140 Participants NeededMy employer runs this trial

Sports Bra for Breast Pain

(HOPE Trial)

SL
Overseen ByStacey L Gorniak, PhD
Age: 18 - 65
Sex: Female
Trial Phase: Phase 1
Sponsor: University of Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if specially designed sports bras, known as interventional sports bras, can reduce neck, shoulder, arm, and back pain in women with larger busts. Researchers will also explore how hormones and inflammation might contribute to this pain. Participants with bra cup sizes D to I who experience discomfort during physical activities may be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative intervention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this sports bra is safe for full-busted women?

Research has shown that sports bras can greatly reduce breast pain during exercise. In one study, 87% of women reported that a specially recommended sports bra was better than their usual one. This suggests that choosing the right sports bra can be very helpful.

While specific safety data for this particular sports bra is unavailable, sports bras in general are considered safe. Designed to provide support and comfort, they can help reduce pain during activities. As a common part of athletic wear, sports bras are generally well-accepted by most people.12345

Why are researchers excited about this trial?

Researchers are excited about the interventional sports bra because it aims to address breast pain in women with larger cup sizes (D-I) through a specialized design tailored for physical activities. Unlike standard sports bras, which might not adequately support larger breasts during vigorous movement, this interventional sports bra is expected to reduce pain by optimizing biomechanical support. Additionally, it might offer insights into how specialized sports bras can affect body composition, brain activity, and even blood-based biomarkers, potentially paving the way for more personalized solutions for breast pain during exercise.

What evidence suggests that this interventional sports bra is effective for alleviating neck, shoulder, arm, and back pain?

Research has shown that wearing a sports bra can significantly reduce breast pain and discomfort. One study found that 85% of women experienced less breast pain with a sports bra compared to other options. Another study discovered that sports bras limit breast movement, reducing pain during physical activities. In this trial, women with larger breasts (cup sizes D - I) will receive an interventional sports bra to evaluate its effectiveness in reducing pain and enhancing comfort during exercise. The control group, consisting of women with smaller cup sizes (A - C), will not receive the interventional sports bra. Overall, evidence suggests that sports bras effectively reduce breast pain and improve comfort during exercise.26789

Who Is on the Research Team?

SL

Stacey L Gorniak, PhD

Principal Investigator

University of Houston

Are You a Good Fit for This Trial?

This trial is for women with larger busts who experience neck, shoulder, arm, or back pain. Participants may be of any age and should not have conditions that would prevent them from wearing a sports bra or participating in the study.

Inclusion Criteria

I am between 18 and 60 years old.
Assigned female sex at birth
Right-handed by self-declaration
See 8 more

Exclusion Criteria

I am not willing to attend all required testing sessions.
Bra band size greater than 40" or less than 32"
IPAQ-SF score of 1 or lower
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Measurement of kinematic and kinetic data, study questionnaires, pain measures, body composition, brain activity, and blood-based biomarkers are collected

1 week
1 visit (in-person)

Intervention

Intervention group receives sports bras and undergoes physical activity tracking via smartwatch for 3 months

3 months
1 visit (in-person) at 3 months

Follow-up

Participants are monitored for changes in pain measures, physical activity, and other biomarkers

3 months
1 visit (in-person) at 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Interventional Sports bra

Trial Overview

The study tests whether specially designed sports bras can help reduce pain in full-busted women. It also looks at how hormones, inflammation, and brain changes might play a role in this type of pain.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Interventional Sports BraExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Houston

Lead Sponsor

Trials
155
Recruited
48,600+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials
508
Recruited
1,090,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials
974
Recruited
361,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10476977/

An analysis of movement and discomfort of the female ...

The results showed that wearing external support for the breast tissue reduced absolute vertical movement and maximum downward deceleration force on the breast.

A multi-phase intervention study of sports bra prescription ...

This multi-phase intervention assessed breast/bra knowledge, preferences, issues via surveys and breast/bra assessments.

The Impact of Breasts and Bras on Physical Activity ...

Meta-analyses revealed that women and girls with larger breasts reported more exercise-induced breast pain and experienced greater breast mediolateral velocity.

Multi-study randomised controlled trial to develop ...

The sports bra was effective at reducing breast pain in 85% of cases compared to Danazol, which was effective in 58% of cases. However, regardless of their ...

Hormones, Outcomes, and Pain Pathways in Exercise Study

This study involves use of observation and analysis of behavior in assessing breast motion and associated health outcomes while using a provided ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35711113/

A multi-phase intervention study of sports bra prescription ...

Post-intervention, 63% reported improved knowledge and 97% reported their prescribed bra as better than their original bra. Eighty-seven per ...

a scoping review of a female-specific sports injury

This review aimed to collate and summarise published research on breast injuries in women's sports, highlighting the limitations and gaps in the literature.

'Don't tell the coach': contact breast injury and breast pain in ...

Incidence of CBI and EIBP was 39% and 43%, respectively. Seventy-seven percent of players affected by CBI had experienced multiple incidents in ...

Breast‐Related Issues in Community‐Based Women's ...

This study investigated the prevalence and severity of breast injuries and pain and the use and perception of breast protective equipment and ...