A Phase 1 interventional study of Interventional Sports bra in Breast Pain, Mastalgia and Back Pain, sponsored by University of Houston. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by University of Houston · Phase 1, Interventional, and Basic science
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.
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)
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.
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.
Also known as: Bounceless bra, Shefit Ultimate bra
Pain Measures
Qualitative assessment of pain via self-report (no units)
Time frame: Baseline and 3 months after baseline
Objective Pain Measure
Nociceptive Flexion Reflex Threshold (mV)
Time frame: Baseline and 3 months after baseline
Physical activity
Frequency and duration of physical activity as measured via smartwatch
Time frame: Baseline and 3 months after baseline
Anthropometry
Percent body fat (%)
Time frame: Baseline and 3 months after baseline
Anthropometry
Body mass index (BMI) (kg/m²)
Time frame: Baseline and 3 months after baseline
Glycated Hemoglobin
A1c (%)
Time frame: Baseline and 3 months after baseline
Lipids
Total Cholesterol (mg/dL)
Time frame: Baseline and 3 months after baseline
Lipids
High Density Lipoprotein Cholesterol (HDL) (mg/dL)
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Muscle activity (mV)
Time frame: Baseline and 3 months after baseline
Neuroimaging Data
Oxygenated Hemoglobin (HbO) (p-value)
Time frame: Baseline and 3 months after baseline
Neuroimaging Data
Deoxygenated Hemoglobin (HbR) (p-value)
Time frame: Baseline and 3 months after baseline
Blood Pressure
Systole and Diastole (mmHg)
Time frame: Baseline and 3 months after baseline
Systemic Inflammation Index
SII (no units)
Time frame: Baseline and 3 months after baseline
Neuroimaging Data
Total Hemoglobin (HbT) (p-value)
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Breast tissue acceleration (m/s2)
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Gait speed (m/s)
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Cadence (Hz)
Time frame: Baseline and 3 months after baseline
Menopausal Status
Age at menopause (years) - if applicable
Time frame: Baseline
Sex-Hormones
Testosterone (mg/dL)
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Estradiol (mg/dL)
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Progesterone (mg/dL)
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Follicle Stimulating Hormone (mg/dL)
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Sex Hormone Binding Globulin (nmol/L)
Time frame: Baseline and 3 months after baseline
Plan to share: Yes — 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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