Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Global Rating of Change
研究概览
简要总结
Greater trochanteric pain syndrome (GTPS), or lateral hip pain, is associated with muscle weakness, altered movement patterns and painful daily activities. The disability associated with GTPS is comparable to end stage hip osteoarthritis, primarily affecting young and middle aged women. Few non-operative treatments have demonstrated long-term lasting or satisfactory results. For those who do improve, recurrence rates of pain and disability can be as high as 50%.
Gluteal tendinopathy is the most common condition associated with a GTPS diagnosis. High compressive loads of the gluteal tendons during common activities like walking, stair-climbing, and running are the theorized mechanism for GTPS. These compressive loads are exacerbated with postures and movement patterns that involve the lateral tilting of the pelvis or movement of the thigh across the midline of the body. There is recent evidence that load modification through education and exercise is superior to a corticosteroid injection for reducing pain in these patients. However, it is unknown whether the possible effects of the load modification program were due to exercise alone or the reduction in compressive loads. As current physical therapy interventions for GTPS commonly incorporate high load postures and exercise activities, there is an urgent need to compare outcomes of standard of care physical therapy to load modification.
The goal of this study is to evaluate the short-term effects of load modification education on pain and function in individuals with GTPS. Participants will be randomized to receive either standard exercise education or load modification education. Both groups will complete a series of questionnaires about their pain and function, and undergo a brief 2-dimensional assessment of their posture and movement. Between follow-up sessions, participants will be asked to respond to brief weekly online surveys to document their home program compliance, pain, and function. It is hypothesized that the group of participants receiving load modification will have the highest proportion of individuals with significant improvements in pain and function, and will demonstrate improved posture and movement.
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
- •Unilateral diagnosis of GTPS, as confirmed by physician using the following criteria:
- •Lateral hip pain, worst over greater trochanter, for >/= 3 months
- •Pain with palpation over greater trochanter
- •Average pain intensity of >/= 4/10 most days of the week
- •Lateral hip pain reproduced during a 30 second single leg stance, or at least one of the following positive tests:
- •>/= 2/10 lateral hip pain reproduce with passive hip flexion, adduction, and external rotation (ie. FADER)
- •lateral hip pain reproduced with resisted internal rotation in the passive hip flexion, adduction, and external rotation position (ie. FADER-R)
- •lateral hip pain reproduce with overpressure into passive hip adduction in sidelying (ie. ADD)
- •lateral hip pain reproduced with resisted hip abduction in the hip hip adducted position (ie. ADD-R)
- •lateral hip pain reproduced with hip flexion, abduction, external rotation (ie. FABER)
排除标准
- •Any of the following treatments within the last 3 months:
- •corticosteroid injection in the affected hip
- •physical therapy or other skilled exercise intervention by a medical or rehabilitation professional
- •Any of the following concomitant impairments or conditions:
- •a) Known or observed advanced spine, hip, knee, or ankle joint pathology, including: i. Spinal or lower extremity surgery within the last 6 months ii. Imaging data showing Kellgren Lawrence grade >/=2 in any lower extremity joint with concurrent complaint >/=2/10 most days of the week.
- •iii. Groin pain as the primary hip pain complaint >/=2/10 most days of the week.
- •iv. <90 degrees of active hip and knee flexion bilaterally v. <0 degrees of active ankle dorsiflexion
- •b) Systemic inflammatory diseases, or any systemic disease that affects the nervous or musculoskeletal system or uncontrolled diabetes, or active malignancy c) Individuals who cannot tolerate or should not assume the positions required for the exercises for any reason other than hip discomfort
结局指标
主要结局
Global Rating of Change
时间窗: 4 weeks after enrollment
Participant perception of functional change, measured on an 11-point likert scale from 'very much worse' (minimum, worse outcome) to 'very much better' (maximum, better outcome). Results were then dichotomized into those who indicated they were at least 'moderately better' and those who did not.
Change in Numeric Pain Rating Scale
时间窗: at the time of enrollment and 4 weeks after enrollment
The Numeric Pain Rating Scale (NPRS) is a self-report survey of a participant's worst hip pain in the last week on an 11-point (0-10) scale, where 0 is no pain, 10 is the worst pain imaginable. The Change in NPRS is calculated by subtracting the baseline NPRS from the 4-week NPRS. A positive response to treatment was defined less than or equal to -2 (i.e., pain reduction by 2 points).
次要结局
- Change in Pain Self-Efficacy Questionnaire (PSEQ)(at the time of enrollment and 4 weeks after enrollment)
- Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G)(at the time of enrollment and 4 weeks after enrollment)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function(at the time of enrollment and 4 weeks after enrollment)
- Patient Acceptable Symptomatic State Question(4 weeks after enrollment)
- Tegner Activity Level Scale(4 weeks after enrollment)
研究者
Stephanie Di Stasi
Associate Professor
Ohio State University