Neck Pain — Efficacy of the InterX 5000 in the Treatment of Chronic Neck Pain
Citation(s)
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Godfrey CM, Morgan PP, Schatzker J A randomized trial of manipulation for low-back pain in a medical setting. Spine (Phila Pa 1976). 1984 Apr;9(3):301-4.
Pope MH, Phillips RB, Haugh LD, Hsieh CY, MacDonald L, Haldeman S A prospective randomized three-week trial of spinal manipulation, transcutaneous muscle stimulation, massage and corset in the treatment of subacute low back pain. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2571-7.
Teodorczyk-Injeyan JA, Injeyan HS, Ruegg R Spinal manipulative therapy reduces inflammatory cytokines but not substance P production in normal subjects. J Manipulative Physiol Ther. 2006 Jan;29(1):14-21.
Evaluation of the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
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.