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NCT Number: NCT07579182

Hormones, Outcomes, and Pain Pathways in Exercise Study

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Houston

Houston, Texas, 77204, United States

Location status: Recruiting

Location contact

Stacey L Gorniak, PhD

CONTACT

[email protected]

713-743-4802

Stacey L Gorniak, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • History of joint disease including osteoarthritis and/or Rheumatoid Arthritis
  • 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)

Treatment and study plan

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.

Other names: Bounceless bra, Shefit Ultimate bra

Primary outcomes

  1. Pain Measures

    Time frame: Baseline and 3 months after baseline

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

  2. Objective Pain Measure

    Time frame: Baseline and 3 months after baseline

    Nociceptive Flexion Reflex Threshold (mV)

  3. Physical activity

    Time frame: Baseline and 3 months after baseline

    Frequency and duration of physical activity as measured via smartwatch

  4. Anthropometry

    Time frame: Baseline and 3 months after baseline

    Percent body fat (%)

  5. Anthropometry

    Time frame: Baseline and 3 months after baseline

    Body mass index (BMI) (kg/m²)

  6. Glycated Hemoglobin

    Time frame: Baseline and 3 months after baseline

    A1c (%)

  7. Lipids

    Time frame: Baseline and 3 months after baseline

    Total Cholesterol (mg/dL)

  8. Lipids

    Time frame: Baseline and 3 months after baseline

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

  9. Biomechanical Data

    Time frame: Baseline and 3 months after baseline

    Muscle activity (mV)

  10. Neuroimaging Data

    Time frame: Baseline and 3 months after baseline

    Oxygenated Hemoglobin (HbO) (p-value)

  11. Neuroimaging Data

    Time frame: Baseline and 3 months after baseline

    Deoxygenated Hemoglobin (HbR) (p-value)

Secondary outcomes

  1. Blood Pressure

    Time frame: Baseline and 3 months after baseline

    Systole and Diastole (mmHg)

  2. Systemic Inflammation Index

    Time frame: Baseline and 3 months after baseline

    SII (no units)

  3. Neuroimaging Data

    Time frame: Baseline and 3 months after baseline

    Total Hemoglobin (HbT) (p-value)

  4. Biomechanical Data

    Time frame: Baseline and 3 months after baseline

    Breast tissue acceleration (m/s2)

  5. Biomechanical Data

    Time frame: Baseline and 3 months after baseline

    Gait speed (m/s)

  6. Biomechanical Data

    Time frame: Baseline and 3 months after baseline

    Cadence (Hz)

  7. Menopausal Status

    Time frame: Baseline

    Age at menopause (years) - if applicable

  8. Sex-Hormones

    Time frame: Baseline and 3 months after baseline

    Testosterone (mg/dL)

  9. Sex-Hormones

    Time frame: Baseline and 3 months after baseline

    Estradiol (mg/dL)

  10. Sex-Hormones

    Time frame: Baseline and 3 months after baseline

    Progesterone (mg/dL)

  11. Sex-Hormones

    Time frame: Baseline and 3 months after baseline

    Follicle Stimulating Hormone (mg/dL)

  12. Sex-Hormones

    Time frame: Baseline and 3 months after baseline

    Sex Hormone Binding Globulin (nmol/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Stacey L Gorniak, PhD

CONTACT

[email protected]

713-743-4802

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Collaborators

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

Registry information

Official study title

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

Acronym: HOPE

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 12, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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