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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Unilateral neutral shoe insert
DeviceIn 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
DeviceFor 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 interventionFor 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
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