We use cookies to improve your experience. By continuing to browse this site, you accept our cookie policy.×
Skip main navigation
Aging Health
Bioelectronics in Medicine
Biomarkers in Medicine
Breast Cancer Management
CNS Oncology
Colorectal Cancer
Concussion
Epigenomics
Future Cardiology
Future Medicine AI
Future Microbiology
Future Neurology
Future Oncology
Future Rare Diseases
Future Virology
Hepatic Oncology
HIV Therapy
Immunotherapy
International Journal of Endocrine Oncology
International Journal of Hematologic Oncology
Journal of 3D Printing in Medicine
Lung Cancer Management
Melanoma Management
Nanomedicine
Neurodegenerative Disease Management
Pain Management
Pediatric Health
Personalized Medicine
Pharmacogenomics
Regenerative Medicine

Management of fibromyalgia syndrome in 2016

    Akiko Okifuji

    *Author for correspondence:

    E-mail Address: akiko.okifuji@hsc.utah.edu

    Department of Anaesthesiology, Pain Management & Research Center, University of Utah, 615 Arapeen Drive, Suite 200, Salt Lake City, UT 84108, USA

    ,
    Jeff Gao

    Department of Anaesthesiology, Pain Management & Research Center, University of Utah, 615 Arapeen Drive, Suite 200, Salt Lake City, UT 84108, USA

    ,
    Christina Bokat

    Department of Anaesthesiology, Pain Management & Research Center, University of Utah, 615 Arapeen Drive, Suite 200, Salt Lake City, UT 84108, USA

    &
    Bradford D Hare

    Department of Anaesthesiology, Pain Management & Research Center, University of Utah, 615 Arapeen Drive, Suite 200, Salt Lake City, UT 84108, USA

    Published Online:https://doi.org/10.2217/pmt-2016-0006

    Fibromyalgia syndrome is a chronic pain disorder and defies definitively efficacious therapy. In this review, we summarize the results from the early treatment research as well as recent research evaluating the pharmacological, interventional and nonpharmacological therapies. We further discuss future directions of fibromyalgia syndrome management; we specifically focus on the issues that are associated with currently available treatments, such as the need for personalized approach, new technologically oriented and interventional treatments, the importance of understanding and harnessing placebo effects and enhancement of patient engagement in therapy.

    References

    • 1 Wolfe F, Smythe HA, Yunus MB et al. The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee [see comments]. Arthritis Rheum. 33(2), 160–172 (1990).
    • 2 White KP, Speechley M, Harth M, Ostbye T. The London Fibromyalgia Epidemiology Study: direct health care costs of fibromyalgia syndrome in London, Canada. J. Rheumatol. 26(4), 885–889 (1999).
    • 3 Lawrence RC, Felson DT, Helmick CG et al. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 58(1), 26–35 (2008).
    • 4 Arroyo JF, Cohen ML. Abnormal responses to electrocutaneous stimulation in fibromyalgia [see comments]. J. Rheumatol. 20(11), 1925–1931 (1993).
    • 5 Gibson SJ, Littlejohn GO, Gorman MM, Helme RD, Granges G. Altered heat pain thresholds and cerebral event-related potentials following painful CO2 laser stimulation in subjects with fibromyalgia syndrome. Pain 58(2), 185–193 (1994).
    • 6 Kosek E, Hansson P. Modulatory influence on somatosensory perception from vibration and heterotopic noxious conditioning stimulation (HNCS) in fibromyalgia patients and healthy subjects. Pain 70(1), 41–51 (1997).
    • 7 Petzke F, Clauw DJ, Ambrose K, Khine A, Gracely RH. Increased pain sensitivity in fibromyalgia: effects of stimulus type and mode of presentation. Pain 105(3), 403–413 (2003).
    • 8 Gracely RH, Petzke F, Wolf JM, Clauw DJ. Functional magnetic resonance imaging evidence of augmented pain processing in fibromyalgia. Arthritis Rheum. 46(5), 1333–1343 (2002).
    • 9 Lorenz J, Grasedyck K, Bromm B. Middle and long latency somatosensory evoked potentials after painful laser stimulation in patients with fibromyalgia syndrome. Electroencephalogr. Clin. Neurophysiol. 100(2), 165–168 (1996).
    • 10 Staud R. Peripheral pain mechanisms in chronic widespread pain. Best Pract. Res. Clin. Rheumatol. 25(2), 155–164 (2011).
    • 11 Light KC, White AT, Tadler S, Iacob E, Light AR. Genetics and gene expression involving stress and distress pathways in fibromyalgia with and without comorbid chronic fatigue syndrome. Pain Res. Treat. 2012, 427869 (2012).
    • 12 Martinez-Lavin M. Biology and therapy of fibromyalgia. Stress, the stress response system, and fibromyalgia. Arthritis Res. Ther. 9(4), 216 (2007).
    • 13 Clark S, Tindall E, Bennett RM. A double blind crossover trial of prednisone versus placebo in the treatment of fibrositis. J. Rheumatol. 12(5), 980–983 (1985).
    • 14 Wolfe F, Anderson J, Harkness D et al. Health status and disease severity in fibromyalgia: results of a six-center longitudinal study. Arthritis Rheum. 40(9), 1571–1579 (1997).
    • 15 Goldenberg DL, Felson DT, Dinerman H. A randomized, controlled trial of amitriptyline and naproxen in the treatment of patients with fibromyalgia. Arthritis Rheum. 29(11), 1371–1377 (1986).
    • 16 Yunus MB, Masi AT, Aldag JC. Short term effects of ibuprofen in primary fibromyalgia syndrome: a double blind, placebo controlled trial. J. Rheumatol. 16(4), 527–532 (1989).
    • 17 Russell IJ, Fletcher EM, Michalek JE, Mcbroom PC, Hester GG. Treatment of primary fibrositis/fibromyalgia syndrome with ibuprofen and alprazolam. A double-blind, placebo-controlled study. Arthritis Rheum. 34(5), 552–560 (1991).
    • 18 Quijada-Carrera J, Valenzuela-Castano A, Povedano-Gomez J et al. Comparison of tenoxicam and bromazepan in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. Pain 65(2–3), 221–225 (1996).
    • 19 Moldofsky H, Lue FA, Mously C, Roth-Schechter B, Reynolds WJ. The effect of zolpidem in patients with fibromyalgia: a dose ranging, double blind, placebo controlled, modified crossover study. J. Rheumatol. 23(3), 529–533 (1996).
    • 20 Drewes AM, Andreasen A, Jennum P, Nielsen KD. Zopiclone in the treatment of sleep abnormalities in fibromyalgia. Scand. J. Rheumatol. 20(4), 288–293 (1991).
    • 21 Moldofsky H. The significance of dysfunctions of the sleeping/waking brain to the pathogenesis and treatment of fibromyalgia syndrome. Rheum. Dis. Clin. North Am. 35(2), 275–283 (2009).
    • 22 Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Javors MA, Bowden CA. Platelet 3H-imipramine uptake receptor density and serum serotonin levels in patients with fibromyalgia/fibrositis syndrome [see comments]. J. Rheumatol. 19(1), 104–109 (1992).
    • 23 Wolfe F, Russell IJ, Vipraio G, Ross K, Anderson J. Serotonin levels, pain threshold, and fibromyalgia symptoms in the general population. J. Rheumatol. 24(3), 555–559 (1997).
    • 24 Ginsberg F, Mancaux A, Joos E, Vanhove P, Famaey J-P. A randomized placebo-controlled trial of sustained-release amitriptyline in primary fibromyalgia. J. Musculoskel. Pain 4, 37–47 (1996).
    • 25 Bennett RM, Gatter RA, Campbell SM, Andrews RP, Clark SR, Scarola JA. A comparison of cyclobenzaprine and placebo in the management of fibrositis. A double-blind controlled study. Arthritis Rheum. 31(12), 1535–1542 (1988).
    • 26 Santandrea S, Montrone F, Sarzi Puttini P, Boccassini L, Caruso I. A double-blind crossover study of two cyclobenzaprine regimens in primary fibromyalgia syndrome. J. Int. Med. Res. 21, 74–80 (1983).
    • 27 Liderman S, Clauw DJ, Gendreau J et al. TNX-102 SL for the treatment of fibromyalgia: role of nonrestorative sleep on pain centralization. Ann. Rheum. Dis. 74, 313 (2015).
    • 28 Arnold LM, Keck PE Jr, Welge JA. Antidepressant treatment of fibromyalgia. A meta-analysis and review. Psychosomatics 41(2), 104–113 (2000).
    • 29 Carette S, Bell MJ, Reynolds WJ et al. Comparison of amitriptyline, cyclobenzaprine, and placebo in the treatment of fibromyalgia. A randomized, double-blind clinical trial [see comments]. Arthritis Rheum. 37(1), 32–40 (1994).
    • 30 Moore RA, Derry S, Aldington D, Cole P, Wiffen PJ. Amitriptyline for neuropathic pain in adults. Cochrane Database Syst. Rev. 7, CD008242 (2015).
    • 31 Goldenberg D, Mayskiy M, Mossey C, Ruthazer R, Schmid C. A randomized, double-blind crossover trial of fluoxetine and amitriptyline in the treatment of fibromyalgia. Arthritis Rheum. 39(11), 1852–1859 (1996).
    • 32 Wolfe F, Cathey MA, Hawley DJ. A double-blind placebo controlled trial of fluoxetine in fibromyalgia. Scand. J. Rheumatol. 23(5), 255–259 (1994).
    • 33 Walitt B, Urrutia G, Nishishinya MB, Cantrell SE, Hauser W. Selective serotonin reuptake inhibitors for fibromyalgia syndrome. Cochrane Database Syst. Rev. 6, CD011735 (2015).
    • 34 Bernik M, Sampaio TP, Gandarela L. Fibromyalgia comorbid with anxiety disorders and depression: combined medical and psychological treatment. Curr Pain Headache Rep 17(9), 358 (2013).
    • 35 Arnold LM, Russell IJ, Diri EW et al. A 14-week, randomized, double-blinded, placebo-controlled monotherapy trial of pregabalin in patients with fibromyalgia. J. Pain 9(9), 792–805 (2008).
    • 36 Hauser W, Bernardy K, Uceyler N, Sommer C. Treatment of fibromyalgia syndrome with gabapentin and pregabalin – a meta-analysis of randomized controlled trials. Pain 145(1–2), 69–81 (2009).
    • 37 Straube S, Derry S, Moore RA, Mcquay HJ. Pregabalin in fibromyalgia: meta-analysis of efficacy and safety from company clinical trial reports. Rheumatology (Oxford) 49(4), 706–715 (2010).
    • 38 Arnold LM, Rosen A, Pritchett YL et al. A randomized, double-blind, placebo-controlled trial of duloxetine in the treatment of women with fibromyalgia with or without major depressive disorder. Pain 119(1–3), 5–15 (2005).
    • 39 Arnold LM, Lu Y, Crofford LJ et al. A double-blind, multicenter trial comparing duloxetine with placebo in the treatment of fibromyalgia patients with or without major depressive disorder. Arthritis Rheum. 50(9), 2974–2984 (2004).
    • 40 Russell IJ, Mease PJ, Smith TR et al. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain 136(3), 432–444 (2008).
    • 41 Mease PJ, Russell IJ, Kajdasz DK et al. Long-term safety, tolerability, and efficacy of duloxetine in the treatment of fibromyalgia. Semin. Arthritis Rheum. 39(6), 454–464 (2010).
    • 42 Arnold LM, Clauw DJ, Wohlreich MM et al. Efficacy of duloxetine in patients with fibromyalgia: pooled analysis of 4 placebo-controlled clinical trials. Prim. Care Companion J. Clin. Psychiatry 11(5), 237–244 (2009).
    • 43 Vitton O, Gendreau M, Gendreau J, Kranzler J, Rao SG. A double-blind placebo-controlled trial of milnacipran in the treatment of fibromyalgia. Hum. Psychopharmacol. 19(Suppl. 1), S27–S35 (2004).
    • 44 Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin. Ther. 30(11), 1988–2004 (2008).
    • 45 Mease PJ, Clauw DJ, Gendreau RM et al. The efficacy and safety of milnacipran for treatment of fibromyalgia. a randomized, double-blind, placebo-controlled trial. J. Rheumatol. 36(2), 398–409 (2009).
    • 46 Geisser ME, Palmer RH, Gendreau RM, Wang Y, Clauw DJ. A pooled analysis of two randomized, double-blind, placebo-controlled trials of milnacipran monotherapy in the treatment of fibromyalgia. Pain Pract. 11(2), 120–131 (2011).
    • 47 Arnold LM, Palmer RH, Ma Y. A 3-year, open-label, flexible-dosing study of milnacipran for the treatment of fibromyalgia. Clin. J. Pain 29(12), 1021–1028 (2013).
    • 48 Arnold LM, Zhang S, Pangallo BA. Efficacy and safety of duloxetine 30 mg/d in patients with fibromyalgia: a randomized, double-blind, placebo-controlled study. Clin. J. Pain 28(9), 775–781 (2012).
    • 49 Hauser W, Sarzi-Puttini P, Tolle TR, Wolfe F. Placebo and nocebo responses in randomised controlled trials of drugs applying for approval for fibromyalgia syndrome treatment: systematic review and meta-analysis. Clin. Exp. Rheumatol. 30(6 Suppl. 74), 78–87 (2012).
    • 50 Goetz CG, Wuu J, Mcdermott MP et al. Placebo response in Parkinson's disease: comparisons among 11 trials covering medical and surgical interventions. Mov. Disord. 23(5), 690–699 (2008).
    • 51 Nickel JC. Placebo therapy of benign prostatic hyperplasia: a 25-month study. Canadian PROSPECT study group. Br. J. Urol. 81(3), 383–387 (1998).
    • 52 Cherkin DC, Sherman KJ, Avins AL et al. A randomized trial comparing acupuncture, simulated acupuncture, and usual care for chronic low back pain. Arch. Intern. Med. 169(9), 858–866 (2009).
    • 53 Painter JT, Crofford LJ, Talbert J. Geographic variation of chronic opioid use in fibromyalgia. Clin. Ther. 35(3), 303–311 (2013).
    • 54 Fitzcharles MA, Ste-Marie PA, Gamsa A, Ware MA, Shir Y. Opioid use, misuse, and abuse in patients labeled as fibromyalgia. Am. J. Med. 124(10), 955–960 (2011).
    • 55 Okifuji A, Donaldson GW, Barck L, Fine PG. Relationship between fibromyalgia and obesity in pain, function, mood, and sleep. J. Pain 11(12), 1329–1337 (2010).
    • 56 Peng X, Robinson RL, Mease P et al. Long-term evaluation of opioid treatment in fibromyalgia. Clin. J. Pain 31(1), 7–13 (2015).
    • 57 Fitzcharles MA, Faregh N, Ste-Marie PA, Shir Y. Opioid use in fibromyalgia is associated with negative health related measures in a prospective cohort study. Pain Res. Treat. 2013, 898493 (2013).
    • 58 Bennett RM, Kamin M, Karim R, Rosenthal N. Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am. J. Med. 114(7), 537–545 (2003).
    • 59 Combined Behavioral and Analgesic Trial for Fibromyalglia (COMBAT-FM). https://clinicaltrials.gov/ct2/show/NCT01598753.
    • 60 Younger J, Mackey S. Fibromyalgia symptoms are reduced by low-dose naltrexone: a pilot study. Pain Med. 10(4), 663–672 (2009).
    • 61 Younger J, Noor N, Mccue R, Mackey S. Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. Arthritis Rheum. 65(2), 529–538 (2013).
    • 62 Holman AJ. Ropinirole, open preliminary observations of a dopamine agonist for refractory fibromyalgia. J. Clin. Rheumatol. 9(4), 277–279 (2003).
    • 63 Holman AJ, Myers RR. A randomized, double-blind, placebo-controlled trial of pramipexole, a dopamine agonist, in patients with fibromyalgia receiving concomitant medications. Arthritis Rheum. 52(8), 2495–2505 (2005).
    • 64 The use of rotigotine for treatment of reducing signs and symptoms of fibromyalgia in adults. https://clinicaltrials.gov/ct2/show/NCT00464737.
    • 65 Fibromyalgia study in adults. https://clinicaltrials.gov/ct2/show/NCT00256893.
    • 66 Pramipexole ER vs. placebo in fibromyalgia. https://clinicaltrials.gov/ct2/show/NCT00689052.
    • 67 Skrabek RQ, Galimova L, Ethans K, Perry D. Nabilone for the treatment of pain in fibromyalgia. J. Pain 9(2), 164–173 (2008).
    • 68 Ware MA, Fitzcharles MA, Joseph L, Shir Y. The effects of nabilone on sleep in fibromyalgia: results of a randomized controlled trial. Anesth. Analg. 110(2), 604–610 (2010).
    • 69 Kahan M, Srivastava A, Spithoff S, Bromley L. Prescribing smoked cannabis for chronic noncancer pain: preliminary recommendations. Can. Fam. Physician 60(12), 1083–1090 (2014).
    • 70 Hill KP. Medical marijuana for treatment of chronic pain and other medical and psychiatric problems: a clinical review. JAMA 313(24), 2474–2483 (2015).
    • 71 Carter LP, Pardi D, Gorsline J, Griffiths RR. Illicit gamma-hydroxybutyrate (GHB) and pharmaceutical sodium oxybate (Xyrem): differences in characteristics and misuse. Drug Alcohol Depend. 104(1–2), 1–10 (2009).
    • 72 Wang YG, Swick TJ, Carter LP, Thorpy MJ, Benowitz NL. Sodium oxybate: updates and correction to previously published safety data. J. Clin. Sleep Med. 7(4), 415–416 (2011).
    • 73 Pardi D, Black J. gamma-Hydroxybutyrate/sodium oxybate: neurobiology, and impact on sleep and wakefulness. CNS Drugs 20(12), 993–1018 (2006).
    • 74 Scharf MB, Baumann M, Berkowitz DV. The effects of sodium oxybate on clinical symptoms and sleep patterns in patients with fibromyalgia. J. Rheumatol. 30(5), 1070–1074 (2003).
    • 75 Russell IJ, Perkins AT, Michalek JE. Sodium oxybate relieves pain and improves function in fibromyalgia syndrome: a randomized, double-blind, placebo-controlled, multicenter clinical trial. Arthritis Rheum. 60(1), 299–309 (2009).
    • 76 Russell IJ, Holman AJ, Swick TJ, Alvarez-Horine S, Wang YG, Guinta D. Sodium oxybate reduces pain, fatigue, and sleep disturbance and improves functionality in fibromyalgia: results from a 14-week, randomized, double-blind, placebo-controlled study. Pain 152(5), 1007–1017 (2011).
    • 77 Spaeth M, Bennett RM, Benson BA, Wang YG, Lai C, Choy EH. Sodium oxybate therapy provides multidimensional improvement in fibromyalgia: results of an international Phase 3 trial. Ann. Rheum. Dis. 71(6), 935–942 (2012).
    • 78 Food and Drug Administration (04-03), Xyrem® (sodium oxybate) (2013). www.fda.gov/ohrms/dockets/dockets/05n0479/05N-0479-EC9-Attach-2.pdf.
    • 79 Alarcon GS. Questioning the likelihood that sodium oxybate can be used to successfully treat fibromyalgia: comment on the article by Russell et al. Arthritis Rheum. 60(9), 2854 (2009).
    • 80 Moldofsky H, Inhaber NH, Guinta DR, Alvarez-Horine SB. Effects of sodium oxybate on sleep physiology and sleep/wake-related symptoms in patients with fibromyalgia syndrome: a double-blind, randomized, placebo-controlled study. J. Rheumatol. 37(10), 2156–2166 (2010).
    • 81 US FDA: Summary Minutes of the Joint Meeting of the Aruthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. Bethesda, MD, USA (2010). www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM227134.pdf.
    • 82 Sutherland AM, Clarke HA, Katz J, Katznelson R. Hyperbaric oxygen therapy: a new treatment for chronic pain? Pain Pract. doi:10.1111/papr.12312 (2015) (Epub ahead of print).
    • 83 Mengshoel AM, Vollestad NK, Forre O. Pain and fatigue induced by exercise in fibromyalgia patients and sedentary healthy subjects. Clin. Exp. Rheumatol. 13(4), 477–482 (1995).
    • 84 Kelley GA, Kelley KS, Jones DL. Efficacy and effectiveness of exercise on tender points in adults with fibromyalgia: a meta-analysis of randomized controlled trials. Arthritis 2011, 125485 (2011).
    • 85 Jones KD, Adams D, Winters-Stone K, Burckhardt CS. A comprehensive review of 46 exercise treatment studies in fibromyalgia (1988–2005). Health Qual. Life Outcomes 4, 67 (2006).
    • 86 Hauser W, Klose P, Langhorst J et al. Efficacy of different types of aerobic exercise in fibromyalgia syndrome: a systematic review and meta-analysis of randomised controlled trials. Arthritis Res. Ther. 12(3), R79 (2010).
    • 87 Busch AJ, Webber SC, Brachaniec M et al. Exercise therapy for fibromyalgia. Curr. Pain Headache Rep. 15(5), 358–367 (2011).
    • 88 Liu W, Zahner L, Cornell M et al. Benefit of Qigong exercise in patients with fibromyalgia: a pilot study. Int. J. Neurosci. 122(11), 657–664 (2012).
    • 89 Lynch M, Sawynok J, Hiew C, Marcon D. A randomized controlled trial of qigong for fibromyalgia. Arthritis Res. Ther. 14(4), R178 (2012).
    • 90 Jones KD, Sherman CA, Mist SD, Carson JW, Bennett RM, Li F. A randomized controlled trial of 8-form Tai chi improves symptoms and functional mobility in fibromyalgia patients. Clin. Rheumatol. 31(8), 1205–1214 (2012).
    • 91 Wang C, Schmid CH, Rones R et al. A randomized trial of tai chi for fibromyalgia. N. Engl. J. Med. 363(8), 743–754 (2010).
    • 92 Carson JW, Carson KM, Jones KD, Bennett RM, Wright CL, Mist SD. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia. Pain 151(2), 530–539 (2010).
    • 93 Oka T, Tanahashi T, Chijiwa T, Lkhagvasuren B, Sudo N, Oka K. Isometric yoga improves the fatigue and pain of patients with chronic fatigue syndrome who are resistant to conventional therapy: a randomized, controlled trial. Biopsychosoc. Med. 8(1), 27 (2014).
    • 94 Mist SD, Firestone KA, Jones KD. Complementary and alternative exercise for fibromyalgia: a meta-analysis. J. Pain Res. 6, 247–260 (2013).
    • 95 Bote ME, Garcia JJ, Hinchado MD, Ortega E. An exploratory study of the effect of regular aquatic exercise on the function of neutrophils from women with fibromyalgia: role of IL-8 and noradrenaline. Brain Behav. Immun. 39, 107–112 (2014).
    • 96 Ortega E, Bote ME, Giraldo E, Garcia JJ. Aquatic exercise improves the monocyte pro- and anti-inflammatory cytokine production balance in fibromyalgia patients. Scand. J. Med. Sci. Sports 22(1), 104–112 (2012).
    • 97 Bote ME, Garcia JJ, Hinchado MD, Ortega E. Fibromyalgia: anti-inflammatory and stress responses after acute moderate exercise. PLoS ONE 8(9), e74524 (2013).
    • 98 Flodin P, Martinsen S, Mannerkorpi K et al. Normalization of aberrant resting state functional connectivity in fibromyalgia patients following a three month physical exercise therapy. Neuroimage Clin. 9, 134–139 (2015).
    • 99 Jones KD, Burckhardt CS, Deodhar AA, Perrin NA, Hanson GC, Bennett RM. A six-month randomized controlled trial of exercise and pyridostigmine in the treatment of fibromyalgia. Arthritis Rheum. 58(2), 612–622 (2008).
    • 100 Bernardy K, Fuber N, Klose P, Hauser W. Efficacy of hypnosis/guided imagery in fibromyalgia syndrome – a systematic review and meta-analysis of controlled trials. BMC Musculoskelet. Disord. 12, 133 (2011).
    • 101 Okifuji A, Hare BD. Mangement of musculoskeletal pain. In: Behavioral and Pharmacologic Pain Management. Ebert MH, Kerns RD (Eds). Cambridge University Press, Cambridge, UK (2010).
    • 102 Grossman P, Tiefenthaler-Gilmer U, Raysz A, Kesper U. Mindfulness training as an intervention for fibromyalgia: evidence of postintervention and 3-year follow-up benefits in well-being. Psychother. Psychosom. 76(4), 226–233 (2007).
    • 103 Schmidt S, Grossman P, Schwarzer B, Jena S, Naumann J, Walach H. Treating fibromyalgia with mindfulness-based stress reduction: results from a 3-armed randomized controlled trial. Pain 152(2), 361–369 (2011).
    • 104 Davis MC, Zautra AJ. An online mindfulness intervention targeting socioemotional regulation in fibromyalgia: results of a randomized controlled trial. Ann. Behav. Med. 46(3), 273–284 (2013).
    • 105 Okifuji A, Turk DC. Behavioral and cognitive-behavioral approaches to treating patients with chronic pain: thinking outside the pill box. J. Rational Cog. Psychol. 33(3), 218–238 (2015).
    • 106 Alda M, Luciano JV, Andres E et al. Effectiveness of cognitive behaviour therapy for the treatment of catastrophisation in patients with fibromyalgia: a randomised controlled trial. Arthritis Res. Ther. 13(5), R173 (2011).
    • 107 Wicksell RK, Kemani M, Jensen K et al. Acceptance and commitment therapy for fibromyalgia: a randomized controlled trial. Eur. J. Pain 17(4), 599–611 (2013).
    • 108 Bernardy K, Fuber N, Kollner V, Hauser W. Efficacy of cognitive-behavioral therapies in fibromyalgia syndrome – a systematic review and metaanalysis of randomized controlled trials. J. Rheumatol. 37(10), 1991–2005 (2010).
    • 109 Karlsson B, Burell G, Anderberg U, Svardsudd K. Cognitive behaviour therapy in women with fibromyalgia: a randomized clinical trial. Scand. J. Pain 9, 11–21 (2015).
    • 110 Clauw DJ, Crofford LJ. Chronic widespread pain and fibromyalgia: what we know, and what we need to know. Best Pract. Res. Clin. Rheumatol. 17(4), 685–701 (2003).
    • 111 Bennett RM. Multidisciplinary group programs to treat fibromyalgia patients. Rheum. Dis. Clin. North Am. 22(2), 351–367 (1996).
    • 112 Goldenberg DL, Clauw DJ, Fitzcharles MA. New concepts in pain research and pain management of the rheumatic diseases. Semin. Arthritis Rheum. 41(3), 319–334 (2011).
    • 113 Scascighini L, Toma V, Dober-Spielmann S, Sprott H. Multidisciplinary treatment for chronic pain: a systematic review of interventions and outcomes. Rheumatology (Oxford) 47(5), 670–678 (2008).
    • 114 Martin J, Torre F, Padierna A et al. Six-and 12-month follow-up of an interdisciplinary fibromyalgia treatment programme: results of a randomised trial. Clin. Exp. Rheumatol. 30(6 Suppl. 74), 103–111 (2012).
    • 115 Arnold LM, Clauw DJ, Dunegan LJ, Turk DC. A framework for fibromyalgia management for primary care providers. Mayo Clin. Proc. 87(5), 488–496 (2012).
    • 116 Ang DC, Jensen MP, Steiner JL, Hilligoss J, Gracely RH, Saha C. Combining cognitive–behavioral therapy and milnacipran for fibromyalgia: a feasibility randomized-controlled trial. Clin. J. Pain 29(9), 747–754 (2013).
    • 117 Loeser JD. Comprehensive pain programs versus other treatments for chronic pain. J. Pain 7(11), 800–801, discussion 804–806 (2006).
    • 118 Alaujan S, Elliott R, Knaggs R. Systematic review of economic evaluations in multidisciplinary pain management services for managing people with fibromyalgia or chronic widespread pain. Value Health 18(7), A660 (2015).
    • 119 Hooten WM, Townsend CO, Sletten CD, Bruce BK, Rome JD. Treatment outcomes after multidisciplinary pain rehabilitation with analgesic medication withdrawal for patients with fibromyalgia. Pain Med. 8(1), 8–16 (2007).
    • 120 Jones KD, Bennett RM, Ward RL, Deodhar AA. Description of a half-day interprofessional fibromyalgia clinic with an evaluation of patient satisfaction. Am. J. Phys. Med. Rehabil. 90(10), 825–833 (2011).
    • 121 Pfeiffer A, Thompson JM, Nelson A et al. Effects of a 1.5-day multidisciplinary outpatient treatment program for fibromyalgia: a pilot study. Am. J. Phys. Med. Rehabil. 82(3), 186–191 (2003).
    • 122 Magis D, Jensen R, Schoenen J. Neurostimulation therapies for primary headache disorders: present and future. Curr. Opin. Neurol. 25(3), 269–276 (2012).
    • 123 Thimineur M, De Ridder D. C2 area neurostimulation: a surgical treatment for fibromyalgia. Pain Med. 8(8), 639–646 (2007).
    • 124 Plazier M, Dekelver I, Vanneste S et al. Occipital nerve stimulation in fibromyalgia: a double-blind placebo-controlled pilot study with a six-month follow-up. Neuromodulation 17(3), 256–263 (2014).
    • 125 Plazier M, Ost J, Stassijns G, De Ridder D, Vanneste S. C2 Nerve field stimulation for the treatment of fibromyalgia: a prospective, double-blind, randomized, controlled cross-over study. Brain Stimul. 8(4), 751–757 (2015).
    • 126 Chen YF, Bramley G, Unwin G et al. Occipital nerve stimulation for chronic migraine-a systematic review and meta-analysis. PLoS ONE 10(3), e0116786 (2015).
    • 127 Bonica J. The Management of Pain. Lea & Febiger, PA, USA (1953).
    • 128 Petersen KL, Rowbotham MC. Will ion-channel blockers be useful for management of nonneuropathic pain? J. Pain 1(3 Suppl.), 26–34 (2000).
    • 129 Finnerup NB, Biering-Sorensen F, Johannesen IL et al. Intravenous lidocaine relieves spinal cord injury pain: a randomized controlled trial. Anesthesiology 102(5), 1023–1030 (2005).
    • 130 Tremont-Lukats IW, Challapalli V, Mcnicol ED, Lau J, Carr DB. Systemic administration of local anesthetics to relieve neuropathic pain: a systematic review and meta-analysis. Anesth. Analg. 101(6), 1738–1749 (2005).
    • 131 Bennett MI, Tai YM. Intravenous lignocaine in the management of primary fibromyalgia syndrome. Int. J. Clin. Pharmacol. Res. 15(3), 115–119 (1995).
    • 132 Posner I. Treatment of fibromyalgia syndrome with intravenous lidocaine: a prospective, randomized pilot study. J. Musculoskel. Pain 2, 55–65 (1994).
    • 133 Schafranski MD, Malucelli T, Machado F et al. Intravenous lidocaine for fibromyalgia syndrome: an open trial. Clin. Rheumatol. 28(7), 853–855 (2009).
    • 134 Mccleane G. Does intravenous lidocaine reduce fibromyalgia pain? A rancomized double-blind, placebo controlled cross-over study. Pain Clinics 12(3), 181–185 (2000).
    • 135 Vlainich R, Issy AM, Gerola LR, Sakata RK. Effect of intravenous lidocaine on manifestations of fibromyalgia. Pain Pract. 10(4), 301–305 (2010).
    • 136 Raphael JH, Southall JL, Treharne GJ, Kitas GD. Efficacy and adverse effects of intravenous lignocaine therapy in fibromyalgia syndrome. BMC Musculoskelet. Disord. 3, 21 (2002).
    • 137 Gibbons CR, Liu S, Zhang Y et al. Involvement of brain opioid receptors in the anti-allodynic effect of hyperbaric oxygen in rats with sciatic nerve crush-induced neuropathic pain. Brain Res. 1537, 111–116 (2013).
    • 138 Wilson HD, Wilson JR, Fuchs PN. Hyperbaric oxygen treatment decreases inflammation and mechanical hypersensitivity in an animal model of inflammatory pain. Brain Res. 1098(1), 126–128 (2006).
    • 139 Yildiz S, Kiralp MZ, Akin A et al. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J. Int. Med. Res. 32(3), 263–267 (2004).
    • 140 Efrati S, Golan H, Bechor Y et al. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome – prospective clinical trial. PLoS ONE 10(5), e0127012 (2015).
    • 141 Elder GJ, Taylor JP. Transcranial magnetic stimulation and transcranial direct current stimulation: treatments for cognitive and neuropsychiatric symptoms in the neurodegenerative dementias? Alzheimers Res. Ther. 6(9), 74 (2014).
    • 142 Galhardoni R, Correia GS, Araujo H et al. Repetitive transcranial magnetic stimulation in chronic pain: a review of the literature. Arch Phys. Med. Rehabil. 96(4 Suppl.), S156–S172 (2015).
    • 143 O'Connell NE, Wand BM, Marston L, Spencer S, Desouza LH. Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst. Rev. 4, CD008208 (2014).
    • 144 Luedtke K, Rushton A, Wright C, Geiss B, Juergens TP, May A. Transcranial direct current stimulation for the reduction of clinical and experimentally induced pain: a systematic review and meta-analysis. Clin. J. Pain 28(5), 452–461 (2012).
    • 145 Boyer L, Dousset A, Roussel P et al. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology 82(14), 1231–1238 (2014).
    • 146 Knijnik LM, Dussan-Sarria JA, Rozisky JR et al. Repetitive transcranial magnetic stimulation for fibromyalgia: systematic review and meta-analysis. Pain Pract. 16(3), 294–304 (2015).
    • 147 Castillo-Saavedra L, Gebodh N, Bikson M et al. Clinically effective treatment of fibromyalgia pain with high-definition transcranial direct current stimulation: Phase II open-label dose optimization. J. Pain 17(1), 14–26 (2015).
    • 148 Okifuji A, Donaldson GW. Use of ecological momentary assessment to monitor fibromyalgia. Pain Manag. 1(3), 195–197 (2011).
    • 149 Rusu A, Boersma K, Turk DC. Ubgroups of pain patients – the potential of customizing treatments. In: From Acute to Chronic Back Pain: Risk Factors, Mechanisms, and Clinical Implications. Hasenbring M, Rusu A, Turk DC (Eds). Oxford University Press, Oxford, UK (2012).
    • 150 Ventegodt S, Andersen NJ, Brom B, Merrick J, Greydanus DE. Evidence-based medicine: four fundamental problems with the randomized clinical trial (RCT) used to document chemical medicine. Int. J. Adolesc. Med. Health 21(4), 485–496 (2009).
    • 151 Carey TA, Stiles WB. Some problems with randomized controlled trials and some viable alternatives. Clin. Psychol. Psychother. 23(1), 87–95 (2015).
    • 152 Wasserstein RL, Lazar NA. The ASA's statement on p-values: context, process, and purpose. Am. Stat. doi:10.1080/00031305.2016.1154108 (2016) (Epub ahead of print).
    • 153 Donaldson GW, Nakamura Y, Moinpour C. Mediators, moderators, and modulators of causal effects in clinical trials – Dynamically Modified Outcomes (DYNAMO) in health-related quality of life. Qual. Life Res. 18(2), 137–145 (2009).
    • 154 Almirall D, Compton SN, Gunlicks-Stoessel M, Duan N, Murphy SA. Designing a pilot sequential multiple assignment randomized trial for developing an adaptive treatment strategy. Stat. Med. 31(17), 1887–1902 (2012).
    • 155 Okifuji A, Bradshaw DH, Donaldson GW, Turk DC. Sequential analyses of daily symptoms in women with fibromyalgia syndrome. J. Pain 12(1), 84–93 (2011).
    • 156 Balasubramaniam R, De Leeuw R, Zhu H, Nickerson RB, Okeson JP, Carlson CR. Prevalence of temporomandibular disorders in fibromyalgia and failed back syndrome patients: a blinded prospective comparison study. Oral Surg. Oral Med. Oral Pathol. Oral Radiol. Endod. 104(2), 204–216 (2007).
    • 157 Kato K, Sullivan PF, Evengard B, Pedersen NL. Chronic widespread pain and its comorbidities: a population-based study. Arch Intern Med. 166(15), 1649–1654 (2006).
    • 158 Davis JA, Robinson RL, Le TK, Xie J. Incidence and impact of pain conditions and comorbid illnesses. J. Pain Res. 4, 331–345 (2011).
    • 159 Cakit BD, Taskin S, Nacir B, Unlu I, Genc H, Erdem HR. Comorbidity of fibromyalgia and cervical myofascial pain syndrome. Clin. Rheumatol. 29(4), 405–411 (2010).
    • 160 Hartzell MM, Neblett R, Perez Y, Brede E, Mayer TG, Gatchel RJ. Do comorbid fibromyalgia diagnoses change after a functional restoration program in patients with chronic disabling occupational musculoskeletal disorders? Spine (Phila. Pa 1976) 39(17), 1393–1400 (2014).
    • 161 Moss P, Knight E, Wright A. Subjects with knee osteoarthritis exhibit widespread hyperalgesia to pressure and cold. PLoS ONE 11(1), e0147526 (2016).
    • 162 Giamberardino MA, Affaitati G, Fabrizio A, Costantini R. Effects of treatment of myofascial trigger points on the pain of fibromyalgia. Curr. Pain Headache Rep. 15(5), 393–399 (2011).
    • 163 Kirsch I, Sapirstein G. Listening to Prozac but hearing placebo: a meta-analysis of antidepressant medication. Prev. Treat. 1(2), 2a (1998).
    • 164 Colloca L, Miller FG. Harnessing the placebo effect: the need for translational research. Philos. Trans. R Soc. Lond. B Biol. Sci. 366(1572), 1922–1930 (2011).
    • 165 Roose SP, Schatzberg AF. The efficacy of antidepressants in the treatment of late-life depression. J. Clin. Psychopharmacol. 25(4 Suppl. 1), S1–S7 (2005).
    • 166 Schmidt L, Braun EK, Wager TD, Shohamy D. Mind matters: placebo enhances reward learning in Parkinson's disease. Nat. Neurosci. 17(12), 1793–1797 (2014).
    • 167 Pecina M, Zubieta JK. Molecular mechanisms of placebo responses in humans. Mol. Psychiatry 20(4), 416–423 (2015).
    • 168 Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: a meta-analysis of effects and processes. Adv. Exp. Soc. Psychol. 38, 69–119 (2006).
    • 169 Glombiewski JA, Hartwich-Tersek J, Rief W. Attrition in cognitive-behavioral treatment of chronic back pain. Clin. J. Pain 26(7), 593–601 (2010).
    • 170 Thompson E, Broadbent J, Bertino MD, Staiger PK. Do pain-related beliefs influence treatment adherence? a systematic review. Clin. J. Pain 32(2), 164–178 (2015).
    • 171 Burton LC, Shapiro S, German PS. Determinants of physical activity initiation and maintenance among community-dwelling older persons. Prev. Med. 29(5), 422–430 (1999).
    • 172 Centers for Disease Control and Prevention: Overcoming Barriers to Physical Activity (2011). www.cdc.gov/physicalactivity/basics/adding-pa/barriers.html.
    • 173 Richards SC, Scott DL. Prescribed exercise in people with fibromyalgia: parallel group randomised controlled trial. BMJ 325(7357), 185 (2002).
    • 174 Schachter CL, Busch AJ, Peloso PM, Sheppard MS. Effects of short versus long bouts of aerobic exercise in sedentary women with fibromyalgia: a randomized controlled trial. Phys. Ther. 83(4), 340–358 (2003).
    • 175 Bair MJ, Matthias MS, Nyland KA et al. Barriers and facilitators to chronic pain self-management: a qualitative study of primary care patients with comorbid musculoskeletal pain and depression. Pain Med. 10(7), 1280–1290 (2009).
    • 176 Coppack RJ, Kristensen J, Karageorghis CI. Use of a goal setting intervention to increase adherence to low back pain rehabilitation: a randomized controlled trial. Clin. Rehabil. 26(11), 1032–1042 (2012).
    • 177 Escolar-Reina P, Medina-Mirapeix F, Gascon-Canovas JJ, Montilla-Herrador J, Valera-Garrido JF, Collins SM. Self-management of chronic neck and low back pain and relevance of information provided during clinical encounters: an observational study. Arch. Phys. Med. Rehabil. 90(10), 1734–1739 (2009).
    • 178 Miller W. Motivational interviewing with problem drinkers. Behav. Psychother. 11, 147–172 (1983).
    • 179 Okifuji A, Turk DC. Engagement of patients in the self-management of pain. In: Practical Strategies and Tools to Promote Treatment Engagemen. O'Donohue W, James L, Snipes C (Eds). Springer, NY, USA (In Press).
    • 180 Jensen MP. Enhancing motivation to change in pain treatment. In: Psychological Approaches to Pain Management: a Practitioner's Handbook. Turk DC, Gatchel RJ (Eds). Guilford Press, NY, USA 71–93 (2002).
    • 181 Okifuji A, Turk DC. Motivating pain patients for behavioral change. In: Bonica's Management of Pain. Fishman SM, Ballantyne JC, Rathmell JP (Eds). Lippincott Williams & Wilkins Media, PA, USA (2009).
    • 182 Ang DC, Kaleth AS, Bigatti S et al. Research to encourage exercise for fibromyalgia (REEF): use of motivational interviewing, outcomes from a randomized-controlled trial. Clin. J. Pain 29(4), 296–304 (2013).
    • 183 Tse MM, Vong SK, Tang SK. Motivational interviewing and exercise programme for community-dwelling older persons with chronic pain: a randomised controlled study. J. Clin. Nurs. 22(13–14), 1843–1856 (2013).
    • 184 Vong SK, Cheing GL, Chan F, So EM, Chan CC. Motivational enhancement therapy in addition to physical therapy improves motivational factors and treatment outcomes in people with low back pain: a randomized controlled trial. Arch. Phys. Med. Rehabil. 92(2), 176–183 (2011).
    • 185 Chang YP, Compton P, Almeter P, Fox CH. The effect of motivational interviewing on prescription opioid adherence among older adults with chronic pain. Perspect. Psychiatr. Care 51(3), 211–219 (2014).
    • 186 Belanger-Gravel A, Godin G, Bilodeau A, Poirier P. The effect of implementation intentions on physical activity among obese older adults: a randomised control study. Psychol. Health 28(2), 217–233 (2013).
    • 187 Arbour KP, Martin Ginis KA. A randomised controlled trial of the effects of implementation intentions on women's walking behaviour. Psychol. Health 24(1), 49–65 (2009).
    • 188 Sniehotta FF, Scholz U, Schwarzer R. Action plans and coping plans for physical exercise: a longitudinal intervention study in cardiac rehabilitation. Br. J. Health Psychol. 11(Pt 1), 23–37 (2006).
    • 189 Thoolen BJ, De Ridder D, Bensing J, Gorter K, Rutten G. Beyond good intentions: The role of proactive coping in achieving sustained behavioural change in the context of diabetes management. Psychol. Health 24(3), 237–254 (2009).
    • 190 Belanger-Gravel A, Godin G, Amireault S. A meta-analytic review of the effect of implementation intentions on physical activity. Health Psychol. Rev. 7(1), 23–54 (2013).
    • 191 Wilson HD, Starz TW, Robinson JP, Turk DC. Heterogeneity within the fibromyalgia population: theoretical implications of variable tender point severity ratings. J. Rheumatol. 36(12), 2795–2801 (2009).
    • 192 Thieme K, Turk DC. Heterogeneity of psychophysiological stress responses in fibromyalgia syndrome patients. Arthritis Res. Ther. 8(1), R9 (2006).
    • 193 Nuesch E, Hauser W, Bernardy K, Barth J, Juni P. Comparative efficacy of pharmacological and non-pharmacological interventions in fibromyalgia syndrome: network meta-analysis. Ann. Rheum. Dis. 72(6), 955–962 (2013).