Activity, Motor, Back Pain, Back Pain, Low, Breast Pain, Chest Pain, Gonadal Steroid Hormones, Healthy Aging, Inflammation, Mastalgia, Neck Pain, Neuromuscular Manifestations, Neuronal Plasticity, Weight, Body
Conditions
Brief 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. 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.
Interventions
OTHERInterventional 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.
Sponsors
University of Houston
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
The University of Texas Health Science Center, Houston
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Biostatistician & PI on the project will be blinded to the intervention assignments.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Able to provide informed consent 2. Age of 18 to 60 years 3. Assigned female sex at birth 4. Right-handed by self-declaration 5. Willing to participate in one online testing session and up to four in-person testing sessions 6. Bra band size between 32-40" 7. International Physical Activity Questionnaire - Short Form (IPAQ-SF) score of 2 or higher 8. An answer of "NO" to any item of the general health questions of the PARQ+ 9. No history of surgery to the: back, neck, or shoulders or joint replacement 10. No history of implanted pacemakers or other stimulation devices 11. No history of spinal cord injury (SCI)
Exclusion criteria
1. Inability to provide informed consent 2. Age 17 years old or younger or 61 years or older 3. Assigned male sex at birth 4. Left-handed by self-declaration 5. Not willing to participate in one online testing session and up to four in-person testing sessions 6. Bra band size greater than 40" or less than 32" 7. IPAQ-SF score of 1 or lower 8. An answer of "YES" to any item of the general health questions of the PARQ+ 9. History of limb amputation (upper or lower extremity) 10. Presence of open pressure sores on the upper or lower extremities 11. Currently pregnant or lactating/breastfeeding 12. History of surgery to the: back, neck, or shoulders or joint replacement 13. History of breast cancer and/or mastectomy 14. History of implanted pacemakers or other stimulation devices 15. History of spinal cord injury (SCI) 16. History of joint disease including osteoarthritis and/or Rheumatoid Arthritis 17. 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: 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Measures | Baseline and 3 months after baseline | Qualitative assessment of pain via self-report (no units) |
| Objective Pain Measure | Baseline and 3 months after baseline | Nociceptive Flexion Reflex Threshold (mV) |
| Physical activity | Baseline and 3 months after baseline | Frequency and duration of physical activity as measured via smartwatch |
| Anthropometry | Baseline and 3 months after baseline | Percent body fat (%) |
| Glycated Hemoglobin | Baseline and 3 months after baseline | A1c (%) |
| Lipids | Baseline and 3 months after baseline | Total Cholesterol (mg/dL) |
| Biomechanical Data | Baseline and 3 months after baseline | Muscle activity (mV) |
| Neuroimaging Data | Baseline and 3 months after baseline | Oxygenated Hemoglobin (HbO) (p-value) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | Baseline and 3 months after baseline | Systole and Diastole (mmHg) |
| Systemic Inflammation Index | Baseline and 3 months after baseline | SII (no units) |
| Neuroimaging Data | Baseline and 3 months after baseline | Total Hemoglobin (HbT) (p-value) |
| Biomechanical Data | Baseline and 3 months after baseline | Breast tissue acceleration (m/s2) |
| Menopausal Status | Baseline | Age at menopause (years) - if applicable |
| Sex-Hormones | Baseline and 3 months after baseline | Testosterone (mg/dL) |
Countries
United States
Contacts
CONTACTStacey L Gorniak, PhD
PRINCIPAL_INVESTIGATORStacey L Gorniak, PhD
University of Houston
Outcome results
None listed