The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

Last updated: March 6, 2025
Sponsor: Loyola University
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Education

Cryotherapy

Clinical Study ID

NCT04469192
212358
  • Ages 18-50
  • Female

Study Summary

The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second and third trimester.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • English speaking pregnant women presenting in their second or third trimester withacute posterior PGP (occurring within the last 3 months). Trimester will bedetermined from the date of last menses or ultrasound date.

  • Current VAS pain score between 2-4

  • Written informed consent

Exclusion

Exclusion Criteria:

  • Non-English speaking pregnant women <18 or >50 years old

  • Women presenting with low back pain, or posterior pelvic pain in the first trimester (<13 weeks gestation).

  • Women with acute low back pain in 2nd and 3rd trimester

  • Women with anterior pelvic girdle pain (pubic symphysis) alone

  • Chronic low back pain (current or past history, defined as > 6 weeks of low backpain)

  • History of lumbar or pelvic fracture; degenerative disc disease; neoplasm;inflammatory disease; active urogenital infection or active gastrointestinalillness; previous surgery of the lumbar spine, pelvic girdle, hip joint or femur

  • History or signs of radiculopathy or other systemic neurologic disease

  • Narcotic medication use

Study Design

Total Participants: 39
Treatment Group(s): 2
Primary Treatment: Education
Phase:
Study Start date:
January 01, 2020
Estimated Completion Date:
February 01, 2025

Study Description

The primary objective of this unblinded randomized controlled trial is to determine whether superficial cryotherapy results in improved Numeric Pain Rating Scale (NPRS) scores among pregnant women with posterior pelvic girdle pain. The investigators hypothesize that superficial cryotherapy, in addition to receipt of an educational pamphlet, will result in improved NPRS scores compared to receipt of an educational pamphlet alone.

This study will include English-speaking pregnant women presenting to Loyola University Medical Center obstetrics or rehabilitation clinics in their second or third trimester with posterior pelvic girdle pain, defined as an NPRS score > 2 onset within the past 3 months and pain experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the [pubic] symphysis. NPRS scores will be measured as a continuous, numerical integer ranging from a value of 0 (No pain) to a value of 10 (Worst possible pain).

Connect with a study center

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.