Study Design. A randomized trial was conducted on a representative sam
ple of patients with untreated low back pain lasting 7 weeks or longer
, or having more than 6 episodes in 12 months. Objectives. To contrast
the effectiveness of manipulation, a manipulation mimic, and a back e
ducation program. Methodologic criticisms of earlier studies were addr
essed. Summary of Background Data. Published meta-analyses suggest cli
nical benefit from manipulation for acute patients. Data are inconclus
ive for patients having symptoms for longer than 1 month. Methods. A t
otal of 1267 consecutive patients were screened. Block randomization w
as used to assign 209 qualifying patients to treatment groups. Self-re
ported pain and activity tolerance served as primary outcome measures.
Patients were assessed at enrollment, after 2 weeks of treatment, and
again after 2 weeks without treatment. Multiple teams conducted recru
itment, randomization, assessment, treatment, and data analysis indepe
ndently without sharing information. Treatments were carefully describ
ed, monitored, and balanced for physician attention and physical conta
ct effects. Results. A total of 81.3% of subjects completed the study.
Confounding factors and missing data were identified in approximately
20% of those completing the final follow-up. Analysis of the remainin
g data was carried out. A strong time effect under treatment was obser
ved. Greater improvement was noted in pain and activity tolerance in t
he manipulation group. Immediate benefit from pain relief continued to
accrue after manipulation, even for the last encounter at the end of
the 2-week treatment interval. Conclusion. Time is a strong ally of th
e low back pain patient. In human terms, however, there appears to be
clinical value to treatment according to a defined plan using manipula
tion even in low back pain exceeding 7 weeks' duration.