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Published in: Trials 1/2022

Open Access 01-12-2022 | Back Pain | Study protocol

Immediate effects of spinal manipulation on painful sensitivity and postural stability in patients with chronic nonspecific low back pain: study protocol for a controlled randomised clinical trial

Authors: João Paulo Freitas, Leticia Amaral Corrêa, Juliana Valentim Bittencourt, Karine Marcondes Armstrong, Leandro Alberto Calazans Nogueira

Published in: Trials | Issue 1/2022

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Abstract

Background

Low back pain is one of the main public health concerns. Chronic low back pain (cLBP) reduces functional capacity and affects postural stability. Although health professionals widely use spinal manipulation, its immediate effect on painful sensitivity and postural stability is lacking. This study aims to verify the immediate effects of lumbar spinal manipulation on the pressure pain threshold and postural stability in individuals with cLBP.

Methods

A two-arm, placebo-controlled clinical trial with parallel groups and examiner-blinded will be conducted with 80 participants with cLBP from an outpatient physical therapy department, randomly allocated at a 1:1 distribution. The experimental group will receive a lumbar spinal manipulation technique, and the placebo group will receive a simulated lumbar spinal manipulation. Both groups will receive one session of treatment and will be evaluated before and immediately after the intervention. The primary outcomes will be the pressure pain threshold and postural stability. Pain intensity and patient’s expectation will be assessed as a secondary outcome. The pressure pain threshold will be assessed using a pressure algometer in 6 different anatomical regions. The evaluation of postural stability will be performed in a baropodometry exam by displacing the centre of pressure. The pain intensity will be measured using the Numeric Pain Rating Scale. A Likert scale will be used for the patient’s expectation about the treatment. A two-way analysis of variance will compare the effect of the interventions between groups.

Discussion

This study will provide insights regarding the immediate effects of spinal manipulation in patients with cLBP against a simulated spinal manipulation using objective outcomes and considering patients’ expectations regarding the treatment.

Trial registration

Brazilian Registry of Clinical Trials RBR-3ksq2c. Registered on 13 July 2020
Literature
1.
go back to reference James SL, Abate D, Abate KH, Abay SM, Abbafati C, Abbasi N, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–858. https://doi.org/10.1016/S0140-6736(18)32279-7.CrossRef James SL, Abate D, Abate KH, Abay SM, Abbafati C, Abbasi N, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–858. https://​doi.​org/​10.​1016/​S0140-6736(18)32279-7.CrossRef
6.
go back to reference National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management (NG59). NICE. National Institute for Health and Care Excellence (UK); 2016. National Institute for Health and Care Excellence. Low back pain and sciatica in over 16s: assessment and management (NG59). NICE. National Institute for Health and Care Excellence (UK); 2016.
7.
go back to reference Murtagh S, Bryant E, Hebron C, Ridehalgh C, Horler C, Trosh C, et al. Management of low back pain: treatment provision within private practice in the UK in the context of clinical guidelines. Musculoskeletal Care. 2021;(February). Murtagh S, Bryant E, Hebron C, Ridehalgh C, Horler C, Trosh C, et al. Management of low back pain: treatment provision within private practice in the UK in the context of clinical guidelines. Musculoskeletal Care. 2021;(February).
9.
go back to reference Rushton A, Beeton K, Jordaan R, Langendoen J, Levesque L, Maffey L, et al. Educational standards in orthopaedic manipulative therapy. In: PART A: EDUCATIONAL STANDARDS 2016. 2016. p. 91. Rushton A, Beeton K, Jordaan R, Langendoen J, Levesque L, Maffey L, et al. Educational standards in orthopaedic manipulative therapy. In: PART A: EDUCATIONAL STANDARDS 2016. 2016. p. 91.
12.
go back to reference Gevers-Montoro C, Provencher B, Descarreaux M, Ortega de Mues A, Piché M. Neurophysiological mechanisms of chiropractic spinal manipulation for spine pain. Eur J Pain (United Kingdom). 2021; Gevers-Montoro C, Provencher B, Descarreaux M, Ortega de Mues A, Piché M. Neurophysiological mechanisms of chiropractic spinal manipulation for spine pain. Eur J Pain (United Kingdom). 2021;
17.
go back to reference Honoré M, Leboeuf-Yde C, Gagey O. The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review. Vol. 26, Chiropractic and Manual Therapies. BioMed Central Ltd.; 2018, The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review. Honoré M, Leboeuf-Yde C, Gagey O. The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review. Vol. 26, Chiropractic and Manual Therapies. BioMed Central Ltd.; 2018, The regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects: a systematic literature review.
18.
go back to reference Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham. Chiropr Man Ther. 2020;28(1):1–12. https://doi.org/10.1186/s12998-020-00326-5.CrossRef Aspinall SL, Jacques A, Leboeuf-Yde C, Etherington SJ, Walker BF. Pressure pain threshold and temporal summation in adults with episodic and persistent low back pain trajectories: a secondary analysis at baseline and after lumbar manipulation or sham. Chiropr Man Ther. 2020;28(1):1–12. https://​doi.​org/​10.​1186/​s12998-020-00326-5.CrossRef
24.
25.
go back to reference de Zoete A, de Boer MR, Rubinstein SM, van Tulder MW, Underwood M, Hayden JA, et al. Moderators of the effect of spinal manipulative therapy on pain relief and function in patients with chronic low back pain: an individual participant data meta-analysis. Spine (Phila Pa 1976). 2021;46(8):E505–17. https://doi.org/10.1097/BRS.0000000000003814.CrossRef de Zoete A, de Boer MR, Rubinstein SM, van Tulder MW, Underwood M, Hayden JA, et al. Moderators of the effect of spinal manipulative therapy on pain relief and function in patients with chronic low back pain: an individual participant data meta-analysis. Spine (Phila Pa 1976). 2021;46(8):E505–17. https://​doi.​org/​10.​1097/​BRS.​0000000000003814​.CrossRef
26.
go back to reference Costa N, Hodges PW, Ferreira ML, Makovey J, Setchell J. What triggers an LBP flare? A content analysis of individuals’ perspectives. Vol. 21, Pain Medicine (United States). Oxford University Press; 2020. p. 13–20, What Triggers an LBP Flare? A Content Analysis of Individuals’ Perspectives, 1, DOI: https://doi.org/10.1093/pm/pnz021. Costa N, Hodges PW, Ferreira ML, Makovey J, Setchell J. What triggers an LBP flare? A content analysis of individuals’ perspectives. Vol. 21, Pain Medicine (United States). Oxford University Press; 2020. p. 13–20, What Triggers an LBP Flare? A Content Analysis of Individuals’ Perspectives, 1, DOI: https://​doi.​org/​10.​1093/​pm/​pnz021.
30.
go back to reference JPM d R, Bittencourt JV, Corrêa LA, Freynhagen R, FJJ d R, de Melo TB, et al. Cross-cultural adaptation of the PainDETECT Questionnaire into Brazilian Portuguese Language (in press). Brazilian J Anesthesiol. JPM d R, Bittencourt JV, Corrêa LA, Freynhagen R, FJJ d R, de Melo TB, et al. Cross-cultural adaptation of the PainDETECT Questionnaire into Brazilian Portuguese Language (in press). Brazilian J Anesthesiol.
31.
go back to reference Boutron I, Barbour V, Johnston M, Mcculloch P. Assistant Editor Professor of Medical Sociology. Boutron I, Barbour V, Johnston M, Mcculloch P. Assistant Editor Professor of Medical Sociology.
32.
33.
go back to reference Lavazza C, Galli M, Abenavoli A, Maggiani A. Sham treatment effects in manual therapy trials on back pain patients: a systematic review and pairwise meta-analysis. BMJ Open. 2021;11(5). Lavazza C, Galli M, Abenavoli A, Maggiani A. Sham treatment effects in manual therapy trials on back pain patients: a systematic review and pairwise meta-analysis. BMJ Open. 2021;11(5).
37.
go back to reference Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (sf. Arthritis Care Res (Hoboken). 2011;63(S11):S240–S252, Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF, DOI: https://doi.org/10.1002/acr.20543. Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (sf. Arthritis Care Res (Hoboken). 2011;63(S11):S240–S252, Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF, DOI: https://​doi.​org/​10.​1002/​acr.​20543.
Metadata
Title
Immediate effects of spinal manipulation on painful sensitivity and postural stability in patients with chronic nonspecific low back pain: study protocol for a controlled randomised clinical trial
Authors
João Paulo Freitas
Leticia Amaral Corrêa
Juliana Valentim Bittencourt
Karine Marcondes Armstrong
Leandro Alberto Calazans Nogueira
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06111-4

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