Pelvic Girdle PainPhase 2NCT02044991
Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain
A Phase 2 study testing Corticosteroid in people with Pelvic Girdle Pain, run by Loyola University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2013to 22 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Health System
Maywood, Illinois, 60153
About this study
Official title: The Efficacy of Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Pelvic Girdle Pain
- Being tested
- Corticosteroid, Placebo Injection
- Keywords
- Sciatica, Pelvic girdle pain
- Medical subject headings
- Pelvic Girdle Pain, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Medrol
40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine
Placebo InjectionDrug
Also called Saline
A placebo injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | Participants randomized to this arm will receive a corticosteroid. This is 40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine Receives: Drug: Corticosteroid |
| Placebo | Placebo comparator | Participant's randomized to this condition will receive a placebo injection once weekly Receives: Drug: Placebo Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study start24 Oct 2013
- Primary completion22 Feb 2017
- Study completion22 Feb 2017
Why it stopped: The study was halted prematurely due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to receive either an injection of methylprednisolone acetate plus lidocaine or to receive an injection of saline with lidocaine using a randomized block design with a 1:1 allocation.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Physical Medicine and Rehabilitation
- Responsible party
- Principal investigator, Colleen Fitzgerald, Loyola University
- Investigators
- Colleen Fitzgerald, MD, Principal investigator, Loyola Univ Med Cntr-
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044991
- Sponsor's protocol ID
- 205418
- Status last verified
- Jul 2018
- First submitted
- 17 Jan 2014
- Last updated
- 8 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Publications
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.
PubMed 15338362Ekman EF, Koman LA. Acute pain following musculoskeletal injuries and orthopaedic surgery: mechanisms and management. Instr Course Lect. 2005;54:21-33.
PubMed 15948432Kristiansson 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.
PubMed 8942512Stapleton 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.
PubMed 12495090Gutke 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.
PubMed 17545912Brynhildsen 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.
PubMed 9469272Stuge 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.
PubMed 14616270Stuge 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.
PubMed 15094530Albert H, Godskesen M, Westergaard J. Prognosis in four syndromes of pregnancy-related pelvic pain. Acta Obstet Gynecol Scand. 2001 Jun;80(6):505-10.
PubMed 11380285Stuge 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.
PubMed 15131454Elden 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.
PubMed 18947338Haugland 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.
PubMed 17091411Bastiaenen 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.
PubMed 16504165Lin 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.
PubMed 10954443Le 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.
PubMed 22206650
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ultrasound Guided Posterior Sacroiliac Ligament Corticosteroid Injection in Pregnancy-Related Pelvic Girdle Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02044991
- Acronym / sponsor ID
- 205418
- Conditions
- Pelvic Girdle Pain
- Keywords
- Sciatica, Pelvic girdle pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted prematurely due to poor recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- American Academy of Physical Medicine and Rehabilitation
- Study start
- 24 Oct 2013 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 22 Feb 2017 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Posted 12 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned to receive either an injection of methylprednisolone acetate plus lidocaine or to receive an injection of saline with lidocaine using a randomized block design with a 1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: CorticosteroidParticipants randomized to this arm will receive a corticosteroid. This is 40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine |
| Placebo | Placebo comparator | Drug: Placebo InjectionParticipant's randomized to this condition will receive a placebo injection once weekly |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorticosteroidAlso: Medrol40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine | Drug | Treatment |
| Placebo InjectionAlso: SalineA placebo injection | Drug | Placebo |
Primary outcome
Change in Pain
Time frame: 8 weeks
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.
2 secondary outcomes
Pelvic Functioning
Time frame: 8 weeks
Disability
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15338362Wu 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: PubMed 15948432Ekman EF, Koman LA. Acute pain following musculoskeletal injuries and orthopaedic surgery: mechanisms and management. Instr Course Lect. 2005;54:21-33.
- Background: PubMed 8942512Kristiansson 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: PubMed 12495090Stapleton 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: PubMed 17545912Gutke 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: PubMed 9469272Brynhildsen 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: PubMed 14616270Stuge 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: PubMed 15094530Stuge 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: PubMed 11380285Albert 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: PubMed 15131454Stuge 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: PubMed 18947338Elden 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: PubMed 17091411Haugland 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.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Fitzgerald, MD principal investigator
Loyola Univ Med Cntr-
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Corticosteroid in people with Pelvic Girdle Pain, run by Loyola University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02044991, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.