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

NCT ID: NCT06891001

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-01
• Study Completion Date: 2029-01-01

Brief 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.

Conditions

Gluteus Medius Muscle Strength; Lateral Hip Pain; Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Physical Therapy

This arm will undergo a standardized physical therapy protocol alone.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

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.

Physical Therapy Plus Bilateral Shoe Insert

This arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert bilaterally.

Group Type: SHAM_COMPARATOR

Bilateral Shoe Insert

Intervention Type: DEVICE

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 .

Physical Therapy Plus Unilateral Shoe Insert

This arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert on the involved side.

Group Type: EXPERIMENTAL

Unilateral neutral shoe insert

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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 .

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects with a history of unilateral hip pain lasting more than three months.
• Subjects with a VAS pain score of at least 3/10 localized to the lateral hip.
• Subjects with pain with palpation to lateral hip.
• Subjects with pain with either resisted hip abduction in relative adduction testing position and/or single leg stance test

Exclusion Criteria

• Subjects wearing custom foot orthoses at the time of recruitment.
• Subjects who endorse current low back pain ≥ 3 on the NRS or lumbar radiculopathy
• Subjects with a medical history of spinal or lower limb surgery in the past 6 months.
• Subjects with a medical history of total joint replacement of hip, knee, or ankle on the symptomatic side
• Subjects who have had a corticosteroid injection at the hip within the last 12 months;
• Subjects demonstrating clinical signs and symptoms of intra-articular hip joint pathology with ≥ 3/10 groin pain including imaging confirmed significant labral tearing requiring surgery or osteoarthritis > 2 (mild) on Kellgren-Lawrence score on radiographs.
• Subjects previously diagnosed with systemic inflammatory conditions; active cancer/malignant tumors; or neurological conditions that would affect gait
• Subjects who have had physical therapy within the past 3 months for hip pain
• If subjects are unable to commit to 12 weeks of therapy with one supervised session weekly
• Subjects who have the intention to perform treatments outside of this study including, but not limited to, dry needling or acupuncture, extracorporeal shockwave, therapeutic ultrasound, a TENEX procedure, medication injection therapies, platelet-rich plasma injections, stem cell injections, and surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Daniel S. Cooper

Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic

Glendale, Arizona, United States

Countries

United States

Central Contacts

Daniel McGurren, Doctorate of Physical Therapy

Role: CONTACT

mcgurren.daniel@mayo.edu

4803426800

Daniel Cooper, Doctorate in Physical Therapy

Role: CONTACT

cooper.daniel@mayo.edu

4803426800

Facility Contacts

Daniel Cooper

Role: primary

Other Identifiers

24-011290

Identifier Type: -

Identifier Source: org_study_id