University of Houston
Houston, Texas, 77204, United States
Location status: Recruiting
Location contact
Stacey L Gorniak, PhD
CONTACT
Stacey L Gorniak, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07579182
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.
Interested in participating?
Request Info18 year–60 year
Female
Interventional
Phase 1
Houston, Texas, 77204, United States
Location status: Recruiting
Stacey L Gorniak, PhD
CONTACT
Stacey L Gorniak, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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)
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
Time frame: Baseline and 3 months after baseline
Qualitative assessment of pain via self-report (no units)
Time frame: Baseline and 3 months after baseline
Nociceptive Flexion Reflex Threshold (mV)
Time frame: Baseline and 3 months after baseline
Frequency and duration of physical activity as measured via smartwatch
Time frame: Baseline and 3 months after baseline
Percent body fat (%)
Time frame: Baseline and 3 months after baseline
Body mass index (BMI) (kg/m²)
Time frame: Baseline and 3 months after baseline
A1c (%)
Time frame: Baseline and 3 months after baseline
Total Cholesterol (mg/dL)
Time frame: Baseline and 3 months after baseline
High Density Lipoprotein Cholesterol (HDL) (mg/dL)
Time frame: Baseline and 3 months after baseline
Muscle activity (mV)
Time frame: Baseline and 3 months after baseline
Oxygenated Hemoglobin (HbO) (p-value)
Time frame: Baseline and 3 months after baseline
Deoxygenated Hemoglobin (HbR) (p-value)
Time frame: Baseline and 3 months after baseline
Systole and Diastole (mmHg)
Time frame: Baseline and 3 months after baseline
SII (no units)
Time frame: Baseline and 3 months after baseline
Total Hemoglobin (HbT) (p-value)
Time frame: Baseline and 3 months after baseline
Breast tissue acceleration (m/s2)
Time frame: Baseline and 3 months after baseline
Gait speed (m/s)
Time frame: Baseline and 3 months after baseline
Cadence (Hz)
Time frame: Baseline
Age at menopause (years) - if applicable
Time frame: Baseline and 3 months after baseline
Testosterone (mg/dL)
Time frame: Baseline and 3 months after baseline
Estradiol (mg/dL)
Time frame: Baseline and 3 months after baseline
Progesterone (mg/dL)
Time frame: Baseline and 3 months after baseline
Follicle Stimulating Hormone (mg/dL)
Time frame: Baseline and 3 months after baseline
Sex Hormone Binding Globulin (nmol/L)
Contact information is provided by the study sponsor or research team.
University of Houston
Other
Mechanical and Non-mechanical Contributions to Chronic Neck, Shoulder, Arm, and Back Pain in Full-busted Women
Acronym: HOPE
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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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