The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

NCT ID: NCT04469192

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-02-01

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).

Conditions

Pelvic Girdle Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cryotherapy + education

intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: OTHER

intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Education

Intervention Type: OTHER

The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

education alone

The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Interventions

Cryotherapy

intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Intervention Type: OTHER

Education

The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: lead

Responsible Party

Colleen M. Fitzgerald, MD, MS

MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Colleen Fitzgwerald, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola Medical Center

Locations

Loyola University Medical Center

Maywood, Illinois, United States

Countries

United States

Other Identifiers

212358

Identifier Type: -

Identifier Source: org_study_id