Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain

Pelvic Girdle Pain Clinical Trial

Official title:

The Efficacy of Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02044991
• Other study ID #: 205418
• Status: Terminated
• Phase: Phase 2
• Start date: October 24, 2013
• Est. completion date: February 22, 2017

Study information

• Verified date: July 2018
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pelvic girdle pain (PGP) in pregnancy is common with prevalence estimates of 45%.1 It is defined as pain experienced between the posterior iliac crest and the gluteal fold, particularly in the region of the sacroiliac joint.2 Pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. In PGP, the endurance capacity for standing, walking and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes and must be reproducible by specific clinical tests. While various pain mechanisms including mechanical, hormonal, inflammatory, and neural have been proposed in the development of PGP, the etiology and pathogenesis is poorly understood. It is possible that musculoskeletal changes influenced by hormonal (Relaxin) elevation in pregnancy predispose pregnant women to acute musculoskeletal injury presenting clinically as PGP. An inflammatory response in other acute musculoskeletal injuries has been well described3 and may also occur in pregnancy related PGP particularly given the musculoskeletal vulnerability during this time. Though PGP is common in pregnancy, no study to date has investigated the efficacy of anti-inflammatory treatment in pregnancy related PGP in order to better establish the contribution of inflammation in the etiology of pregnancy related PGP.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 22, 2017
• Est. primary completion date: February 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women who are not doing other therapies for pain (physical therapy, chiropractic management, pool)

• Women between age 21 and 50 who plan to deliver at Loyola or Gottlieb

• Pain Numeric Rating Scale (NRS) on average of greater than or equal to 5/10 at Visit 1

• Pain must be between the upper level of the iliac crests and the gluteal folds in conjunction with or separately from pain in the pubic symphysis and influenced by position and locomotion

• 2/4 positive physical examination tests on the symptomatic side including the P4 test, the LDL test, pubic symphysis palpation and the acute straight leg rise (ASLR)

Exclusion Criteria:

• Women presenting with PGP in the first or third trimester (<13 weeks gestation or >28 weeks gestation)

• Women with pubic symphysis (anterior) pain alone

• Women who do not plan to deliver a baby at Loyola or Gottlieb

• Pain above the upper level of the iliac crest

• History of lumbar or pelvic fracture, neoplasm, inflammatory disease, active urogenital infection or active gastrointestinal illness, current physical therapy or other therapies for PGP, or previous surgery of the lumbar spine, pelvic girdle, hip joint or femur

• History or signs of radiculopathy or other systemic neurologic disease

• Women with diabetes or gestational diabetes

Related Conditions & MeSH terms

• Pelvic Girdle Pain

Intervention

Drug:
• Corticosteroid
40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine
• Placebo Injection
A placebo injection

Locations

Country	Name	City	State
United States	Loyola University Health System	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	American Academy of Physical Medicine and Rehabilitation

Country where clinical trial is conducted

United States, 

References & Publications (28)

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Baer AN, Witter FR, Petri M. Lupus and pregnancy. Obstet Gynecol Surv. 2011 Oct;66(10):639-53. doi: 10.1097/OGX.0b013e318239e1ee. Review. — View Citation

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. — View Citation

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Cole BJ, Schumacher HR Jr. Injectable corticosteroids in modern practice. J Am Acad Orthop Surg. 2005 Jan-Feb;13(1):37-46. Review. — View Citation

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. — View Citation

Ekman EF, Koman LA. Acute pain following musculoskeletal injuries and orthopaedic surgery: mechanisms and management. Instr Course Lect. 2005;54:21-33. Review. — View Citation

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. — View Citation

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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. — View Citation

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. Review. — View Citation

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Kumar N, Newman RJ. Complications of intra- and peri-articular steroid injections. Br J Gen Pract. 1999 Jun;49(443):465-6. — View Citation

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Pekkafahli MZ, Kiralp MZ, Basekim CC, Silit E, Mutlu H, Oztürk E, Kizilkaya E, Dursun H. Sacroiliac joint injections performed with sonographic guidance. J Ultrasound Med. 2003 Jun;22(6):553-9. — View Citation

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. — View Citation

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Stuge B, Laerum E, Kirkesola G, Vøllestad 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. — View Citation

Stuge B, Veierød MB, Laerum E, Vøllestad 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. — View Citation

Wu WH, Meijer OG, Uegaki K, Mens JM, van Dieën 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. Epub 2004 Aug 27. Review. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain	Pain is measured using the Pain Numeric Rating Scale (NRS), which ranges from 0 to 10 with higher scores indicating greater pain. This measure is recorded at baseline (0 weeks) and 8 weeks. The change in pain between these two time points (i.e., the difference score) is compared between the two groups.	8 weeks
Secondary	Pelvic Functioning	Pelvic functioning is measured at baseline (0 weeks) and week 8 using the Pelvic Girdle Questionnaire (PGQ), which ranges from 0 to 100 points with higher scores revealing greater pelvic girdle pain. The change in pelvic functioning between these two time points (i.e., the difference score) is compared between the two groups.	8 weeks
Secondary	Disability	Disability is measured at baseline (0 weeks) and week 8 using the Oswestry Disability Index (ODI), which is a measure of low back pain that ranges from 0 points to 100 with higher scores indicating greater disability. The change in disability between these two time points (i.e., the difference score) is compared between the two groups.	8 weeks