title: Use of localized human growth hormone and testosterone injections in addition to manual therapy and exercise for lower back pain: a case series with 12-month follow-up.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  A community based hospital affiliated office, and a private practice block suite.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  Outcomes were assessed at 12 months through pain ratings with the Mankowski Pain Scale and the Oswestry Disability Index.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Interventional Pain Management, Division of Anesthesiology, Bon Secours St Francis Hospital, Charleston, SC, USA.
authors.forename: Marc N
authors.initials: MN
authors.lastname: Dubick
authors.affiliation: Musculoskeletal Medicine, Val d'Isere Health Clinic, Denver, CO, USA.
authors.forename: Thomas H
authors.initials: TH
authors.lastname: Ravin
authors.affiliation: Statistical Consultant, Private Practice, Daniel Island, SC, USA.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Michel
authors.affiliation: Division of Physical Therapy, Medical University of South Carolina, SC, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Morrisette
keywords: injections; lumbar; manual therapy; pain management; rehabilitation; sacroiliac joint