The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain

Loyola University

Status: Completed

Conditions: Pelvic Girdle Pain

Treatments: Other: Cryotherapy; Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT04469192

212358

Details and patient eligibility

About

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.

Full 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).

Enrollment: 39 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

cryotherapy + education

Experimental group

Description:

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

Treatment:

Other: Education

Other: Cryotherapy

education alone

Active Comparator group

Description:

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

Treatment:

Other: Education