Healthy Volunteers — Spine Reference Parameters on EOS Imaging
Citation(s)
Borenstein D Low back pain: epidemiology, etiology, diagnostic evaluation, and therapy. Curr Opin Rheumatol. 1991 Apr;3(2):207-17. Review.
Brenner DJ, Hall EJ Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. Review.
Cats-Baril WL, Frymoyer JW Identifying patients at risk of becoming disabled because of low-back pain. The Vermont Rehabilitation Engineering Center predictive model. Spine (Phila Pa 1976). 1991 Jun;16(6):605-7.
Fritzell P, Hägg O, Wessberg P, Nordwall A; Swedish Lumbar Spine Study Group 2001 Volvo Award Winner in Clinical Studies: Lumbar fusion versus nonsurgical treatment for chronic low back pain: a multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group. Spine (Phila Pa 1976). 2001 Dec 1;26(23):2521-32; discussion 2532-4.
Legaye J, Duval-Beaupère G, Hecquet J, Marty C Pelvic incidence: a fundamental pelvic parameter for three-dimensional regulation of spinal sagittal curves. Eur Spine J. 1998;7(2):99-103.
Rossignol M, Suissa S, Abenhaim L Working disability due to occupational back pain: three-year follow-up of 2,300 compensated workers in Quebec. J Occup Med. 1988 Jun;30(6):502-5.
Roussouly P, Berthonnaud E, Dimnet J [Geometrical and mechanical analysis of lumbar lordosis in an asymptomatic population: proposed classification]. Rev Chir Orthop Reparatrice Appar Mot. 2003 Nov;89(7):632-9. French.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
