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Cryotherapy for Pregnancy-Related Pelvic Girdle Pain

N/A

Recruiting

Led By Colleen Fitzgwerald, MD

Research Sponsored by Loyola University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current VAS pain score between 2-4

Be between 18 and 65 years old

Must not have

Women presenting with low back pain, or posterior pelvic pain in the first trimester (<13 weeks gestation).

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on day 6

Awards & highlights

No Placebo-Only Group

Summary

This trial may lead to less pain and better mobility for pregnant women with pelvic girdle pain in the later stages of pregnancy.

Who is the study for?

This trial is for English-speaking pregnant women in their second or third trimester experiencing pelvic girdle pain that started within the last three months. They must have a current pain score of 2-4 and provide written consent. It's not for those under 18 or over 50, with low back pain, chronic conditions, fractures, degenerative diseases, surgeries in relevant areas, neurologic diseases, or narcotic medication use.

What is being tested?

The study tests if cryotherapy—applying extreme cold to reduce inflammation and numb pain—combined with education can lessen pelvic girdle pain and improve mobility in pregnant women during their later stages of pregnancy.

What are the potential side effects?

Cryotherapy may cause temporary discomfort like numbness or tingling at the application site. There might also be redness or skin irritation. The educational component does not have physical side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My current pain level is mild to moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a woman with low back or pelvic pain and I am less than 13 weeks pregnant.

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I have had issues with my lower back, pelvis, or hip, including fractures, diseases, infections, or surgeries.

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I have a history of nerve root problems or other nervous system diseases.

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I am a woman with pain in the front part of my pelvis only.

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I am a pregnant woman, not fluent in English, and I am either younger than 18 or older than 50.

Select...

I am pregnant and experiencing acute low back pain in my 2nd or 3rd trimester.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on day 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on day 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pelvic girdle pain using the Numeric Pain Rating Scale

Change in pelvic girdle pain using the Pelvic Girdle Questionnaire

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: cryotherapy + educationExperimental Treatment2 Interventions

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 II: education aloneActive Control1 Intervention

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

0 / 7Eligibility criteria met