In a controlled 6 month trial, 110 subjects with nonspecific low-back pain (average duration, 14 years) were randomized to have repeated prolotherapy with 20% glucose/0.2% lidocaine (lignocaine) or normal saline injections into tender lumbo-pelvic ligaments. Subjects were also randomized to a program of flexion/extension exercises or to normal activity. With follow-up through 12 months in 96% of subjects and through two years in 80% of subjects.

Throughout the trial, injections resulted in significant and sustained reductions in pain. However, prolotherapy injections were no more effective than saline injections, and the exercise program did not confer any additional benefit over normal activity.

At 12 months, more than 50% reduction in pain from baseline occurred in 46% of the prolotherapy group vs. 36% of the saline group, and in 41% of the exercise group vs. 39% of the normal activity group. More than 50% reduction in disability occurred in 42% of the prolotherapy group vs. 36% of the saline group, and in 36% of the exercise group vs. 38% of the normal activity group. None of these differences were statistically significant.