Clinical trial NCT04469192: The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain
Official title: The Efficacy of Cryotherapy in Pregnancy Related Pelvic Girdle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change in pelvic girdle pain using the Numeric Pain Rating Scale
timeFrame: On day 6
measure: Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
timeFrame: On day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
affiliation: Loyola Medical Center
name: Colleen Fitzgwerald, MD
role: PRINCIPAL_INVESTIGATOR
References: