Clinical trial NCT03571971: Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome
Official title: Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Injuries
Pain
Therapy/Rehabilitation
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy Research
First posted: 2018-06-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria: 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:

  1. \>/= 2/10 lateral hip pain reproduce with passive hip flexion, adduction, and external rotation (ie. FADER)
  2. lateral hip pain reproduced with resisted internal rotation in the passive hip flexion, adduction, and external rotation position (ie. FADER-R)
  3. lateral hip pain reproduce with overpressure into passive hip adduction in sidelying (ie. ADD)
  4. lateral hip pain reproduced with resisted hip abduction in the hip hip adducted position (ie. ADD-R)
  5. lateral hip pain reproduced with hip flexion, abduction, external rotation (ie. FABER)

     Exclusion Criteria:

  <!-- -->

  1. Any of the following treatments within the last 3 months:

     1. corticosteroid injection in the affected hip
     2. physical therapy or other skilled exercise intervention by a medical or rehabilitation professional
  2. 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

Primary outcomes:
measure: Global Rating of Change
timeFrame: 4 weeks after enrollment
measure: Change in Numeric Pain Rating Scale
timeFrame: at the time of enrollment and 4 weeks after enrollment
Secondary outcomes:
measure: Change in Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: at the time of enrollment and 4 weeks after enrollment
measure: Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G)
timeFrame: at the time of enrollment and 4 weeks after enrollment
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function
timeFrame: at the time of enrollment and 4 weeks after enrollment
measure: Tegner Activity Level Scale
timeFrame: 4 weeks after enrollment
measure: Patient Acceptable Symptomatic State Question
timeFrame: 4 weeks after enrollment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Jameson Crane Sports Medicine Institute
state: Ohio
Study officials:
affiliation: Ohio State University
name: Stephanie Di Stasi, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References: