Efficacy of Yijinjing combined with Tuina for patients with non-specific chronic neck pain: study protocol for a randomized controlled trial
Tóm tắt
Non-specific chronic neck pain (NCNP) is a common musculoskeletal disorder which has caused a huge economic burden due to its expensive health costs and high re-occurrence rate. Yijinjing and Tuina are widely used for non-specific chronic neck pain in China. But there is little scientific evidence to evaluate their efficacy for NCNP. The aim of this research is to compare the efficacy of Yijinjng combined with Tuina versus Tuina for patients with NCNP. A randomized controlled trial in which 102 patients with non-specific chronic neck pain will be recruited and randomly allocated to either the Tuina group or the Yijinjng combined with Tuina group in a 1:1 ratio. The interventions for both groups will be carried out three times a week for 8 weeks. The patients in the two groups will receive follow-up 1 month after the intervention. The primary outcome will be the changes in the visual analog scale (VAS). Secondary outcomes will be measured by the Neck Disability Index (NDI), Self-Rating Anxiety Scale (SAS), and Tissue Hardness and Active Range of Motion (AROM). The data will be analyzed at the baseline, 4 weeks during the intervention, at the end of the intervention, and 1 month after the intervention. The significance level sets as 5%. The safety of interventions will be evaluated after each treatment session. The purpose of this trial is to determine whether Yijinjing combined with Tuina is not inferior to Tuina for patients with NCNP. This study will provide clinicians and stakeholders much-needed knowledge for a complementary and alternative therapy for patients with non-specific chronic neck pain. ChiCTR registry
(ChiCTR) 2000036805
. Registered on August 25, 2020
Tài liệu tham khảo
Gummesson C, Isacsson SO, Isacsson AH, et al. The transition of reported pain in different body regions--a one-year follow-up study. BMC Musculoskelet Disord. 2006;7(1):17. https://doi.org/10.1186/1471-2474-7-17.
López-de-Uralde-Villanueva I, Beltran-Alacreu H, Fernández-Carnero J, La Touche R. Pain management using a multimodal physiotherapy program including a biobehavioral approach for chronic nonspecific neck pain: a randomized controlled trial. Physiother Theory Pract. 2020;36(1):45–62. https://doi.org/10.1080/09593985.2018.1480678.
Chiu TT, Leung AS. Neck pain in Hong Kong: a telephone survey on prevalence, consequences, and risk groups. Spine (Phila Pa 1976). 2006;31(16):E540–4. https://doi.org/10.1097/01.brs.0000225999.02326.ad.
Lau HMC, Wing TT, Lam TH. The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain – a randomized controlled trial. Man Ther. 2011;16(2):141–7. https://doi.org/10.1016/j.math.2010.08.003.
Feng B, Liang Q, Wang Y, Andersen LL, Szeto G. Prevalence of work-related musculoskeletal symptoms of the neck and upper extremity among dentists in China. BMJ Open. 2014;4(12):e006451. https://doi.org/10.1136/bmjopen-2014-006451.
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(2):S46–60. https://doi.org/10.1016/j.jmpt.2008.11.010.
Haldeman S, Carroll L, Cassidy JD. Findings from the bone and joint decade 2000 to 2010 task force on neck pain and its associated disorders. J Occup Environ Med. 2010;52(4):424–7. https://doi.org/10.1097/JOM.0b013e3181d44f3b.
Wermeling M, Scherer M, Himmel W. GPs’ experiences of managing non-specific neck pain--a qualitative study. Fam Pract. 2011;28(3):300–6. https://doi.org/10.1093/fampra/cmq109.
Falla DL, Jull GA, Hodges PW. Patients with neck pain demonstrate reduced electromyographic activity of the deep cervical flexor muscles during performance of the craniocervical flexion test. Spine. 2004;29(19):2108–14. https://doi.org/10.1097/01.brs.0000141170.89317.0e.
Kim JY, Kwag KI. Clinical effects of deep cervical flexor muscle activation in patients with chronic neck pain. J Phys Ther Sci. 2016;28(1):269–73. https://doi.org/10.1589/jpts.28.269.
Karimi N, Rezasoltani A, Rahnama L, Noori-Kochi F, Jaberzadeh S. Ultrasonographic analysis of dorsal neck muscles thickness changes induced by isometric contraction of shoulder muscles: a comparison between patients with chronic neck pain and healthy controls. Man Ther. 2016;22:174–8. https://doi.org/10.1016/j.math.2015.12.004.
Barnsley L, Lord S, Bogduk N. Comparative local anaesthetic blocks in the diagnosis of cervical zygapophysial joint pain. Pain. 1993;55(1):99–106. https://doi.org/10.1016/0304-3959(93)90189-V.
Helgadottir H, Kristjansson E, Mottram S, Karduna A, Jonsson H Jr. Altered scapular orientation during arm elevation in patients with insidious onset neck pain and whiplash-associated disorder. J Orthop Sports Phys Ther. 2010;40(12):784–91. https://doi.org/10.2519/jospt.2010.3405.
Cagnie B, Struyf F, Cools A, Castelein B, Danneels L, O’Leary S. The relevance of scapular dysfunction in neck pain: a brief commentary. J Orthop Sports Phys Ther. 2014;44(6):435–9. https://doi.org/10.2519/jospt.2014.5038.
Côté P, van der Velde G, Cassidy JD, Carroll LJ, Hogg-Johnson S, Holm LW, et al. The burden and determinants of neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008;33(4 Suppl):S60–74. https://doi.org/10.1097/BRS.0b013e3181643ee4.
Porta M. A comparative trial of botulinum toxin type A and methylprednisolone for the treatment of myofascial pain syndrome and pain from chronic muscle spasm. Pain. 2000;85(1-2):101–5. https://doi.org/10.1016/S0304-3959(99)00264-X.
Gilron I, Jensen TS, Dickenson AH. Combination pharmacotherapy for management of chronic pain: from bench to bedside. Lancet Neurology. 2013;12(11):1084–95. https://doi.org/10.1016/S1474-4422(13)70193-5.
Graham DY. Prevention of gastroduodenal injury induced by chronic nonsteroidal antiinflamatory drug therapy. Gastroenterology. 1989;96(2Pt2 Suppl):675–81.
Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2013;16(5):821–47. https://doi.org/10.18433/j3vw2f.
Parikh P, Santaguida P, Macdermid J, Gross A, Eshtiaghi A. Comparison of CPG’s for the diagnosis, prognosis and management of non-specific neck pain: a systematic review. BMC Musculoskelet Disord. 2019;20(1):81. https://doi.org/10.1186/s12891-019-2441-3.
Cheng YH, Huang GC. Efficacy of massage therapy on pain and dysfunction in patients with neck pain: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2014;2014:204360. https://doi.org/10.1155/2014/204360. Epub 2014 Feb 20.
Pach D, Piper M, Lotz F, Reinhold T, Dombrowski M, Chang Y, et al. Effectiveness and cost-effectiveness of Tuina for chronic neck pain: a randomized controlled trial comparing Tuina with a no-intervention waiting list. J Altern Complement Med. 2018;24(3):231–7. https://doi.org/10.1089/acm.2017.0209.
Yuan QL, Guo TM, Liu L, Sun F, Zhang YG. Traditional Chinese medicine for neck pain and low back pain: a systematic review and meta-analysis. PLoS One. 2015;10(2):e0117146. https://doi.org/10.1371/journal.pone.0117146.
Patel KC, Gross A, Graham N, Goldsmith CH, Ezzo J, Morien A, et al. Massage for mechanical neck disorders. Cochrane Database Syst Rev. 2012;9:CD004871.
Kong LJ, Zhan HS, Cheng YW, Yuan WA, Chen B, Fang M. Massage therapy for neck and shoulder pain: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2013;10(2013):613279.
Goats GC. Massage—the scientific basis of an ancient art: part 2—physiological and therapeutic effects. Br J Sports Med. 1994;28(3):153–6. https://doi.org/10.1136/bjsm.28.3.153.
Wang X, Pi Y, Chen B, Chen P, Liu Y, Wang R, et al. Effect of traditional Chinese exercise on the quality of life and depression for chronic diseases: a meta-analysis of randomised trials. Sci Rep. 2015;5(1):15913. https://doi.org/10.1038/srep15913.
Bertozzi L, Gardenghi I, Turoni F, Villafañe JH, Capra F, Guccione AA, et al. Effect of therapeutic exercise on pain and disability in the management of chronic nonspecific neck pain: systematic review and meta-analysis of randomized trials. Phys Ther. 2013;93(8):1026–36. https://doi.org/10.2522/ptj.20120412.
Xiang HP, Liu SJ, Jia HR, et al. A brief analysis on the effect of fitness qigong Yijin method on respiratory muscle [in Chinese]. J Hubei Sports Sci. 2006;25:42–6.
Zhao LJ, Liu CX, Zhao LB, et al. Effects of Yijinjing exercising combined with Gutong plaster on physiology curvature of cervical spondylosis with cervical type [in Chinese]. Hebei J Trad Chin Med. 2017;39:830–4.
Liu YJ. The study yijinjing and taijiquan influence of depression on University students [in Chinese]. Sichuan Sport Sci. 2013;6:49–51.
Hou ZP. Mechanism of yi jinjing for the treatment of sub-health state [in Chinese]. J Liaoing Univ TCM. 2009;11:69–70.
Yan XH. Effect of yi jinjing on the respiratory health rehabilitation [in Chinese]. J Nangchang Colleg Educ. 2010;25:166.
Childs JD, Cleland JA, Elliott JM, Teyhen DS, Wainner RS, Whitman JM, et al. Neck pain: clinical practice guidelines linked to the International Classification of Functioning, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association. J Orthop Sports Phys Ther. 2008;38(9):A1–A34. https://doi.org/10.2519/jospt.2008.0303.
Goode AP, Freburger J, Carey T. Prevalence, practice patterns, and evidence for chronic neck pain. Arthritis Care Res (Hoboken). 2010;62(11):1594–601. https://doi.org/10.1002/acr.20270.
Skillgate E, Bill AS, Côté P, Viklund P, Peterson A, Holm LW. 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. Trials. 2015;16(1):414. https://doi.org/10.1186/s13063-015-0926-4.
Bryans R, Decina P, Descarreaux M, Duranleau M, Marcoux H, Potter B, et al. Evidence-based guidelines for the chiropractic treatment of adults with neck pain. J Manipulative Physiol Ther. 2014;37(1):42–63. https://doi.org/10.1016/j.jmpt.2013.08.010.
Wu Z, Kong L, Zhu Q, Song P, Fang M, Sun W, et al. Efficacy of tuina in patients with chronic neck pain: study protocol for a randomized controlled trial. Trials. 2019;20(1):59. https://doi.org/10.1186/s13063-018-3096-3.
Song BL, Fang M. Tuina therapeutics. Beijing: Chinese Traditional Medicine Publishing House; 2016.
Yao F. One finger Chan Tuina. Beijing: Chinese Traditional Medicine Publishing House; 2018.
Lv LJ. Traditional Chinese exercise of tuina. Beijing: Chinese Traditional Medicine Publishing House; 2016.
Hui KK, Nixon EE, Vangel MG, Liu J, Marina O, Napadow V, et al. Characterization of the “deqi” response in acupuncture. BMC Complement Altern Med. 2007;7(1):33. https://doi.org/10.1186/1472-6882-7-33.
Shi GX, Yang XM, Liu CZ, Wang LP. Factors contributing to therapeutic effects evaluated in acupuncture clinical trials. Trials. 2012;13(1):42. https://doi.org/10.1186/1745-6215-13-42.
Tuttle N. Do changes within a manual therapy treatment session predict between-session changes for patients with cervical spine pain? Aust J Physiother. 2005;51(1):43–8. https://doi.org/10.1016/S0004-9514(05)70052-0.
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001;8(12):1153–7. https://doi.org/10.1111/j.1553-2712.2001.tb01132.x.
Vernon H, Mior S. The neck disability index: a study of reliability and validity. J Manipulative Physiol Ther. 1991;14(7):409–15.
Zung WWK. Zung self-rating depression scale and depression status inventory, in: assessment of depression. Berlin, Heidelberg: Springer Berlin Heidelberg; 1986. p. 221–31.
Zheng Z, Wang J, Gao Q, Hou J, Ma L, Jiang C, et al. Therapeutic evaluation of lumbar tender point deep massage for chronic non-specific low back pain. J Tradit Chin Med. 2012;32(4):534–7. https://doi.org/10.1016/S0254-6272(13)60066-7.
Damapong P, Kanchanakhan N, et al. A randomized controlled trial on the effectiveness of court-type traditional Thai massage versus amitriptyline in patients with chronic tension-type headache. Evid Based Complement Alternat Med. 2015;2015:930175.
Lluch E, Schomacher J, Gizzi L, Petzke F, Seegar D, Falla D. Immediate effects of active cranio-cervical flexion exercise versus passive mobilization of the upper cervical spine on pain and performance on the cranio-cervical flexion test. Man Ther. 2014;19(1):25–31. https://doi.org/10.1016/j.math.2013.05.011.
Martel J, Dugas C, Dubois JD, Descarreaux M. A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain. BMC Musculoskelet Disord. 2011;12(1):41. https://doi.org/10.1186/1471-2474-12-41.
Edwards J, Knowles N. Superficial dry needling and active stretching in the treatment of myofascial pain--a randomised controlled trial. Acupunct Med. 2003;21(3):80–6. https://doi.org/10.1136/aim.21.3.80.
Liang BJ, Zhang LC. Effect of cervical spine exercises combined with massage on the treatment of NCNP [in Chinese]. China Rural Med. 2016;23(2):41–2.
Madson TJ, Cieslak KR, Gay RE. Joint mobilization vs massage for chronic mechanical neck pain: a pilot study to assess recruitment strategies and estimate outcome measure variability. J Manipulative Physiol Ther. 2010;33(9):644–51. https://doi.org/10.1016/j.jmpt.2010.08.008.
Schwerla F, Bischoff A, Nurnberger A, Genter P, Guillaume JP, Resch KL. Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy. Forsch Komplementmed. 2008;15(3):138–45. https://doi.org/10.1159/000132397.
Zhang Q, Wang YG, Liu K. Research progresses on application of Yi Jin Jing (Sinew-transforming Qigong exercises) [in Chinese]. Henan Zhongyi. 2013;33(5):774–6.
Guo CQ, Cheng YW, Kong LJ, Bu JH, Yang XC. On Gongfa Gongli of Yi Jin Jing from the perspective of biomechanics [in Chinese]. Changchun Zhongyiyao Daxue Xuebao. 2014;30(2):262–4.
Hu WM, Gong L. The preliminary experience of spreading tuina Yijinjing Gong in the community [in Chinese]. Anmo Yu Kangfu Yixue. 2012;2(10):2–3.
Zhang WC, Zhong ZB, Wu QH, Chen XF, Wang SY, Zhang Y. A research on health Qigong-Yi Jin Jing for slowing down intelligence decline of the aged [in Chinese]. Zhongguo Xingwei Yixue Kexue. 2006;15(9):827.