The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Girdle Pain
• Intervention / Treatment: Other: Cryotherapy; Other: Education

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 Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Tulke, RN; Phone Number: 708-476-2186; Email: mtulke@luc.edu

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Recruiting
      • Loyola University Medical Center
      • Contact: Mary J Tulke, R.N.; Phone Number: 708-216-2067; Email: mtulke@luc.edu
      • Principal Investigator: Colleen Fitzgerald, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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; 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
Active Comparator: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pelvic girdle pain using the Numeric Pain Rating Scale	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).	On day 6
Change in pelvic girdle pain using the Pelvic Girdle Questionnaire	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).	On day 6

Collaborators and Investigators

• Sponsor: Loyola University
• Investigators: Principal Investigator: Colleen Fitzgwerald, MD, Loyola Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: July 10, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Pain; Pelvic Pain; Pelvic Girdle Pain
• Other Study ID Numbers: 212358

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No