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
• Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy
• Lateral Hip Pain

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Unilateral neutral shoe insert — DEVICE
  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.
• Bilateral Shoe Insert — DEVICE
  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 .
• Physical Therapy — OTHER
  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.

Study Details

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.

Key Dates

Start date

Jan 1, 2027

Status verified

Jan 2026

Primary completion

Jan 1, 2028

Completion

Jan 1, 2029

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Physical Therapy
  This arm will undergo a standardized physical therapy protocol alone.
• 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.
• 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.

Primary Outcome Measure

Victorian Institute Sport Assessment - Gluteal Questionnaire [ Time Frame: 12 weeks ]

Central Contacts

• Daniel McGurren, Doctorate of Physical Therapy
  4803426800
  [email protected]
• Daniel Cooper, Doctorate in Physical Therapy
  4803426800
  [email protected]

Locations (1)

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