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

Mayo Clinic

Status: Begins enrollment in 10 months

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

Treatments: Device: Bilateral Shoe Insert; Other: Physical Therapy; Device: Unilateral neutral shoe insert

Study type: Interventional

Funder types: Other

Identifiers

NCT06891001

24-011290

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Physical Therapy

Active Comparator group

Description:

This arm will undergo a standardized physical therapy protocol alone.

Treatment:

Other: Physical Therapy

Physical Therapy Plus Bilateral Shoe Insert

Sham Comparator group

Description:

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

Treatment:

Device: Bilateral Shoe Insert

Physical Therapy Plus Unilateral Shoe Insert

Experimental group

Description:

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

Treatment:

Device: Unilateral neutral shoe insert