Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Hormones, Outcomes, and Pain Pathways in Exercise Study (HOPE)

28. maj 2026 opdateret af: Stacey Gorniak, University of Houston

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

140

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Stacey L Gorniak, PhD
  • Telefonnummer: 713-743-4802
  • E-mail: sgorniak@uh.edu

Studiesteder

  • Forenede Stater
    • Texas
      • Houston, Texas, Forenede Stater, 77204
        • Rekruttering
        • University of Houston
        • Kontakt:
          • Stacey L Gorniak, PhD
          • Telefonnummer: 713-743-4802
          • E-mail: sgorniak@uh.edu
        • Ledende efterforsker:
          • Stacey L Gorniak, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control
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.
Eksperimentel: Interventional Sports Bra
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.
Andet: 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.
Andre navne:
  • Bounceless bra
  • Shefit Ultimate bra

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pain Measures
Tidsramme: Baseline and 3 months after baseline
Qualitative assessment of pain via self-report (no units)
Baseline and 3 months after baseline
Objective Pain Measure
Tidsramme: Baseline and 3 months after baseline
Nociceptive Flexion Reflex Threshold (mV)
Baseline and 3 months after baseline
Physical activity
Tidsramme: Baseline and 3 months after baseline
Frequency and duration of physical activity as measured via smartwatch
Baseline and 3 months after baseline
Anthropometry
Tidsramme: Baseline and 3 months after baseline
Percent body fat (%)
Baseline and 3 months after baseline
Anthropometry
Tidsramme: Baseline and 3 months after baseline
Body mass index (BMI) (kg/m²)
Baseline and 3 months after baseline
Glycated Hemoglobin
Tidsramme: Baseline and 3 months after baseline
A1c (%)
Baseline and 3 months after baseline
Lipids
Tidsramme: Baseline and 3 months after baseline
Total Cholesterol (mg/dL)
Baseline and 3 months after baseline
Lipids
Tidsramme: Baseline and 3 months after baseline
High Density Lipoprotein Cholesterol (HDL) (mg/dL)
Baseline and 3 months after baseline
Biomechanical Data
Tidsramme: Baseline and 3 months after baseline
Muscle activity (mV)
Baseline and 3 months after baseline
Neuroimaging Data
Tidsramme: Baseline and 3 months after baseline
Oxygenated Hemoglobin (HbO) (p-value)
Baseline and 3 months after baseline
Neuroimaging Data
Tidsramme: Baseline and 3 months after baseline
Deoxygenated Hemoglobin (HbR) (p-value)
Baseline and 3 months after baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Blood Pressure
Tidsramme: Baseline and 3 months after baseline
Systole and Diastole (mmHg)
Baseline and 3 months after baseline
Systemic Inflammation Index
Tidsramme: Baseline and 3 months after baseline
SII (no units)
Baseline and 3 months after baseline
Neuroimaging Data
Tidsramme: Baseline and 3 months after baseline
Total Hemoglobin (HbT) (p-value)
Baseline and 3 months after baseline
Biomechanical Data
Tidsramme: Baseline and 3 months after baseline
Breast tissue acceleration (m/s2)
Baseline and 3 months after baseline
Biomechanical Data
Tidsramme: Baseline and 3 months after baseline
Gait speed (m/s)
Baseline and 3 months after baseline
Biomechanical Data
Tidsramme: Baseline and 3 months after baseline
Cadence (Hz)
Baseline and 3 months after baseline
Menopausal Status
Tidsramme: Baseline
Age at menopause (years) - if applicable
Baseline
Sex-Hormones
Tidsramme: Baseline and 3 months after baseline
Testosterone (mg/dL)
Baseline and 3 months after baseline
Sex-Hormones
Tidsramme: Baseline and 3 months after baseline
Estradiol (mg/dL)
Baseline and 3 months after baseline
Sex-Hormones
Tidsramme: Baseline and 3 months after baseline
Progesterone (mg/dL)
Baseline and 3 months after baseline
Sex-Hormones
Tidsramme: Baseline and 3 months after baseline
Follicle Stimulating Hormone (mg/dL)
Baseline and 3 months after baseline
Sex-Hormones
Tidsramme: Baseline and 3 months after baseline
Sex Hormone Binding Globulin (nmol/L)
Baseline and 3 months after baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Houston

Samarbejdspartnere

The University of Texas Health Science Center, Houston
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Efterforskere

  • Ledende efterforsker: Stacey L Gorniak, PhD, University of Houston

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. maj 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

1. september 2029

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00005233
  • R01AR084021-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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)

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Betændelse

Kliniske forsøg med Interventional Sports bra

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Cameroon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner