Breast PainPhase 1HOPENCT07579182
Hormones, Outcomes, and Pain Pathways in Exercise Study
A Phase 1 study testing Interventional Sports bra in people with Breast Pain and Mastalgia, run by University of Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Pain, Mastalgia, Back Pain
- What is being tested?
- Interventional Sports bra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2026to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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"
Show all 11Show fewer
- 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)
Who cannot join
- 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"
Show all 21Show fewer
- 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:
- Self-declared breast size of D-I cup (US sizes: D, E, F, G, H)
- Additional Inclusion Criteria for the Control Group:
- Self-declared breast size of A-C cup (US sizes: AA, A, B, C)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Houston
Houston, Texas, 77204
Stacey L Gorniak, PhD, 713-743-4802, sgorniak@uh.edu
Stacey L Gorniak, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Pain, Mastalgia, Back Pain, Back Pain, Low, Neck Pain, Chest Pain
- Being tested
- Interventional Sports bra
- Medical subject headings
- Mastodynia, Back Pain, Low Back Pain, Neck Pain, Chest Pain, Motor Activity, Body Weight, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional Sports braOther
Also called Bounceless bra, Shefit Ultimate 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interventional Sports bra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measures
Qualitative assessment of pain via self-report (no units)
Measured: Baseline and 3 months after baseline
Objective Pain Measure
Nociceptive Flexion Reflex Threshold (mV)
Measured: Baseline and 3 months after baseline
Physical activity
Frequency and duration of physical activity as measured via smartwatch
Measured: Baseline and 3 months after baseline
Anthropometry
Percent body fat (%)
Measured: Baseline and 3 months after baseline
Anthropometry
Body mass index (BMI) (kg/m²)
Measured: Baseline and 3 months after baseline
Glycated Hemoglobin
A1c (%)
Measured: Baseline and 3 months after baseline
Lipids
Total Cholesterol (mg/dL)
Measured: Baseline and 3 months after baseline
Lipids
High Density Lipoprotein Cholesterol (HDL) (mg/dL)
Measured: Baseline and 3 months after baseline
Biomechanical Data
Muscle activity (mV)
Measured: Baseline and 3 months after baseline
Neuroimaging Data
Oxygenated Hemoglobin (HbO) (p-value)
Measured: Baseline and 3 months after baseline
Neuroimaging Data
Deoxygenated Hemoglobin (HbR) (p-value)
Measured: Baseline and 3 months after baseline
Secondary outcomes (12)
Blood Pressure
Systole and Diastole (mmHg)
Measured: Baseline and 3 months after baseline
Systemic Inflammation Index
SII (no units)
Measured: Baseline and 3 months after baseline
Neuroimaging Data
Total Hemoglobin (HbT) (p-value)
Measured: Baseline and 3 months after baseline
Biomechanical Data
Breast tissue acceleration (m/s2)
Measured: Baseline and 3 months after baseline
Biomechanical Data
Gait speed (m/s)
Measured: Baseline and 3 months after baseline
Biomechanical Data
Cadence (Hz)
Measured: Baseline and 3 months after baseline
Menopausal Status
Age at menopause (years) - if applicable
Measured: Baseline
Sex-Hormones
Testosterone (mg/dL)
Measured: Baseline and 3 months after baseline
Sex-Hormones
Estradiol (mg/dL)
Measured: Baseline and 3 months after baseline
Sex-Hormones
Progesterone (mg/dL)
Measured: Baseline and 3 months after baseline
Sex-Hormones
Follicle Stimulating Hormone (mg/dL)
Measured: Baseline and 3 months after baseline
Sex-Hormones
Sex Hormone Binding Globulin (nmol/L)
Measured: Baseline and 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start17 May 2026
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Stacey Gorniak, University of Houston
- Investigators
- Stacey L Gorniak, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579182
- Sponsor's protocol ID
- STUDY00005233
- Other IDs
- R01AR084021-01A1
- Acronym
- HOPE
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical and Non-mechanical Contributions to Chronic Neck, Shoulder, Arm, and Back Pain in Full-busted Women
- ClinicalTrials.gov ID
- NCT07579182
- Acronym / sponsor ID
- HOPE / STUDY00005233
- Conditions
- Breast Pain, Mastalgia, Back Pain, Back Pain, Low, Neck Pain, Chest Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), The University of Texas Health Science Center, Houston
- Study start
- 17 May 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Interventional Sports braWomen 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional Sports braAlso: Bounceless bra, Shefit Ultimate braThis 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 | Interventional Sports Bra |
Primary outcome
Pain Measures
Time frame: Baseline and 3 months after baseline
Qualitative assessment of pain via self-report (no units)
Objective Pain Measure
Time frame: Baseline and 3 months after baseline
Nociceptive Flexion Reflex Threshold (mV)
Physical activity
Time frame: Baseline and 3 months after baseline
Frequency and duration of physical activity as measured via smartwatch
Anthropometry
Time frame: Baseline and 3 months after baseline
Percent body fat (%)
Anthropometry
Time frame: Baseline and 3 months after baseline
Body mass index (BMI) (kg/m²)
Glycated Hemoglobin
Time frame: Baseline and 3 months after baseline
A1c (%)
Lipids
Time frame: Baseline and 3 months after baseline
Total Cholesterol (mg/dL)
Lipids
Time frame: Baseline and 3 months after baseline
High Density Lipoprotein Cholesterol (HDL) (mg/dL)
Biomechanical Data
Time frame: Baseline and 3 months after baseline
Muscle activity (mV)
Neuroimaging Data
Time frame: Baseline and 3 months after baseline
Oxygenated Hemoglobin (HbO) (p-value)
Neuroimaging Data
Time frame: Baseline and 3 months after baseline
Deoxygenated Hemoglobin (HbR) (p-value)
12 secondary outcomes
Blood Pressure
Time frame: Baseline and 3 months after baseline
Systemic Inflammation Index
Time frame: Baseline and 3 months after baseline
Neuroimaging Data
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Time frame: Baseline and 3 months after baseline
Biomechanical Data
Time frame: Baseline and 3 months after baseline
Menopausal Status
Time frame: Baseline
Sex-Hormones
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Time frame: Baseline and 3 months after baseline
Sex-Hormones
Time frame: Baseline and 3 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacey L Gorniak, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Interventional Sports bra in people with Breast Pain and Mastalgia, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey L Gorniak, PhD (713-743-4802, sgorniak@uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Measures (time frame: Baseline and 3 months after baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.