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

• ClinicalTrials.gov Identifier: NCT03571971
• Recruitment Status: Recruiting
• First Posted: June 28, 2018
• Last Update Posted: September 22, 2021
• Sponsor: Ohio State University
• Collaborator: Foundation for Physical Therapy, Inc.
• Information provided by (Responsible Party): Stephanie Di Stasi, Ohio State University

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.

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

Study Design

• 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: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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

Outcome Measures

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 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
2. 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
3. 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
4. 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
5. 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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Stephanie Di Stasi, PhD, PT; 614-685-9779; stephanie.distasi@osumc.edu

Contact: Kathryn Martin, PT, DPT; kathryn.martin4@osumc.edu

Locations

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: Kathryn Martin, PT, DPT kathryn.martin4@osumc.edu

Principal Investigator: Stephanie Di Stasi, PT, PhD

Sub-Investigator: John Ryan, MD

Sub-Investigator: Lai Wei, PhD

Sub-Investigator: Kathryn Martin, PT, DPT

Sponsors and Collaborators

Ohio State University

Foundation for Physical Therapy, Inc.

Investigators

• Principal Investigator: Stephanie Di Stasi, PhD, PT; Ohio State University

More Information

• Responsible Party: Stephanie Di Stasi, Assistant Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT03571971
• Other Study ID Numbers: 2017H0450
• First Posted: June 28, 2018
• Last Update Posted: September 22, 2021
• Last Verified: September 2021

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.

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

Additional relevant MeSH terms:

Hip Injuries; Wounds and Injuries