Skip to main content
Top
Published in: Trials 1/2020

01-12-2020 | Care | Study protocol

Efficacy of Tuina in patients with chronic low back pain: study protocol for a randomized controlled trial

Authors: Shuaipan Zhang, Lingjun Kong, Qingguang Zhu, Zhiwei Wu, Jianhua Li, Min Fang, Wuquan Sun, Yanbin Cheng, Shanda Xu, Guangxin Guo, Xin Zhou, Zhizhen Lv

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

Low back pain is a common reason for medical care and carries a heavy social burden. The efficacy of Tuina or health care education for low back pain has been evaluated in previous systematic reviews. However, there is no evidence to support the superiority of one form of treatment over another. The aim of this study is to compare the efficacy of Tuina with health care education in the management of low back pain.

Methods/design

This study is a randomized controlled trial with parallel-group design including two groups: a Tuina group and a health care education group. A total of 160 eligible participants will be randomly assigned to the groups in a 1:1 ratio. The interventions of both groups will last for 20 min and be carried out twice each week for a period of 12 weeks. The primary outcome is the Oswestry Disability Index. The secondary outcomes include a visual analogue scale and the 36-item Short Form Health Survey. They will be assessed at baseline, at the end of the intervention every month, and during 6 months and 9 months of follow-up by repeated measures analysis of variance. The significance level is 5%. The safety of Tuina and health care education will be evaluated after each treatment session. This study will focus on the value of Tuina and health care education for low back pain and will highlight any differences in the efficacy of the treatments.

Discussion

This study will evaluate the efficacy and safety of Tuina intervention for low back pain, which could provide reliable evidence for clinical decision making for patients with low back pain.

Trial registration

Chinese Clinical Trial Registry, ChiCTR1900022656​. Registered on 23 April 2019.
Literature
1.
go back to reference Buchbinder R, Hartvigsen J, Dan C, et al. What low back pain is and why we need to pay attention. Lancet. 2018;391(10137):2356–67.CrossRef Buchbinder R, Hartvigsen J, Dan C, et al. What low back pain is and why we need to pay attention. Lancet. 2018;391(10137):2356–67.CrossRef
2.
go back to reference Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64(6):2028–37.PubMedCrossRef Hoy D, Bain C, Williams G, et al. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64(6):2028–37.PubMedCrossRef
3.
go back to reference Yiengprugsawan V, Hoy D, Buchbinder R, Bain C, Seubsman SA, Sleigh AC. Low back pain and limitations of daily living in Asia: longitudinal findings in the Thai cohort study. BMC Musculoskelet Disord. 2017;18:19.PubMedPubMedCentralCrossRef Yiengprugsawan V, Hoy D, Buchbinder R, Bain C, Seubsman SA, Sleigh AC. Low back pain and limitations of daily living in Asia: longitudinal findings in the Thai cohort study. BMC Musculoskelet Disord. 2017;18:19.PubMedPubMedCentralCrossRef
4.
go back to reference Jackson T, Chen H, Iezzi T, Yee M, Chen F. Prevalence and correlates of chronic pain in a random population study of adults in Chongqing, China. Clin J Pain. 2014;30(4):346–52.PubMedCrossRef Jackson T, Chen H, Iezzi T, Yee M, Chen F. Prevalence and correlates of chronic pain in a random population study of adults in Chongqing, China. Clin J Pain. 2014;30(4):346–52.PubMedCrossRef
5.
go back to reference Henschke N, Maher CG, Refshauge KM, et al. Prevalence of and screening for serious spinal pathology in patients presenting to primary care settings with acute low back pain. Arthritis Rheum. 2009;60(10):3072–80.PubMedCrossRef Henschke N, Maher CG, Refshauge KM, et al. Prevalence of and screening for serious spinal pathology in patients presenting to primary care settings with acute low back pain. Arthritis Rheum. 2009;60(10):3072–80.PubMedCrossRef
6.
go back to reference Smith BH, Fors EA, Korwisi B, et al. The IASP classification of chronic pain for ICD-11: applicability in primary care. Pain. 2019;160(1):83–7.PubMedCrossRef Smith BH, Fors EA, Korwisi B, et al. The IASP classification of chronic pain for ICD-11: applicability in primary care. Pain. 2019;160(1):83–7.PubMedCrossRef
7.
go back to reference Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(6):968–74.PubMedCrossRef Hoy D, March L, Brooks P, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(6):968–74.PubMedCrossRef
8.
go back to reference Linton SJ, Boersma K. Early identification of patients at risk of developing a persistent back problem: the predictive validity of the Orebro Musculoskeletal Pain Questionnaire. Clin J Pain. 2003;19(2):80–6.PubMedCrossRef Linton SJ, Boersma K. Early identification of patients at risk of developing a persistent back problem: the predictive validity of the Orebro Musculoskeletal Pain Questionnaire. Clin J Pain. 2003;19(2):80–6.PubMedCrossRef
9.
go back to reference Hill JC, Dunn KM, Lewis M, et al. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008;59(5):632–41.PubMedCrossRef Hill JC, Dunn KM, Lewis M, et al. A primary care back pain screening tool: identifying patient subgroups for initial treatment. Arthritis Rheum. 2008;59(5):632–41.PubMedCrossRef
10.
11.
go back to reference Gunter BR, Butler KA, Wallace RL, Smith SM, Harirforoosh S. Non-steroidal anti-inflammatory drug-induced cardiovascular adverse events: a meta-analysis. J Clin Pharm Ther. 2017;42(1):27–38.PubMedCrossRef Gunter BR, Butler KA, Wallace RL, Smith SM, Harirforoosh S. Non-steroidal anti-inflammatory drug-induced cardiovascular adverse events: a meta-analysis. J Clin Pharm Ther. 2017;42(1):27–38.PubMedCrossRef
12.
go back to reference Deyo RA, Smith DH, Johnson ES, et al. Opioids for back pain patients: primary care prescribing patterns and use of services. J Am Board Fam Med. 2011;24(6):717–27.PubMedCrossRef Deyo RA, Smith DH, Johnson ES, et al. Opioids for back pain patients: primary care prescribing patterns and use of services. J Am Board Fam Med. 2011;24(6):717–27.PubMedCrossRef
13.
go back to reference Kanno H, Aizawa T, Hahimoto K, Itoi E. Minimally invasive discectomy for lumbar disc herniation: current concepts, surgical techniques, and outcomes. Int Orthop. 2019;43(4):917–22.PubMedCrossRef Kanno H, Aizawa T, Hahimoto K, Itoi E. Minimally invasive discectomy for lumbar disc herniation: current concepts, surgical techniques, and outcomes. Int Orthop. 2019;43(4):917–22.PubMedCrossRef
14.
go back to reference Bernstein IA, Malik Q, Carville S, Ward S. Low back pain and sciatica: summary of NICE guidance. BMJ. 2017;356:i6748.PubMedCrossRef Bernstein IA, Malik Q, Carville S, Ward S. Low back pain and sciatica: summary of NICE guidance. BMJ. 2017;356:i6748.PubMedCrossRef
15.
go back to reference Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514–30.PubMedCrossRef Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514–30.PubMedCrossRef
16.
go back to reference Epping R, Verhagen AP, Hoebink EA, Rooker S, Scholten-Peeters G. The diagnostic accuracy and test-retest reliability of the Dutch PainDETECT and the DN4 screening tools for neuropathic pain in patients with suspected cervical or lumbar radiculopathy. Musculoskelet Sci Pract. 2017;30:72–9.PubMedCrossRef Epping R, Verhagen AP, Hoebink EA, Rooker S, Scholten-Peeters G. The diagnostic accuracy and test-retest reliability of the Dutch PainDETECT and the DN4 screening tools for neuropathic pain in patients with suspected cervical or lumbar radiculopathy. Musculoskelet Sci Pract. 2017;30:72–9.PubMedCrossRef
17.
go back to reference Foster NE, Anema JR, Cherkin D, et al. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018;391(10137):2368–83.PubMedCrossRef Foster NE, Anema JR, Cherkin D, et al. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018;391(10137):2368–83.PubMedCrossRef
18.
go back to reference Institute of Medicine, Committee on Advancing Pain Research, Care, and Education. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: National Academies Press; 2011. Institute of Medicine, Committee on Advancing Pain Research, Care, and Education. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: National Academies Press; 2011.
20.
go back to reference Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297–302.PubMedCrossRef Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297–302.PubMedCrossRef
21.
go back to reference Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003;4(4):184–9.PubMedCrossRef Moseley L. Unraveling the barriers to reconceptualization of the problem in chronic pain: the actual and perceived ability of patients and health professionals to understand the neurophysiology. J Pain. 2003;4(4):184–9.PubMedCrossRef
22.
go back to reference Wijma AJ, Speksnijder CM, Crom-Ottens AF, et al. What is important in transdisciplinary pain neuroscience education? A qualitative study. Disabil Rehabil. 2018;40(18):2181–91.PubMedCrossRef Wijma AJ, Speksnijder CM, Crom-Ottens AF, et al. What is important in transdisciplinary pain neuroscience education? A qualitative study. Disabil Rehabil. 2018;40(18):2181–91.PubMedCrossRef
23.
go back to reference Traeger AC, Hubscher M, Henschke N, Moseley GL, Lee H, McAuley JH. Effect of primary care-based education on reassurance in patients with acute low back pain: systematic review and meta-analysis. JAMA Intern Med. 2015;175(5):733–43.PubMedCrossRef Traeger AC, Hubscher M, Henschke N, Moseley GL, Lee H, McAuley JH. Effect of primary care-based education on reassurance in patients with acute low back pain: systematic review and meta-analysis. JAMA Intern Med. 2015;175(5):733–43.PubMedCrossRef
24.
go back to reference Saragiotto BT, Maher CG, Traeger AC, Li Q, McAuley JH. Dispelling the myth that chronic pain is unresponsive to treatment. Br J Sports Med. 2017;51(13):986–8.PubMedCrossRef Saragiotto BT, Maher CG, Traeger AC, Li Q, McAuley JH. Dispelling the myth that chronic pain is unresponsive to treatment. Br J Sports Med. 2017;51(13):986–8.PubMedCrossRef
25.
go back to reference Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: a systematic review. J Back Musculoskelet Rehabil. 2018;30(6):1149–69.PubMedCentralCrossRef Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: a systematic review. J Back Musculoskelet Rehabil. 2018;30(6):1149–69.PubMedCentralCrossRef
26.
go back to reference Kumar S, Beaton K, Hughes T. The effectiveness of massage therapy for the treatment of nonspecific low back pain: a systematic review of systematic reviews. Int J Gen Med. 2013;6:733–41.PubMedPubMedCentralCrossRef Kumar S, Beaton K, Hughes T. The effectiveness of massage therapy for the treatment of nonspecific low back pain: a systematic review of systematic reviews. Int J Gen Med. 2013;6:733–41.PubMedPubMedCentralCrossRef
27.
go back to reference Ruddock JK, Sallis H, Ness A, Perry RE. Spinal manipulation vs sham manipulation for nonspecific low back pain: a systematic review and meta-analysis. J Chiropr Med. 2016;15(3):165–83.PubMedPubMedCentralCrossRef Ruddock JK, Sallis H, Ness A, Perry RE. Spinal manipulation vs sham manipulation for nonspecific low back pain: a systematic review and meta-analysis. J Chiropr Med. 2016;15(3):165–83.PubMedPubMedCentralCrossRef
28.
go back to reference Pach D, Piper M, Lotz F, 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.PubMedCrossRef Pach D, Piper M, Lotz F, 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.PubMedCrossRef
29.
go back to reference Du S, Hu L, Dong J, et al. Self-management program for chronic low back pain: a systematic review and meta-analysis. Patient Educ Couns. 2017;100(1):37–49.PubMedCrossRef Du S, Hu L, Dong J, et al. Self-management program for chronic low back pain: a systematic review and meta-analysis. Patient Educ Couns. 2017;100(1):37–49.PubMedCrossRef
30.
go back to reference Engers A, Jellema P, Wensing M, van der Windt DA, Grol R, van Tulder MW. Individual patient education for low back pain. Cochrane Database Syst Rev. 2008;1:D4057. Engers A, Jellema P, Wensing M, van der Windt DA, Grol R, van Tulder MW. Individual patient education for low back pain. Cochrane Database Syst Rev. 2008;1:D4057.
31.
go back to reference Deng Q, Wu Y, He C, Sun Y, Ma G, Tian Y. Efficacy differences between different position in patients treated with electroacupuncture for lumbar herniated disc [in Chinese]. Zhongguo Zhen Jiu. 2016;36(7):689–93.PubMed Deng Q, Wu Y, He C, Sun Y, Ma G, Tian Y. Efficacy differences between different position in patients treated with electroacupuncture for lumbar herniated disc [in Chinese]. Zhongguo Zhen Jiu. 2016;36(7):689–93.PubMed
32.
go back to reference Zai FL, Wu RL, Zheng MF, Guo LY. Warming needle moxibustion relieves symptoms of lumbar disc herniation patients and upregulates plasma beta-endorphin [in Chinese]. Zhen Ci Yan Jiu. 2018;43(8):512–5.PubMed Zai FL, Wu RL, Zheng MF, Guo LY. Warming needle moxibustion relieves symptoms of lumbar disc herniation patients and upregulates plasma beta-endorphin [in Chinese]. Zhen Ci Yan Jiu. 2018;43(8):512–5.PubMed
33.
go back to reference Zhang K, Xu Y, Ding S, Hong S, Zhao X, Guo Y. Literature study for acupoint selection rule of rheumatoid arthritis treated with acupuncture [in Chinese]. Zhongguo Zhen Jiu. 2017;37(2):221–4.PubMed Zhang K, Xu Y, Ding S, Hong S, Zhao X, Guo Y. Literature study for acupoint selection rule of rheumatoid arthritis treated with acupuncture [in Chinese]. Zhongguo Zhen Jiu. 2017;37(2):221–4.PubMed
34.
go back to reference Chen D, Yang G, Wang F, Qi W. Discussing the relationship among the ashi point, tender point and myofascial trigger point [in Chinese]. Zhongguo Zhen Jiu. 2017;37(2):212–4.PubMed Chen D, Yang G, Wang F, Qi W. Discussing the relationship among the ashi point, tender point and myofascial trigger point [in Chinese]. Zhongguo Zhen Jiu. 2017;37(2):212–4.PubMed
35.
go back to reference Mo Z, Zhang R, Chen J, Shu X, Shujie T. Comparison between oblique pulling spinal manipulation and other treatments for lumbar disc herniation: a systematic review and meta-analysis. J Manip Physiol Ther. 2018;41(9):771–9.CrossRef Mo Z, Zhang R, Chen J, Shu X, Shujie T. Comparison between oblique pulling spinal manipulation and other treatments for lumbar disc herniation: a systematic review and meta-analysis. J Manip Physiol Ther. 2018;41(9):771–9.CrossRef
36.
go back to reference Brodke DS, Goz V, Voss MW, Lawrence BD, Spiker WR, Hung M. PROMIS PF CAT outperforms the ODI and SF-36 Physical Function domain in spine patients. Spine (Phila Pa 1976). 2017;42(12):921–9.CrossRef Brodke DS, Goz V, Voss MW, Lawrence BD, Spiker WR, Hung M. PROMIS PF CAT outperforms the ODI and SF-36 Physical Function domain in spine patients. Spine (Phila Pa 1976). 2017;42(12):921–9.CrossRef
37.
38.
go back to reference Garcia JB, Hernandez-Castro JJ, Nunez RG, et al. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014;17(5):379–91.PubMed Garcia JB, Hernandez-Castro JJ, Nunez RG, et al. Prevalence of low back pain in Latin America: a systematic literature review. Pain Physician. 2014;17(5):379–91.PubMed
39.
go back to reference Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8(1):8–20.PubMedCrossRef Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8(1):8–20.PubMedCrossRef
40.
go back to reference Taylor JB, Goode AP, George SZ, Cook CE. Incidence and risk factors for first-time incident low back pain: a systematic review and meta-analysis. Spine J. 2014;14(10):2299–319.PubMedCrossRef Taylor JB, Goode AP, George SZ, Cook CE. Incidence and risk factors for first-time incident low back pain: a systematic review and meta-analysis. Spine J. 2014;14(10):2299–319.PubMedCrossRef
41.
go back to reference Nan Z, Min F, Zhu Q, et al. Evaluation of biomechanical properties of lumbar and dorsi extensor muscles in the treatment of lumbar disc herniation by massage manipulation. Chin J Trad Chin Med. 2012;27(3):562–6. Nan Z, Min F, Zhu Q, et al. Evaluation of biomechanical properties of lumbar and dorsi extensor muscles in the treatment of lumbar disc herniation by massage manipulation. Chin J Trad Chin Med. 2012;27(3):562–6.
43.
go back to reference Pan F, Yu TY, Wong S, et al. Chinese Tuina downregulates the elevated levels of tissue plasminogen activator in sciatic nerve injured Sprague-Dawley rats. Chin J Integr Med. 2017;23(8):617–24.PubMedCrossRef Pan F, Yu TY, Wong S, et al. Chinese Tuina downregulates the elevated levels of tissue plasminogen activator in sciatic nerve injured Sprague-Dawley rats. Chin J Integr Med. 2017;23(8):617–24.PubMedCrossRef
Metadata
Title
Efficacy of Tuina in patients with chronic low back pain: study protocol for a randomized controlled trial
Authors
Shuaipan Zhang
Lingjun Kong
Qingguang Zhu
Zhiwei Wu
Jianhua Li
Min Fang
Wuquan Sun
Yanbin Cheng
Shanda Xu
Guangxin Guo
Xin Zhou
Zhizhen Lv
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4198-2

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue