Cryotherapy for Pregnancy-Related Pelvic Girdle Pain

Overseen By Mary Tulke, RN

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Loyola University

Must not be taking: Narcotics

Disqualifiers: Low back pain, Fracture, Surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cryotherapy (cold therapy) can reduce pain and improve movement for pregnant women experiencing pelvic girdle pain in their second or third trimester. Participants will receive either educational materials on posture and exercises or those materials plus a 20-minute cryotherapy session. The study seeks English-speaking pregnant women with recent pelvic girdle pain (within the last 3 months) and a moderate pain level. As an unphased trial, it offers participants the chance to contribute to understanding new pain management options during pregnancy.

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.

What prior data suggests that cryotherapy is safe for pregnancy-related pelvic girdle pain?

Research has shown that cryotherapy is generally safe when used properly. Whole-body cryotherapy involves exposing the body to very cold temperatures and has shown some side effects, which are usually minor and manageable. Most people tolerate the treatment well without serious problems. Although specific safety information for pregnancy-related pelvic girdle pain is lacking, the overall safety record of cryotherapy is reassuring. This background information may be helpful for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for pregnancy-related pelvic girdle pain typically involve physical therapy, exercise, and sometimes pain medications. However, researchers are excited about cryotherapy because it offers a non-invasive, drug-free option that could provide quick pain relief. Cryotherapy uses cold therapy, which can reduce inflammation and numb pain rapidly. Additionally, when combined with education on posture, it may enhance overall comfort during pregnancy. This dual approach of immediate relief and long-term posture improvement makes it an intriguing alternative to traditional methods.

What evidence suggests that cryotherapy might be an effective treatment for pelvic girdle pain in pregnancy?

Research has shown that cold therapy, or cryotherapy, might help reduce pain and improve movement for pregnant women with pelvic girdle pain. This type of pain is common during pregnancy and can make moving difficult. Although specific data on cryotherapy for this issue is limited, it is generally known to help with pain and swelling in other conditions. In this trial, one group of participants will receive cryotherapy combined with education, while another group will receive education alone. By reducing swelling and numbing the area, cryotherapy might ease pain and improve mobility for pregnant women. While more research is needed, these early findings suggest cryotherapy could be a promising way to manage this pain. ^{1 3 4 6 7}

Who Is on the Research Team?

Colleen Fitzgwerald, MD

Principal Investigator

Loyola Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: cryotherapy + education Experimental Treatment 2 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 alone Active Control 1 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

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-dependent depth of tissue injury with carbon dioxide cryotherapy in porcine GI tract. Shin, EJ., Amateau, SK., Kim, Y., et al.[2013]

Local cryotherapy, such as using cold packs or sprays, effectively reduces pain and swelling in patients with inflammatory conditions and injuries, making it a useful treatment option.

Whole body cryotherapy at extremely low temperatures (-110 degrees C) has shown some pain-relieving effects, but the high rate of adverse events and limited data do not justify its routine use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryotherapy]. Hermann, J.[2021]

Physiotherapy for women experiencing pelvic girdle relaxation during and after pregnancy can effectively reduce pain and improve daily functioning, with just two to six sessions often being sufficient.

Techniques such as modified walking, side-lying rest with cushions, and additional treatments like massage and relaxation contribute to better pain management and increased blood circulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pelvic relaxation and physiotherapy--prevention and treatment]. Bånerud, BS., Helmert, M., Larun, L.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Pregnant women experiencing pelvic girdle pain (PGP) often wait until their pain becomes unmanageable before seeking physical therapy, indicating a need for earlier intervention and support.

The women expressed a strong desire for personalized care from physical therapists, expecting them to provide expert advice that addresses their unique challenges and helps improve their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expertise and individually tailored interventions are expected by pregnant women with pelvic girdle pain who seek physical therapy: a qualitative study. Ekdahl, AS., Gutke, A., Olsén, MF., et al.[2023]

A case of severe postpartum pelvic girdle pain due to unilateral noninfectious sacroiliitis was effectively treated with nonsteroidal anti-inflammatory drugs and physical therapy, leading to resolution within 2 months.

The study highlights the importance of recognizing and treating pelvic girdle pain during and after pregnancy, which can stem from dynamic instability in the pelvic region.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy-related severe pelvic girdle pain caused by unilateral noninfectious sacroiliitis. A case report and literature review. Mahovic, D., Laktasic-Zerjavic, N., Tudor, KI., et al.[2021]

Pelvic girdle pain is a common condition experienced by many pregnant women, characterized by persistent pain in the pelvic area that can start during pregnancy or after childbirth.

The exact physiological causes of pelvic girdle pain are not well understood, highlighting the need for further research to develop effective management strategies based on the underlying mechanisms of this syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnancy-related pelvic girdle pain: an update. Kanakaris, NK., Roberts, CS., Giannoudis, PV.[2022]

Cervical cryotherapy using carbon dioxide at -89°C was highly effective for treating abundant leucorrhoea, achieving a success rate of 89.5% in 102 out of 114 women, while it was less effective for pelvic pain, with a success rate of only 58%.

The procedure was safe, with no severe complications reported, although some patients experienced mild hydrorrhoea for a few days; success rates were significantly lower in women with recurrent cervicitis, particularly those with three or more episodes in six months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Cryotherapy Friend or Foe for Symptomatic Cervical Ectopy? Çekmez, Y., Şanlıkan, F., Göçmen, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy. Høiness, PR., Hvaal, K., Engebretsen, L.[2005]

Craniosacral therapy, when added to standard treatment, resulted in lower morning pain intensity and improved function in pregnant women with pelvic girdle pain, compared to standard treatment alone, based on a study of 123 participants.

However, the overall treatment effects were small and clinically questionable, indicating that more research is needed before craniosacral therapy can be recommended as a standard treatment for pelvic girdle pain during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of craniosacral therapy as adjunct to standard treatment for pelvic girdle pain in pregnant women: a multicenter, single blind, randomized controlled trial. Elden, H., Östgaard, HC., Glantz, A., et al.[2014]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04469192

The Efficacy of Cryotherapy in Pregnancy Related Pelvic ... 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.

2. withpower.com withpower.com/trial/phase-pelvic-girdle-pain-2020-31c47

Cryotherapy for Pregnancy-Related Pelvic Girdle Pain 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3987347/

Pelvic Girdle Pain during or after Pregnancy - PubMed Central Pelvic girdle pain (PGP) is a common condition during or after pregnancy with pain and disability as most important symptoms.

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04469192/the-efficacy-of-cryotherapy-in-pregnancy-related-pelvic-girdle-pain

The Efficacy of Cryotherapy in Pregnancy Related Pelvic ... The findings from this project may result in pain reduction and improved mobility in pregnant women with pelvic girdle pain in their second ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10874224/

Knowledge Mapping Analysis of Research on Pregnancy ... Knowledge Mapping Analysis of Research on Pregnancy-Related Pelvic Girdle Pain (PPGP) from 2002 to 2022 Using Bibliometrics - PMC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12446167/

Pregnancy-Related Hip and Pelvis Musculoskeletal ... This review article examines the etiology, treatments, and outcomes related to common hip and pelvis musculoskeletal conditions associated ...

7. dovepress.com dovepress.com/knowledge-mapping-analysis-of-research-on-pregnancy-related-pelvic-gir-peer-reviewed-fulltext-article-JPR

Knowledge Mapping Analysis of Research on PPGP. | JPR Physical therapy interventions, such as pelvic floor muscle training and manual therapy, have shown efficacy in mitigating pain and improving ...