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NCT06891001 | NOT YET RECRUITING | Gluteus Medius Muscle Strength

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

Mayo Clinic

Information provided by (Responsible Party):

Daniel S. Cooper

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.

Condition or disease

Gluteus Medius Muscle Strength

Lateral Hip Pain

Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy

Intervention/treatment

Unilateral neutral shoe insert

Bilateral Shoe Insert

Physical Therapy

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : The Utilization of a Shoe Insert on Individuals with Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-01-01
Estimated Study Completion Date : 2027-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
The Utilization of a Shoe Insert on Individuals with Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity

Location Details

NCT06891001

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