Methodological quality of randomized clinical trials on treatment efficacy in low back pain

Bart W. Koes*, Lex M. Bouter, Geert Jmg Van Der Heijden

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

135 Citations (Scopus)


Study Design. This was s review af -criteria-biased meta-analyses. Objectives, To assess the rr.elhodoiogicai quality of published randomized clinical trials on the efficacy of conmonly used interventions in low back pain. Summary nf Background Dnta, during the last several decades, the number of published randomized clinical trials regarding low back pain has continued to yrow. For soma interventions, eojieicf&rable numbers oF trial's are available. Trials have beeb shown lo vsry substantially regaidlny their quality. Methods, A cornputa^-aidcd search was conducted ot pLblished randomized clinical trials into the efficacy of spinal manipulation and mobilization, exercise therapy, back 5 shop Is, bed rest, orthoses, and t racoon therapy. There was additional screening of journals not covered by MadFina and Em base. The methodological quality of the studios was assessed using a set of predefined criteria. ftesudts. Sixty-nine different ran dorr rzed clinics! trials yvcro identified. Methodological scares varied hetwe- en 16 and 82 points (maximum mas 100 points). Methodological queiity tended to be associated with the oulcomes of the studies. Methodological shortcomings were frequently f o u n d — s m a l l sample sizes, no description of tho randnmiiatioti procedure, no description of drop-outs, no pi acc bo-control group, and lack of blinded outcome assessments. Conclusions, Although a considerable number of randomized clinical trials have been carried out to avaluate the effigscy of interventions in lew bach pain, their methodological quality eppaars to be disappointingly low. future trials are cEeafw needed, but much more attention should te paid to the methods of such studies.

Original languageEnglish
Pages (from-to)228-235
Number of pages8
Issue number2
Publication statusPublished - Jan 1995


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