J Manipulative Physiol Ther. 1991 Nov-Dec; 14(9): 498-502.

The effectiveness of manual therapy, physiotherapy and continued treatment by the general practitioner for chronic nonspecific back and neck complaints: design of a randomized clinical trial.

Koes BW, Bouter LM, Knipshild PG, Van Mameren H, Essers A, Houben JP, Verstegen GM, Hofhuizen DM.

Department of Epidemiology and Biostatistics, University of Limburg, The Netherlands.

There are strong arguments for publishing research protocols before the results are available. First, it permits a critical judgment of the design unbiased by knowledge of the results, and second it may prevent publication bias. We present the design of a randomized trial on the effectiveness of manual therapy, physiotherapy, (continued) treatment by the general practitioner and a placebo treatment for patients (n = 300) with chronic (more than 6 wk) nonspecific back and neck complaints. In designing this trial in close cooperation with manual therapists and physiotherapists, special attention has been given to inclusion and exclusion criteria, (blinded) outcome measurements and control (placebo) treatment(s). Outcome measures include severity of complaints rated by a blinded research assistant, global perceived effect assessed by the patient, pain severity, functional status, range of motion (ROM) of the spine and recurrence. Measurements are carried out at baseline and after 3 wk, 6 wk, 3 months, 6 months and 1 yr.