Gluteus Medius Muscle StrengthNCT06891001
The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
A study testing Unilateral neutral shoe insert, Bilateral Shoe Insert and Physical Therapy in people with Gluteus Medius Muscle Strength and Lateral Hip Pain, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gluteus Medius Muscle Strength, Lateral Hip Pain, Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy
- What is being tested?
- Unilateral neutral shoe insert, Bilateral Shoe Insert and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 5 Oct 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gluteus Medius Muscle Strength, Lateral Hip Pain, Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy
- Being tested
- Unilateral neutral shoe insert, Bilateral Shoe Insert, Physical Therapy
- Keywords
- Gluteus medius tendinopathy, Gluteus minimum tendinopathy, Greater trochanteric pain syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral neutral shoe insertDevice
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 InsertDevice
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 TherapyOther
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 group | Role | What they receive |
|---|---|---|
| Physical Therapy | Active comparator | This arm will undergo a standardized physical therapy protocol alone. Receives: Other: Physical Therapy |
| 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. Receives: Device: Bilateral Shoe Insert |
| 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. Receives: Device: Unilateral neutral shoe insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (5)
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.
Measured: 12 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Jul 2027 (estimated)
- Primary completion5 Oct 2028 (estimated)
- Study completion5 Oct 2028 (estimated)
Why it stopped: No funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gluteus Medius Muscle StrengthStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel S. Cooper, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891001
- Sponsor's protocol ID
- 24-011290
- Status last verified
- Oct 2026
- First submitted
- 17 Mar 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
- ClinicalTrials.gov ID
- NCT06891001
- Acronym / sponsor ID
- 24-011290
- Conditions
- Gluteus Medius Muscle Strength, Lateral Hip Pain, Greater Trochanter Pain Syndrome, Gluteus Medius Tendinopathy, Gluteus Minimus Tendinopathy
- Keywords
- Gluteus medius tendinopathy, Gluteus minimum tendinopathy, Greater trochanteric pain syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 5 Oct 2028 (estimated)
- Study completion
- 5 Oct 2028 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Active comparator | Other: Physical TherapyThis arm will undergo a standardized physical therapy protocol alone. |
| Physical Therapy Plus Bilateral Shoe Insert | Sham comparator | Device: Bilateral Shoe InsertThis arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert bilaterally. |
| Physical Therapy Plus Unilateral Shoe Insert | Experimental | Device: Unilateral neutral shoe insertThis arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert on the involved side. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral neutral shoe insertIn 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. | Device | Physical Therapy Plus Unilateral Shoe Insert |
| Bilateral Shoe InsertFor 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 . | Device | Physical Therapy Plus Bilateral Shoe Insert |
| Physical TherapyFor subjects placed in the control group, subjects will undergo a once-weekly 12-week course of physical therapy according to the established standardized protocol. | Other | Physical Therapy |
Primary outcome
Victorian Institute Sport Assessment - Gluteal Questionnaire
Time frame: 12 weeks
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.
5 secondary outcomes
Visual Analog Scale for Pain
Time frame: 12 weeks
Global Rating of Change Scale
Time frame: 12 weeks
Isometric Hip Strength
Time frame: 12 weeks
Single Leg Stance for Pain
Time frame: 12 weeks
Single Leg Stance Biomechanics
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral neutral shoe insert, Bilateral Shoe Insert and Physical Therapy in people with Gluteus Medius Muscle Strength and Lateral Hip Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Victorian Institute Sport Assessment - Gluteal Questionnaire (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.