Marc N Dubick, Thomas H Ravin, Yvonne Michel, David C Morrisette

The objective of this case series was to investigate the feasibility and safety of a novel method for the management of chronic lower back pain. Injections of recombinant human growth hormone and testosterone to the painful and dysfunctional areas in individuals with chronic lower back pain were used. In addition, the participants received manual therapies and exercise addressing physical impairments such as motor control, strength, endurance, pain, and loss of movement. Pain ratings and self-rated functional outcomes were assessed. This is a case series involving consecutive patients with chronic lower back pain who received the intervention of injections of recombinant human growth hormone and testosterone, and attended chiropractic and/or physical therapy. Outcomes were measured at 12 months from the time of injection. A community based hospital affiliated office, and a private practice block suite. A total of 60 consecutive patients attending a pain management practice for chronic lower back pain were recruited for the experimental treatment. Most participants were private pay. Participants who provided informed consent and were determined not to have radicular pain received diagnostic blocks. Those who responded favorably to the diagnostic blocks received injections of recombinant human growth hormone and testosterone in the areas treated with the blocks. Participants also received manipulation- and impairment-based exercises. Outcomes were assessed at 12 months through pain ratings with the Mankowski Pain Scale and the Oswestry Disability Index. Of the 60 patients recruited, 49 provided informed consent, and 39 completed all aspects of the study. Those patients receiving the intervention reported a significant decrease in pain ratings (P<0.01) and a significant improvement in self-rated Oswestry Disability Index scores (P<0.01). In addition, in the Oswestry Disability Index results, 41% of the patients demonstrated a 50% or greater change in their disability score. Of the subjects who withdrew from the study, one was due to the pain created by the injections and nine were for nonstudy factors. The intervention appeared to be safe and the results provide a reasonable expectation that the intervention would be beneficial for a population of individuals with chronic nonradicular lower back pain. Due to the design of the study, causality cannot be inferred, but the results do indicate that further study of the intervention may be warranted.