A randomised controlled trial of multimodal physiotherapy versus advice for recent onset, painful cervical radiculopathy - the PACeR trial protocol

Louise Keating, Caroline Treanor, Julie Sugrue, Dara Meldrum, Ciaran Bolger, Catherine Doody, Louise Keating, Caroline Treanor, Julie Sugrue, Dara Meldrum, Ciaran Bolger, Catherine Doody

Abstract

Background: A research gap exists for optimal management of cervical radiculopathy in the first 12 weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4 week physiotherapy programme (6-8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome.

Methods: Participants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants (n = 64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12 weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12 weeks. Participants' report of pain, disability and their rating of recovery is also recorded by telephone interview at 6 months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200).

Discussion: An internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites.

Trial registration: NCT02449200 . Registered 20/05/15.

Keywords: Cervical radiculopathy; Exercise; Manual therapy; Physiotherapy; Pressure algometry; Unloading tape.

Conflict of interest statement

The authors declare that they have no competing interest.

Figures

Fig. 1
Fig. 1
Neural unloading tape. Hypoallergenic Fixomull applied first as underwrap (left) with zinc oxide applied with tension, with arm supported below the elbow (right)

References

    1. Bono CM, Ghiselli G, Gilbert TJ, Kreiner DS, Reitman C, Summers JT, Baisden JL, Easa J, Fernand R, Lamer T, et al. An evidence-based clinical guideline for the diagnosis and treatment of cervical radiculopathy from degenerative disorders. Spine J. 2011;11(1):64–72. doi: 10.1016/j.spinee.2010.10.023.
    1. Haldeman S, Carroll L, Cassidy J, Schubert J, Nygren A. The bone and joint decade 2000–2010 task force on neck pain and its associated disorders - executive summary. Spine. 2008;33:S5–S7. doi: 10.1097/BRS.0b013e3181643f40.
    1. Blanpied PR, Gross AR, Elliott JM, Devaney LL, Clewley D, Walton DM, Sparks C, Robertson EK. Neck pain: revision 2017. J Orthop Sports Phys Ther. 2017;47(7):A1–A83. doi: 10.2519/jospt.2017.0302.
    1. Alentado VJ, Lubelski D, Steinmetz MP, Benzel EC, Mroz TE. Optimal duration of conservative management prior to surgery for cervical and lumbar radiculopathy: a literature review. Glob Spine J. 2014;4(4):279–286. doi: 10.1055/s-0034-1387807.
    1. Hurwitz EL, Carragee EJ, Velde G, Carroll LJ, Nordin M, Guzman J, Peloso PM, Holm LW, Côté P, Hogg-Johnson S, et al. Treatment of neck pain: noninvasive interventions. Eur Spine J. 2008;17(S1):123–152. doi: 10.1007/s00586-008-0631-z.
    1. Kjaer P, Kongsted A, Hartvigsen J, Isenberg-Jorgensen A, Schiottz-Christensen B, Soborg B, Krog C, Moller CM, Halling CMB, Lauridsen HH, et al. National clinical guidelines for non-surgical treatment of patients with recent onset neck pain or cervical radiculopathy. Eur Spine J. 2017;26(9):2242–2257. doi: 10.1007/s00586-017-5121-8.
    1. Cote P, Wong J, Sutton D, Shearer H, Mior S, Randhawa K, Ameis A, Carroll L, Nordin M, Yu H, et al. Management of neck pain and associated disorders: a clinical practice guideline from the Ontario protocol for traffic injury management (OPTIMa) collaboration. Eur Spine J. 2016;25:2002–2022. doi: 10.1007/s00586-016-4467-7.
    1. Salemi GSG, Meneghini F, et al. Prevalence of cervical spondylotic radiculopathy: a door-to-door survey in a Sicilian municipality. Acta Neurol Scan. 1996;93(2–3):184–188.
    1. Boyles R, Toy P, Mellon J, Jr, Hayes M, Hammer B. Effectiveness of manual physical therapy in the treatment of cervical radiculopathy: a systematic review. J Man Manip Ther. 2011;19(3):135–142. doi: 10.1179/2042618611Y.0000000011.
    1. Gross A, Langevin P, Burnie SJ, Bedard-Brochu MS, Empey B, Dugas E, Faber-Dobrescu M, Andres C, Graham N, Goldsmith CH, et al. Manipulation and mobilisation for neck pain contrasted against an inactive control or another active treatment. Cochrane Database Syst Rev. (2015, 9):CD004249.
    1. Cleland JA, Fritz JM, Whitman JM, Heath R. Predictors of short-term outcome in people with a clinical diagnosis of cervical radiculopathy. Phys Ther. 2007;87(12):1619–1632. doi: 10.2522/ptj.20060287.
    1. Gross AR, Paquin JP, Dupont G, Blanchette S, Lalonde P, Cristie T, Graham N, Kay TM, Burnie SJ, Gelley G, et al. Exercises for mechanical neck disorders: a Cochrane review update. Man Ther. 2016;24:25–45. doi: 10.1016/j.math.2016.04.005.
    1. Vernon H, Mior S. The neck disability index: a study of reliability and validity. J Manip Physiol Ther. 1991;14:409–415.
    1. Jensen M, Turner J, Romano J. What is the maximum number of levels needed in pain intensity measurement? Pain. 1994;58:387–392. doi: 10.1016/0304-3959(94)90133-3.
    1. Cheak-Zamora NC, Wyrwich KW, McBride TD. Reliability and validity of the SF-12v2 in the medical expenditure panel survey. Qual Life Res. 2009;18(6):727–735. doi: 10.1007/s11136-009-9483-1.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–370. doi: 10.1111/j.1600-0447.1983.tb09716.x.
    1. Waddell G, Newton M, Henderson I, Somerville D, Main C. A fear-avoidance beliefs questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52:157–168. doi: 10.1016/0304-3959(93)90127-B.
    1. Landers MR, Creger RV, Baker CV, Stutelberg KS. The use of fear-avoidance beliefs and nonorganic signs in predicting prolonged disability in patients with neck pain. Man Ther. 2008;13(3):239–248. doi: 10.1016/j.math.2007.01.010.
    1. Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407–415. doi: 10.1016/0197-2456(89)90005-6.
    1. Walton DM, Macdermid JC, Nielson W, Teasell RW, Chiasson M, Brown L. Reliability, standard error and minimum detectable change of clinical pressure pain threshold testing in people with and without acute neck pain. J Orthop Sports Phys Ther. 2011;41:644–650. doi: 10.2519/jospt.2011.3666.
    1. Grieve's Modern Manual Therapy: The Vertebral Column. Edited by Boyling JD, Palastanga N, Grieve G. London: Churchill Livingstone; 1994: p. 577–585.
    1. Wainner RS, Gill H. Diagnosis and nonoperative management of cervical radiculopathy. J Orthop Sports Phys Ther. 2000;30(12):728–744. doi: 10.2519/jospt.2000.30.12.728.
    1. Freynhagen R, Baron R, Gockel U, Tolle TR. painDETECT: a new screening questionnaire to identify neuropathic components in patients with back pain. Curr Med Res Opin. 2006;22(10):1911–1920. doi: 10.1185/030079906X132488.
    1. Boutron I, Moher D, Altman DG, Schulz K, PftCG R. Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008;148:295–309. doi: 10.7326/0003-4819-148-4-200802190-00008.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Nee RJ, Vicenzino B, Jull GA, Cleland JA, Coppieters MW. A novel protocol to develop a prediction model that identifies patients with nerve-related neck and arm pain who benefit from the early introduction of neural tissue management. Contemp Clin Trials. 2011;32(5):760–770. doi: 10.1016/j.cct.2011.05.018.
    1. Langevin P, Roy JS, Desmeules F. Cervical radiculopathy: study protocol of a randomised clinical trial evaluating the effect of mobilisations and exercises targeting the opening of intervertebral foramen [NCT01500044] BMC Musculoskelet Disord. 2012;13:10. doi: 10.1186/1471-2474-13-10.
    1. 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(1):52–62. doi: 10.1097/00007632-200301010-00014.
    1. Thoomes EJ, Scholten-Peeters GG, de Boer AJ, Olsthoorn RA, Verkerk K, Lin C, Verhagen AP. Lack of uniform diagnostic criteria for cervical radiculopathy in conservative intervention studies: a systematic review. Eur Spine J. 2012;21(8):1459–1470. doi: 10.1007/s00586-012-2297-9.
    1. Childs JD, Fritz JM, Piva SR, Whitman JM. Proposal of a classification system for patients with neck pain. J Orthop Sports Phys Ther. 2004;34(11):686–696. doi: 10.2519/jospt.2004.34.11.686.
    1. Kuijper B, Tans JT, Beelen A, Nollet F, de Visser M. Cervical collar or physiotherapy versus wait and see policy for recent onset cervical radiculopathy: randomised trial. BMJ. 2009;339:b3883. doi: 10.1136/bmj.b3883.
    1. Nee RJ, Vicenzino B, Jull GA, Cleland JA, Coppieters MW. Neural tissue management provides immediate clinically relevant benefits without harmful effects for patients with nerve-related neck and arm pain: a randomised trial. J Phys. 2012;58(1):23–31.
    1. Vicenzino B, Neal R, Collins D, Wright A. The displacement, velocity and frequency profile of the frontal plane motion produced by the cervical lateral glide treatment technique. Clin Biomech. 1999;14:515–521. doi: 10.1016/S0268-0033(99)00011-X.
    1. Maitland G. Vertebral manipulation. Management of Neuromusculoskeletal Disorders - volume 1. 8th edn. London: Churchill Livingstone; 2014.
    1. Tampin B, Slater H, Hall T, Lee G, Briffa NK. Quantitative sensory testing somatosensory profiles in patients with cervical radiculopathy are distinct from those in patients with nonspecific neck-arm pain. Pain. 2012;153(12):2403–2414. doi: 10.1016/j.pain.2012.08.007.
    1. Langevin P, Desmeules F, Lamothe M, Robitaille S, Roy JS. Comparison of 2 manual therapy and exercise protocols for cervical radiculopathy: a randomized clinical trial evaluating short-term effects. J Orthop Sports Phys Ther. 2015;45(1):4–17. doi: 10.2519/jospt.2015.5211.
    1. MCCONNELL J. Taping Techniques. 2004. Taping for pain relief; pp. 15–27.
    1. Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010;40(5):318–323. doi: 10.2519/jospt.2010.3180.
    1. Schmid AB, Brunner F, Luomajoki H, Held U, Bachmann LM, Kunzer S, Coppieters MW. Reliability of clinical tests to evaluate nerve function and mechanosensitivity of the upper limb peripheral nervous system. BMC Musculoskelet Disord. 2009;10:11. doi: 10.1186/1471-2474-10-11.
    1. Vernon H. The neck disability index: state-of-the-art, 1991-2008. J Manip Physiol Ther. 2008;31(7):491–502. doi: 10.1016/j.jmpt.2008.08.006.
    1. Nordin M, Carragee EJ, Hogg-Johnson S, Weiner SS, Hurwitz EL, Peloso PM, Guzman J, Velde G, Carroll LJ, Holm LW, et al. Assessment of neck pain and its associated disorders. Eur Spine J. 2008;17(S1):101–122. doi: 10.1007/s00586-008-0630-0.
    1. Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manip Physiol Ther. 2004;27:26–35. doi: 10.1016/j.jmpt.2003.11.003.
    1. Cleland JA, Childs JD, Whitman JM. Psychometric properties of the neck disability index and numeric pain rating scale in patients with mechanical neck pain. Arch Phys Med Rehabil. 2008;89(1):69–74. doi: 10.1016/j.apmr.2007.08.126.
    1. Ware J, Kosinski M, Keller S. A 12-item short-form health survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996;34(3):220–233. doi: 10.1097/00005650-199603000-00003.
    1. Jenkinson C, Layte R, Jenkinson D, Lawrence K, Petersen S, Paice C, Stradling J. A shorter form health survey: can the SF-12 replicate results from the SF-36 in longitudinal studies. J Public Health Med. 1997;19(2):179–186. doi: 10.1093/oxfordjournals.pubmed.a024606.
    1. Bjellanda I, Dahlb A, Haugc T, Neckelmannd D. The validity of the hospital anxiety and depression scale: an updated literature review. J Psychosom Res. 2002;52:69–77. doi: 10.1016/S0022-3999(01)00296-3.
    1. Chien A, Eliav E, Sterling M. Whiplash (grade II) and cervical radiculopathy share a similar sensory presentation: an investigation using quantitative sensory testing. Clin J Pain. 2008;24(7):595–603. doi: 10.1097/AJP.0b013e31816ed4fc.
    1. Cleland JA, Fritz JM, Whitman JM, Palmer JA. The reliability and construct validity of the neck disability index and patient specific functional scale in patients with cervical radiculopathy. Spine. 2006;31(5):598–602. doi: 10.1097/01.brs.0000201241.90914.22.
    1. Chang, A. 1999. Sample size calculator for comparing means of two independent groups [Online]. Dept of Obstetrics Gynaecology, The Chinese University of Hong Kong. Available: . Accessed 15 Jan 2014.
    1. Machin D, Campbell M, Fayers P, Pinol A. Sample Size Tables for Clinical Studies, Second Ed. Oxford: Blackwell Science; 1997.

Source: PubMed

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