The Utilization of a Shoe Insert on Individuals With Unilateral Greater Trochanteric Pain Syndrome on Single Leg Stance, Biomechanics, and Pain Intensity
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- Mayo Clinic
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Victorian Institute Sport Assessment - Gluteal Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
- •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.
研究组 & 干预措施
Physical Therapy
This arm will undergo a standardized physical therapy protocol alone.
干预措施: Physical Therapy (Other)
Physical Therapy Plus Bilateral Shoe Insert
This arm will undergo a standardized physical therapy protocol with the addition of a neutral shoe insert bilaterally.
干预措施: Bilateral Shoe Insert (Device)
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.
干预措施: Unilateral neutral shoe insert (Device)
结局指标
主要结局
Victorian Institute Sport Assessment - Gluteal Questionnaire
时间窗: 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.
次要结局
- Visual Analog Scale for Pain(12 weeks)
- Global Rating of Change Scale(12 weeks)
- Isometric Hip Strength(12 weeks)
- Single Leg Stance for Pain(12 weeks)
- Single Leg Stance Biomechanics(12 weeks)