Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome

NCT03571971 | Completed Results

• 1 other identifier: 2017H0450
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Global Rating of Change

  Participant perception of functional change, measured on an 11-point likert scale from 'very much worse' (minimum, worse outcome) to 'very much better' (maximum, better outcome). Results were then dichotomized into those who indicated they were at least 'moderately better' and those who did not.

  4 weeks after enrollment

• Change in Numeric Pain Rating Scale

  The Numeric Pain Rating Scale (NPRS) is a self-report survey of a participant's worst hip pain in the last week on an 11-point (0-10) scale, where 0 is no pain, 10 is the worst pain imaginable. The Change in NPRS is calculated by subtracting the baseline NPRS from the 4-week NPRS. A positive response to treatment was defined less than or equal to -2 (i.e., pain reduction by 2 points).

  at the time of enrollment and 4 weeks after enrollment

Secondary Outcomes (5)

• Change in Pain Self-Efficacy Questionnaire (PSEQ)

  at the time of enrollment and 4 weeks after enrollment

• Change in Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome (VISA-G)

  at the time of enrollment and 4 weeks after enrollment

• Change in Patient Reported Outcomes Measurement Information System (PROMIS) Bank v2.0 Physical Function

  at the time of enrollment and 4 weeks after enrollment

• Tegner Activity Level Scale

  4 weeks after enrollment

• Patient Acceptable Symptomatic State Question

  4 weeks after enrollment

Study Arms (2)

Load modification education

EXPERIMENTAL

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

Standard exercise education

ACTIVE COMPARATOR

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

Other: Standard exercise education

Interventions

Load modification education 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.

Also known as: Load modification

Load modification education

Standard exercise education OTHER

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

Also known as: Standard exercise

Standard exercise education

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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• 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

Sponsors & Collaborators

• Ohio State University: lead
• Foundation for Physical Therapy Research: collaborator

Study Sites (1)

Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

MeSH Terms

Conditions

Hip Injuries; Pain

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Stephanie Di Stasi, Principal Investigator
• Organization: The Ohio State University

stephanie.distasi@osumc.edu

614-293-4220

Study Officials

• Stephanie Di Stasi, PhD, PT

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 28, 2018
• Study Start: July 17, 2018
• Primary Completion: March 14, 2022
• Study Completion: September 30, 2022
• Last Updated: December 5, 2024
• Results First Posted: December 5, 2024

Record last verified: 2024-10

Locations

US (1)