The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

Not Applicable

Completed

• Conditions: Pelvic Girdle Pain

• Registration Number: NCT04469192
• Lead Sponsor: Loyola University

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-06-16
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-13
• Status Verified: 2023-10
• Primary Completion: 2024-12-01
• Study Completion: 2025-02-01
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 39

Inclusion Criteria

• English speaking pregnant women presenting in their second or third trimester with acute posterior PGP (occurring within the last 3 months). Trimester will be determined from the date of last menses or ultrasound date.
• Current VAS pain score between 2-4
• Written informed consent

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 back pain)
• History of lumbar or pelvic fracture; degenerative disc disease; neoplasm; inflammatory disease; active urogenital infection or active gastrointestinal illness; 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in pelvic girdle pain using the Numeric Pain Rating Scale	On day 6	The change in the Numeric Pain Rating Scale (NPRS) from baseline to day 6 (i.e., the delta value of NPRS) will be compared between the two groups. NPRS scores range from 0 (no pain) to 10 (worst possible pain).
Change in pelvic girdle pain using the Pelvic Girdle Questionnaire	On day 6	The change in the the Pelvic Girdle Questionnaire (PGQ) from baseline to day 6 (i.e., the delta value of PGQ) will be compared between the two groups. The PGQ measures problems with carrying out daily activities and ranges from 0 (no problem at all) to 100 (experiences problems to a large extent).

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States