Bijur PE, Silver W, Gallagher EJ Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7.
Elden H, Fagevik-Olsen M, Ostgaard HC, Stener-Victorin E, Hagberg H Acupuncture as an adjunct to standard treatment for pelvic girdle pain in pregnant women: randomised double-blinded controlled trial comparing acupuncture with non-penetrating sham acupuncture. BJOG. 2008 Dec;115(13):1655-68. doi: 10.1111/j.1471-0528.2008.01904.x. Epub 2008 Oct 15.
Elden H, Ladfors L, Olsen MF, Ostgaard HC, Hagberg H Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised single blind controlled trial. BMJ. 2005 Apr 2;330(7494):761. Epub 2005 Mar 18.
Foti T, Davids JR, Bagley A A biomechanical analysis of gait during pregnancy. J Bone Joint Surg Am. 2000 May;82(5):625-32.
Gallagher EJ, Liebman M, Bijur PE Prospective validation of clinically important changes in pain severity measured on a visual analog scale. Ann Emerg Med. 2001 Dec;38(6):633-8.
Gilleard W, Crosbie J, Smith R Effect of pregnancy on trunk range of motion when sitting and standing. Acta Obstet Gynecol Scand. 2002 Nov;81(11):1011-20.
Kelly AM Does the clinically significant difference in visual analog scale pain scores vary with gender, age, or cause of pain? Acad Emerg Med. 1998 Nov;5(11):1086-90.
Laslett M, Young SB, Aprill CN, McDonald B Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97.
Leadbetter RE, Mawer D, Lindow SW The development of a scoring system for symphysis pubis dysfunction. J Obstet Gynaecol. 2006 Jan;26(1):20-3.
Moher D, Schulz KF, Altman DG The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4.
Pennick VE, Young G Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2007 Apr 18;(2):CD001139. Review. Update in: Cochrane Database Syst Rev. 2013;8:CD001139.
Stratford, P , Gill, C., Westaway, M., & Binkley, J., Assessing disability and change on individual patients: a report of a patient specific measure. Physiotherapy Canada, 47, 258-263. 1995
Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8. Review.
Randomised Controlled Trial for the Treatment of Pelvic Girdle Pain in Pregnancy
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.
