ann Intern Med. 2013 Feb 5;158(3):200-7. (PMID: 23295957)
J Pain. 2019 Oct;20(10):1140.e1-1140.e22. (PMID: 30831273)
Pain Pract. 2019 Apr;19(4):363-369. (PMID: 30450792)
J Am Coll Dent. 2014 Summer;81(3):14-8. (PMID: 25951678)
J Pers Med. 2022 Feb 17;12(2):. (PMID: 35207790)
Musculoskelet Sci Pract. 2022 Feb;57:102494. (PMID: 34953290)

Date Created: 20241104 Date Completed: 20241104 Latest Revision: 20241120

20250114

PMC11534247

10.1371/journal.pone.0309679

39495728