Hormones, Outcomes, and Pain Pathways in Exercise Study

NCT07579182 | Recruiting Phase 1

• 2 other identifiers: STUDY00005233R01AR084021-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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; Chest Pain; Activity, Motor; Healthy Aging; Weight, Body; Inflammation; Gonadal Steroid Hormones; Neuronal Plasticity; Neuromuscular Manifestations

Outcome Measures

Primary Outcomes (11)

• Pain Measures

  Qualitative assessment of pain via self-report (no units)

  Baseline and 3 months after baseline

• Objective Pain Measure

  Nociceptive Flexion Reflex Threshold (mV)

  Baseline and 3 months after baseline

• Physical activity

  Frequency and duration of physical activity as measured via smartwatch

  Baseline and 3 months after baseline

• Anthropometry

  Percent body fat (%)

  Baseline and 3 months after baseline

• Anthropometry

  Body mass index (BMI) (kg/m²)

  Baseline and 3 months after baseline

• Glycated Hemoglobin

  A1c (%)

  Baseline and 3 months after baseline

• Lipids

  Total Cholesterol (mg/dL)

  Baseline and 3 months after baseline

• Lipids

  High Density Lipoprotein Cholesterol (HDL) (mg/dL)

  Baseline and 3 months after baseline

• Biomechanical Data

  Muscle activity (mV)

  Baseline and 3 months after baseline

• Neuroimaging Data

  Oxygenated Hemoglobin (HbO) (p-value)

  Baseline and 3 months after baseline

• Neuroimaging Data

  Deoxygenated Hemoglobin (HbR) (p-value)

  Baseline and 3 months after baseline

Secondary Outcomes (12)

• Blood Pressure

  Baseline and 3 months after baseline

• Systemic Inflammation Index

  Baseline and 3 months after baseline

• Neuroimaging Data

  Baseline and 3 months after baseline

• Biomechanical Data

  Baseline and 3 months after baseline

• Biomechanical Data

  Baseline and 3 months after baseline

Study Arms (2)

Control

NO INTERVENTION

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.

Interventional Sports Bra

EXPERIMENTAL

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.

Other: Interventional Sports bra

Interventions

Interventional Sports bra OTHER

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.

Also known as: Bounceless bra, Shefit Ultimate bra

Interventional Sports Bra

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Inability to provide informed consent
• Age 17 years old or younger or 61 years or older
• Assigned male sex at birth
• Left-handed by self-declaration
• Not willing to participate in one online testing session and up to four in-person testing sessions
• Bra band size greater than 40" or less than 32"
• IPAQ-SF score of 1 or lower
• An answer of "YES" to any item of the general health questions of the PARQ+
• History of limb amputation (upper or lower extremity)
• Presence of open pressure sores on the upper or lower extremities
• Currently pregnant or lactating/breastfeeding
• History of surgery to the: back, neck, or shoulders or joint replacement
• History of breast cancer and/or mastectomy
• History of implanted pacemakers or other stimulation devices
• History of spinal cord injury (SCI)

Sponsors & Collaborators

• University of Houston: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Mastodynia; Back Pain; Low Back Pain; Neck Pain; Chest Pain; Motor Activity; Body Weight; Inflammation; Neuromuscular Manifestations

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Pathologic Processes; Nervous System Diseases

Study Officials

• Stacey L Gorniak, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacey L Gorniak, PhD

CONTACT

713-743-4802; sgorniak@uh.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Biostatistician \& PI on the project will be blinded to the intervention assignments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 12, 2026
• Study Start: May 17, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available as soon as possible but no later than within one year of the completion of the funded project period or upon acceptance of specific data for publication. Data will be available for 5 years after the completion of the funded project.
• Access Criteria: Deidentified data will be made available to the research community via Zenodo. Potential data users must agree to: (1) credit the original study, study team, and investigators; (2) protect study participants by limiting data use to scientific research and aggregate statistical reporting; (3) will not attempt to identify and/or contact study participants, and (4) will agree not to share or redistribute any data downloads.

Locations

US (1)