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

28. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

140

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

  • Vereinigte Staaten
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77204
        • Rekrutierung
        • University of Houston
        • Kontakt:
          • Stacey L Gorniak, PhD
          • Telefonnummer: 713-743-4802
          • E-Mail: sgorniak@uh.edu
        • Hauptermittler:
          • Stacey L Gorniak, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Experimental: 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.
Sonstiges: 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.
Andere Namen:
  • Bounceless bra
  • Shefit Ultimate bra

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Houston

Mitarbeiter

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

Ermittler

  • Hauptermittler: Stacey L Gorniak, PhD, University of Houston

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. Mai 2026

Primärer Abschluss (Geschätzt)

1. Juni 2029

Studienabschluss (Geschätzt)

1. September 2029

Studienanmeldedaten

Zuerst eingereicht

4. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

12. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00005233
  • R01AR084021-01A1 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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-Sharing-Zugriffskriterien

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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