Clinical trial NCT06891001: The Utilization of a Shoe Insert on Individuals with Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
Official title: The Utilization of a Shoe Insert on Individuals with Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Victorian Institute Sport Assessment - Gluteal Questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual Analog Scale for Pain
timeFrame: 12 weeks
measure: Global Rating of Change Scale
timeFrame: 12 weeks
measure: Isometric Hip Strength
timeFrame: 12 weeks
measure: Single Leg Stance for Pain
timeFrame: 12 weeks
measure: Single Leg Stance Biomechanics
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References: