Dry cupping in the treatment of individuals with non-specific chronic low back pain: a protocol for a placebo-controlled, randomised, double-blind study

Hugo Jário de Almeida Silva, Bruno T Saragiotto, Rodrigo Scattone Silva, Caio Alano de Almeida Lins, Marcelo Cardoso de Souza, Hugo Jário de Almeida Silva, Bruno T Saragiotto, Rodrigo Scattone Silva, Caio Alano de Almeida Lins, Marcelo Cardoso de Souza

Abstract

Background: Low back pain is a very prevalent condition in the population and cupping therapy has been presented as a frequently used non-pharmacological treatment in this population. However, there is a lack of well-designed studies that evaluate the effects of this technique. This protocol describes a placebo-controlled, randomised, double-blind study that aims to evaluate the effect of dry cupping therapy on pain, physical function, trunk range of motion, quality of life and psychological symptoms in individuals with non-specific chronic low back pain.

Methods and analysis: Ninety individuals with chronic non-specific low back pain, aged from 18 to 59 years, will be randomised into two groups: intervention group, which will be submitted to dry cupping therapy application with two suctions; and placebo group which will undergo placebo dry cupping therapy. Both applications will occur bilaterally in parallel to the vertebrae from L1 to L5. The application will be performed once a week for 8 weeks. The volunteers will be evaluated before the treatment (T0), immediately after the first intervention (T1), after 4 weeks of intervention (T4) and after 8 weeks of intervention (T8). The primary outcome will be pain intensity, and secondary outcomes will be physical function, lumbar range of motion, patient expectation, overall perception of effect, quality of life and psychological factors.

Ethics and dissemination: This protocol has been approved by the Ethics Committee of FACISA/UFRN (number: 3639814). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.

Trial registration number: NCT03909672.

Keywords: chronic pain; cupping therapy; traditional chinese medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Study fluxogram.
Figure 2
Figure 2
Schedule of the study protocol according to the Standard Protocol Items: Recommendations for Interventional Trials checklist. GPE, Global Perception Scale; Trunk ROM, trunk range of movement.
Figure 3
Figure 3
Application of dry cupping therapy with two suctions.
Figure 4
Figure 4
Application of placebo dry cupping therapy.

References

    1. Vos T, Abajobir AA, Abate KH, et al. . Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the global burden of disease study 2016. Lancet 2017;390:1211–59. 10.1016/S0140-6736(17)32154-2
    1. Manchikanti L, Singh V, Falco FJE, et al. . Epidemiology of low back pain in adults. Neuromodulation 2014;17(Suppl 2):3–10. 10.1111/ner.12018
    1. Maher C, Underwood M, Buchbinder R. Non-Specific low back pain. Lancet 2017;389:736–47. 10.1016/S0140-6736(16)30970-9
    1. Carvalho FA, Maher CG, Franco MR, et al. . Fear of movement is not associated with objective and subjective physical activity levels in chronic nonspecific low back pain. Arch Phys Med Rehabil 2017;98:96–104. 10.1016/j.apmr.2016.09.115
    1. Chou R, Qaseem A, Snow V, et al. . Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of physicians and the American pain Society. Ann Intern Med 2007;147:478–91. 10.7326/0003-4819-147-7-200710020-00006
    1. Waters T, Genaidy A, Barriera Viruet H, et al. . The impact of operating heavy equipment vehicles on lower back disorders. Ergonomics 2008;51:602–36. 10.1080/00140130701779197
    1. Shiri R, Karppinen J, Leino-Arjas P, et al. . The association between smoking and low back pain: a meta-analysis. Am J Med 2010;123:87.e7–35. 10.1016/j.amjmed.2009.05.028
    1. George SZ, Fritz JM, Childs JD. Investigation of elevated fear-avoidance beliefs for patients with low back pain: a secondary analysis involving patients enrolled in physical therapy clinical trials. J Orthop Sports Phys Ther 2008;38:50–8. 10.2519/jospt.2008.2647
    1. Wessels T, van Tulder M, Sigl T, et al. . What predicts outcome in non-operative treatments of chronic low back pain? A systematic review. Eur Spine J 2006;15:1633–44. 10.1007/s00586-006-0073-4
    1. Pinheiro MB, Ferreira ML, Refshauge K, et al. . Symptoms of depression and risk of new episodes of low back pain: a systematic review and meta-analysis. Arthritis Care Res (Hoboken) 2015;67:1591–603. 10.1002/acr.22619
    1. Alschuler KN, Neblett R, Wiggert E, et al. . Flexion-relaxation and clinical features associated with chronic low back pain. Clin J Pain 2009;25:760–6. 10.1097/AJP.0b013e3181b56db6
    1. Demoulin C, Crielaard J-M, Vanderthommen M. Spinal muscle evaluation in healthy individuals and low-back-pain patients: a literature review. Joint Bone Spine 2007;74:9–13. 10.1016/j.jbspin.2006.02.013
    1. Young AE, Wasiak R, Gross DP. Recurrence of work-related low back pain and disability: association between self-report and workers' compensation data. Spine 2013;38:2279–86. 10.1097/BRS.0000000000000016
    1. 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;8:8–20. 10.1016/j.spinee.2007.10.005
    1. Maetzel A, Li L. The economic burden of low back pain: a review of studies published between 1996 and 2001. Best Pract Res Clin Rheumatol 2002;16:23–30. 10.1053/berh.2001.0204
    1. Qaseem A, Wilt TJ, McLean RM, et al. . Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of physicians. Ann Intern Med 2017;166:514–30. 10.7326/M16-2367
    1. Powers CM, Bolgla LA, Callaghan MJ, et al. . Patellofemoral pain: proximal, distal, and local factors, 2nd international research retreat. J Orthop Sports Phys Ther 2012;42:A1–54. 10.2519/jospt.2012.0301
    1. Yuan Q-ling, Guo T-mao, Liu L, et al. . Traditional Chinese medicine for neck pain and low back pain: a systematic review and meta-analysis. PLoS One 2015;10:e0117146 10.1371/journal.pone.0117146
    1. de Lacey S, Smith C. Traditional Chinese medicine In: How to improve your ART success rates: an evidence-based review of adjuncts to IVF (Cambridge medicine (Paperback)), 2011: 208–12.
    1. Manheimer E, Wieland S, Kimbrough E, et al. . Evidence from the Cochrane collaboration for traditional Chinese medicine therapies. J Altern Complement Med 2009;15:1001–14. 10.1089/acm.2008.0414
    1. Vickers AJ, Cronin AM, Maschino AC, et al. . Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med 2012;172:1444–53. 10.1001/archinternmed.2012.3654
    1. Lauche R, Spitzer J, Schwahn B, et al. . Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep 2016;6:37316 10.1038/srep37316
    1. Ahmed SM, Madbouly NH, Maklad SS, et al. . Immunomodulatory effects of blood letting cupping therapy in patients with rheumatoid arthritis. Egypt J Immunol 2005;12:39–51.
    1. Lauche R, Cramer H, Hohmann C, et al. . The effect of traditional cupping on pain and mechanical thresholds in patients with chronic nonspecific neck pain: a randomised controlled pilot study. Evid Based Complement Alternat Med 2012;2012:429718:1–10. 10.1155/2012/429718
    1. Lauche R, Materdey S, Cramer H, et al. . Effectiveness of home-based cupping massage compared to progressive muscle relaxation in patients with chronic neck pain--a randomized controlled trial. PLoS One 2013;8:e65378 10.1371/journal.pone.0065378
    1. Saha FJ, Schumann S, Cramer H, et al. . The Effects of Cupping Massage in Patients with Chronic Neck Pain - A Randomised Controlled Trial. Complement Med Res 2017;24:26–32. 10.1159/000454872
    1. Michalsen A, Bock S, Lüdtke R, et al. . Effects of traditional cupping therapy in patients with carpal tunnel syndrome: a randomized controlled trial. J Pain 2009;10:601–8. 10.1016/j.jpain.2008.12.013
    1. Cao H, Liu J. P04.46. Cupping therapy for facial paralysis: a systematic review of randomized controlled trials. BMC Complement Altern Med 2012;12:P316 10.1186/1472-6882-12-S1-P316
    1. Zhang C-Y, Wang Y-X. [Comparison of therapeutic effects between plum-blossom needle tapping plus cupping and laser irradiation in the treatment of acute facial palsy patients with concomitant peri-auricular pain]. Zhen Ci Yan Jiu 2011;36:433–6.
    1. Aboushanab TS, AlSanad S. Cupping therapy: an overview from a modern medicine perspective. J Acupunct Meridian Stud 2018;11:83–7. 10.1016/j.jams.2018.02.001
    1. Teut M, Ullmann A, Ortiz M, et al. . Pulsatile dry cupping in chronic low back pain - a randomized three-armed controlled clinical trial. BMC Complement Altern Med 2018;18:115 10.1186/s12906-018-2187-8
    1. Chirali IZ. Traditional Chinese medicine cupping therapy: third edition. 3 edn London: Churchill Livingstone Elsever, 2015.
    1. Mehta P, Dhapte V. Cupping therapy: a prudent remedy for a plethora of medical ailments. J Tradit Complement Med 2015;5:127–34. 10.1016/j.jtcme.2014.11.036
    1. Tham LM, Lee HP, Lu C. Cupping: from a biomechanical perspective. J Biomech 2006;39:2183–93. 10.1016/j.jbiomech.2005.06.027
    1. Markowski A, Sanford S, Pikowski J, et al. . A pilot study analyzing the effects of Chinese cupping as an adjunct treatment for patients with subacute low back pain on relieving pain, improving range of motion, and improving function. J Altern Complement Med 2014;20:113–7. 10.1089/acm.2012.0769
    1. Lin M-L, Wu J-H, Lin C-W, et al. . Clinical effects of laser acupuncture plus Chinese cupping on the pain and plasma cortisol levels in patients with chronic nonspecific lower back pain: a randomized controlled trial. Evid Based Complement Alternat Med 2017;2017:3140403:1–7. 10.1155/2017/3140403
    1. Wang Y-T, Qi Y, Tang F-Y, et al. . The effect of cupping therapy for low back pain: a meta-analysis based on existing randomized controlled trials. J Back Musculoskelet Rehabil 2017;30:1187–95. 10.3233/BMR-169736
    1. Qureshi NA, Ali GI, Abushanab TS, et al. . History of cupping (Hijama): a narrative review of literature. J Integr Med 2017;15:172–81. 10.1016/S2095-4964(17)60339-X
    1. Moura CdeC, Chaves Érika de Cássia Lopes, Cardoso ACLR, et al. . Cupping therapy and chronic back pain: systematic review and meta-analysis. Rev Lat Am Enfermagem 2018;26:e3094 10.1590/1518-8345.2888.3094
    1. Yamato T, Maher C, Saragiotto B, et al. . The TIDieR checklist will benefit the physiotherapy profession. Physiother Theory Pract 2017;33:267–8. 10.1080/09593985.2017.1304065
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Airaksinen O, Brox JI, Cedraschi C, et al. . Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J 2006;15(Suppl 2):s192–300. 10.1007/s00586-006-1072-1
    1. Kovacs FM, Abraira V, Royuela A, et al. . Minimal clinically important change for pain intensity and disability in patients with nonspecific low back pain. Spine 2007;32:2915–20. 10.1097/BRS.0b013e31815b75ae
    1. Magalhães MO, Muzi LH, Comachio J, et al. . The short-term effects of graded activity versus physiotherapy in patients with chronic low back pain: a randomized controlled trial. Man Ther 2015;20:603–9. 10.1016/j.math.2015.02.004
    1. Benzon HT, Asher YG, Hartrick CT. Back pain and neuraxial anesthesia. Anesth Analg 2016;122:2047–58. 10.1213/ANE.0000000000001270
    1. Wolfe F, Clauw DJ, Fitzcharles M-A, et al. . The American College of rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res 2010;62:600–10. 10.1002/acr.20140
    1. Raine C, Keat A. Axial spondyloarthritis. Medicine 2018;46:231–6. 10.1016/j.mpmed.2018.01.005
    1. Lee MS, Kim J-I, Kong JC, et al. . Developing and validating a sham cupping device. Acupunct Med 2010;28:200–4. 10.1136/aim.2010.002329
    1. Bang H, Flaherty SP, Kolahi J, et al. . Blinding assessment in clinical trials: a review of statistical methods and a proposal of blinding assessment protocol. Clin Res Regul Aff 2010;27:42–51. 10.3109/10601331003777444
    1. Al-Bedah A, Aboushanab TS, Alqaed M, et al. . Classification of cupping therapy: a tool for modernization and standardization. J Complement Altern Med Res 2017;1:1–10.
    1. Cupping therapy. J. Acupunct. Tuina. Sci. 2003;1 10.1007/BF02874744
    1. Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs 2005;14:798–804. 10.1111/j.1365-2702.2005.01121.x
    1. Fairbank JC, Pynsent PB. The Oswestry disability index. Spine 2000;25:2940–53. 10.1097/00007632-200011150-00017
    1. Vigatto R, Alexandre NMC, Correa Filho HR. Development of a Brazilian Portuguese version of the Oswestry disability index: cross-cultural adaptation, reliability, and validity. Spine 2007;32:481–6. 10.1097/01.brs.0000255075.11496.47
    1. Hirano K, Imagama S, Hasegawa Y, et al. . Impact of low back pain, knee pain, and timed up-and-go test on quality of life in community-living people. J Orthop Sci 2014;19:164–71. 10.1007/s00776-013-0476-0
    1. Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991;39:142–8. 10.1111/j.1532-5415.1991.tb01616.x
    1. Perret C, Poiraudeau S, Fermanian J, et al. . Validity, reliability, and responsiveness of the fingertip-to-floor test. Arch Phys Med Rehabil 2001;82:1566–70. 10.1053/apmr.2001.26064
    1. Freitas P, Pires D, Nunes C, et al. . Cross-Cultural adaptation and psychometric properties of the European Portuguese version of the global perceived effect scale in patients with chronic low back pain. Disabil Rehabil 2019:1–7. 10.1080/09638288.2019.1648568
    1. Costa LOP, Maher CG, Latimer J, et al. . Clinimetric testing of three self-report outcome measures for low back pain patients in Brazil: which one is the best? Spine 2008;33:2459–63. 10.1097/BRS.0b013e3181849dbe
    1. Ware JE, Sherbourne CD. The mos 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care 1992;30:473–83.
    1. Ciconelli R, Ferraz M, Santos W, et al. . Tradução para a língua portuguesa E validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). Revista Brasileira de Reumatologia 1999.
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x
    1. Botega NJ, Bio MR, Zomignani MA, et al. . [Mood disorders among inpatients in ambulatory and validation of the anxiety and depression scale HAD]. Rev Saude Publica 1995;29:355–63. 10.1590/s0034-89101995000500004
    1. Beasley MJ, Ferguson-Jones EA, Macfarlane GJ. Treatment expectations but not preference affect outcome in a trial of CBT and exercise for pain. Can J Pain 2017;1:161–70. 10.1080/24740527.2017.1384297
    1. Akbarzadeh M, Ghaemmaghami M, Yazdanpanahi Z, et al. . The effect dry cupping therapy at Acupoint BL23 on the intensity of postpartum low back pain in primiparous women based on two types of questionnaires, 2012; a randomized clinical trial. Int J Community Based Nurs Midwifery 2014;2:112–20.
    1. Hartvigsen J, Hancock MJ, Kongsted A, et al. . What low back pain is and why we need to pay attention. Lancet 2018;391:2356–67. 10.1016/S0140-6736(18)30480-X
    1. Hush JM, Cameron K, Mackey M. Patient satisfaction with musculoskeletal physical therapy care: a systematic review. Phys Ther 2011;91:25–36. 10.2522/ptj.20100061
    1. Lauche R, Cramer H, Choi K-E, et al. . The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study. BMC Complement Altern Med 2011;11:63 10.1186/1472-6882-11-63
    1. Yoo SS, Tausk F. Cupping: East meets West. Int J Dermatol 2004;43:664–5. 10.1111/j.1365-4632.2004.02224.x

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel