Birth Control Pills for Hand and Wrist Injuries

Overseen By Randi Richardson, DPT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how hormone levels might affect the risk of hand and wrist injuries, particularly in females. Researchers compare muscle strength and nerve activation among females using birth control pills, females not using them, and males, all while wearing a wrist and hand splint for a week. The study aims to determine whether hormones influence injury risk. Females who have consistently used or avoided monophasic birth control pills (a type of oral contraceptive) for the past six months and right-handed males may be suitable participants. As an unphased trial, this study allows participants to contribute to groundbreaking research on hormone-related injury risks.

What prior data suggests that this protocol is safe for participants?

Research has shown that birth control pills, commonly used to prevent pregnancy, are generally safe for many women. These pills have been used safely for over 50 years, and most people do not experience serious problems. Some common side effects include headaches, nausea, or mood changes, but these often subside after a few months.

The FDA has approved birth control pills for various uses, indicating their safety. However, everyone is different. Concerns should be discussed with a doctor to determine if birth control pills are suitable for individual needs.

Why are researchers excited about this trial?

Researchers are excited about wrist and hand immobilization using a rigid splint because it offers a unique approach to treating hand and wrist injuries. Unlike standard treatments that often involve medication or physical therapy, this method focuses on complete immobilization to potentially promote faster healing. By restricting all movement for just 7 days, the splint may provide effective stabilization, possibly reducing the need for longer-term treatments or interventions.

What evidence suggests that this trial's treatments could be effective for hand and wrist injuries?

Research shows that hormonal differences might explain why women experience more hand and wrist injuries than men. Studies indicate that this higher risk begins at puberty and continues throughout life, suggesting a possible link between injury risk and hormones related to the menstrual cycle or birth control. However, little research directly connects birth control pills to changes in muscle strength or injury prevention. While some believe hormonal birth control could affect injury risk, more evidence is needed to fully understand this connection.

In this trial, participants will wear a rigid splint to immobilize their wrist and hand continuously for 7 days to study the effects of immobilization on hand and wrist injuries.

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+