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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR084021-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| The University of Texas Health Science Center, Houston | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacey L Gorniak, PhD | Contact | 713-743-4802 | sgorniak@uh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stacey L Gorniak, PhD | University of Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston | Recruiting | Houston | Texas | 77204 | United States |
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)
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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.
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.
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Biostatistician & PI on the project will be blinded to the intervention assignments.
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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 |
| 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 |
| ID | Term |
|---|---|
| D059373 | Mastodynia |
| D001416 | Back Pain |
| D017116 | Low Back Pain |
| D019547 | Neck Pain |
| D002637 | Chest Pain |
| D009043 | Motor Activity |
| D001835 | Body Weight |
| D007249 | Inflammation |
| D020879 | Neuromuscular Manifestations |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D009422 | Nervous System Diseases |
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