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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 6
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My current pain level is mild to moderate.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ on day 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pelvic girdle pain using the Numeric Pain Rating Scale
Change in pelvic girdle pain using the Pelvic Girdle Questionnaire
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
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Who is running the clinical trial?
Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,846 Total Patients Enrolled
2 Trials studying Pelvic Girdle Pain
65 Patients Enrolled for Pelvic Girdle Pain
Colleen Fitzgwerald, MDPrincipal InvestigatorLoyola Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Using strong painkillers.Pregnant women in their second or third trimester who are experiencing recent acute posterior PGP and can speak English.I am a woman with low back or pelvic pain and I am less than 13 weeks pregnant.I have had issues with my lower back, pelvis, or hip, including fractures, diseases, infections, or surgeries.I have a history of nerve root problems or other nervous system diseases.I am a woman with pain in the front part of my pelvis only.I am a pregnant woman, not fluent in English, and I am either younger than 18 or older than 50.I have had low back pain for more than 6 weeks.My current pain level is mild to moderate.I am pregnant and experiencing acute low back pain in my 2nd or 3rd trimester.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: education alone
- Group 2: cryotherapy + education
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor stipulate an age limit for potential participants?
"This trial is enrolling participants aged 18 and older, but must be below 50 years of age."
Answered by AI
Are there any remaining slots for this research endeavor?
"Affirmative. Clinicaltrials.gov indicates that recruitment for this medical study is ongoing, having been posted on January 1st 2020 and edited as recently as March 29th 2022. 88 participants are needed from a single clinical centre to complete the trial's objectives."
Answered by AI
How can I become a participant in this research endeavor?
"Patients who suffer from pelvic girdle pain and are between 18-50 years old can apply to this trial. Up to 88 participants will be accepted."
Answered by AI
What is the scope of this research in terms of participants?
"Affirmative. The clinical trial is actively recruiting, according to information published on clinicaltrials.gov; it was first posted on January 1st 2020 and recently updated March 29th 2022. A total of 88 subjects are being sought out at a single location for the study."
Answered by AI
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