Birth Control Pills for Hand and Wrist Injuries

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Central Florida

Must be taking: Monophasic contraceptives

Must not be taking: Corticosteroids, Antidepressants, Antipsychotics, others

Disqualifiers: Menstrual irregularities, Neuromuscular disease, Metabolic disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Studies across various sports and physical activities have consistently shown that females incur more injuries compared to their male counterparts, but the underlying reasons for this disparity remain poorly understood. While differences in hormone levels between males and females have been speculated to play a role, very little rigorous research has been conducted to directly examine potential connections between sex hormones and injury risk. Specifically, females have been shown to be at greater risk for hand and wrist injuries. The higher injury incidence begins at puberty and persists across the lifespan, suggesting a link to hormonal factors. However, significant gaps remain in understanding the relationships between the menstrual cycle, exogenous hormones from birth control, and risk factors for sports-related injury in females. The purpose of this study is to examine changes in muscle strength and neuromuscular activation among females using monophasic oral contraceptives, females not using oral contraceptives, and males during one week of wrist/hand immobilization.

Eligibility Criteria

This trial is for females who are either using monophasic oral contraceptives or not, and males. It aims to understand the impact of hormones on hand/wrist injury risk by studying muscle strength and control during a week of immobilization.

Inclusion Criteria

I am right-handed.

I am between 18 and 35 years old.

For females, consistent use of monophasic oral contraceptives for the previous 6 months OR having completely refrained from contraceptives for the previous 6 months

Exclusion Criteria

Implant of any kind

Body Mass Index less than 18.5 kg/m2 or greater than 29.9 kg/m2

Unwillingness to avoid exercise and alcohol 24 hours prior to each testing visit

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immobilization

Participants will have their wrist and hand immobilized using a rigid splint continuously for 7 days

1 week

1 visit (in-person) for splint application

Recovery and Monitoring

Participants' grip strength and muscle activation will be tested weekly until grip strength returns to baseline levels

At least 3 weeks

Weekly visits (in-person) for testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Trial Overview The study tests how one week of wrist/hand immobilization affects muscle strength and neuromuscular activation in three groups: women on birth control pills, women not on them, and men.

Participant Groups

Group I: Wrist/hand immobilization Experimental Treatment 1 Intervention

Participants will have their wrist and hand immobilized using a rigid splint continuously for 7 days. The splint will restrict all wrist and hand movement and must be worn at all times for the full 7 day period, and may only be removed under supervision of the research participants.

Who Is Running the Clinical Trial?

University of Central Florida

Lead Sponsor

Trials

101

Recruited

1,191,000+