Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome

NCT ID: NCT03571971

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-17
• Study Completion Date: 2022-09-30

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.

Conditions

Hip Injuries; Pain; Therapy/Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Load modification education

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Standard exercise education

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Standard exercise education

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

Intervention Type: OTHER

Other Intervention Names

Load modification; Standard exercise

Eligibility Criteria

Inclusion 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

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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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation for Physical Therapy Research

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Stephanie Di Stasi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Di Stasi, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Jameson Crane Sports Medicine Institute

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2017H0450

Identifier Type: -

Identifier Source: org_study_id