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

NCT02044991 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 205418
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Girdle Pain

Keywords

Sciatica; Pelvic girdle pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pelvic Functioning

  8 weeks

• Disability

  8 weeks

Study Arms (2)

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

Drug: Corticosteroid

Placebo

PLACEBO COMPARATOR

Participant's randomized to this condition will receive a placebo injection once weekly

Drug: Placebo Injection

Interventions

Corticosteroid DRUG

40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine

Also known as: Medrol

Treatment

Placebo Injection DRUG

A placebo injection

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• /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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead
• American Academy of Physical Medicine and Rehabilitation: collaborator

Study Sites (1)

Loyola University Health System

Maywood, Illinois, 60153, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Pelvic Girdle Pain; Sciatica

Interventions

Adrenal Cortex Hormones; Methylprednisolone; Sodium Chloride

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The trial was terminated in February 2017 due to poor recruitment

Results Point of Contact

• Title: Colleen Fitzgerald, M.D., M.S.
• Organization: Loyola University

cfitzgerald@lumc.edu

708-216-2180

Study Officials

• Colleen Fitzgerald, MD

  Loyola Univ Med Cntr-

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 24, 2014
• Study Start: October 24, 2013
• Primary Completion: February 22, 2017
• Study Completion: February 22, 2017
• Last Updated: August 8, 2018
• Results First Posted: May 12, 2017

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)