drugset / Trial / NCT02044991
Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain
Phase 2
Terminated
2 enrolled
Loyola University
American Academy of Physical Medicine and Rehabilitation · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to see if pelvic girdle pain can be more effectively treated with the use of injectable anti-inflammatory medication plus physical therapy compared with physical therapy and a saline injection.
Timeline
- Start
- 2013-10-24
- Primary completion
- 2017-02-22
- Completion
- 2017-02-22
Publications
- Background Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieen JH, Wuisman PI, Ostgaard HC. Pregnancy-related pelvic girdle pain (PPP), I: Terminology, clinical presentation, and prevalence. Eur Spine J. 2004 Nov;13(7):575-89. doi: 10.1007/s00586-003-0615-y. Epub 2004 Aug 27.
- Background Ekman EF, Koman LA. Acute pain following musculoskeletal injuries and orthopaedic surgery: mechanisms and management. Instr Course Lect. 2005;54:21-33.
- Background Kristiansson P, Svardsudd K, von Schoultz B. Serum relaxin, symphyseal pain, and back pain during pregnancy. Am J Obstet Gynecol. 1996 Nov;175(5):1342-7. doi: 10.1016/s0002-9378(96)70052-2.
- Background Stapleton DB, MacLennan AH, Kristiansson P. The prevalence of recalled low back pain during and after pregnancy: a South Australian population survey. Aust N Z J Obstet Gynaecol. 2002 Nov;42(5):482-5. doi: 10.1111/j.0004-8666.2002.00482.x.
- Background Gutke A, Josefsson A, Oberg B. Pelvic girdle pain and lumbar pain in relation to postpartum depressive symptoms. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1430-6. doi: 10.1097/BRS.0b013e318060a673.
- Background Brynhildsen J, Hansson A, Persson A, Hammar M. Follow-up of patients with low back pain during pregnancy. Obstet Gynecol. 1998 Feb;91(2):182-6. doi: 10.1016/s0029-7844(97)00630-3.
- Background Stuge B, Hilde G, Vollestad N. Physical therapy for pregnancy-related low back and pelvic pain: a systematic review. Acta Obstet Gynecol Scand. 2003 Nov;82(11):983-90. doi: 10.1034/j.1600-0412.2003.00125.x.
- Background Stuge B, Laerum E, Kirkesola G, Vollestad N. The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy: a randomized controlled trial. Spine (Phila Pa 1976). 2004 Feb 15;29(4):351-9. doi: 10.1097/01.brs.0000090827.16926.1d.
- Background Albert H, Godskesen M, Westergaard J. Prognosis in four syndromes of pregnancy-related pelvic pain. Acta Obstet Gynecol Scand. 2001 Jun;80(6):505-10.
- Background Stuge B, Veierod MB, Laerum E, Vollestad N. The efficacy of a treatment program focusing on specific stabilizing exercises for pelvic girdle pain after pregnancy: a two-year follow-up of a randomized clinical trial. Spine (Phila Pa 1976). 2004 May 15;29(10):E197-203. doi: 10.1097/00007632-200405150-00021.
- Background 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.
- Background Haugland KS, Rasmussen S, Daltveit AK. Group intervention for women with pelvic girdle pain in pregnancy. A randomized controlled trial. Acta Obstet Gynecol Scand. 2006;85(11):1320-6. doi: 10.1080/00016340600780458.
- Background Bastiaenen CH, de Bie RA, Wolters PM, Vlaeyen JW, Leffers P, Stelma F, Bastiaanssen JM, Essed GG, van den Brandt PA. Effectiveness of a tailor-made intervention for pregnancy-related pelvic girdle and/or low back pain after delivery: short-term results of a randomized clinical trial [ISRCTN08477490]. BMC Musculoskelet Disord. 2006 Feb 27;7:19. doi: 10.1186/1471-2474-7-19.
- Background Lin J, Fessell DP, Jacobson JA, Weadock WJ, Hayes CW. An illustrated tutorial of musculoskeletal sonography: part I, introduction and general principles. AJR Am J Roentgenol. 2000 Sep;175(3):637-45. doi: 10.2214/ajr.175.3.1750637. No abstract available.
- Background Le Goff B, Berthelot JM, Maugars Y. Ultrasound assessment of the posterior sacroiliac ligaments. Clin Exp Rheumatol. 2011 Nov-Dec;29(6):1014-7. Epub 2011 Dec 22.
- Background Pekkafahli MZ, Kiralp MZ, Basekim CC, Silit E, Mutlu H, Ozturk E, Kizilkaya E, Dursun H. Sacroiliac joint injections performed with sonographic guidance. J Ultrasound Med. 2003 Jun;22(6):553-9. doi: 10.7863/jum.2003.22.6.553.
- Background Schull WJ, Otake M. Cognitive function and prenatal exposure to ionizing radiation. Teratology. 1999 Apr;59(4):222-6. doi: 10.1002/(SICI)1096-9926(199904)59:43.0.CO;2-M.
- Background Ruiz-Irastorza G, Khamashta MA. Managing lupus patients during pregnancy. Best Pract Res Clin Rheumatol. 2009 Aug;23(4):575-82. doi: 10.1016/j.berh.2009.04.004.
- Background Baer AN, Witter FR, Petri M. Lupus and pregnancy. Obstet Gynecol Surv. 2011 Oct;66(10):639-53. doi: 10.1097/OGX.0b013e318239e1ee.
- Background Roberts D, Dalziel S. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004454. doi: 10.1002/14651858.CD004454.pub2.
- Background Ostensen M, Ramsey-Goldman R. Treatment of inflammatory rheumatic disorders in pregnancy: what are the safest treatment options? Drug Saf. 1998 Nov;19(5):389-410. doi: 10.2165/00002018-199819050-00006.
- Background Cole BJ, Schumacher HR Jr. Injectable corticosteroids in modern practice. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):37-46. doi: 10.5435/00124635-200501000-00006.
- Background Kumar N, Newman RJ. Complications of intra- and peri-articular steroid injections. Br J Gen Pract. 1999 Jun;49(443):465-6.
- Background Slotkoff AT, Katz P. Approach to the patient with rheumatoid arthritis. Adv Intern Med. 1994;39:197-240.
- Background Plastaras CT, Joshi AB, Garvan C, Chimes GP, Smeal W, Rittenberg J, Lento P, Stanos S, Fitzgerald C. Adverse events associated with fluoroscopically guided sacroiliac joint injections. PM R. 2012 Jul;4(7):473-8. doi: 10.1016/j.pmrj.2012.02.001. Epub 2012 Apr 28.
- Background Jacobs JW, Michels-van Amelsfort JM. How to perform local soft-tissue glucocorticoid injections? Best Pract Res Clin Rheumatol. 2013 Apr;27(2):171-94. doi: 10.1016/j.berh.2013.03.003.
- Background Elimian A, Goodman JR, Knudtson E, Wagner A, Wilson P, Williams M. Local anesthesia and pain perception during amniocentesis: a randomized double blind placebo-controlled trial. Prenat Diagn. 2013 Dec;33(12):1158-61. doi: 10.1002/pd.4214. Epub 2013 Sep 1.
- Background Edelman A, Nichols MD, Leclair C, Astley S, Shy K, Jensen JT. Intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2004 Jun;103(6):1267-72. doi: 10.1097/01.AOG.0000127981.53911.0e.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Methylprednisolone | Other / unclassified | 40 mg | — |
| Comparator | Lidocaine | Other / unclassified | 1 ml | — |
Indications
No indication recorded.