Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Therapy | Active Comparator | This arm will undergo a standardized physical therapy protocol alone. |
|
| Physical Therapy Plus Bilateral Shoe Insert | Sham Comparator | This arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert bilaterally. |
|
| Physical Therapy Plus Unilateral Shoe Insert | Experimental | This arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert on the involved side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Global Rating of Change Scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel McGurren, Doctorate of Physical Therapy | Contact | 4803426800 | mcgurren.daniel@mayo.edu | |
| Daniel Cooper, Doctorate in Physical Therapy | Contact | 4803426800 | cooper.daniel@mayo.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Glendale | Arizona | 85031 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
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. |
| 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| Single Leg Stance Biomechanics | Prior to the test, the examiner will place a total of six reflective markers on the patient. The markers will be placed on the bilateral acromion process of the scapula, the bilateral anterior superior iliac spine, and the bilateral second metatarsal head. A first photograph will be taken of the subject in a bilateral-limb stance. The participant will be asked to balance in a single-leg stance. Once the patient is in a single-leg stance, a photo will be taken every 0.5s for 2s. A second grouping of photos will be taken with the patient standing in a single-limb stance with the addition of a neutral heel lift. Retrospective analysis will be performed on these photos. The mean values of the angles will be calculated using the analysis software. The angles to be calculated include the trunk sway angle, the pelvic tilt angle, and the pelvic-on-femur angle. | 12 weeks |
| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
Not provided
Not provided