Load Modification Versus Standard Exercise for Greater Trochanteric Pain Syndrome

Not Applicable

Completed

• Conditions: Hip Injuries; Therapy/Rehabilitation; Pain
• Interventions: Other: Standard exercise education; Other: Load modification education

• Registration Number: NCT03571971
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-06-18
• Study First Posted: 2018-06-28
• Study Start: 2018-07-17
• Primary Completion: 2022-03-14
• Study Completion: 2022-09-30
• Results First Submitted: 2023-09-27
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-18
• Last Update Submitted: 2024-10-18
• Results First Posted: 2024-12-05
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard exercise education	Standard exercise education	Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
Load modification education	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.

Primary Outcome Measures

Name	Time	Method
Global Rating of Change	4 weeks after enrollment	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.
Change in Numeric Pain Rating Scale	at the time of enrollment and 4 weeks after enrollment	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).

Secondary Outcome Measures

Name	Time	Method
Change in Pain Self-Efficacy Questionnaire (PSEQ)	at the time of enrollment and 4 weeks after enrollment	The Pain Self-Efficacy Questionnaire is a 10-question survey about confidence with activities of daily living, and each question uses a 7-point likert scale, where 0 represents "not at all confident" and 6 represents "completely confident." Answers to each of the 10 questions are summed to generate a total score. Higher scores represent a better outcome; the best score is 60, the worst score is 0. We used the change in PSEQ from the time of enrollment to 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	The Victorian Institute of Sport Assessment for Greater Trochanteric Pain Syndrome is a 8-question survey about perceived hip pain and associated functional limitations during various daily activities. Question 1 asks respondents about their usual hip pain severity, scored from 0-10 (1-unit intervals), with 0 represent the worst pain. Questions 2-7 have 5 options that are scored 0, 2, 5, 7, or 10 points, with 0's representing extreme difficulty or inability and 10's representing no difficulty with the activity. Question 8 requires respondents to choose one subsection (A, B, or C) that best corresponds with how their hip pain affects their exercise; the minimum score is 0, the maximum is 30. To calculate the total score, scores from each question are summed. Higher total scores represent a better outcome; the best score is 100, the worst score is 0. We used the change in VISA-G from the time of enrollment to 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	The Patient Reported Outcomes Measurement Information System Bank v2.0 Physical Function assesses self-reported physical function of respondents using computerized adaptive testing techniques. It uses responses to each item to calculate a T-score and it is recommended that scoring occur in REDCapTM or similar scoring service to calculate scores using response pattern scoring. The mean score for adults in the United States is 50 with a standard deviation of 10. Higher T-scores are associated with better function and lower T-scores are associated with worse physical function, and T-scores generally range from 20-80. We used the change in PROMIS-PF from the time of enrollment to 4 weeks after enrollment.
Patient Acceptable Symptomatic State Question	4 weeks after enrollment	The Patient Acceptable Symptomatic State is a single question (yes/no response) asking respondents whether or not they are satisfied with their current state, considering all daily activities, their level of pain, and perceived functional impairment. Selecting 'Yes' would indicate the respondent is satisfied with their current state, selecting 'No' would indicate the respondent is not satisfied with their current state.
Tegner Activity Level Scale	4 weeks after enrollment	Tegner Activity Level Scale is a self-report scale of physical activity. The scale has 11 categorical options ranging from complete disability/inactivity (0) to national elite-level sports (11). The best score is 11, indicating elite-level activity participation.

Trial Locations

Locations (1)

Jameson Crane Sports Medicine Institute; 🇺🇸 Columbus, Ohio, United States