How to prepare an optimal design of a clinical study focusing on chronic low back pain: guidelines based on a review of scientific papers published in 2014–2019

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39. Areeudomwong P, Buttagat V. Proprioceptive neuromuscular facilitation training improves pain-related and balance outcomes in working-age patients with chronic low back pain: a randomized controlled trial. Braz J Phys Ther 2019; 23(5): 428–436. doi: 10.1016/j. bjpt.2018.10.005.

40. Straudi S, Buja S, Baroni A et al. The effects of transcranial direct current stimulation (tDCS) combined with group exercise treatment in subjects with chronic low back pain: a pilot randomized control trial. Clin Rehabil 2018; 32(10): 1348–1356. doi: 10.1177/0269215518777881.

41. Matheve T, Claes G, Olivieri E et al. Serious gaming to support exercise therapy for patients with chronic nonspecific low back pain: a feasibility study. Games Health J 2018; 7(4): 262–270. doi: 10.1089/g4h.2017.0173.

42. Knox MF, Chipchase LS, Schabrun SM et al. Improved compensatory postural adjustments of the deep abdominals following exercise in people with chronic low back pain. J Electromyograph Kinesiolog 2017; 37: 117–124. doi: 10.1016/j.jelekin.2017.10.009.

43. Steele J, Bruce-Low S, Smith D et al. A randomized controlled trial of the effects of isolated lumbar extension exercise on lumbar kinematic pattern variability during gait in chronic low back pain. PM R 2016; 8(2): 105–114. doi: 10.1016/j.pmrj.2015.06.012.

44. Cai C, Kong PW. Low back and lower-limb muscle performance in male and female recreational runners with chronic low back pain. J Orthop Sports Phys Ther 2015; 45(6): 436–443. doi: 10.2519/jospt.2015.5460.

45. Murray A, Hall AM, Williams GC et al. Effect of a self-determination theory-based communication skills training program on physiotherapists’ psychological support for their patients with chronic low back pain: a randomized controlled trial. Arch Phys Med Rehabil 2015; 96(5): 809–816. doi: 10.1016/j.apmr.2014.11.007.

46. Lisón JF, Ortega-Santana B, Antón-Nogués Á et al. Effects and underlying mechanisms of unstable shoes on chronic low back pain: a randomized controlled trial. Clin Rehabil 2018; 32(5): 654–662. doi: 10.1177/0269215517753972.

47. Annaswamy TM, Armstead C, Carlson L et al. Intra-articular triamcinolone versus hyaluronate injections for low back pain with symptoms suggestive of lumbar zygapophyseal joint arthropathy: a pragmatic, double-blind randomized controlled trial. Am J Phys Med Rehabil 2018; 97(4): 278–284. doi: 10.1097/ PHM.0000000000000879.

48. Liu L, Skinner MA, McDonough SM et al. Acupuncture for chronic low back pain: a randomized controlled feasibility trial comparing treatment session numbers. Clin Rehabil 2017; 31(12): 1592–1603. doi: 10.1177/0269215517705690.

49. Vieira ER, Brunt D. Does wearing unstable shoes reduce low back pain and disability in nurses? A randomized controlled pilot study. Clin Rehabil 2016; 30(2): 167–173. doi: 10.1177/0269215515576812.

50. Gavish L, Barzilay Y, Koren C et al. Novel continuous passive motion device for self-treatment of chronic lower back pain: a randomised controlled study. Physiotherapy 2015; 101(1): 75–81. doi: 10.1016/j.physio.2014.06.003.

51. Leonhardt C, Kuss K, Becker A et al. Graded exposure for chronic low back pain in older adults. J Geriatr Phys Ther 2017; 40(1): 51–59. doi: 10.1519/JPT.0000000000000083.

52. Zadro JR, Shirley D, Simic M et al. Video-game–based exercises for older people with chronic low back pain: a randomized controlledtable trial (GAMEBACK). Phys Ther 2019; 99(1): 14–27. doi: 10.1093/ptj/pzy112.

53. Goode AP, Taylor SS, Hastings SN et al. Effects of a home-based telephone-supported physical activity program for older adult veterans with chronic low back pain. Phys Ther 2018; 98(5): 369–380. doi: 10.1093/ptj/pzy026.

54. Cruz-Díaz D, Romeu M, Velasco-González C et al. The effectiveness of 12 weeks of Pilates intervention on disability, pain and kinesiophobia in patients with chronic low back pain: a randomized controlled trial. Clin Rehabil 2018; 32(9): 1249–1257. doi: 10.1177/0269215518768393.

55. Pardo GB, Girbés EL, Roussel NA et al. Pain neurophysiology education and therapeutic exercise for patients with chronic low back pain: a single-blind randomized controlled trial. Arch Physic Med Rehabil 2018; 99(2): 338–347. doi: 10.1016/j.apmr.2017.10.016.

56. Highland KB, Schoomaker A, Rojas W et al. Benefits of the restorative exercise and strength training for operational resilience and excellence yoga program for chronic low back pain in service members: a pilot randomized controlled trial. Arch Phys Med Rehabil 2018; 99(1): 91–98. doi: 10.1016/j.apmr.2017.08.473.

57. Magalhães MO, Comachio J, Ferreira PH et al. Effectiveness of graded activity versus physiotherapy in patients with chronic nonspecific low back pain: midterm follow up results of a randomized controlled trial. Braz J Phys Ther 2018; 22(1): 82–91. doi: 10.1016/j. bjpt.2017.07.002.

58. Valenza MC, Rodríguez-Torres J, Cabrera- -Martos I et al. Results of a Pilates exercise program in patients with chronic non-specific low back pain: a randomized controlled trial. Clin Rehabil 2016; 31(6): 753–760. doi: 10.1177/0269215516651978.

59. Paolucci T, Zangrando F, Iosa M et al. Improved interoceptive awareness in chronic low back pain: a comparison of Back school versus Feldenkrais method. Disabil Rehabil 2016; 39(10): 994–1001. doi:10.1080/09638288.2016.1175035.

60. Halliday MH, Pappas E, Hancock MJ et al. A randomized controlled trial comparing the McKenzie method to Motor control exercises in people with chronic low back pain and a directional preference. J Orthop Sports Phys Ther 2016; 46(7): 514–522. doi: 10.2519/ jospt.2016.6379.

61. Jacobs JV, Lomond KV, Hitt JR et al. Effects of low back pain and of stabilization or movement- -system-impairment treatments on induced postural responses: a planned secondary analysis of a randomised controlled trial. Man Ther 2016; 21: 210–219. doi: 10.1016/j.math.2015.08.006.

62. 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(4): 603–609. doi: 10.1016/j. math.2015.02.004.

63. Kim TH, Kim E-H, Cho H. The effects of the CORE programme on pain at rest, movement-induced and secondary pain, active range of motion, and proprioception in female office workers with chronic low back pain: a randomized controlled trial. Clin Rehabil 2015; 29(7): 653–662. doi: 10.1177/0269215514552075.

64. Pires D, Cruz EB, Caeiro C. Aquatic exercise and pain neurophysiology education versus aquatic exercise alone for patients with chronic low back pain: a randomized controlled trial. Clin Rehabil 2015; 29(6): 538–547. doi: 10.1177/0269215514549033.

65. Oliveira CB, Pinto RZ, Schabrun SM et al. Association between clinical tests related to motor control dysfunction and changes in pain and disability after lumbar stabilization exercises in individuals with chronic low back pain. Arch Phys Med Rehabil 2019; 100(7): 1226–1233. doi: 10.1016/j.apmr.2019.01.019.

66. Martí-Salvador M, Hidalgo-Moreno L, Doménech- Fernández J et al. Osteopathic manipulative treatment including specific diaphragm techniques improves pain and disability in chronic nonspecific low back pain: a randomized trial. Arch Phys Med Rehabil 2018; 99(9): 1720–1729. doi: 10.1016/j.apmr.2018.04.022.

67. Velasco-Roldán O, Riquelme I, Ferragut-Garcías A et al. Immediate and short-term effects of Kinesio taping tightness in mechanical low back pain: a randomized controlled trial. PM R 2018; 10(1): 28–35. doi: 10.1016/j.pmrj.2017.05.003.

68. Albornoz-Cabello M, Maya-Martín J, Domínguez- Maldonado G et al. Effect of interferential current therapy on pain perception and disability level in subjects with chronic low back pain: a randomized controlled trial. Clin Rehabil 2017; 31(2): 242–249. doi: 10.1177/0269215516639653.

69. Tuakli-Wosornu YA, Terry A, Boachie-Adjei K et al. Lumbar intradiskal Platelet-Rich Plasma (PRP) injections: a prospective, double-blind, randomized controlled study. PM R 2016; 8(1): 1–10. doi: 10.1016/j.pmrj.2015.08.010.

70. van Erp RM, Huijnen IP, Verbunt JA et al. A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial. J Physiother 2015; 61(3): 155. doi: 10.1016/j. jphys.2015.03.003.

71. Nugraha B, Günther JT, Rawert H et al. Effects of whole body cryo-chamber therapy on pain in patients with chronic low back pain: a prospective double blind randomised controlled trial. Eur J Phys Rehabil Med 2015; 51(2): 143–148.

72. Wang X-Q, Gu W, Chen B-L et al. Effects of whole-body vibration exercise for non-specific chronic low back pain: an assessor-blind, randomized controlled trial. Clin Rehabil 2019; 33(9): 1445–1457. doi: 10.1177/0269215519848076.

73. Elshiwi AM, Hamada HA, Mosaad D et al. Effect of pulsed electromagnetic field on nonspecific low back pain patients: a randomized controlled trial. Braz J Phys Ther 2019; 23(3): 244–249. doi: 10.1016/j.bjpt.2018.08.004.

74. Ferreira G, Stieven F, Araujo F et al. Neurodynamic treatment did not improve pain and disability at two weeks in patients with chronic nerve-related leg pain: a randomised trial. J Physiother 2016; 62(4): 197–202. doi: 10.1016/j. jphys.2016.08.007.

75. Matheve T, Brumagne S, Demoulin C. Sensor- based postural feedback is more effective than conventional feedback to improve lumbopelvic movement control in patients with chronic low back pain: a randomised controlled trial. J Neuroeng Rehabil 2018; 15(1): 85. doi: 10.1186/s12984-018-0423-6.

76. Malfliet A, Kregel J, Meeus M et al. Patients with chronic spinal pain benefit from pain neuroscience education regardless the self-reported signs of central sensitization: secondary analysis of a randomized controlled multicenter trial. PM R 2018; 10(12): 1330–1343.e1. doi: 10.1016/j.pmrj.2018.04.010.

77. Filiz MB, Kiliç Z, Uçkun A et al. Mechanical traction for lumbar radicular pain: Supine or Prone? A randomized controlled trial. Am J Phys Med Rehabil 2018; 97(6): 433–439.

78. Leininger B, Schulz C, Gao Z et al. Accelerometer- determined physical activity and clinical low back pain measures in adolescents with chronic or subacute recurrent low back pain. J Orthop Sports Phys Ther 2017; 47(10): 769–774. doi: 10.2519/jospt.2017.7345.

79. Ronzi Y, Roche-Leboucher G, Bègue C et al. Efficiency of three treatment strategies on occupational and quality of life impairments for chronic low back pain patients: is the multidisciplinary approach the key feature to success? Clin Rehabil 2017; 31(10): 1364–1373. doi: 10.1177/0269215517691086.

80. Jassi FJ, Antônio TD, Moraes R et al. Effects of functional taping compared with sham taping and minimal intervention on pain intensity and static postural control for patients with non-specific chronic low back pain: a randomised clinical trial protocol. Physiotherapy 2017; 103(2): 154– 159. doi: 10.1016/j.physio.2016.05.008.

81. Van Dillen LR, Norton BJ, Sahrmann SA et al. Efficacy of classification-specific treatment and adherence on outcomes in people with chronic low back pain. A one-year follow-up, prospective, randomized, controlled clinical trial. Man Ther 2016; 24: 52–64. doi: 10.1016/j. math.2016.04.003.

82. Ickmans K, Moens M, Putman K et al. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial. J Physiother 2016; 62(3): 165. doi: 10.1016/j.jphys.2016.05.009.

83. Ebenbichler GR, Leitgeb J, Amtmann G et al. Degeneration and instability and the relation to patients’ function late after lumbar disc surgery. Am J Phys Med Rehabil 2016; 95(12): 871–879. doi: 10.1097/PHM.0000000000000522.

84. Cruz-Díaz D, Martínez-Amat A, Osuna-Pérez MC et al. Short- and long-term effects of a six- -week clinical Pilates program in addition to physical therapy on postmenopausal women with chronic low back pain: a randomized controlled trial. Disabil Rehabil 2015; 38(13): 1300– 1308. doi: 10.3109/09638288.2015.1090485.

85. Claus D, Coudeyre E, Chazal J et al. An evidence- based information booklet helps reduce fear-avoidance beliefs after first-time discectomy for disc prolapse. Ann Phys Rehabil Med 2017; 60(2): 68–73. doi: 10.1016/j. rehab.2015.10.008.

86. Saner J, Kool J, Sieben JM et al. A tailored exercise program versus general exercise for a subgroup of patients with low back pain and movement control impairment: a randomised controlled trial with one-year follow-up. Man Ther 2015; 20(5): 672–679. doi: 10.1016/j. math.2015.02.005.

87. Ben-Ami N, Shapiro Y, Pincus T. Outcomes in distressed patients with chronic low back pain: subgroup analysis of a clinical trial. J Orthop Sports Phys Ther 2018; 48(6): 491–495. doi: 10.2519/jospt.2018.7670.

88. Ekedahl H, Jönsson B, Annertz M et al. The 1-year results of lumbar transforaminal epidural steroid injection in patients with chronic unilateral radicular pain: the relation to MRI findings and clinical features. Am J Phys Med Rehabil 2017; 96(9): 654–662. doi: 10.1097/ PHM.0000000000000730.

89. de Brito Macedo L, Richards J, Borges DT et al. Kinesio taping reduces pain and improves disability in low back pain patients: a randomised controlled trial. Physiotherapy 2019; 105(1): 65–75. doi: 10.1016/j.physio.2018.07.005.

90. Garcia AN, Costa L, Hancock M et al. Identifying patients with chronic low back pain who respond best to mechanical diagnosis and therapy: secondary analysis of a randomized controlled trial. Phys Ther 2016; 96(5): 623–630. doi: 10.2522/ptj.20150295.

91. Belache FTC, de Souza CP, Fernandez J et al. Trial protocol: cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain. J Physiother 2018; 64(3): 192. doi: 10.1016/j.jphys.2018.02.018.

92. Azevedo DC, Ferreira PH, Santos HO et al. Movement system impairment-based classification treatment versus general exercises for chronic low back pain: randomized controlled trial. Phys Ther 2018; 98(1): 28–39. doi: 10.1093/ptj/ pzx094.

93. Maiers M, Hondras MA, Salsbury SA et al. What do patients value about spinal manipulation and home exercise for back-related leg pain? A qualitative study within a controlled clinical trial. Man Ther 2016; 26: 183–191. doi: 10.1016/j.math.2016.09.008.

94. Franco KM, Franco YDS, de Oliveira NB et al. Is interferential current before Pilates exercises more effective than placebo in patients with chronic nonspecific low back pain? A randomized controlled trial. Arch Phys Med Rehabil 2017; 98(2): 320–328. doi: 10.1016/j.apmr.2016.08.485.

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96. Araujo AC, do Carmo Silva Parreira P, Junior LCH et al. Medium term effects of Kinesio taping in patients with chronic non-specific low back pain: a randomized controlled trial. Physiotherapy 2018; 104(1): 149–151. doi: 10.1016/j. physio.2016.12.001.

97. Ben-Ami N, Chodick G, Mirovsky Y et al. Increasing recreational physical activity in patients with chronic low back pain: a pragmatic controlled clinical trial. J Orthop Sports Phys Ther 2017; 47(2): 57–66. doi: 10.2519/jospt.2017.7057.

98. Cambron JA, Dexheimer JM, Duarte M et al. Shoe orthotics for the treatment of chronic low back pain: a randomized controlled trial. Arch Phys Med Rehabil 2017; 98(9): 1752–1762. doi: 10.1016/j.apmr.2017.03.028.

99. Lonsdale C, Hall AM, Murray A et al. Communication skills training for practitioners to increase patient adherence to home-based rehabilitation for chronic low back pain: results of a cluster randomized controlled trial. Arch Phys Med Rehabil 2017; 98(9): 1732–1743. doi: 10.1016/j.apmr.2017.02.025.

100. Miyamoto GC, Moura KF, Franco YR et al. Effectiveness and cost-effectiveness of different weekly frequencies of Pilates for chronic low back pain: randomized controlled trial. Phys Ther 2016; 96(3): 382–389. doi: 10.2522/ ptj.20150404.

101. Nambi G, Kamal W, Es S et al. Spinal manipulation plus laser therapy versus laser therapy alone in the treatment of chronic non-specific low back pain: a randomized controlled study. Eur J Phys Rehabil Med 2018; 54(6): 880–889. doi: 10.23736/S1973-9087.18.05005-0.

102. Suri P, Pearson AM, Scherer EA et al. Recurrence of pain after usual nonoperative care for symptomatic lumbar disk herniation: analysis of data from the spine patient outcomes research trial. PM R 2016; 8(5): 405–414. doi: 10.1016/j. pmrj.2015.10.016.

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104. Díaz-Arribas MJ, Kovacs FM, Royuela A et al. Effectiveness of the Godelieve Denys- -Struyf (GDS) method in people with low back pain: cluster randomized controlled trial. Phys Ther 2015; 95(3): 319–336. doi: 10.2522/ ptj.20140099.