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Imperfect placebos are common in low back pain trials: a systematic review of the literature

European Spine Journal volume 17, pages 889–904 (2008)Cite this article

Abstract

The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Trial selection and data extraction were performed by two reviewers independently. A total of 126 trials using over 25 different placebo interventions were included. The strategy most commonly used to enhance blinding was the provision of structurally equivalent placebos. Adequacy of blinding was assessed in only 13% of trials. In 20% of trials the placebo intervention was a potentially genuine treatment. Most trials that assessed patients’ expectations showed that the placebo generated lower expectations than the experimental intervention. Taken together, these results demonstrate that imperfect placebos are common in low back pain trials; a result suggesting that many trials provide potentially biased estimates of treatment efficacy. This finding has implications for the interpretation of published trials and the design of future trials. Implementation of strategies to facilitate blinding and balance expectations in randomised groups need a higher priority in low back pain research.

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References

  1. Alcoff J, Jones E, Rust P, Newman R (1982) Controlled trial of imipramine for chronic low back pain. J Fam Pract 14:841–846

    PubMed  CAS  Google Scholar 

  2. Amlie E, Weber H, Holme I (1987) Treatment of acute low-back pain with piroxicam: results of a double-blind placebo-controlled trial. Spine 12:473–476

    PubMed  CAS  Google Scholar 

  3. Arden N, Price C, Reading I, Stubbing J, Hazelgrove J, Dunne C, Michel M, Rogers P, Cooper C (2005) A multicentre randomized controlled trial of epidural corticosteroid injections for sciatica: the WEST study. Rheumatology 44:1399–1406

    PubMed  CAS  Google Scholar 

  4. Atkinson J, Slater M, Wahlgren D, Williams R, Zisook S, Pruitt S, Epping-Jordan J, Patterson T, Grant I, Abramson I, Garfin S (1999) Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity. Pain 83:137–145

    PubMed  CAS  Google Scholar 

  5. Atkinson J, Slater M, Williams R, Zisook S, Patterson T, Grant I, Wahlgren D, Abramson I, Garfin S (1998) A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain. Pain 76:287–296

    PubMed  CAS  Google Scholar 

  6. Babej-Dolle R, Freytag S, Eckmeyer J, Zerle G, Schinzel S, Schmeider G, Stankov G (1994) Parenteral dipyrone versus diclofenac and placebo in patients with acute lumbago or sciatic pain: randomized observer-blind multicenter study. Int J Clin Pharmacol Ther 32:204–209

    PubMed  CAS  Google Scholar 

  7. Bannwarth B, Allaert F, Avouac B, Rossignol M, Rozenberg S, Valat J (2005) A randomized, double-blind, placebo controlled study of oral adenosine triphosphate in subacute low back pain. J Rheumatol 32:1114–1117

    PubMed  CAS  Google Scholar 

  8. Basford J, Sheffield C, Harmsen W (1999) Laser therapy: a randomized, controlled trial of the effects of low-intensity Nd:YAG laser irradiation on musculoskeletal back pain. Arch Phys Med Rehabil 80:647–652

    PubMed  CAS  Google Scholar 

  9. Baskin T, Tierney C, Minami T, Wampold B (2003) Establishing specificity in psychotherapy: a meta-analysis of structural equivalence of placebo controls. J Consult Clin Psychol 71:973–979

    PubMed  Google Scholar 

  10. Basler H, Bertalanffy H, Quint S, Wilke A, Wolf U (2007) TTM-based counselling in physiotherapy does not contribute to an increase of adherence to activity recommendations in older adults with chronic low back pain. A randomised controlled trial. Eur J Pain 11:31–37

    PubMed  Google Scholar 

  11. Bergquist-Ullman M, Larsson U (1977) Acute low back pain in industry. A controlled prospective study with special reference to therapy and confounding factors. Acta Orthop Scand 170:1–117

    PubMed  Google Scholar 

  12. Berry H, Bloom B, Hamilton E, Swinson D (1982) Naproxen sodium, diflunisal, and placebo in the treatment of chronic back pain. Ann Rheum Dis 41:129–132

    Article  PubMed  CAS  Google Scholar 

  13. Berry H, Hutchinson D (1988) A multicentre placebo-controlled study in general practice to evaluate the efficacy and safety of tizanidine in acute low-back pain. J Int Med Res 16:75–82

    PubMed  CAS  Google Scholar 

  14. Berry H, Hutchinson D (1988) Tizanidine and ibuprofen in acute low-back pain: results of a double-blind multicentre study in general practice. J Int Med Res 16:83–91

    PubMed  CAS  Google Scholar 

  15. Bertalanffy A, Kober A, Bertalanffy P, Gustorff B, Gore O, Adel S, Hoerauf K (2005) Transcutaneous electrical nerve stimulation reduces acute low back pain during emergency transport. Acad Emerg Med 12:607–611

    PubMed  Google Scholar 

  16. Beurskens AJ, van der Heijden GJ, de Vet HC, Koke AJ, Lindeman E, Regtop W, Knipschild PG (1995) The efficacy of traction for lumbar back pain: design of a randomized clinical trial. J Manipulative Physiol Ther 18:141–147

    PubMed  CAS  Google Scholar 

  17. Birbara C, Puopolo A, Munoz D, Sheldon E, Mangione A, Bohidar N, Geba G (2003) Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability. A randomized, placebo-controlled, 3-month trial. J Pain 4:307–315

    PubMed  CAS  Google Scholar 

  18. Borkovec T, Sibrava N (2005) Problems with the use of placebo conditions in psychotherapy research, suggested alternatives, and some strategies for the pursuit of the placebo phenomenon. J Clin Psychol 61:805–818

    PubMed  CAS  Google Scholar 

  19. Brena S, Wolf S, Chapman S, Hammonds W (1980) Chronic back pain: electromyographic, motion and behavioral assessments following sympathetic nerve blocks and placebos. Pain 8:1–10

    PubMed  CAS  Google Scholar 

  20. Brizzi A, Giusti A, Giacchetti P, Stefanelli S, Provinciali L, Ceravolo M (2004) A randomised controlled trial on the efficacy of hydroelectrophoresis in acute recurrences in chronic low back pain patients. Eura Medicophys 40:303–309

    PubMed  CAS  Google Scholar 

  21. Bush C, Ditto B, Feuerstein M (1985) A controlled evaluation of paraspinal EMG biofeedback in the treatment of chronic low back pain. Health Psychol 4:307–321

    PubMed  CAS  Google Scholar 

  22. Bush K, Hillier S (1991) A controlled study of caudal epidural injections of triamcinolone plus procaine for the management of intractable sciatica. Spine 16:572–575

    PubMed  CAS  Google Scholar 

  23. Carette S, Leclaire R, Marcoux S, Morin F, Blaise G, St-Pierre A, Truchon R, Parent F, Levesque J, Bergeron V, Montminy P, Blanchette C (1997) Epidural corticosteroid injections for sciatica due to herniated nucleus pulposus. N Engl J Med 336:1634–1640

    PubMed  CAS  Google Scholar 

  24. Carette S, Marcoux S, Truchon R, Grondin C, Gagnon J, Allard Y, Latulippe M (1991) A controlled trial of corticosteroid injections into facet joints for chronic low back pain. N Engl J Med 325:1002–1007

    PubMed  CAS  Google Scholar 

  25. Carlsson C, Sjolund B (2001) Acupuncture for chronic low back pain: a randomized placebo-controlled study with long-term follow-up. Clin J Pain 17:296–305

    PubMed  CAS  Google Scholar 

  26. Chapman S, Brena S (1982) Learned helplessness and responses to nerve blocks in chronic low back pain patients. Pain 14:355–364

    PubMed  CAS  Google Scholar 

  27. Cheing G, Hui-Chan C (1999) Transcutaneous electrical nerve stimulation: nonparallel antinociceptive effects on chronic clinical pain and acute experimental pain. Arch Phys Med Rehabil 80:305–312

    PubMed  CAS  Google Scholar 

  28. Chenard J, Marchand S, Charest J, Li J, Lavignolle B (1991) Évaluation d’un traitement comportemental de la lombalgie chronique: l’ “école interactionnelle du dos”. Science et Comportement 21:225–239

    Google Scholar 

  29. Cherkin D, Deyo R, Battie M, Street J, Barlow W (1998) A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain. N Engl J Med 339:1021–1029

    PubMed  CAS  Google Scholar 

  30. Chrubasik S, Eisenberg E, Balan E, Weinberger T, Luzzati R, Conradt C (2000) Treatment of low back pain exacerbations with willow bark extract: a randomized double-blind study. Am J Med 109:9–14

    PubMed  CAS  Google Scholar 

  31. Chrubasik S, Junck H, Breitschwerdt H, Conradt C, Zappe H (1999) Effectiveness of Harpagophytum extract WS 1531 in the treatment of exacerbation of low back pain: a randomized, placebo-controlled, double-blind study. Eur J Anaesthesiol 16:118–129

    PubMed  CAS  Google Scholar 

  32. Coats T, Borenstein D, Nangia N, Brown M (2004) Effects of valdecoxib in the treatment of chronic low back pain: results of a randomized, placebo-controlled trial. Clin Ther 26:1249–1260

    PubMed  CAS  Google Scholar 

  33. Collacott E, Zimmerman J, White D, Rindone J (2000) Bipolar permanent magnets for the treatment of chronic low back pain: a pilot study. JAMA 283:1322–1325

    PubMed  CAS  Google Scholar 

  34. Critelli J, Neumann K (1984) The placebo: conceptual analysis of a construct in transition. Am Psychol 39:32–39

    PubMed  CAS  Google Scholar 

  35. Dapas F, Hartman S, Martinez L, Northrup B, Nussdorf R, Silberman H, Gross H (1985) Baclofen for the treatment of acute low-back syndrome. A double-blind comparison with placebo. Spine 10:345–349

    PubMed  CAS  Google Scholar 

  36. Dechow E, Davies R, Carr A, Thompson P (1999) A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain. Rheumatology 38:1255–1259

    PubMed  CAS  Google Scholar 

  37. Deyo R, Walsh N, Martin D, Schoenfeld L, Ramamurthy S (1990) A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med 322:1627–1634

    PubMed  CAS  Google Scholar 

  38. Deyo R, Walsh N, Schoenfeld L, Ramamurthy S (1990) Can trials of physical treatments be blinded? The example of transcutaneous electrical nerve stimulation for chronic pain. Am J Phys Med Rehabil 69:6–10

    PubMed  CAS  Google Scholar 

  39. Dickens C, Jayson M, Sutton C, Creed F (2000) The relationship between pain and depression in a trial using paroxetine in sufferers of chronic low back pain. Psychosomatics 41:490–499

    PubMed  CAS  Google Scholar 

  40. Dreiser R, Le Parc J, Velicitat P, Lleu P (2001) Oral meloxicam is effective in acute sciatica: two randomised, double-blind trials versus placebo or diclofenac. Inflamm Res 50:S17–S23

    PubMed  CAS  Google Scholar 

  41. Dreiser R, Marty M, Ionescu E, Gold M, Liu J (2003) Relief of acute low back pain with diclofenac-K 12.5 mg tablets: a flexible dose, ibuprofen 200 mg and placebo-controlled clinical trial. Int J Clin Pharmacol Ther 41:375–385

    PubMed  CAS  Google Scholar 

  42. Duplan B, Cabanel G, Piton J, Grauer J, Phelip X (1983) Acupuncture et lombosciatique à la phase aiguë. Etude en double aveugle de trente cas. Sem Hop Paris 59:3109–3114

    PubMed  CAS  Google Scholar 

  43. Faas A, Chavannes A, van Eijk J, Gubbels J (1993) A randomized, placebo-controlled trial of exercise therapy in patients with acute low back pain. Spine 18:1388–1395

    PubMed  CAS  Google Scholar 

  44. Fergusson D, Glass K, Waring D, Shapiro S (2004) Turning a blind eye: the success of blinding reported in a random sample of randomised, placebo controlled trials. BMJ 328(7437):432. doi:10.1136/bmj.37952.631667.EE

    PubMed  Google Scholar 

  45. Finckh A, Zufferey P, Schurch M, Balague F, Waldburger M, So A (2006) Short-term efficacy of intravenous pulse glucocorticoids in acute discogenic sciatica. A randomized controlled trial. Spine 31:377–381

    PubMed  Google Scholar 

  46. Fine P, Roberts W, Gillette R, Child T (1994) Slowly developing placebo responses confound tests of intravenous phentolamine to determine mechanisms underlying idiopathic chronic low back pain. Pain 56:235–242

    PubMed  CAS  Google Scholar 

  47. Frerick H, Keitel W, Kuhn U, Schmidt S, Bredehorst A, Kuhlmann M (2003) Topical treatment of chronic low back pain with a capsicum plaster. Pain 106:59–64

    PubMed  CAS  Google Scholar 

  48. Geisser M, Wiggert E, Haig A, Colwell M (2005) A randomized, controlled trial of manual therapy and specific adjuvant exercise for chronic low back pain. Clin J Pain 21:463–470

    PubMed  Google Scholar 

  49. Ghoname E, Craig W, White P, Ahmed H, Hamza M, Gajraj N, Vakharia A, Noe C (1999) The effect of stimulus frequency on the analgesic response to percutaneous electrical nerve stimulation in patients with chronic low back pain. Anesth Analg 88:841–846

    PubMed  CAS  Google Scholar 

  50. Ghoname E, Craig W, White P, Ahmed H, Hamza M, Henderson B, Gajraj N, Huber P, Gatchel R (1999) Percutaneous electrical nerve stimulation for low back pain: a randomized crossover study. JAMA 281:818–823

    PubMed  CAS  Google Scholar 

  51. Ghoname E, White P, Ahmed H, Hamza M, Craig W, Noe C (1999) Percutaneous electrical nerve stimulation: an alternative to TENS in the management of sciatica. Pain 83:193–199

    PubMed  CAS  Google Scholar 

  52. Ghosh P, Taylor T, Meachin D (1981) A double blind crossover trial of indomethacin, flurbiprofen and placebo in the management of lumbar spondylosis. Curr Therapeutic Res 30:318–326

    Google Scholar 

  53. Ghozlan R, Dropsy R (1996) Study of analgesic activity (single dose) of etodolac p.o., tenoxicam i.m. and placebo in acute sciatica. Rhumatologie 48:83–90

    Google Scholar 

  54. Gibson T, Grahame R, Harkness J, Woo P, Blagrave P, Hills R (1985) Controlled comparison of short-wave diathermy treatment with osteopathic treatment in non-specific low back pain. Lancet 1:1258–1261

    PubMed  CAS  Google Scholar 

  55. Ginsberg F, Famaey J (1987) A double-blind study of topical massage with Rado-Salil ointment in mechanical low-back pain. J Int Med Res 15:148–153

    PubMed  CAS  Google Scholar 

  56. Ginsberg F, Mingard P, Weber T (1987) Double-blind study on antitissue immunoglobulin injections versus placebo in the treatment of acute lumbar pain with muscular spasms. Int J Clin Pharmacol Res 7:401–405

    PubMed  CAS  Google Scholar 

  57. Glaser J, Baltz M, Nietert P, Bensen C (2001) Electrical muscle stimulation as an adjunct to exercise therapy in the treatment of nonacute low back pain: a randomized trial. J Pain 2:295–300

    PubMed  CAS  Google Scholar 

  58. Gold R (1978) Orphenadrine citrate: sedative or muscle relaxant? Clin Ther 1:451–453

    Google Scholar 

  59. Goldby L, Moore A, Doust J, Trew M (2006) A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder. Spine 31:1083–1093

    PubMed  Google Scholar 

  60. Goodkin K, Gullion C, Agras W (1990) A randomized, double-blind, placebo-controlled trial of trazodone hydrochloride in chronic low back pain syndrome. J Clin Psychopharmacol 10:269–278

    PubMed  CAS  Google Scholar 

  61. Goodsell M, Lee M, Latimer J (2000) Short-term effects of lumbar posteroanterior mobilization in individuals with low-back pain. J Manipulative Physiol Ther 23:332–342

    PubMed  CAS  Google Scholar 

  62. Goossens M, Rutten-Van Molken M, Kole-Snijders A, Vlaeyen J, Van Breukelen G, Leidl R (1998) Health economic assessment of behavioural rehabilitation in chronic low back pain: a randomised clinical trial. Health Econ 7:39–51

    PubMed  CAS  Google Scholar 

  63. Hackenberg L, Schafer U, Micke O, Liljenqvist U (2001) Radiotherapy for pain in chronic, degenerative low back pain syndrome: results of a prospective randomized study. Z Orthop Ihre Grenzgeb 139:294–297

    PubMed  CAS  Google Scholar 

  64. Haimovic I, Beresford H (1986) Dexamethasone is not superior to placebo for treating lumbosacral radicular pain. Neurology 36:1593–1594

    PubMed  CAS  Google Scholar 

  65. Hall T, Hardt S, Schafer A, Wallin L (2006) Mulligan bent leg raise technique: a preliminary randomized trial of immediate effects after a single intervention. Man Ther 11:130–135

    PubMed  Google Scholar 

  66. Hancock M, Maher C, Latimer J, McAuley J (2006) Selecting an appropriate placebo for a trial of spinal manipulative therapy. Aust J Physiother 52:135–138

    PubMed  Google Scholar 

  67. Hansen F, Bendix T, Skov P, Jensen C, Kristensen J, Krohn L, Schioeler H (1993) Intensive, dynamic back-muscle exercises, conventional physiotherapy, or placebo-control treatment of low-back pain. A randomized, observer-blind trial. Spine 18:98–108

    PubMed  CAS  Google Scholar 

  68. Hawk C, Long C, Rowell R, Gudavalli M, Jedlicka J (2005) A randomized trial investigating a chiropractic manual placebo: a novel design using standardized forces in the delivery of active and control treatments. J Altern Complement Med 11:109–117

    PubMed  Google Scholar 

  69. Herman E, Williams R, Stratford P, Fargas-Babjak A, Trott M (1994) A randomized controlled trial of transcutaneous electrical nerve stimulation (CODETRON) to determine its benefits in a rehabilitation program for acute occupational low back pain. Spine 19:561–568

    PubMed  CAS  Google Scholar 

  70. Hill C, LaValley M, Felson D (2002) Discrepancy between published report and actual conduct of randomized clinical trials. J Clin Epidemiol 55:783–786

    PubMed  Google Scholar 

  71. Hofferberth B, Gottschaldt M, Grass H, Buttner K (1982) The usefulness of dexamethasonephosphate in the conservative treatment of lumbar pain: a double-blind study. Arch Psychiatr Nervenkr 231:359–367

    PubMed  CAS  Google Scholar 

  72. Hoiriis K, Pfleger B, McDuffie F, Cotsonis G, Elsangak O, Hinson R, Verzosa G (2004) A randomized clinical trial comparing chiropractic adjustments to muscle relaxants for subacute low back pain. J Manipulative Physiol Ther 27:388–398

    PubMed  Google Scholar 

  73. Inoue M, Kitakoji H, Ishizaki N, Tawa M, Yano T, Katsumi Y, Kawakita K (2006) Relief of low back pain immediately after acupuncture treatment: a randomised, placebo controlled trial. Acupunct Med 24:103–108

    PubMed  Google Scholar 

  74. Itoh K, Katsumi Y, Hirota S, Kitakoji H (2006) Effects of trigger point acupuncture on chronic low back pain in elderly patients: a sham-controlled randomised trial. Acupunct Med 24:5–12

    PubMed  Google Scholar 

  75. Jagemann V (1983) Treatment of acute lumbago with diflunisal. Controlled double-blind study with placebos. Munch Med Wschr 125:29–31

    CAS  Google Scholar 

  76. Jarzem P, Harvey E, Arcaro N, Kaczorowski J (2005) Transcutaneous electrical nerve stimulation [TENS] for chronic low back pain. J Musculoskelet Pain 13:3–9

    Google Scholar 

  77. Jarzem P, Harvey E, Arcaro N, Kaczorowski J (2005) Transcutaneous electrical nerve stimulation [TENS] for short-term treatment of low back pain: randomized double blind crossover study of sham versus conventional TENS. J Musculoskelet Pain 13:11–17

    Google Scholar 

  78. Jayson M, Sims-Williams H, Young S, Baddeley H, Collins E (1981) Mobilization and manipulation for low-back pain. Spine 6:409–416

    PubMed  CAS  Google Scholar 

  79. Jüni P, Altman G, Egger M (2001) Assessing the quality of controlled clinical trials. BMJ 323:42–46

    PubMed  Google Scholar 

  80. Kaptchuk T, Goldman P, Stone D, Stason W (2000) Do medical devices have enhanced placebo effects? J Clin Epidemiol 53:786–792

    PubMed  CAS  Google Scholar 

  81. Kaptchuk T, Stason W, Davis R, Legedza A, Schnyer R, Kerr C, Stone D, Nam B, Kirsch I, Goldman R (2006) Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ 332(7538):391–397. doi:10.1136/bmj.38726.603310.55

    PubMed  Google Scholar 

  82. Katz J, Pennella-Vaughan J, Hetzel R, Kanazi G, Dworkin R (2005) A randomized, placebo-controlled trial of bupropion sustained release in chronic low back pain. J Pain 6:656–661

    PubMed  CAS  Google Scholar 

  83. Katz N, Ju W, Krupa D, Sperling R, Bozalis R, Gertz B, Gimbel J, Coleman S, Fisher C, Nabizadeh S, Borenstein D, Vioxx Chronic Low Back Pain Study Group (2003) Efficacy and safety of rofecoxib in patients with chronic low back pain: results from two 4-week, randomized, placebo-controlled, parallel-group, double-blind trials. Spine 28:851–858

    PubMed  Google Scholar 

  84. Keitel W, Frerick H, Kuhn U, Schmidt U, Kuhlmann M, Bredehorst A (2001) Capsicum pain plaster in chronic non-specific low back pain. Arzneimittelforschung/Drug Res 51:896–903

    CAS  Google Scholar 

  85. Kerr D, Walsh D, Baxter D (2003) Acupuncture in the management of chronic low back pain: a blinded randomized controlled trial. Clin J Pain 19:364–370

    PubMed  Google Scholar 

  86. Ketenci A, Ozcan E, Karamursel S (2005) Assessment of efficacy and psychomotor performances of thiocolchicoside and tizanidine in patients with acute low back pain. Int J Clin Pract 59:764–770

    PubMed  CAS  Google Scholar 

  87. Khoromi S, Patsalides A, Parada S, Salehi V, Meegan J, Max M (2005) Topiramate in chronic lumbar radicular pain. J Pain 6:829–836

    PubMed  CAS  Google Scholar 

  88. Khot A, Bowditch M, Powell J, Sharp D (2004) The use of intradiscal steroid therapy for lumbar spinal discogenic pain: a randomized controlled trial. Spine 29:833–836

    PubMed  Google Scholar 

  89. Klein R, Eek B (1990) Low-energy laser treatment and exercise for chronic low back pain: double-blind controlled trial. Arch Phys Med Rehabil 71:34–37

    PubMed  CAS  Google Scholar 

  90. Klenerman L, Greenwood R, Davenport H, White D, Peskett S (1984) Lumbar epidural injections in the treatment of sciatica. Br J Rheumatol 23:35–38

    PubMed  CAS  Google Scholar 

  91. Koes B, Van Tulder M, Thomas S (2006) Diagnosis and treatment of low back pain. BMJ 332:1430–1434

    PubMed  CAS  Google Scholar 

  92. Korhonen T, Karppinen J, Paimela L, Malmivaara A, Lindgren K, Jarvinen S, Niinimaki J, Veeger N, Seitsalo S, Hurri H (2005) The treatment of disc herniation-induced sciatica with infliximab: results of a randomized controlled, 3-month follow-up study. Spine 30:2724–2728

    PubMed  Google Scholar 

  93. Kovacs F, Abraira V, Pozo F, Kleinbaum D, Beltran J, Mateo I, de Ayala C, Pena A, Zea A, Gonzalez-Lanza M, Morillas L (1997) Local and remote sustained trigger point therapy for exacerbations of chronic low back pain: a randomized, double-blind, controlled, multicenter trial. Spine 22:786–797

    PubMed  CAS  Google Scholar 

  94. Lee P, Kim Y, Lim Y, Lee C, Choi S, Park S, Lee J, Lee S (2006) Efficacy of pulsed electromagnetic therapy for chronic lower back pain: a randomized, double-blind, placebo-controlled study. J Int Med Res 34:160–167

    PubMed  CAS  Google Scholar 

  95. Leibing E, Leonhardt U, Koster G, Goerlitz A, Rosenfeldt J, Hilgers R, Ramadori G (2002) Acupuncture treatment of chronic low-back pain—a randomized, blinded, placebo-controlled trial with 9-month follow-up. Pain 96:189–196

    PubMed  Google Scholar 

  96. Licciardone J, Stoll S, Fulda K, Russo D, Siu J, Winn W, Swift J Jr (2003) Osteopathic manipulative treatment for chronic low back pain: a randomized controlled trial. Spine 28:1355–1362

    PubMed  Google Scholar 

  97. Lilius G, Laasonen E, Myllynen P, Harilainen A, Salo L (1989) Lumbar facet joint syndrome. Significance of non-organic signs. A randomized placebo-controlled clinical study. Rev Chir Orthop Reparatrice Appar Mot 75:493–500

    PubMed  CAS  Google Scholar 

  98. Lund I, Lundeberg T (2006) Are minimal, superficial or sham acupuncture procedures acceptable as inert placebo controls? Acupunct Med 24:13–15

    PubMed  Google Scholar 

  99. Macdonald A, Macrae K, Master B, Rubin A (1983) Superficial acupuncture in the relief of chronic low back pain. Ann R Coll Surg Eng 65:44–46

    CAS  Google Scholar 

  100. Maher CG, Sherrington C, Herbert R, Moseley A, Elkins M (2003) Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther 83:713–721

    PubMed  Google Scholar 

  101. Marcel C, Rezvani Y, Revel M (1990) Evaluation of thiocolchicoside as monotherapy in low back pain. Results of a randomized study versus placebo. Presse Med 19:1133–1136

    PubMed  CAS  Google Scholar 

  102. Mauro G, Martorana U, Cataldo P, Brancato G (2000) Vitamin B12 in low back pain: a randomised, double-blind, placebo-controlled study. Eur Rev Med Pharmacol Sci 4:53–58

    PubMed  CAS  Google Scholar 

  103. Medrik-Goldberg T, Lifschitz D, Pud D, Adler R, Eisenberg E (1999) Intravenous lidocaine, amantadine, and placebo in the treatment of sciatica: a double-blind, randomized, controlled study. Reg Anesth Pain Med 24:534–540

    PubMed  CAS  Google Scholar 

  104. Mendelson G, Selwood T, Kranz H, Loh T, Kidson M, Scott D (1983) Acupuncture treatment of chronic back pain. A double-blind placebo-controlled trial. Am J Med 74:49–55

    PubMed  CAS  Google Scholar 

  105. Moher D, Schulz K, Altman D, for the CONSORT Group (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357:1191–1194

    Google Scholar 

  106. Molsberger A, Mau J, Pawelec D, Winkler J (2002) Does acupuncture improve the orthopedic management of chronic low back pain: a randomized, blinded, controlled trial with 3 months follow up. Pain 99:579–587

    PubMed  Google Scholar 

  107. Moore S, Shurman J (1997) Combined neuromuscular electrical stimulation and transcutaneous electrical nerve stimulation for treatment of chronic back pain: a double-blind, repeated measures comparison. Arch Phys Med Rehabil 78:55–60

    PubMed  CAS  Google Scholar 

  108. Muehlbacher M, Nickel M, Kettler C, Tritt K, Lahmann C, Leiberich P, Nickel C, Krawczyk J, Mitterlehner F, Rother W, Loew T, Kaplan P (2006) Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study. Clin J Pain 22:526–531

    PubMed  Google Scholar 

  109. Nadler S, Steiner D, Erasala G, Hengehold D, Abeln S, Weingand K (2003) Continuous low-level heatwrap therapy for treating acute nonspecific low back pain. Arch Phys Med Rehabil 84:329–334

    PubMed  Google Scholar 

  110. Nadler S, Steiner D, Petty S, Erasala G, Hengehold D, Weingand K (2003) Overnight use of continuous low-level heatwrap therapy for relief of low back pain. Arch Phys Med Rehabil 84:335–342

    PubMed  Google Scholar 

  111. Nicholas M, Wilson P, Goyen J (1992) Comparison of cognitive-behavioral group treatment and an alternative non-psychological treatment for chronic low back pain. Pain 48:339–347

    PubMed  CAS  Google Scholar 

  112. Pallay R, Seger W, Adler J, Ettlinger R, Quaidoo E, Lipetz R, O’Brien K, Mucciola L, Skalky C, Petruschke R, Bohidar N, Geba G (2004) Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial. Scad J Rheumatol 33:257–266

    CAS  Google Scholar 

  113. Paterson C, Dieppe P (2005) Characteristic and incidental (placebo) effects in complex interventions such as acupuncture. BMJ 330:1202–1205

    PubMed  Google Scholar 

  114. Peloso P, Fortin L, Beaulieu A, Kamin M, Rosenthal N (2004) Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol 31:2454–2463

    PubMed  CAS  Google Scholar 

  115. Pheasant H, Bursk A, Goldfarb J, Azen S, Weiss J, Borelli L (1983) Amitriptyline and chronic low-back pain. A randomized double-blind crossover study. Spine 8:552–557

    PubMed  CAS  Google Scholar 

  116. Preyde M (2000) Effectiveness of massage therapy for subacute low-back pain: a randomized controlled trial. CMAJ 162:1815–1820

    PubMed  CAS  Google Scholar 

  117. Reust P, Chantraine A, Vischer T (1988) Treatment of lumbar sciatica with or without neurological deficit using mechanical traction. A double-blind study. Schweiz Med Wschr 118:271–274

    PubMed  CAS  Google Scholar 

  118. Revel M, Poiraudeau S, Auleley G, Payan C, Denke A, Nguyen M, Chevrot A, Fermanian J (1998) Capacity of the clinical picture to characterize low back pain relieved by facet joint anesthesia. Proposed criteria to identify patients with painful facet joints. Spine 23:1972–1976

    PubMed  CAS  Google Scholar 

  119. Rosenthal D, Frank J (1956) Psychotherapy and the placebo effect. Psychol Bull 53:294–302

    PubMed  CAS  Google Scholar 

  120. Ruoff G, Rosenthal N, Jordan D, Karim R, Kamin M (2003) Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study. Clin Ther 25:1123–1141

    PubMed  CAS  Google Scholar 

  121. Sanders G, Reinert O, Tepe R, Maloney P (1990) Chiropractic adjustive manipulation on subjects with acute low back pain: visual analog pain scores and plasma beta-endorphin levels. J Manipulative Physiol Ther 13:391–395

    PubMed  CAS  Google Scholar 

  122. Sator-Katzenschlager S, Scharbert G, Kozek-Langenecker S, Szeles J, Finster G, Schiesser A, Heinze G, Kress H (2004) The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg 98:1359–1364

    PubMed  Google Scholar 

  123. Schnebel B, Simmons J (1988) The use of oral colchicine for low-back pain. A double-blind study. Spine 13:354–357

    PubMed  CAS  Google Scholar 

  124. Schnitzer T, Gray W, Paster R, Kamin M (2000) Efficacy of tramadol in treatment of chronic low back pain. J Rheumatol 27:772–778

    PubMed  CAS  Google Scholar 

  125. Schulz K, Chalmers I, Altman D (2002) The landscape and lexicon of blinding in randomized trials. Ann Intern Med 136:254–259

    PubMed  Google Scholar 

  126. Schulz K, Chalmers I, Hayes R, Altman D (1995) Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273:408–412

    PubMed  CAS  Google Scholar 

  127. Shabat S, Gefen T, Nyska M, Folman Y, Gepstein R (2005) The effect of insoles on the incidence and severity of low back pain among workers whose job involves long-distance walking. Eur Spine J 14:546–550

    PubMed  CAS  Google Scholar 

  128. Sherman K, Hogeboom C, Cherkin D, Deyo R (2002) Description and validation of a noninvasiive placebo acupuncture procedure. J Altern Complement Med 8:11–19

    PubMed  Google Scholar 

  129. Sherry E, Kitchener P, Smart R (2001) A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurol Res 23:780–784

    PubMed  CAS  Google Scholar 

  130. Snook S, Webster B, McGorry R, Fogleman M, McCann K (1998) The reduction of chronic nonspecific low back pain through the control of early morning lumbar flexion. A randomized controlled trial. Spine 23:2601–2607

    PubMed  CAS  Google Scholar 

  131. Spratt K, Weinstein J, Lehmann T, Woody J, Sayre H (1993) Efficacy of flexion and extension treatments incorporating braces for low-back pain patients with retrodisplacement, spondylolisthesis, or normal sagittal translation. Spine 18:1839–1849

    PubMed  CAS  Google Scholar 

  132. Strong J (1998) Incorporating cognitive-behavioral therapy with occupational therapy: a comparative study with patients with low back pain. J Occup Rehabil 8:61–71

    Google Scholar 

  133. Stuckey S, Jacobs A, Goldfarb J (1986) EMG biofeedback training, relaxation training, and placebo for the relief of chronic back pain. Percept Mot Skills 63:1023–1036

    PubMed  CAS  Google Scholar 

  134. Szpalski M, Hayez J (1994) Objective functional assessment of the efficacy of tenoxicam in the treatment of acute low back pain. A double-blind placebo-controlled study. Br J Rheumatol 33:74–78

    PubMed  CAS  Google Scholar 

  135. Tajiri K, Takahashi K, Ikeda K, Tomita K (1998) Common peroneal nerve block for sciatica. Clin Orthop 347:203–207

    PubMed  Google Scholar 

  136. Tasleem R, Buth B, Koul P, Kadri S (2003) Chronic low back pain - comparative analysis of treatment response to drugs and different physical modalities. JK Pract 10:201–204

    Google Scholar 

  137. Topuz O, Ozfidan E, Ozgen M, Ardic F (2004) Efficacy of transcutaneous electrical nerve stimulation and percutaneous neuromodulation therapy in chronic low back pain. J Back Musculoskeletal Rehabil 17:127–133

    Google Scholar 

  138. Treves R, Montaine de la Roque P, Dumond J, Bertin P, Arnaud M, Desproges-Gotteron R (1991) Prospective study of the analgesic action of clomipramine versus placebo in refractory lumbosciatica (68 cases). Rev Rhum Mal Osteoartic 58:549–552

    PubMed  CAS  Google Scholar 

  139. Tuzun F, Unalan H, Oner N, Ozguzel H, Kirazli Y, Icagasioglu A, Kuran B, Tuzun S, Basar G (2003) Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain. Joint Bone Spine 70:356–361

    PubMed  Google Scholar 

  140. Van Tulder M, Furlan A, Bombardier C, Bouter L (2003) Uptaded method guidelines for systematic reviews in the Cochrane Collaboration Back Review Group. Spine 28:1290–1299

    PubMed  Google Scholar 

  141. Wasan A, Davar G, Jamison R (2005) The association between negative affect and opioid analgesia in patients with discogenic low back pain. Pain 117:450–461

    PubMed  CAS  Google Scholar 

  142. Weber H, Holme I, Amlie E (1993) The natural course of acute sciatica with nerve root symptoms in a double-blind placebo-controlled trial evaluating the effect of piroxicam Spine 18:1433–1438

    PubMed  CAS  Google Scholar 

  143. Weiner D, Rudy T, Glick R, Boston J, Lieber S, Morrow L, Taylor S (2003) Efficacy of percutaneous electrical nerve stimulation for the treatment of chronic low back pain in older adults. J Am Geriatr Soc 51:599–608

    PubMed  Google Scholar 

  144. White A, Filshie J, Cummings T, International Acupuncture Research Forum (IARF) (2001) Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med 9:237–245

    PubMed  CAS  Google Scholar 

  145. Worz R, Bolten W, Heller B, Krainick J, Pergande G (1996) Flupirtine in comparison with chlormezanone in chronic musculoskeletal back pain. Results of a multicenter randomized double-blind study. MMW Fortschr Med 114:500–504

    CAS  Google Scholar 

  146. Wreje U, Nordgren B, Aberg H (1992) Treatment of pelvic joint dysfunction in primary care - a controlled study. Scand J Prim Health Care 10:310–315

    PubMed  CAS  Google Scholar 

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Authors and Affiliations

  1. Back Pain Research Group, Musculoskeletal Division, The George Institute for International Health, Missenden Rd, P.O. Box M201, Camperdown, NSW, 2050, Australia

    L. A. C. Machado, S. J. Kamper, R. D. Herbert, C. G. Maher & J. H. McAuley

  2. Faculty of Medicine, The University of Sydney, Sydney, Australia

    L. A. C. Machado, S. J. Kamper, R. D. Herbert, C. G. Maher & J. H. McAuley

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  1. L. A. C. Machado
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  2. S. J. Kamper
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  3. R. D. Herbert
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Machado, L.A.C., Kamper, S.J., Herbert, R.D. et al. Imperfect placebos are common in low back pain trials: a systematic review of the literature. Eur Spine J 17, 889–904 (2008). https://doi.org/10.1007/s00586-008-0664-3

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Keywords

  • Systematic review
  • Low back pain
  • Trial methodology
  • Blinding
  • Expectation