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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: Physical TherapyActive comparator 1 intervention
Group B: Physical Therapy Plus Bilateral Shoe InsertSham comparator 1 intervention
Group C: Physical Therapy Plus Unilateral Shoe InsertExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Victorian Institute Sport Assessment - Gluteal Questionnaire

The VISA-G is a self-reported scale to quantify disability associated with gluteal tendinopathy. The instrument is freely available, and scores range from 0-100, with 100 indicating no hip-related disability and 0 indicating fully disabled. The questionnaire includes eight items asking questions about usual pain (item 1), pain with tendon loading (items 2, 3, 4, and 6), difficulty moving after sitting (item 5), and activity participation (items 7 and 8). Item 8 asks the subject to choose one of 3 sections (A, B, or C) and check the appropriate response related to the ability to perform weight-bearing activities including walking, shopping, or running.

Time frame
12 weeks

Secondary outcomes

1

Visual Analog Scale for Pain

The Visual Analog Scale for Pain is a measurement instrument that is used to quantify pain and discomfort by having an individual select a number on a Likert scale between 0 and 10, with 0 being no pain and 10 being the worst imaginable pain.

Time frame
12 weeks
2

Global Rating of Change Scale

The GROC scale is a single-item instrument that asks the subject to rate the global or overall change and to what extent, if any, since initiating treatment. The GROC uses a Likert scale to indicate the direction of change (worsening or improving) and to what extent ("tiny" to "very great"). This scale is only administered after treatment has occurred and is not necessary prior to initiation of treatment.

Time frame
12 weeks
3

Isometric Hip Strength

The subject will be placed supine with the uninvolved knee bent/foot on the table. The affected/other leg will be straight with knee fully extended with a gait belt anchored around the table and leg. A handheld dynamometer measuring in Newtons will be in between the gait belt and leg and the sensor will be placed 5 cm proximal to the lateral malleoli. The subject will be asked to abduct/lift the leg out to the side with as much force as possible against the dynamometer for 5 seconds. Two trials will be completed.

Time frame
12 weeks
4

Single Leg Stance for Pain

Subject stands on test leg/one leg with an opposite fingertip on the wall for balance for up to 30 seconds. A positive test is a familiar pain. The examiner will note the subjects' pain rating via VAS. A neutral shoe insert will be added to the subjects' stock shoe insert and the test will be repeated again noting the pain rating to assess for any changes.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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