NCT02611583 - Clinical Trial References

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.

Citation(s)

Bertalanffy A, Kober A, Bertalanffy P, Gustorff B, Gore O, Adel S, Hoerauf K
Transcutaneous electrical nerve stimulation reduces acute low back pain during emergency transport. Acad Emerg Med. 2005 Jul;12(7):607-11.
Cypress BK
Characteristics of physician visits for back symptoms: a national perspective. Am J Public Health. 1983 Apr;73(4):389-95.
Marchand S, Charest J, Li J, Chenard JR, Lavignolle B, Laurencelle L
Is TENS purely a placebo effect? A controlled study on chronic low back pain. Pain. 1993 Jul;54(1):99-106.
Patrick N, Emanski E, Knaub MA
Acute and chronic low back pain. Med Clin North Am. 2014 Jul;98(4):777-89, xii. doi: 10.1016/j.mcna.2014.03.005. Review.
Thorsteinsson G, Stonnington HH, Stillwell GK, Elveback LR
The placebo effect of transcutaneous electrical stimulation. Pain. 1978 Jun;5(1):31-41.

Double-blind, Randomized, Placebo Controlled Trial of Transcutaneous Electrical Nerve Stimulation (TENS) Treatment Plus Ibuprofen for the Treatment of Acute Back Pain in the Emergency Department

Details for clinical trial NCT02611583

Clinical trial NCT02611583 - References