Study Design. Narrative review and discussion of the selected literatu
re. Objectives. To discuss some important methodologic challenges in l
ow back pain research in primary care. Summary of Background Data. Man
y methodologic problems must be confronted when conducting low back pa
in research. Some of these problems are back pain specific or specific
to the primary care setting. Methods. Methodologic problems related t
o four research issues wilt be discussed: study designs, definition of
low back pain, determinants of low back pain, and outcome assessment.
Results. Two fundamentally different study designs are frequently use
d in low back pain research, namely observational studies and experime
ntal studies. The definition of low back pain is typically restricted
to a highly variable self-reported symptom, the sensation of pain in t
he back. There clearly is a need for an evidence-based classification
system for low back pain. Because a tenable theoretical framework is l
acking, it is difficult to know which determinants of low back pain sh
ould be quantified. Low back pain studies focus usually on health-rela
ted quality-of-life outcome parameters. The identification of the mini
mum clinically relevant changes for the most important outcome instrum
ents needs further consideration. Conclusions. In years to come, low b
ack pain researchers are challenged to overcome some of these (and oth
er) problems to enhance the quality of low back pain research in prima
ry care.