Study design: A randomized trial was conducted on a representative sample 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 education program. Methodologic criticisms of earlier studies were addressed.
Summary of background data: Published meta-analyses suggest clinical benefit from manipulation for acute patients. Data are inconclusive for patients having symptoms for longer than 1 month.
Methods: A total of 1267 consecutive patients were screened. Block randomization was used to assign 209 qualifying patients to treatment groups. Self-reported 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 recruitment, randomization, assessment, treatment, and data analysis independently without sharing information. Treatments were carefully described, monitored, and balanced for physician attention and physical contact 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 remaining data was carried out. A strong time effect under treatment was observed. Greater improvement was noted in pain and activity tolerance in the 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 the low back pain patient. In human terms, however, there appears to be clinical value to treatment according to a defined plan using manipulation even in low back pain exceeding 7 weeks' duration.