The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

NCT04469192 | Completed

• 1 other identifier: 212358
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Girdle Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

cryotherapy + education

EXPERIMENTAL

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; Other: Education

education alone

ACTIVE COMPARATOR

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

Interventions

Cryotherapy 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

cryotherapy + education

Education 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

cryotherapy + education; education alone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Interventions

Cryotherapy; Educational Status

Condition Hierarchy (Ancestors)

Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pelvic Pain

Intervention Hierarchy (Ancestors)

Therapeutics; Socioeconomic Factors; Population Characteristics

Study Officials

• Colleen Fitzgwerald, MD

  Loyola Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Model Details: Study participants will then be randomized to cryotherapy + education vs. 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. Those randomized to the intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) at this initial visit where they will be monitored for any adverse response as well as for any immediate change to the NPRS and PGQ. The participant will place the icepack over the low back region and the sacrum if the pain is bilateral. If the pain is unilateral will place the icepack over just that side.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: July 13, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: March 10, 2025

Record last verified: 2023-10

Locations

US (1)