Skip to main content

Advertisement

Log in

Challenges in demonstrating the effectiveness of multidisciplinary treatment on quality of life, participation and health care utilisation in patients with fibromyalgia: a randomised controlled trial

  • Original Article
  • Published:
Clinical Rheumatology Aims and scope Submit manuscript

Abstract

This study aimed to examine the effectiveness of a multidisciplinary intervention with aftercare (MD) compared to aerobic exercise (AE) and usual care (UC) in recently diagnosed patients with fibromyalgia (FM). In a Zelen-like design, eligible patients from the outpatient rheumatology clinics of three medical centres in the South of the Netherlands were consecutively recruited and pre-randomised to MD (n = 108), AE (n = 47) or UC (n = 48). MD consisted of a 12-week course of sociotherapy, physiotherapy, psychotherapy and creative arts therapy (three half days per week), followed by five aftercare meetings in 9 months. AE was given twice a week in a 12-week course. UC varied but incorporated at least education and lifestyle advice. Primary outcomes were health-related quality of life (HR-Qol), participation and health care utilisation. Secondary outcome was the Fibromyalgia Impact Questionnaire (FIQ). Total follow-up duration of the study was 21–24 months. As willingness to participate in AE was limited, this group has been analysed but interpretation of the data is considered arguable. Within the MD group, a statistically significantly improved HR-Qol and a statistically significant reduction in number of hours sick leave, number of contacts with general practitioners and number of contacts with medical specialists was found. Moreover, statistically significant improvements were found on the FIQ, which increased after the intervention. However, no statistically significant between-group differences were found at the endpoint of the study. MD seemed to yield positive effects, but firm conclusions with regard to effectiveness cannot be formulated due to small between-group differences and limitations of the study.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. White KP, Harth M (2001) Classification, epidemiology, and natural history of fibromyalgia. Curr Pain Headache Rep 5(4):320–329

    Article  PubMed  CAS  Google Scholar 

  2. Wolfe F, Smythe HA, Yunus MB, Bennett RM, Bombardier C, Goldenberg DL et al (1990) The American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia. Report of the Multicenter Criteria Committee. Arthritis Rheum 33(2):160–172

    Article  PubMed  CAS  Google Scholar 

  3. Arnold LM, Crofford LJ, Mease PJ, Burgess SM, Palmer SC, Abetz L et al (2008) Patient perspectives on the impact of fibromyalgia. Patient Educ Counsel 73(1):114–120

    Article  Google Scholar 

  4. Assefi NP, Coy TV, Uslan D, Smith WR, Buchwald D (2003) Financial, occupational, and personal consequences of disability in patients with chronic fatigue syndrome and fibromyalgia compared to other fatiguing conditions. J Rheumatol 30(4):804–808

    PubMed  Google Scholar 

  5. Boonen A, van den Heuvel R, van Tubergen A, Goossens M, Severens JL, van der Heijde D et al (2005) Large differences in cost of illness and wellbeing between patients with fibromyalgia, chronic low back pain, or ankylosing spondylitis. Ann Rheum Dis 64(3):396–402

    Article  PubMed  CAS  Google Scholar 

  6. White KP, Speechley M, Harth M, Ostbye T (1999) The London Fibromyalgia Epidemiology Study: comparing the demographic and clinical characteristics in 100 random community cases of fibromyalgia versus controls. J Rheumatol 26(7):1577–1585

    PubMed  CAS  Google Scholar 

  7. White LA, Birnbaum HG, Kaltenboeck A, Tang J, Mallett D, Robinson RL (2008) Employees with fibromyalgia: medical comorbidity, healthcare costs, and work loss. J Occup Environ Med 50(1):13–24

    Article  PubMed  Google Scholar 

  8. Burckhardt CS (2006) Multidisciplinary approaches for management of fibromyalgia. Curr Pharm Des 12(1):59–66

    Article  PubMed  CAS  Google Scholar 

  9. Clauw DJ (2007) Fibromyalgia: update on mechanisms and management. J Clin Rheumatol 13(2):102–109

    Article  PubMed  Google Scholar 

  10. Hauser W, Bernardy K, Arnold B, Offenbacher M, Schiltenwolf M (2009) Efficacy of multicomponent treatment in fibromyalgia syndrome: a meta-analysis of randomized controlled clinical trials. Arthritis Rheum 61(2):216–224

    Article  PubMed  Google Scholar 

  11. van Koulil S, Effting M, Kraaimaat FW, van Lankveld W, van Helmond T, Cats H et al (2007) Cognitive-behavioural therapies and exercise programmes for patients with fibromyalgia: state of the art and future directions. Ann Rheum Dis 66(5):571–581

    Article  PubMed  Google Scholar 

  12. van der Werf SP, de Vree B, Alberts M, van der Meer JW, Bleijenberg G (2002) Natural course and predicting self-reported improvement in patients with chronic fatigue syndrome with a relatively short illness duration. J Psychosom Res 53(3):749–753

    Article  PubMed  Google Scholar 

  13. Carville SF, Choy EH (2008) Systematic review of discriminating power of outcome measures used in clinical trials of fibromyalgia. J Rheumatol 35(11):2094–2105

    Article  PubMed  Google Scholar 

  14. Kroese M, Schulpen G, Bessems M, Nijhuis F, Severens J, Landewe R (2009) The feasibility and efficacy of a multidisciplinary intervention with aftercare meetings for fibromyalgia. Clin Rheumatol 28(8):923–929

    Article  PubMed  Google Scholar 

  15. Schwartz D, Lellouch J (1967) Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 20(8):637–648

    Article  PubMed  CAS  Google Scholar 

  16. Zelen M (1979) A new design for randomized clinical trials. N Eng J Med 300(22):1242–1245

    Article  CAS  Google Scholar 

  17. Berne E (1958) Transactional analysis: a new and effective method of group therapy. Am J Psychoth 12:735–743

    CAS  Google Scholar 

  18. Berne E, Steiner CM, Dusay JM (1996) Transactional analysis. In: Groves JE (ed) Essential papers on short term dynamic therapy (essential papers in psychoanalysis). New York University Press, New York, pp 149–170

    Google Scholar 

  19. Ofman D (2001) Core qualities; a gateway to human resources. Scriptum, Schiedam

    Google Scholar 

  20. Ellis A (1969) Rational-emotive therapy. J Cont Psychoth 1(2):82–90

    Article  Google Scholar 

  21. Ellis A (2002) Overcoming resistance: a rational emotive behavior therapy integrated approach, 2nd edn. Springer, New York

    Google Scholar 

  22. Rothschild BH (1993) RET and chronic pain. In: Dryden W, Hill LK (eds) Innovations in rational-emotive therapy. Sage, Thousand Oaks, pp 91–115

    Google Scholar 

  23. American C, Sports M, Stand P (1998) The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc 30:975–991

    Article  Google Scholar 

  24. The EuroQol Group (1990) EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16(3):199–208

    Article  Google Scholar 

  25. Dolan P (1997) Modeling valuations for EuroQol health states. Med Care 35(11):1095–1108

    Article  PubMed  CAS  Google Scholar 

  26. Post MWM (1998) Utrechtse activiteitenlijst. In: van Asbeck FWA (ed) Handboek dwarslaesierevalidatie. Bohn Stafleu van Longum, Houten

    Google Scholar 

  27. Goossens MEJB, Mölken MPMHR-v, Vlaeyen JWS, van der Linden SMJP (2000) The cost diary: a method to measure direct and indirect costs in cost-effectiveness research. J Clin Epid 53(7):688

    Article  CAS  Google Scholar 

  28. Bennett R (2005) The Fibromyalgia Impact Questionnaire (FIQ): a review of its development, current version, operating characteristics and uses. Clin Exp Rheumatol 23(5 Suppl 39):S154–S162

    PubMed  CAS  Google Scholar 

  29. Burckhardt CS, Clark SR, Bennett RM (1991) The fibromyalgia impact questionnaire: development and validation. J Rheumatol 18(5):728–733

    PubMed  CAS  Google Scholar 

  30. Tan FES (2008) Best practices in analysis of longitudinal data: a multilevel approach. In: Osborne JW (ed) Best practices in quantitative methods. Sage, Los Angeles, pp 451–471

    Chapter  Google Scholar 

  31. Molenberghs G, Kenward ME (2007) Missing data in clinical studies, chapter III. Wiley, New York

    Book  Google Scholar 

  32. Cohen J (1998) Statistical power analysis for the behavioral sciences, 2nd edn. Lawrence Erlbaum Associates, Hillsdale

    Google Scholar 

  33. Nakagawa S, Cuthill IC (2007) Effect size, confidence interval and statistical significance: a practical guide for biologists. Biol Rev 82:591–605

    Article  PubMed  Google Scholar 

  34. Verbunt JA, Pernot DH, Smeets RJ (2008) Disability and quality of life in patients with fibromyalgia. Health Qual Life Outcomes 6:8

    Article  PubMed  Google Scholar 

  35. Hammond A, Freeman K (2006) Community patient education and exercise for people with fibromyalgia: a parallel group randomized controlled trial. Clin Rehabil 20(10):835–846

    PubMed  Google Scholar 

  36. Lorig KR, Ritter PL, Laurent DD, Plant K (2008) The Internet-based arthritis self-management program: a one-year randomized trial for patients with arthritis or fibromyalgia. Arthritis Rheum 59(7):1009–1017

    Article  PubMed  Google Scholar 

  37. Kroese M, Severens J, Schulpen G, Bessems M, Nijhuis F, Landewe R (2011) Specialized rheumatology nurse substitutes for rheumatologists in the diagnostic process of fibromyalgia: a cost-consequence analysis and a randomized controlled trial. J Rheumatol 38(7):1413–1422. doi:10.3899/jrheum.100753

    Article  PubMed  Google Scholar 

  38. van Santen M, Bolwijn P, Landewe R, Verstappen F, Bakker C, Hidding A et al (2002) High or low intensity aerobic fitness training in fibromyalgia: does it matter? J Rheumatol 29(3):582–587

    PubMed  Google Scholar 

  39. Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P (2000) Framework for design and evaluation of complex interventions to improve health. BMJ 321:694–696. doi:10.1136/bmj.321.7262.694

    Article  PubMed  CAS  Google Scholar 

  40. van Koulil S, van Lankveld W, Kraaimaat FW, van Helmond T, Vedder A, van Hoorn H et al (2010) Tailored cognitive-behavioral therapy and exercise training for high-risk fibromyalgia patients. Arthritis Care Res (Hoboken) 62(10):1377–1385

    Article  Google Scholar 

  41. van Eijk-Hustings Y, Boonen A, Landewé R (2010) A randomized trial of Tai Chi for fibromyalgia. N Engl J Med 363(23):2266–2267 (author reply 2266–2267)

    PubMed  Google Scholar 

  42. Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL et al (2010) A randomized trial of Tai Chi for fibromyalgia. N Engl J Med 363(8):743–754

    Article  PubMed  CAS  Google Scholar 

Download references

Acknowledgments

The study was supported by Maastricht University Medical Centre and by Care Renewal Grants of medical insurance companies in the region.

Disclosures

None.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Yvonne van Eijk-Hustings.

Additional information

Trial registration: ISRCTN32542621.

Rights and permissions

Reprints and permissions

About this article

Cite this article

van Eijk-Hustings, Y., Kroese, M., Tan, F. et al. Challenges in demonstrating the effectiveness of multidisciplinary treatment on quality of life, participation and health care utilisation in patients with fibromyalgia: a randomised controlled trial. Clin Rheumatol 32, 199–209 (2013). https://doi.org/10.1007/s10067-012-2100-7

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10067-012-2100-7

Keywords

Navigation