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.
44 studies on the registry are indexed under Mastodynia; 10 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 37 interventional studies indexed under Mastodynia.
Browse Mastodynia studies →University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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.
Data sharing details ↗ · zenodo.org
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