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NOT YET RECRUITING
NCT06891001
NA

The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

Summary

We hypothesize that the addition of a unilateral neutral shoe insert combined with standard physical therapy (PT+SI) will have greater improvements in pain and function at 12 weeks and 6 months compared to physical therapy with sham inserts (PT+Sham) and physical therapy (PT) alone. In addition, we hypothesize that the addition of a neutral shoe insert in the involved limb will immediately improve biomechanics and pain with the single-leg stance test.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2027-01-01

Completion Date

2029-01-01

Last Updated

2026-01-22

Healthy Volunteers

No

Interventions

DEVICE

Unilateral neutral shoe insert

In the treatment group, subjects will undergo the addition of a neutral shoe insert to the involved lower extremity according to manufacturer guidelines at the initial visit. These subjects will also undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol.

DEVICE

Bilateral Shoe Insert

For subjects placed in the sham group, subjects will undergo the addition of a neutral shoe insert to both lower extremities according to manufacturer guidelines at the initial visit. These subjects will also undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol with guidelines .

OTHER

Physical Therapy

For subjects placed in the control group, subjects will undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol.

Locations (1)

Mayo Clinic

Glendale, Arizona, United States