Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Effect of manual versus mechanically assisted manipulations of the thoracic spine in neck pain patients: study protocol of a randomized controlled trial

Authors: Anke Langenfeld, B. Kim Humphreys, Rob A. de Bie, Jaap Swanenburg

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

Neck pain is a common musculoskeletal condition with a point prevalence of around 15 % in males and 23 % in females that often presents in physiotherapy practice.
Physical therapy and/or manipulation therapy is generally the first management option for patients with mechanical neck pain. Physical therapists treat mechanical neck pain with a number of interventions including joint mobilization and/or manipulation, therapeutic exercises or education. However, manipulation of the cervical spine carries some risks. Treating the thoracic spine for neck pain is an alternative approach. Emerging evidence suggests that it may be effective for treating neck pain without the risks associated with cervical spine manipulation. A new electromechanical device has recently been developed and tested for delivering multiple high velocity, low amplitude thrust manipulations to the spine. This device incorporates both auditory and visual systems that provide real time feedback on the applied treatment. The objective of this study is to compare the short- and long-term effects of manual versus mechanically assisted manipulations of the thoracic spine for neck pain patients.

Methods/Design

A 6-month, randomized controlled trial consisting of 54 patients with acute or chronic neck pain patients will be conducted. Patients with no signs of major pathology and with little or no interference with daily activities will be recruited. Three treatment sessions with 4-day intervals will be carried out. The patients will be randomly assigned to receive either manually performed manipulations or electromechanical manipulations at the thoracic spine. The primary outcome is pain intensity as measured by the Visual Analogue Pain Rating Scale. The secondary outcome measures are neck physical disability using the Neck Disability Index, quality of life measured by the European Quality of Life 5 Dimensions 5 Levels and patients’ improvement using the Patient’s Global Impression of Change Scale.

Discussion

It is expected that both interventions will improve neck pain. This would be a significant finding, as thoracic spine manipulation for neck pain does not carry the same risk of injury as cervical spine manipulation. In addition, the results may provide useful information about therapeutic options for health care providers and patients for the problem of neck pain.

Trial registration

Current Controlled Trials ISRCTN88585962, registered January 2013
Appendix
Available only for authorised users
Literature
1.
Haldeman S, Carroll L, Cassidy JD, Schubert J, Nygren A. The bone and joint decade 2000–2010 task force on neck pain and its associated disorders: executive summary. J Manipulative Physiol Ther. 2008;32 Suppl 2:S7–9.
2.
Leaver AM, Maher CG, McAuley JH, Jull G, Latimer J, Refshauge KM. People seeking treatment for a new episode of neck pain typically have rapid improvement in symptoms: an observational study. J Geophys Res. 2013;59:31–7.
3.
Hogg-Johnson S, van der Velde G, Carroll LJ, Holm LW, Cassidy JD, Guzman J, et al. The burden and determinants of neck pain in the general population: results of the bone and joint decade 2000–2010 task force on neck pain and its associated disorders. J Manipulative Physiol Ther. 2009;32 Suppl 2:S46–60.CrossRefPubMed
4.
Carroll LJ, Hogg-Johnson S, Van Der VG, Haldeman S, Holm LW, Carragee EJ, et al. Course and prognostic factors for neck pain in the general population neck pain and its associated disorders. Spine (Phila Pa 1976). 2008;33:75–82.CrossRef
5.
Bogduk N, McGuirk B. Management of acute and chronic neck pain: an evidence-based approach. 1st ed. Edinburgh, London, New York, Oxford, Philadelphia, St. Louis, Sydney, Toronto: Elsevier; 2006.
6.
Guzman J, Haldeman S, Carroll LJ, Carragee EJ, Hurwitz EL, Peloso P, et al. Clinical practice implications of the bone and joint decade 2000–2010 task force on neck pain and its associated disorders: from concepts and findings to recommendations. J Manipulative Physiol Ther. 2008;32 Suppl 2:S227–43.
7.
Walton DM, Macdermid JC, Santaguida PL, Gross A, Carlesso L. Results of an international survey of practice patterns for establishing prognosis in neck pain: the ICON project. Open Orthop J. 2013;7:387–95.CrossRefPubMedPubMedCentral
8.
Costello J, Jull G. Evidence-based clinical statement neck pain. Pain. 2002;6:45.
9.
10.
11.
12.
Sweeney A, Doody C. Manual therapy for the cervical spine and reported adverse effects: a survey of Irish manipulative physiotherapists. Man Ther. 2010;15:32–6.CrossRefPubMed
13.
Thiel HW, Bolton JE, Docherty S, Portlock JC. Safety of chiropractic manipulation of the cervical spine: a prospective national survey. Spine (Phila Pa 1976). 2007;32:2375–8. discussion 2379.CrossRef
14.
Miley ML, Wellik KE, Wingerchuk DM, Demaerschalk BM. Does cervical manipulative therapy cause vertebral artery dissection and stroke? Neurologist. 2008;14:66–73.CrossRefPubMed
15.
Thomas LC, Rivett DA, Attia JR, Parsons M, Levi C. Risk factors and clinical features of craniocervical arterial dissection. Man Ther. 2011;16:351–6.CrossRefPubMed
16.
Cassidy JD, Boyle E, Coté P, He Y, Hogg-Johnson S, Silver FL, et al. Risk of vertebrobasilar stroke and chiropractic care: results of a population based case control and case-crossover study. Spine. 2008;36:92. author reply 92.CrossRef
17.
Marx P, Püschmann H, Haferkamp G, Busche T, Neu J. Manipulative treatment of the cervical spine and stroke. Fortschr Neurol Psychiatr. 2009;77:83–90.CrossRefPubMed
18.
Murphy DR. Current understanding of the relationship between cervical manipulation and stroke: what does it mean for the chiropractic profession? Chiropr Osteopat. 2010;18:22.CrossRefPubMedPubMedCentral
19.
Fernández-de-las-Peñas C, Palomeque-del-Cerro L, Rodríguez-Blanco C, Gómez-Conesa A, Miangolarra-Page JC. Changes in neck pain and active range of motion after a single thoracic spine manipulation in subjects presenting with mechanical neck pain: a case series. J Manipulative Physiol Ther. 2007;30:312–20.CrossRefPubMed
20.
Cleland JA, Childs JD, McRae M, Palmer JA, Stowell T. Immediate effects of thoracic manipulation in patients with neck pain: a randomized clinical trial. Man Ther. 2005;10:127.CrossRefPubMed
21.
Norlander S, Gustavsson B, Lindell J, Nordgren B. Reduced mobility in the cervico-thoracic motion segment - a risk factor for musculoskeletal neck-shoulder pain: a two-year prospective follow-up study. Scand J Rehabil Med. 1997;29:167–74.PubMed
22.
Norlander S, Nordgren B. Clinical symptoms related to musculoskeletal neck-shoulder pain and mobility in the cervico-thoracic spine. Scand J Rehabil Med. 1998;30:243–51.CrossRefPubMed
23.
Norlander S, Aste-Norlander U, Nordgren B, Sahlstedt B. Mobility in the cervico-thoracic motion segment: an indicative factor of musculo-skeletal neck-shoulder pain. Scand J Rehabil Med. 1996;28:183–92.PubMed
24.
González-Iglesias J, Fernández-de-las-Peñas C, Cleland JA, Alburquerque-Sendín F, Palomeque-del-Cerro L, Méndez-Sánchez R. Inclusion of thoracic spine thrust manipulation into an electro-therapy/thermal program for the management of patients with acute mechanical neck pain: a randomized clinical trial. Man Ther. 2009;14:306–13.CrossRefPubMed
25.
Childs JD, Cleland JA, Elliott JM, Teyhem DS, Wainner RS, Whitman JM, et al. Neck pain: clinical practice guidelines linked to International Classification of Functioning, Disability, and Health from the Orthopaedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008;38:A1–34.CrossRefPubMed
26.
Cleland JA, Glynn P, Whitman JM, Eberhart SL, MacDonald C, Childs JD. Short-term effects of thrust versus nonthrust mobilization/manipulation directed at the thoracic spine in patients with neck pain: a randomized clinical trial. Phys Ther. 2007;87:431–40.CrossRefPubMed
27.
Lau HMC, Wing Chiu TT, Lam T-H. The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial. Man Ther. 2011;16:141–7.CrossRefPubMed
28.
Walser RF, Meserve BB, Boucher TR. The effectiveness of thoracic spine manipulation for the management of musculoskeletal conditions: a systematic review and meta-analysis of randomized clinical trials. J Man Manip Ther. 2009;17:237–46.CrossRefPubMedPubMedCentral
29.
Cross KM, Kuenze C, Grindstaff TL, Hertel J. Thoracic spine thrust manipulation improves pain, range of motion, and self-reported function in patients with mechanical neck pain: a systematic review. J Orthop Sports Phys Ther. 2011;41:633–42.CrossRefPubMed
30.
Gross A, Miller J, D’Sylva J, Burnie S, Goldsmith C, Graham N, et al. Manipulation or mobilisation for neck pain (Review). Cochrane Libr. 2010;5:1–110.
31.
Young JL, Walker D, Snyder S, Daly K. Thoracic manipulation versus mobilization in patients with mechanical neck pain: a systematic review. J Man Manip Ther. 2014;22:141–53.CrossRefPubMedPubMedCentral
32.
Kawchuk GN, Prasad NG, McLeod RC, Liddle T, Li T, Zhu Q. Variability of force magnitude and force duration in manual and instrument-based manipulation techniques. J Manipulative Physiol Ther. 2006;29:611–8.CrossRefPubMed
33.
Colloca CJ, Keller TS, Black P, Normand MC, Harrison DE, Harrison DD. Comparison of mechanical force of manually assisted chiropractic adjusting instruments. J Manipulative Physiol Ther. 2005;28:414–22.CrossRefPubMed
34.
Wood TG, Colloca CJ, Matthews R. A pilot randomized clinical trial on the relative effect of instrumental (MFMA) versus manual (HVLA) manipulation in the treatment of cervical spine dysfunction. J Manipulative Physiol Ther. 2001;24:260–71.CrossRefPubMed
35.
Shearar KA, Colloca CJ, White HL. A randomized clinical trial of manual versus mechanical force manipulation in the treatment of sacroiliac joint syndrome. J Manipulative Physiol Ther. 2005;28:493–501.CrossRefPubMed
36.
37.
38.
Price D, McGrath P, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983;17:45–56.CrossRefPubMed
39.
Price D, Bush F, Long S, Harkins S. A comparison of pain measurement characteristics of mechanical visual analogue and simple numerical rating scales. Pain. 1994;56:217–26.CrossRefPubMed
40.
Deloach LJ, Stiff JL, Caplan AB. The Visual Analog Scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scale. Anesth Analg. 1998;86:102–6.PubMed
41.
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 1994;2005:798–804.
42.
43.
Vernon H. The Neck Disability Index: state-of-the-art, 1991–2008. J Manipulative Physiol Ther. 2008;31:491–502.CrossRefPubMed
44.
Kim SH, Kim HJ, Lee S-I, Jo M-W. Comparing the psychometric properties of the EQ-5D-3L and EQ-5D-5L in cancer patients in Korea. Qual Life Res. 2012;21:1065–73.CrossRefPubMed
45.
Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22:1717–27.CrossRefPubMed
46.
Swanenburg J, Gruber C, Brunner F, Wirth B. Patients’ and therapists’ perception of change following physiotherapy in an orthopedic hospital’s outpatient clinic. Physiother Theory Pract. 2014;3985:1–6.
47.
Spurling R, Scoville W. Lateral rupture of the cervical intervertebral discs: a common cause of shoulder and arm pain. Surgery, Gynecol Obstet. 1944;78:350–8.
48.
Wainner RS, Fritz JM, Irrgang JJ, Boninger ML, Delitto A, Allison S. Reliability and diagnostic accuracy of the clinical examination and patient self-report measures for cervical radiculopathy. Spine. 2003;28:52–62.CrossRefPubMed
49.
Cleland JA, Koppenhaver S. Cervical Spine. In: Netter’s orthopaedic clinical examination: an evidence-based approach. 2nd ed. Philadelphia: Saunders, an imprint of Elsevier Inc; 2011. p. 66–128.
50.
Shacklock M. Clinical neurodynamics: a new system of musculoskeletal treatment. 1st ed. Edinburgh, London, New York, Oxford, Philadelphia, St. Louis, Sydney, Toronto: Butterworth-Heinemann, an imprint of Elsevier Inc; 2005.
51.
Seffinger MA, Najm WI, Mishra SI, Adams A, Dickerson VM, Murphy LS, et al. Reliability of spinal palpation for diagnosis of back and neck pain: a systematic review of the literature. Spine. 2004;29:E413–25.CrossRefPubMed
52.
Schneider M, Erhard R, Brach J, Tellin W, Imbarlina F, Delitto A. Spinal palpation for lumbar segmental mobility and pain provocation: an interexaminer reliability study. J Manipulative Physiol Ther. 2008;31:465–73.CrossRefPubMed
53.
Krauss JR, Evjenth O, Creighton D. Translatoric spinal manipulation for physical therapists. 1st ed. A Lakeview Media L.L.C: Publication; 2006.
54.
Colloca CJ. Neuromechanical Innovations: impulse adjusting system. 1st ed. Chandler, Arizona: Neuromechanical Innovations; 2012.
55.
Jull GA, Falla D, Treleaven J, Sterling M, O’Leary S. A therapeutic exercise approach for cervical disorders. In: Boyling JD, Jull GA, editors. Grieves Mod Man Ther vertebral Column. 3rd ed. Edinburgh, London, New York, Oxford, Philadelphia, St. Louis, Sydney, Toronto: Elsevier, Churchill, Livingston; 2004. p. 451–71.
56.
O’Leary S, Jull G, Kim M, Vicenzino B. Specificity in retraining craniocervical flexor muscle performance. J Orthop Sports Phys Ther. 2007;37:3–9.CrossRefPubMed
57.
58.
Farrar JT, Young JP, Lamoreaux L, Werth JL, Poole RM. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001;94:149–58.CrossRefPubMed
59.
Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004;27:26–35.CrossRefPubMed
60.
Noordzij M, Tripepi G, Dekker FW, Zoccali C, Tanck MW, Jager KJ. Sample size calculations: basic principles and common pitfalls. Nephrol Dial Transplant. 2010;25:1388–93.CrossRefPubMed
61.
Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001;18:205–7.CrossRefPubMedPubMedCentral
62.
Metadata
Title
Effect of manual versus mechanically assisted manipulations of the thoracic spine in neck pain patients: study protocol of a randomized controlled trial
Authors
Anke Langenfeld
B. Kim Humphreys
Rob A. de Bie
Jaap Swanenburg
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0763-5

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Editorial

Making research articles fit for purpose: structured reporting of key methods and findings

Study protocol

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial

Study protocol

Virtual restorative environment therapy as an adjunct to pain control during burn dressing changes: study protocol for a randomised controlled trial

Letter

Are urgent care centers a viable venue for recruitment in clinical trials?

Study protocol

The effect of massage therapy and/or exercise therapy on subacute or long-lasting neck pain - the Stockholm neck trial (STONE): study protocol for a randomized controlled trial

Study protocol

Interaction of titanium, zirconia and lithium disilicate with peri-implant soft tissue: study protocol for a randomized controlled trial