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

2026년 5월 28일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

140

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Stacey L Gorniak, PhD
  • 전화번호: 713-743-4802
  • 이메일: sgorniak@uh.edu

연구 장소

  • 미국
    • Texas
      • Houston, Texas, 미국, 77204
        • 모병
        • University of Houston
        • 연락하다:
          • Stacey L Gorniak, PhD
          • 전화번호: 713-743-4802
          • 이메일: sgorniak@uh.edu
        • 수석 연구원:
          • Stacey L Gorniak, PhD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

예

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 기초 과학
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: 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.
실험적: 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.
다른: 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.
다른 이름들:
  • Bounceless bra
  • Shefit Ultimate bra

연구는 무엇을 측정합니까?

주요 결과 측정

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

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Houston

협력자

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

수사관

  • 수석 연구원: Stacey L Gorniak, PhD, University of Houston

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 17일

기본 완료 (추정된)

2029년 6월 1일

연구 완료 (추정된)

2029년 9월 1일

연구 등록 날짜

최초 제출

2026년 5월 4일

QC 기준을 충족하는 최초 제출

2026년 5월 4일

처음 게시됨 (실제)

2026년 5월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 28일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY00005233
  • R01AR084021-01A1 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

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 공유 액세스 기준

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

염증에 대한 임상 시험

Interventional Sports bra에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Malaysia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다