Actively Recruiting
Mechanical and Non-mechanical Contributions to Chronic Neck, Shoulder, Arm, and Back Pain in Full-busted Women
Led by University of Houston · Updated on 2026-06-02
140
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University of Houston
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how mechanical and non-mechanical factors contribute to chronic neck, shoulder, arm, and back pain in full-busted women. This study focuses on women with larger bra cup sizes, exploring how sex hormones, inflammation, and brain changes affect pain. The project aims to fill gaps in understanding pain mechanisms in women with chronic musculoskeletal pain related to breast size. The study evaluates a mechanical intervention using specially designed sports bras for full-busted women (cup sizes D to I) to see if they help reduce pain. Participants in the intervention group will receive one of two types of interventional sports bras to wear for three months. A control group of women with smaller cup sizes (A to C) will be observed without receiving the intervention. Both groups will undergo various baseline and follow-up assessments over three months. Participants will complete online and in-person sessions including questionnaires, pain assessments, body measurements, blood tests, and brain imaging at the start and after three months. Physical activity will be monitored using a smartwatch during the study period. Researchers will collect multiple measures to understand pain, activity, hormone levels, inflammation, biomechanics, and brain activity. The study lasts at least three months, with detailed follow-up to assess the impact of the sports bras and related pain pathways.
CONDITIONS
Brief Title
Hormones, Outcomes, and Pain Pathways in Exercise Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 inches
- International Physical Activity Questionnaire - Short Form (IPAQ-SF) score of 2 or higher
- Answers "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
- For intervention group: self-declared breast size of D-I cup
- For control group: self-declared breast size of A-C cup
You will not qualify if you...
- Inability to provide informed consent
- Age younger than 18 years or older than 60 years
- Assigned male sex at birth
- Left-handed by self-declaration
- Unwilling to participate in testing sessions
- Bra band size less than 32 inches or greater than 40 inches
- IPAQ-SF score of 1 or lower
- Answers "YES" to any item of the general health questions of the PARQ+
- History of limb amputation
- Presence of open pressure sores on limbs
- Currently pregnant or breastfeeding
- History of surgery to the back, neck, or shoulders or joint replacement
- History of breast cancer or mastectomy
- History of implanted pacemakers or stimulation devices
- History of spinal cord injury
- History of joint diseases including osteoarthritis or rheumatoid arthritis
- History of neurological diseases such as stroke, Alzheimer's, dementia, Huntington's, traumatic brain injury, multiple sclerosis, Parkinson's, polio, demyelinating neuropathy, myasthenia gravis, muscular dystrophy, Guillain-Barré syndrome, scoliosis, Charcot-Marie-Tooth disorder, or other hereditary neuropathies
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Up to 5 testing sessions including one online and up to four in-person sessions
Duration - At baseline
Participants undergo baseline assessments including questionnaires, pain measures, body composition, brain activity, blood-based biomarkers, and physical activity tracking.
1 baseline visit (in-person) and continuous physical activity tracking via smartwatch for 3 months
Duration - 3 months
Participants with bra cup sizes D to I receive an interventional sports bra and wear it for 3 months to assess changes in pain and physical activity.
Physical activity tracked continuously via smartwatch for 3 months
Duration - 3 months after baseline
Participants undergo follow-up assessments including the same measures as baseline to evaluate changes after the intervention or observation period.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
University of Houston
Houston, Texas, United States, 77204
Actively Recruiting
Research Team
S
Stacey L Gorniak, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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