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Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome (GLAM)

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ClinicalTrials.gov Identifier: NCT03571971
Recruitment Status : Recruiting
First Posted : June 28, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
Foundation for Physical Therapy, Inc.
Information provided by (Responsible Party):
Stephanie Di Stasi, Ohio State University

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.


Condition or disease Intervention/treatment Phase
Hip Injuries Pain Therapy/Rehabilitation Other: Load modification education Other: Standard exercise education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
Actual Study Start Date : July 17, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Load modification education
Load modification education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities, but will also include education on common daily postures and movement patterns that may increase load and stress on the muscles and tendons around the hip.
Other: Load modification education
Load modification education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities, but will also include education on common daily postures and movement patterns that may increase load and stress on the muscles and tendons around the hip.
Other Name: Load modification

Active Comparator: Standard exercise education
Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Other: Standard exercise education
Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Other Name: Standard exercise




Primary Outcome Measures :
  1. Global Rating of Change [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    Participant perception of functional change, measured on an 11-point likert scale

  2. Change in Numeric Pain Rating Scale [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    Participant perception of best and worst hip pain in the last week, on an 11 point scale


Secondary Outcome Measures :
  1. Change in frontal plane kinematics of the trunk, pelvis, hip, and knee during a single leg squat [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    2-dimensional video will be used to measure frontal plane angles and excursions of the trunk, pelvis, hip, and knee during a single leg squat

  2. Change in Pain Self-Efficacy Questionnaire (PSEQ) [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    10-question survey about confidence with activities of daily living, using a 7-point likert scale

  3. Change in Victorian Institute of Sport Assessment for Greater trochanteric pain syndrome (VISA-G) [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    8 questions asking about severity of functional limitation based on the participant's hip pain

  4. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    Assesses physical function of participants using computerized adaptive testing techniques

  5. Change in Tegner Activity Level Scale [ Time Frame: at the time of enrollment and 4 weeks after enrollment ]
    Activity scale with 11 options ranging from complete disability to national elite level sports

  6. Patient Acceptable Symptomatic State question [ Time Frame: 4 weeks after enrollment ]
    A single question (yes/not response) asking participants whether or not they are satisfied with their current state, considering all daily activities, their level of pain, and perceived functional impairment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571971


Contacts
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Contact: Stephanie Di Stasi, PhD, PT 614-685-9779 stephanie.distasi@osumc.edu
Contact: Lindsey Brown, DPT 614-685-9777 lindsey.brown@osumc.edu

Locations
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United States, Ohio
Jameson Crane Sports Medicine Institute Recruiting
Columbus, Ohio, United States, 43202
Contact: Stephanie Di Stasi, PT, PhD    614-685-9779    stephanie.distasi@osumc.edu   
Contact: Lindsey Brown, PT    6146859777    lindsey.brown@osumc.edu   
Principal Investigator: Stephanie Di Stasi, PT, PhD         
Sponsors and Collaborators
Ohio State University
Foundation for Physical Therapy, Inc.
Investigators
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Principal Investigator: Stephanie Di Stasi, PhD, PT Ohio State University

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Responsible Party: Stephanie Di Stasi, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03571971     History of Changes
Other Study ID Numbers: 2017H0450
First Posted: June 28, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: At this time, individual participant data (IPD) will be shared only with researchers listed on the funding associated with this project and the Institutional Review Board list of approved key personnel. Deidentified IPD will be made available upon request for purposes of manuscript review and submission. Deidentified IPD may be made available to individuals upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hip Injuries
Wounds and Injuries