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

NCT06891001 | Not Yet Recruiting

• 1 other identifier: 24-011290
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Gluteus medius tendinopathy; Gluteus minimum tendinopathy; Greater trochanteric pain syndrome

Outcome Measures

Primary Outcomes (1)

• Victorian Institute Sport Assessment - Gluteal Questionnaire

  The VISA-G is a self-reported scale to quantify disability associated with gluteal tendinopathy. The instrument is freely available, and scores range from 0-100, with 100 indicating no hip-related disability and 0 indicating fully disabled. The questionnaire includes eight items asking questions about usual pain (item 1), pain with tendon loading (items 2, 3, 4, and 6), difficulty moving after sitting (item 5), and activity participation (items 7 and 8). Item 8 asks the subject to choose one of 3 sections (A, B, or C) and check the appropriate response related to the ability to perform weight-bearing activities including walking, shopping, or running.

  12 weeks

Secondary Outcomes (5)

• Visual Analog Scale for Pain

  12 weeks

• Global Rating of Change Scale

  12 weeks

• Isometric Hip Strength

  12 weeks

• Single Leg Stance for Pain

  12 weeks

• Single Leg Stance Biomechanics

  12 weeks

Study Arms (3)

Physical Therapy

ACTIVE COMPARATOR

This arm will undergo a standardized physical therapy protocol alone.

Other: Physical Therapy

Physical Therapy Plus Bilateral Shoe Insert

SHAM COMPARATOR

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

Device: Bilateral Shoe Insert

Physical Therapy Plus Unilateral Shoe Insert

EXPERIMENTAL

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

Device: Unilateral neutral shoe insert

Interventions

Unilateral neutral shoe insert 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.

Physical Therapy Plus Unilateral Shoe Insert

Bilateral Shoe Insert 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 Bilateral Shoe Insert

Physical Therapy 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Glendale, Arizona, 85031, United States

Location

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Daniel McGurren, Doctorate of Physical Therapy

CONTACT

4803426800; mcgurren.daniel@mayo.edu

Daniel Cooper, Doctorate in Physical Therapy

CONTACT

4803426800; cooper.daniel@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 24, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (1)