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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lateral Hip Pain; Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy; Gluteus Medius Muscle Strength
• Intervention / Treatment: Other: Physical Therapy; Device: Bilateral Shoe Insert; Device: Unilateral neutral shoe insert

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel McGurren, Doctorate of Physical Therapy; Phone Number: 4803426800; Email: mcgurren.daniel@mayo.edu
• Study Contact Backup: Name: Daniel Cooper, Doctorate in Physical Therapy; Phone Number: 4803426800; Email: cooper.daniel@mayo.edu

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85031
      • Mayo Clinic
      • Contact: Daniel Cooper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Physical Therapy; This arm will undergo a standardized physical therapy protocol alone.	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.
Sham Comparator: Physical Therapy Plus Bilateral Shoe Insert; This arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert bilaterally.	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 .
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Pain	The Visual Analog Scale for Pain is a measurement instrument that is used to quantify pain and discomfort by having an individual select a number on a Likert scale between 0 and 10, with 0 being no pain and 10 being the worst imaginable pain.	12 weeks
Global Rating of Change Scale	The GROC scale is a single-item instrument that asks the subject to rate the global or overall change and to what extent, if any, since initiating treatment. The GROC uses a Likert scale to indicate the direction of change (worsening or improving) and to what extent ("tiny" to "very great"). This scale is only administered after treatment has occurred and is not necessary prior to initiation of treatment.	12 weeks
Isometric Hip Strength	The subject will be placed supine with the uninvolved knee bent/foot on the table. The affected/other leg will be straight with knee fully extended with a gait belt anchored around the table and leg. A handheld dynamometer measuring in Newtons will be in between the gait belt and leg and the sensor will be placed 5 cm proximal to the lateral malleoli. The subject will be asked to abduct/lift the leg out to the side with as much force as possible against the dynamometer for 5 seconds. Two trials will be completed.	12 weeks
Single Leg Stance for Pain	Subject stands on test leg/one leg with an opposite fingertip on the wall for balance for up to 30 seconds. A positive test is a familiar pain. The examiner will note the subjects' pain rating via VAS. A neutral shoe insert will be added to the subjects' stock shoe insert and the test will be repeated again noting the pain rating to assess for any changes.	12 weeks
Single Leg Stance Biomechanics	Prior to the test, the examiner will place a total of six reflective markers on the patient. The markers will be placed on the bilateral acromion process of the scapula, the bilateral anterior superior iliac spine, and the bilateral second metatarsal head. A first photograph will be taken of the subject in a bilateral-limb stance. The participant will be asked to balance in a single-leg stance. Once the patient is in a single-leg stance, a photo will be taken every 0.5s for 2s. A second grouping of photos will be taken with the patient standing in a single-limb stance with the addition of a neutral heel lift. Retrospective analysis will be performed on these photos. The mean values of the angles will be calculated using the analysis software. The angles to be calculated include the trunk sway angle, the pelvic tilt angle, and the pelvic-on-femur angle.	12 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Greater trochanteric pain syndrome; Gluteus medius tendinopathy; Gluteus minimum tendinopathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Mental Disorders; Wounds and Injuries; Pathologic Processes; Joint Diseases; Disease; Tendon Injuries; Pain; Somatoform Disorders; Syndrome; Bursitis; Tendinopathy; Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: 24-011290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No