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RECRUITING

NCT07579182

PHASE1

Hormones, Outcomes, and Pain Pathways in Exercise Study

Sponsor: University of Houston

View on ClinicalTrials.gov

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.

Official title: Mechanical and Non-mechanical Contributions to Chronic Neck, Shoulder, Arm, and Back Pain in Full-busted Women

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-05-17

Completion Date

2029-09

Last Updated

2026-06-02

Healthy Volunteers

Yes

Conditions

Breast Pain Mastalgia Back Pain Back Pain, Low Neck Pain Chest Pain Activity, Motor Healthy Aging Weight, Body Inflammation Gonadal Steroid Hormones Neuronal Plasticity Neuromuscular Manifestations

Interventions

OTHER

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.

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)

Locations (1)

University of Houston

Houston, Texas, United States