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Withdrawn
NCT06891001
The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
Conditions: Gluteus Medius Muscle Strength, Lateral Hip Pain, Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Sponsor: Mayo Clinic
Location: Mayo Clinic Glendale Arizona
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.
Source: ClinicalTrials.gov (NCT06891001). StuddyBuddy aggregates publicly available trial information.