RANDOMIZED CLINICAL TRIAL OF CONSERVATIVE TREATMENT FOR PATIENTS WITH WHIPLASH-ASSOCIATED DISORDERS:CONSIDERATIONS FOR THE DESIGN AND DYNAMIC TREATMENT PROTOCOL Gwendolijne G.M. Scholten-Peeters, MSc, a Arianne P. Verhagen, PhD, b Catharina W.M. Neeleman-van der Steen, MSc, c John C.A.M. Hurkmans, MSc, d Ria W.A. Wams, MSc, e and Rob A.B. Oostendorp, PhD f ABSTRACT Background: Whiplash concerns a considerable problem to health care. Available evidence from systematic reviews indicates beneficial effects of active interventions for patients with whiplash injury. In order to evaluate whether a general practitioner or a physiotherapist should provide these active interventions, we have designed a randomized clinical trial. Objective: The purpose of this article is to present the design of the trial and to provide transparency into the dynamic treatment protocol used. Patients: Patients with whiplash-associated disorders grade I and II who still have symptoms and disabilities 4 weeks after the accident. Interventions: A dynamic treatment protocol consisting of 4 different subprotocols. The primary aim is to increase their activities and to improve their quality of life. Content and intensity of treatment are described. Outcome Measures: The primary outcome measures are pain and disability. The short-term effects are measured at 12 weeks and long-term effects at 1 year after the trauma. Conclusion: To date, generally the effect of one intervention compared to another intervention has been examined. In our opinion, this cannot be considered as usual care for physiotherapy or general practice. Therefore, a dynamic treatment protocol has been developed to structure the black box of usual physiotherapy and general practice treatment. The results of this trial will be available in 0.5 year. (J Manipulative Physiol Ther 2003;26:412-20) Key Indexing Terms: Conservative Treatment; Design; General Practice Care; Physiotherapy; Randomized Clinical Trial; Whiplash I NTRODUCTION W hy publish only the design? Presenting the design at the start of the study provides trans- parency into the researchers’ plan of work. For clinical practice, adequate information of the interventions used is of the utmost importance, especially when health care providers are not very familiar with the type of treat- ment. Another advantage of publishing the design of a trial before the results are available is to prevent publication bias. a Investigator, Dutch National Institute of Allied Health Profes- sions, Amersfoort, The Netherlands; Lector, Faculty of Medicine and Pharmacology, Postgraduate Education in Manual Therapy, Vrije Universiteit Brussel, Brussels, Belgium; Investigator, Center for Quality of Care Research, University Medical Center Nijme- gen, Nijmegen, The Netherlands; and Physiotherapist and Manual therapist, Spine and Rehabilitation Center of Uden, Uden, The Netherlands. b Senior Investigator, Department of General Practice, Erasmus University of Rotterdam, Rotterdam, The Netherlands. c Investigator, Dutch National Institute of Allied Health Profes- sions, Amersfoort, The Netherlands. d Physiotherapist and Manual therapist, Practice of Physical and Manual Therapy, Drunen, The Netherlands. e Scientific director, Dutch National Institute of Allied Health Professions, Amersfoort, The Netherlands. f General director, Dutch National Institute of Allied Health Professions, Amersfoort, The Netherlands. This research is supported financially by grants from the Dutch College of Care (CvZ). Submit requests for reprints to: Gwendolijne G.M. Scholten- Peeters, Dutch National Institute of Allied Health Professions, PO Box1161,3800BDAmersfoort,TheNetherlands(e-mail: scholten@ paramedisch.org). Paper submitted May 10, 2002. Copyright © 2003 by National University of Health Sciences. 0161-4754/2003/$30.00 + 0 doi:10.1016/S0161-4754(03)00092-7 412