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Dechow E, Davies RK, Carr AJ, et al: A randomized, double-blind, placebo-controlled trial of sclerosing injections in patients with chronic low back pain. Rheumatology 39:1255, 1999.
Dr. Reeves' Notes: Incorrect injection sites along with failure to examine lead to worse rather than better outcomes. The third study on chronic low back pain was led by a chief investigator (rheumatologist) who had a mandate to "prove or disprove prolotherapy", was armed with a complete lack of knowledge of prolotherapy technique or referral patterns for ligament or tendon, and brilliantly, but probably unwittingly, designed the study to fail. Failure was ensured by:
1. Accepting patients with axial (back) pain only and excluding patients with leg pain referral.
2. Finding a physician who was conversant with prolotherapy but preventing him from examining the patients for areas to inject. Rather the physician was forced to inject only specified areas.
3. Allowing treatment only on ligaments that would cause leg pain and not any ligaments that would treat axial (back) pain, and ...
4. Injecting inflammatory (phenol-based) proliferant in these incorrect areas.
As a consequence of injecting inflammatory solution in completely wrong areas, this study is recorded as a prolotherapy study in which the active group did worse than the control. This study is worthy of inclusion in a discussion of back pain studies because of what it says about study design in musculoskeletal medicine; ie, it trumpets the importance of knowing anatomy, and referral patterns in connective tissue, and of hands-on examination.