Health TrialsbyHealthPanel

Hormones, Outcomes, and Pain Pathways in Exercise Study

ConditionsBreast PainMastalgiaBack PainBack Pain, LowNeck PainChest PainActivity, MotorHealthy AgingWeight, BodyInflammationGonadal Steroid HormonesNeuronal PlasticityNeuromuscular Manifestations
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity of Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Able to provide informed consent

Age of 18 to 60 years

Assigned female sex at birth

Right-handed by self-declaration

Disqualifiers

Inability to provide informed consent

Age 17 years old or younger or 61 years or older

Assigned male sex at birth

Left-handed by self-declaration

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interventional Sports bra

    Other intervention

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Interventional Sports BraExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain Measures

Qualitative assessment of pain via self-report (no units)

Time frame
Baseline and 3 months after baseline
2

Objective Pain Measure

Nociceptive Flexion Reflex Threshold (mV)

Time frame
Baseline and 3 months after baseline
3

Physical activity

Frequency and duration of physical activity as measured via smartwatch

Time frame
Baseline and 3 months after baseline
4

Anthropometry

Percent body fat (%)

Time frame
Baseline and 3 months after baseline

Secondary outcomes

1

Blood Pressure

Systole and Diastole (mmHg)

Time frame
Baseline and 3 months after baseline
2

Systemic Inflammation Index

SII (no units)

Time frame
Baseline and 3 months after baseline
3

Neuroimaging Data

Total Hemoglobin (HbT) (p-value)

Time frame
Baseline and 3 months after baseline
4

Biomechanical Data

Breast tissue acceleration (m/s2)

Time frame
Baseline and 3 months after baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Houston

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

Source ClinicalTrials.gov
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