Recruiting
Phase 1

Sports Bras

Sponsor:

University of Houston

Code:

NCT07579182

Conditions

Breast Pain

Mastalgia

Back Pain

Back Pain, Low

Neck Pain

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Interventional Sports bra

Study Details

Brief summary:

The goal of the proposed project is to evaluate a mechanical intervention (sports bras designed specifically for full busted women) to alleviate neck, shoulder, arm, and back pain in full-busted women and investigate the contribution of non-mechanical pathways associated with this type of pain in women. Specifically, the investigators will investigate how sex-hormones, inflammation, and remapping of specific regions of the brain contribute to the manifestation of neck, shoulder, arm, and back pain in full-busted women across the lifespan.

Conditions

Breast Pain

Mastalgia

Back Pain

Back Pain, Low

Neck Pain

Study ID

NCT07579182

Start date

May 17, 2026

Status verified date

May, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Able to provide informed consent
2. Age of 18 to 60 years
3. Assigned female sex at birth
4. Right-handed by self-declaration
5. Willing to participate in one online testing session and up to four in-person testing sessions
6. Bra band size between 32-40"
7. International Physical Activity Questionnaire - Short Form (IPAQ-SF) score of 2 or higher
8. An answer of "NO" to any item of the general health questions of the PARQ+
9. No history of surgery to the: back, neck, or shoulders or joint replacement
10. No history of implanted pacemakers or other stimulation devices
11. No history of spinal cord injury (SCI)

Exclusion Criteria:

1. Inability to provide informed consent
2. Age 17 years old or younger or 61 years or older
3. Assigned male sex at birth
4. Left-handed by self-declaration
5. Not willing to participate in one online testing session and up to four in-person testing sessions
6. Bra band size greater than 40" or less than 32"
7. IPAQ-SF score of 1 or lower
8. An answer of "YES" to any item of the general health questions of the PARQ+
9. History of limb amputation (upper or lower extremity)
10. Presence of open pressure sores on the upper or lower extremities
11. Currently pregnant or lactating/breastfeeding
12. History of surgery to the: back, neck, or shoulders or joint replacement
13. History of breast cancer and/or mastectomy
14. History of implanted pacemakers or other stimulation devices
15. History of spinal cord injury (SCI)
16. History of joint disease including osteoarthritis and/or Rheumatoid Arthritis
17. History of the following neurological diseases: Cerebrovascular accident (CVA, stroke), Alzheimer's Disease (AD), Dementia (of any form), Huntington's Disease, Traumatic Brain Injury (TBI), Spinal cord injury (SCI), Multiple Sclerosis (MS), Parkinson's Disease (PD), Polio, Paraproteinaemic Demyelinating Neuropathy (PDN) and/or Monoclonal Gammopathy of Undetermined Significance (MGUS), Myasthenia Gravis, Muscular Dystrophy, Guillain-Barré Syndrome, Scoliosis, Charcot-Marie-Tooth Disorder or other hereditary neuropathies

Additional Inclusion Criteria for Intervention Group:

a. Self-declared breast size of D-I cup (US sizes: D, E, F, G, H)

Additional Inclusion Criteria for the Control Group:

a. Self-declared breast size of A-C cup (US sizes: AA, A, B, C)

Study Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

no intervention: Control

Women with bra cup sizes A - C. Control group will undergo measurement of kinematic and kinetic data during physical activities at baseline. Study questionnaires, pain measures, body composition, brain activity, and blood-based biomarkers will be collected at baseline. Physical activity will be tracked via smartwatch for 3 months after baseline.

experimental: Interventional Sports Bra

Women with bra cup sizes D - I. Intervention group will undergo measurement of kinematic and kinetic data during physical activities at baseline and 3 months after receiving their interventional sports bras. Study questionnaires, pain measures, body composition, brain activity, and blood-based biomarkers will be collected at baseline and 3 months after receiving the interventional sports bras. Physical activity will be tracked via smartwatch for 3 months after baseline.

Interventions

Interventional Sports bra

This study involves use of observation and analysis of behavior in assessing breast motion and associated health outcomes while using a provided interventional sports bra of participant choice (Bounceless bra or Shefit Ultimate bra) for 3 months.

Primary outcome measure

  • Pain Measures [ Time Frame: Baseline and 3 months after baseline ]
  • Objective Pain Measure [ Time Frame: Baseline and 3 months after baseline ]
  • Physical activity [ Time Frame: Baseline and 3 months after baseline ]
  • Anthropometry [ Time Frame: Baseline and 3 months after baseline ]
  • Anthropometry [ Time Frame: Baseline and 3 months after baseline ]
  • Glycated Hemoglobin [ Time Frame: Baseline and 3 months after baseline ]
  • Lipids [ Time Frame: Baseline and 3 months after baseline ]
  • Lipids [ Time Frame: Baseline and 3 months after baseline ]
  • Biomechanical Data [ Time Frame: Baseline and 3 months after baseline ]
  • Neuroimaging Data [ Time Frame: Baseline and 3 months after baseline ]
  • Neuroimaging Data [ Time Frame: Baseline and 3 months after baseline ]

Central Contacts and Locations

Central contacts

Stacey L Gorniak, PhD

713-743-4802sgorniak@uh.edu

Locations

University of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Stacey L Gorniak, PhD

713-743-4802sgorniak@uh.edu

Principal Investigator:

Stacey L Gorniak, PhD

More Information

Sponsor

University of Houston

Last update posted

Jun 2, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by University of Houston on 2026-06-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.