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Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Neck Pain | Study protocol

The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial

Authors: Anders Galaasen Bakken, Iben Axén, Andreas Eklund, Søren O’Neill

Published in: Trials | Issue 1/2019

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Abstract

Background

Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with persistent neck pain (NP) have also been found to have disturbances in autonomic nervous system (ANS) regulation. A common way to study the ANS is to measure heart rate variability (HRV). It is not known whether deviations in HRV are related to changes in pain perception or to the treatment response to SMT.
Commonly, an individual in pain will experience pain reduction when exposed to a second pain stimulus, a mechanism known as conditioned pain modulation (CPM). Patients with persistent pain have been found to have a reduced CPM reaction. It is not known whether this is predictive of treatment response to SMT.
The aim of the study is to examine the effects of SMT on HRV and pain. Further, a secondary aim is to test whether a CPM test can be used to predict treatment response in a population of patients with recurrent and persistent NP.

Method/design

A multicentre randomized controlled clinical trial will be carried out in multidisciplinary primary care clinics. This setting is chosen to minimize bias resulting from patient preference for the treatment modality and provider.
The subjects are either self-referred or referred from other health care practitioners locally. The treatment modalities are two well-known interventions for NP; SMT and stretching exercises compared to stretching exercises alone.
HRV will be measured using a portable heart monitor. The subjective pain experience will be investigated by assessing pain intensity and the affective quality of pain. CPM will be measured with a standardized cold pressor test. Measurements will be performed three times during a 2-week treatment series.

Discussion

The study will utilize normal clinical procedures, which should aid the transferability and external validity of the results. The study will provide knowledge regarding the underlying mechanisms of the effects of SMT. Furthermore, the study will examine whether a CPM test is predictive of treatment outcome in a population of patients with recurrent and persistent NP.

Trial registration

ClinicalTrials.gov, NCT03576846. Registered on 3 July 2018.
Appendix
Available only for authorised users
Literature
1.
Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163–96.PubMedPubMedCentralCrossRef
2.
Leboeuf-Yde C, Fejer R, Nielsen J, Kyvik KO, Hartvigsen J. Consequences of spinal pain: do age and gender matter? A Danish cross-sectional population-based study of 34,902 individuals 20–71 years of age. BMC Musculoskelet Disord. 2011;12:39.PubMedPubMedCentralCrossRef
3.
Woolf CJ, Max MB. Mechanism-based pain diagnosis: issues for analgesic drug development. Anesthesiology. 2001;95(1):241–9.PubMedCrossRef
4.
Gross AR, Goldsmith C, Hoving JL, Haines T, Peloso P, Aker P, et al. Conservative management of mechanical neck disorders: a systematic review. J Rheumatol. 2007;34(5):1083–102.PubMed
5.
Rubinstein SM, van Middelkoop M, Kuijpers T, Ostelo R, Verhagen AP, de Boer MR, et al. A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain. Eur Spine J. 2010;19(8):1213–28.PubMedPubMedCentralCrossRef
6.
Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, et al. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006;15 Suppl 2:S192–300.PubMedCrossRef
7.
Coulter ID, et al. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis. Spine J. 2018;18(5):866–879.
8.
Millan M, Leboeuf-Yde C, Budgell B, Amorim MA. The effect of spinal manipulative therapy on experimentally induced pain: a systematic literature review. Chiropr Man Ther. 2012;20(1):26.CrossRef
9.
Coronado RA, Gay CW, Bialosky JE, Carnaby GD, Bishop MD, George SZ. Changes in pain sensitivity following spinal manipulation: a systematic review and meta-analysis. J Electromyogr Kinesiol. 2012;22(5):752–67.PubMedPubMedCentralCrossRef
10.
Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009;89(12):1292–303.PubMedPubMedCentralCrossRef
11.
Kingston L, Claydon L, Tumilty S. The effects of spinal mobilizations on the sympathetic nervous system: a systematic review. Man Ther. 2014;19(4):281–7.PubMedCrossRef
12.
Hallman DM, Olsson EMG, von Schéele B, Melin L, Lyskov E. Effects of heart rate variability biofeedback in subjects with stress-related chronic neck pain: a pilot study. Appl Psychophysiol Biofeedback. 2011;36(2):71–80.PubMedCrossRef
13.
Farinatti PT, Brandao C, Soares PP, Duarte AF. Acute effects of stretching exercise on the heart rate variability in subjects with low flexibility levels. J Strength Cond Res. 2011;25(6):1579–85.PubMedCrossRef
14.
Mueck-Weymann M, Janshoff G, Mueck H. Stretching increases heart rate variability in healthy athletes complaining about limited muscular flexibility. Clin Auton Res. 2004;14(1):15–8.PubMedCrossRef
15.
Shrier I, Gossal K. Myths and truths of stretching: individualized recommendations for healthy muscles. Phys Sportsmed. 2000;28(8):57–63.PubMedCrossRef
16.
Ylinen J, Kautiainen H, Wiren K, Hakkinen A. Stretching exercises vs manual therapy in treatment of chronic neck pain: a randomized, controlled cross-over trial. J Rehabil Med. 2007;39(2):126–32.PubMedCrossRef
17.
Saunders J, Wainwright P. Risk, Helsinki 2000 and the use of placebo in medical research. Clin Med (London, England). 2003;3(5):435–9.PubMedCentralCrossRef
18.
Sarigiovannis P, Hollins B. Effectiveness of manual therapy in the treatment of non-specific neck pain: a review. Physical Therapy Reviews. 2005;10(1):35–50.CrossRef
19.
Leboeuf-Yde C, Hennius B, Rudberg E, Leufvenmark P, Thunman M. Side effects of chiropractic treatment: a prospective study. J Manip Physiol Ther. 1997;20(8):511–5.
20.
Axén I, Rosenbaum A, Röbech R, Wren T, Leboeuf-Yde C. Can patient reactions to the first chiropractic treatment predict early favorable treatment outcome in persistent low back pain? J Manip Physiol Ther. 2002;25(7):450–4.CrossRef
21.
22.
O'Neill S, O'Neill L. Improving QST reliability—more raters, tests, or occasions? A multivariate generalizability study. J Pain. 2015;16(5):454–62.PubMedCrossRef
23.
von Baeyer CL, Piira T, Chambers CT, Trapanotto M, Zeltzer LK. Guidelines for the cold pressor task as an experimental pain stimulus for use with children. J Pain. 2005;6(4):218–27.CrossRef
24.
Furlan AD, Yazdi F, Tsertsvadze A, Gross A, Van Tulder M, Santaguida L, et al. A systematic review and meta-analysis of efficacy, cost-effectiveness, and safety of selected complementary and alternative medicine for neck and low-back pain. Evid Based Complement Alternat Med. 2012;2012:953139.PubMedCrossRef
25.
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005;14(7):798–804.PubMedCrossRef
26.
Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27(1):117–26.PubMedCrossRef
27.
Wideman TH, Hill JC, Main CJ, Lewis M, Sullivan MJ, Hay EM. Comparing the responsiveness of a brief, multidimensional risk screening tool for back pain to its unidimensional reference standards: the whole is greater than the sum of its parts. Pain. 2012;153(11):2182–91.PubMedCrossRef
28.
Forsbrand M, Grahn B, Hill JC, Petersson IF, Sennehed CP, Stigmar K. Comparison of the Swedish STarT Back Screening Tool and the Short Form of the Orebro Musculoskeletal Pain Screening Questionnaire in patients with acute or subacute back and neck pain. BMC Musculoskelet Disord. 2017;18(1):89.PubMedPubMedCentralCrossRef
29.
Dworkin RH, Turk DC, Trudeau JJ, Benson C, Biondi DM, Katz NP, et al. Validation of the short-form McGill Pain Questionnaire-2 (SF-MPQ-2) in acute low back pain. J Pain. 2015;16(4):357–66.PubMedCrossRef
30.
Burckhardt CS, Bjelle A. A Swedish version of the short-form McGill Pain Questionnaire. Scand J Rheumatol. 1994;23(2):77–81.PubMedCrossRef
31.
Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, et al. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015;19(6):805–6.PubMedCrossRef
32.
Stein PK, Pu Y. Heart rate variability, sleep and sleep disorders. Sleep Med Rev. 2012;16(1):47–66.PubMedCrossRef
33.
Kristjansdottir OB, Fors EA, Eide E, Finset A, van Dulmen S, Wigers SH, et al. Written online situational feedback via mobile phone to support self-management of chronic widespread pain: a usability study of a Web-based intervention. BMC Musculoskelet Disord. 2011;12:51.PubMedPubMedCentralCrossRef
34.
Johansen B, Wedderkopp N. Comparison between data obtained through real-time data capture by SMS and a retrospective telephone interview. Chiropr Osteopat. 2010;18:10.PubMedPubMedCentralCrossRef
35.
Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996;93(5):1043–65.CrossRef
36.
Hallman DM, Srinivasan D, Mathiassen SE. Short- and long-term reliability of heart rate variability indices during repetitive low-force work. Eur J Appl Physiol. 2015;115(4):803–12.PubMedCrossRef
37.
Araujo FXd, et al. Autonomic function and pressure pain threshold following thoracic mobilization in asymptomatic subjects: A randomized controlled trial. J Bodyw Mov Ther. 2018;22(2):313–320.PubMedCrossRef
38.
Laborde S, Mosley E, Thayer JF. Heart rate variability and cardiac vagal tone in psychophysiological research—recommendations for experiment planning, data analysis, and data reporting. Front Psychol. 2017;8:213.PubMedPubMedCentralCrossRef
39.
Bronfort G, Haas M, Evans R, Kawchuk G, Dagenais S. Chapter 17—spinal manipulation and mobilization. In: Dagenais S, Halderman S, editors. Evidence-based management of low back pain. Saint Louis: Mosby; 2012. p. 229–47.CrossRef
40.
Griswold D, Learman K, Kolber MJ, O'Halloran B, Cleland JA. Pragmatically Applied Cervical and Thoracic Nonthrust Manipulation Versus Thrust Manipulation for Patients With Mechanical Neck Pain: A Multicenter Randomized Clinical Trial. J Orthop Sports Phys Ther. 2018;48(3):137–45.PubMedCrossRef
41.
Koenig J, Jarczok MN, Fischer JE, Thayer JF. The association of (effective and ineffective) analgesic intake, pain interference and heart rate variability in a cross-sectional occupational sample. Pain Med (Malden, Mass). 2015;16(12):2261–70.CrossRef
42.
Amoroso Borges BL, Bortolazzo GL, Neto HP. Effects of spinal manipulation and myofascial techniques on heart rate variability: a systematic review. J Bodyw Mov Ther. 2018;22(1):203–8.PubMedCrossRef
43.
Yarnitsky D, Crispel Y, Eisenberg E, Granovsky Y, Ben-Nun A, Sprecher E, et al. Prediction of chronic post-operative pain: pre-operative DNIC testing identifies patients at risk. Pain. 2008;138(1):22–8.PubMedCrossRef
44.
Gerhardt A, Eich W, Treede RD, Tesarz J. Conditioned pain modulation in patients with nonspecific chronic back pain with chronic local pain, chronic widespread pain, and fibromyalgia. Pain. 2017;158(3):430–9.PubMedCrossRef
45.
46.
Ackelman BH, Lindgren U. Validity and reliability of a modified version of the neck disability index. J Rehabil Med. 2002;34(6):284–7.PubMedCrossRef
47.
Bjork S, Norinder A. The weighting exercise for the Swedish version of the EuroQol. Health Econ. 1999;8(2):117–26.PubMedCrossRef
48.
Brooks R. EuroQol: the current state of play. Health Policy (Amsterdam, Netherlands). 1996;37(1):53–72.CrossRef
49.
Cagnie B, Vinck E, Beernaert A, Cambier D. How common are side effects of spinal manipulation and can these side effects be predicted? Man Ther. 2004;9(3):151–6.PubMedCrossRef
50.
Senstad O, Leboeuf-Yde C, Borchgrevink C. Frequency and characteristics of side effects of spinal manipulative therapy. Spine (Phila Pa 1976). 1997;22(4):435–40 discussion 440–441.CrossRef
Metadata
Title
The effect of spinal manipulative therapy on heart rate variability and pain in patients with chronic neck pain: a randomized controlled trial
Authors
Anders Galaasen Bakken
Iben Axén
Andreas Eklund
Søren O’Neill
Publication date
01-12-2019
Publisher
BioMed Central
Keyword
Neck Pain
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3678-8

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