Hormones, Outcomes, and Pain Pathways in Exercise Study (HOPE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Back Pain; Neuromuscular Manifestations; Chest Pain; Neck Pain; Healthy Aging; Weight, Body; Mastalgia; Activity, Motor; Breast Pain; Back Pain, Low; Neuronal Plasticity; Gonadal Steroid Hormones
• Intervention / Treatment: Other: Interventional Sports bra

Detailed Description

Approximately 130 million individuals in the US (39% of the US population) are living with chronic musculoskeletal pain. Women experience more localizations of pain across their lifespan. Women report significantly more pain in the neck, shoulders, arms, back, and breasts due to altered musculoskeletal activity within in the neck and thoracic region due to the presence of breast tissue. Neck, shoulder, arm, and back (NSAB) pain has been strongly linked to bra cup size. Since 2000, there has been a significant increase in women's average bra cup size from B to E; women with cup sizes D and above are considered "full-busted". Most commercially available sport bras are designed for low- to medium-impact activities for women with cup size C or smaller, leaving women with cup sizes of D or larger without adequate breast support during physical activity. While the primary source of NSAB pain in these women is likely mechanical, evidence suggests non-mechanical pain pathways that may contribute to pain expression in women. Specifically, evidence of sex-hormone influences, systemic inflammation, and cortical remapping in female animal models with respect to chronic musculoskeletal pain is emerging; however, characterization of the influences of sex-hormone levels, inflammation, and concurrent cortical changes in the somatosensory and motor regions particularly in reference to chronic NSAB pain in women across the lifespan is a major gap in the evidence base. This critical gap in understanding physiological and neurological sex differences in chronic NSAB pain manifestation in full-busted women will be filled by our proposed project. In this project, the investigators will evaluate a non-pharmacological (mechanical) intervention to alleviate NSAB pain in full-busted women and investigate non-mechanical pathways associated with chronic NSAB pain in women. The investigators will measure both self-reported and objective measures of pain in conjunction with objective measures of behavior and blood-based measures to assess: (1) the impact of the mechanical intervention and (2) non-mechanical factors contributing to chronic musculoskeletal pain in women. The findings from this project will advance multifactorial understanding of pain in full-busted women, a population that lives with chronic musculoskeletal pain.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Stacey L Gorniak, PhD; Phone Number: 713-743-4802; Email: sgorniak@uh.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Recruiting
      • University of Houston
      • Contact: Stacey L Gorniak, PhD; Phone Number: 713-743-4802; Email: sgorniak@uh.edu
      • Principal Investigator: Stacey L Gorniak, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Bounceless bra; Shefit Ultimate bra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Systole and Diastole (mmHg)	Baseline and 3 months after baseline
Systemic Inflammation Index	SII (no units)	Baseline and 3 months after baseline
Neuroimaging Data	Total Hemoglobin (HbT) (p-value)	Baseline and 3 months after baseline
Biomechanical Data	Breast tissue acceleration (m/s2)	Baseline and 3 months after baseline
Biomechanical Data	Gait speed (m/s)	Baseline and 3 months after baseline
Biomechanical Data	Cadence (Hz)	Baseline and 3 months after baseline
Menopausal Status	Age at menopause (years) - if applicable	Baseline
Sex-Hormones	Testosterone (mg/dL)	Baseline and 3 months after baseline
Sex-Hormones	Estradiol (mg/dL)	Baseline and 3 months after baseline
Sex-Hormones	Progesterone (mg/dL)	Baseline and 3 months after baseline
Sex-Hormones	Follicle Stimulating Hormone (mg/dL)	Baseline and 3 months after baseline
Sex-Hormones	Sex Hormone Binding Globulin (nmol/L)	Baseline and 3 months after baseline

Collaborators and Investigators

• Sponsor: University of Houston
• Collaborators: The University of Texas Health Science Center, Houston; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Stacey L Gorniak, PhD, University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Back Pain; Body Weight; Inflammation; Low Back Pain; Neck Pain; Chest Pain; Mastodynia; Neuromuscular Manifestations; Motor Activity
• Other Study ID Numbers: STUDY00005233; R01AR084021-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

What data outputs will the research generate?

Biomechanical Evaluation Data Blood-based Biomarker Data (e.g., inflammation markers, sex-hormone values) Health State Data (e.g., blood pressure values, BMI, body composition values, menopausal status) Pain Data Physical Activity Data Functional Neuroimaging Data (t-values of Cortical Oxygenated, Deoxygenated, and Total Hemoglobin)

Manuscripts (which will also be publicly available via Pubmed upon publication)

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No