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

Primary Purpose

Hip Injuries, Pain, Therapy/Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Load modification education
Standard exercise education
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jameson Crane Sports Medicine Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Load modification education

Standard exercise education

Arm Description

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.

Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.

Outcomes

Primary Outcome Measures

Global Rating of Change
Participant perception of functional change, measured on an 11-point likert scale
Change in Numeric Pain Rating Scale
Participant perception of best and worst hip pain in the last week, on an 11 point scale

Secondary Outcome Measures

Change in Pain Self-Efficacy Questionnaire (PSEQ)
10-question survey about confidence with activities of daily living, using a 7-point likert scale
Change in Victorian Institute of Sport Assessment for Greater trochanteric pain syndrome (VISA-G)
8 questions asking about severity of functional limitation based on the participant's hip pain
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function
Assesses physical function of participants using computerized adaptive testing techniques
Change in Tegner Activity Level Scale
Activity scale with 11 options ranging from complete disability to national elite level sports
Patient Acceptable Symptomatic State question
A single question (yes/no 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

Full Information

First Posted
June 18, 2018
Last Updated
January 13, 2023
Sponsor
Ohio State University
Collaborators
Foundation for Physical Therapy, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03571971
Brief Title
Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome
Acronym
GLAM
Official Title
Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 17, 2018 (Actual)
Primary Completion Date
March 14, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Foundation for Physical Therapy, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Injuries, Pain, Therapy/Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Load modification education
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard exercise education
Arm Type
Active Comparator
Arm Description
Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Intervention Type
Other
Intervention Name(s)
Load modification education
Other Intervention Name(s)
Load modification
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard exercise education
Other Intervention Name(s)
Standard exercise
Intervention Description
Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Primary Outcome Measure Information:
Title
Global Rating of Change
Description
Participant perception of functional change, measured on an 11-point likert scale
Time Frame
4 weeks after enrollment
Title
Change in Numeric Pain Rating Scale
Description
Participant perception of best and worst hip pain in the last week, on an 11 point scale
Time Frame
at the time of enrollment and 4 weeks after enrollment
Secondary Outcome Measure Information:
Title
Change in Pain Self-Efficacy Questionnaire (PSEQ)
Description
10-question survey about confidence with activities of daily living, using a 7-point likert scale
Time Frame
at the time of enrollment and 4 weeks after enrollment
Title
Change in Victorian Institute of Sport Assessment for Greater trochanteric pain syndrome (VISA-G)
Description
8 questions asking about severity of functional limitation based on the participant's hip pain
Time Frame
at the time of enrollment and 4 weeks after enrollment
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function
Description
Assesses physical function of participants using computerized adaptive testing techniques
Time Frame
at the time of enrollment and 4 weeks after enrollment
Title
Change in Tegner Activity Level Scale
Description
Activity scale with 11 options ranging from complete disability to national elite level sports
Time Frame
at the time of enrollment and 4 weeks after enrollment
Title
Patient Acceptable Symptomatic State question
Description
A single question (yes/no 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
Time Frame
4 weeks after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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: >/= 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Di Stasi, PhD, PT
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jameson Crane Sports Medicine Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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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Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome

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