39 Participants Needed

Cryotherapy for Pregnancy-Related Pelvic Girdle Pain

MT
Overseen ByMary Tulke, RN
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Loyola University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who use narcotic medications.

Is cryotherapy generally safe for humans?

Whole-body cryotherapy is generally considered safe when guidelines are followed, with some documented adverse events that are within acceptable limits. However, there are reports of severe injuries from specific cryotherapy methods, such as continuous cryocompression therapy, which can cause tissue damage if not properly managed.12345

How is cryotherapy different from other treatments for pregnancy-related pelvic girdle pain?

Cryotherapy (cold therapy) is unique because it involves applying cold temperatures to reduce inflammation and pain, which is different from other treatments like physiotherapy or craniosacral therapy that focus on movement and relaxation techniques. This approach may offer a novel way to manage pain by directly targeting the affected area with cold, potentially providing relief without the need for medication.678910

What is the purpose of this trial?

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.

Research Team

CF

Colleen Fitzgwerald, MD

Principal Investigator

Loyola Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Pregnant women in their second or third trimester who are experiencing recent acute posterior PGP and can speak English.
My current pain level is mild to moderate.
Written informed consent

Exclusion Criteria

Using strong painkillers.
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.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either cryotherapy plus education or education alone for pelvic girdle pain

6 days
1 visit (in-person)

Follow-up

Participants are monitored for changes in pelvic girdle pain using NPRS and PGQ

1 week

Treatment Details

Interventions

  • Cryotherapy
  • Education
Trial Overview 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.
Participant Groups
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

Cryotherapy is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Cryotherapy for:
  • Pain relief
  • Inflammation reduction
  • Muscle spasm treatment
  • Rheumatoid arthritis
  • Stress and anxiety relief
🇺🇸
Approved in United States as Cryotherapy for:
  • Pain management
  • Muscle soreness reduction
  • Recovery after exercise
  • Fibromyalgia treatment
  • Skin health improvement
🇨🇦
Approved in Canada as Cryotherapy for:
  • Pain relief
  • Inflammation reduction
  • Muscle spasm treatment
  • Arthritis management
  • Postpartum recovery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials
161
Recruited
31,400+

Findings from Research

The study demonstrated a clear dose-dependent relationship between the amount of CO2 cryotherapy applied and the depth of tissue injury in the esophagus, stomach, and colon of pigs, indicating that higher doses lead to greater tissue damage.
In particular, the esophagus showed greater average injury compared to the stomach at similar cryotherapy doses, with tissue injury depths ranging from 1.2 to 2.5 mm in the esophagus and colon, suggesting that different gastrointestinal tissues may respond differently to cryotherapy.
Dose-dependent depth of tissue injury with carbon dioxide cryotherapy in porcine GI tract.Shin, EJ., Amateau, SK., Kim, Y., et al.[2013]
Whole-body cryotherapy (WBC) has shown potential benefits for improving sleep quality, enhancing recovery after exercise, and alleviating chronic pain, with some evidence suggesting positive effects on mental health and cognitive functions due to increased BDNF levels.
Despite some safety concerns raised by health authorities regarding adverse events, a review of the literature indicates that the risks associated with true WBC are manageable and can be minimized by following established guidelines and recommendations.
Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium.Legrand, FD., Dugué, B., Costello, J., et al.[2023]
A rare case of iatrogenic hypothermic injury occurred in a patient after using cryocompression therapy for an ankle fracture, leading to significant soft tissue damage including skin epidermolysis and partial nerve damage.
This incident highlights the potential risks associated with cryocompression therapy, which is commonly used for pain and swelling, suggesting that careful monitoring is necessary to prevent hypothermic injuries.
Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy.Høiness, PR., Hvaal, K., Engebretsen, L.[2005]

References

Dose-dependent depth of tissue injury with carbon dioxide cryotherapy in porcine GI tract. [2013]
Evaluating safety risks of whole-body cryotherapy/cryostimulation (WBC): a scoping review from an international consortium. [2023]
Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy. [2005]
[Cryotherapy]. [2021]
Is Cryotherapy Friend or Foe for Symptomatic Cervical Ectopy? [2022]
[Pelvic relaxation and physiotherapy--prevention and treatment]. [2013]
Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial. [2014]
Expertise and individually tailored interventions are expected by pregnant women with pelvic girdle pain who seek physical therapy: a qualitative study. [2023]
Pregnancy-related severe pelvic girdle pain caused by unilateral noninfectious sacroiliitis. A case report and literature review. [2021]
Pregnancy-related pelvic girdle pain: an update. [2022]
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