Load Modification Versus Standard Exercise to Inform Treatment for Individuals With Greater Trochanteric Pain Syndrome
Phase: NA
Conditions: Hip Injuries, Pain, Therapy/Rehabilitation
Sponsor: Ohio State University

Study Title: Load ModiﬁcaƟon Versus Standard Exercise to Inform Treatment for Individuals With Greater 
Trochanteric Pain Syndrome.  
NCT: NCT03571971 
Date: January 31, 2022 

Load Modification Hip Study (2017H0450)               Version: 5 
PI: Stephanie Di Stasi Roewer 
IRB Approved: 1/31/2022 
 
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Approach: 
Overview: This pragmatic, feasibility randomized controlled trial (RCT) will consist of up to 64 adult 
women and men (ratio of approximately 4:1, respectively) between the ages of 18 and 70 who are diagnosed 
with unilateral greater trochanteric pain syndrome (GTPS) during their initial physician evaluation within 
the Jameson Crane Sports Medicine Institute physician clinics at The Ohio State University Wexner Medical 
Center (OSUWMC). All patients will have their standard clinical evaluation with their physician. The group of 
patients invited to participate in this study will be individuals who meet our clinical diagnostic criteria for GTPS 
who do not have systemic health or serious musculoskeletal disorders or recent treatment for their hip pain 
(Table 1). Members of the study team involved in recruitment and consenting will use a two-part process to 
ensure eligibility using the “Patient Screen Checklist” and the “Eligibility Criteria Checklist,” described in detail in 
the Standard Operating Procedures document. The baseline study visit will occur immediately following the 
standard clinical examination with the physician.  
 
Table 1. Eligibility Table 
 
FADER, flexion adduction external rotation; FABER, flexion abduction external rotation 
As part of the clinic-based testing for the study, participants will be asked to (1) complete online surveys with 
validated patient-reported questionnaires about their pain and function. The single-session of education and 
instruction (load modification vs standard exercise) will be performed by a licensed physical therapist 
immediately after the testing procedures are complete. Participants will undergo the same clinic-based testing 
protocol at the 4-week follow-up prior to their visit with the physician in the Jameson Crane Sports Medicine 
Institute at OSUWMC. For 4-weeks following the initial evaluation and clinic-based testing, participants will be 
asked to complete weekly online/telephone surveys to document their hip pain and function as well as their 
compliance with the prescribed home exercise program. Key variables of interest (Table 2) include the Global 
Rating of Change scale18 and the Numeric Pain Rating Scale18,33,34. The other secondary variables of interest 
will help us more completely assess the effect of the proposed program hip function questionnaires, overall 
function,35–37 activity level,38 and self-efficacy.39 
 
 
 
 
Table 2. Variables of Interest 

Load Modification Hip Study (2017H0450)               Version: 5 
PI: Stephanie Di Stasi Roewer 
IRB Approved: 1/31/2022 
 
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Primary VOIs 
Secondary VOIs 
Global Rating of Change (GROC) 
(Mellor 2016) 
Frontal plane kinematics of the trunk, pelvis, hip, and knee during a 
single leg squat 
Numeric Pain Rating Scale (NPRS) 
(Farrar 2010, Fearon 2017, Mellor 
2016) 
Victorian Institute of Sport Assessment for Greater trochanteric pain 
syndrome (VISA-G) (Fearon 2014) 
Pain Self-Efficacy Questionnaire (PSEQ) (Nicholas MK 2007) 
Patient Acceptable Symptomatic State question (PASS) (Levy 2016, 
Chalal 2015) 
Patient Reported Outcomes Measurement Information System 
(PROMIS) Bank v2.0 Physical Function 
Tegner Activity Level Scale (TALS) (Mohtadi 2012) 
 
A. Sample size estimation: 
To inform our sample size estimation for this feasibility randomized controlled trial, we used the available 
literature which reported a 7% treatment success rate at 4-weeks following a single, standard exercise session 
(ie. non-load modifying)6 and the hypothesized 70% treatment success rate following an 8-week to a supervised 
load modification program.18 Conservatively, we estimated that the standard exercise (SE) group and load 
modification (LM) group would have a 20% and 50% success rate, respectively. With one-side type I error=0.1, 
power=80%, and allocation ratio is 1:1, we will need 22 participants in each group (total N=44). We will 
recruit 64 individuals with GTPS to account for up to 30% attrition over the course of the study due to 
drop-out. To fully recruit the study after proper regulatory approval is in place and staff are trained, we anticipate 
a 15-month recruitment time-frame for the 60 participants. This factors in a recruitment rate of 5 participants per 
month (see Letters of Support/Collaboration), from an eligible 10 (minimum 50% recruitment rate).  
 
Recruitment and Informed Consent (Figure 1): Prior to enrollment, written informed consent will be 
obtained from all potential participants after information about the purpose, methods, and demands of the study 
is provided both verbally and in writing (via the consent documentation) to the participant. The participants for 
this trial will be recruited from the Jameson Crane Sports Medicine Institute physician clinics at OSUWMC during 
their on-site medical visit. Once the treating physician confirms GTPS diagnosis through our standardized and 
validated clinical examination process (Table 1, Inclusion Criteria),18,31 the study recruiter will then discuss the 
study opportunity with the patient and proceed with the consenting process when appropriate. 
 
All participants will be provided verbal and/or written information (depending on preference) detailing the 
purpose of the study, type of testing and treatment involved, and potential risks and benefits of participation. 
Participants will be given time to ask questions and determine their interest in participation without coercion. 
Patients will be informed during the recruiting process, that if they consent to study participation, they cannot 
receive a corticosteroid injection that day or during the 4 weeks of the trial. A 4-week follow-up visit to the 
physician is standard of care for patients with GTPS seen in the Jameson Crane Sports Medicine Institute. This 
allows physicians to evaluate the effects of common treatments like medication, injections, ‘wait and see’ advice, 
and/or physical therapy; at that time, they determine next step interventions based on the initial treatment 
response. Our research will work within this same 4-week ‘trial’ period during their regularly scheduled doctor’s 
visits to provide one of two different types of exercise education. 

Load Modification Hip Study (2017H0450)               Version: 5 
PI: Stephanie Di Stasi Roewer 
IRB Approved: 1/31/2022 
 
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Patients who refuse to forgo injections for 4 weeks will be 
excluded from the study. Individuals who, for medical reasons, cannot tolerate or should not assume the positions 
required for the exercises for any reason other than hip discomfort will be excluded. Patients must enroll on the 
same day as the visit with their physician in order to receive the intervention; however, they do not have to 
complete the REDCap questionnaires during that visit. All participants will have the option to complete their 
questionnaires via a unique link to their personal survey or verbally by phone; the online link be sent to them via 
email to be completed at their earliest convenience. The participants will be required to sign the IRB-approved 
consent and HIPAA forms prior to participation in the study. 
B. Randomization, concealed allocation, and blinding: A randomization list will be generated and secured 
with the study biostatistician prior to the start of the study. It will contain study-specific unique identifiers (ie. 
GTPS1, GTPS2, etc) and a binary code for treatment group (ie. 0 or 1). A copy of this list will be provided to the 
Sports Medicine Clinical Research Manager who provides administrative support to all clinical trials in the Sports 
Medicine Institute. The Manager will determine the group assignment (e.g. 0 = LM, 1 = SE) independent of the 
biostatistician and the PI. The PI will put together 30 concealed envelopes for each treatment group that contain 
the group assignment and the appropriate exercise program instructions (SE vs LM) and provide these to the 

Load Modification Hip Study (2017H0450)               Version: 5 
PI: Stephanie Di Stasi Roewer 
IRB Approved: 1/31/2022 
 
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Manager. The Manager will then label, seal, and place them in a drawer in the physician. The Manager will not 
be involved in the recruitment, testing, or analysis involved with this trial. She will be the only person with the 
UID, randomization order, and treatment allocation data all in one place. These data will be stored under lock 
and key in the private office of the Manager, and in a password-protected file, accessible only to the Manager.  
After consent, participants will proceed with testing by a blinded tester. Randomization and group 
allocation will occur immediately following testing. After testing, the tester will inform the treating physical 
therapist of group (e.g. 0 vs 1). The drawer with the concealed/sealed envelopes will be accessible to the treating 
physical therapist and the physicians. The treating physical therapist  will select the next available envelope from 
the appropriate group (0 vs 1) and proceed with the assigned treatment; only when she or he breaks the envelope 
seal will she or he know the group assignment (LM vs SE).  
 
C. Blinding: Investigators involved in the participant testing and statistical analysis of the outcome variables 
of interest will be blinded to group allocation. The treating physicians, physical therapist interventionists and 
patients cannot feasibly be blinded to treatment arm. Participants will not be informed of the study hypotheses 
and unblinded investigators will not share group allocation information with the blinded investigators. All 
references to group assignment in other research documentation (ie. REDCapTM, video data collection form) will 
be coded (ie. ‘0’ and ‘1’) to maintain blinding. One trained tester will consent and perform baseline and 4-week 
follow-up testing. At the 4-week follow-up, the physician will re-evaluate the participant with the clinical diagnostic 
criteria and discuss their compliance and response to the home exercise program. As is consistent with standard 
of care, the physician and patient will determine the next course of treatment. The treatment plan will be entered 
using custom coding (ie. ‘smart phrases’) to allow discrete data to be queried. Statistical analysis will be 
performed by the blinded study biostatistician with input from the PI (see Statistical Analysis Plan). After the 
physician finishes his/her visit with the participant, the tester will proceed with the 4-week follow-up testing and 
will remind the participant she or he is blinded to treatment and cannot receive any information about the group 
to which they have been assigned.  
 
D. Clinic-based testing: Baseline testing and treatment will occur in the clinic, immediately following the 
physician evaluation and confirmation of GTPS diagnosis, for all patients who consent to participate in the study. 
The clinic-based testing sessions will occur at baseline (immediately after randomization) and at the 4-week 
clinical visit by a blinded tester. These testing sessions will take about 10 minutes for the questionnaires. Clinic-
based testing will include patient-reported questionnaires using Research Electronic Data Capture (REDCapTM) 
survey. REDCapTM is a secure, web-based application that supports data capture, auditing, and exporting40 to 
gather baseline data with regard to their pain and level of function41 and is hosted at The Ohio State University. 
Participants will be given the option to complete the survey on either our research handheld tablet (iPad) or 
laptop or desktop provided by the researcher.  
 
E. 
Intervention: The single physical therapy educational and instructional session will occur at baseline, 
immediately following the clinic-based testing. This session will be administered by the unblinded physical 
therapist interventionists who is trained to administer these protocols. Participants will receive either (1) 
standard exercise education and instruction (SE) or (2) load modification education and instruction (LM), 
based on their treatment group randomization. Standard exercise education includes exercises currently 
prescribed by physical therapists, like stretching and strengthening activities. Participants randomized to the load 
modification group will undergo approximately 5 additional minutes of education and instruction about their 
posture and movement modifications and will also be provided an information sheet with text and pictures (see 
Appendix: Supplements). Both groups will be instructed to perform the home exercise program once per day, 
performing Level 1 activities for the first two weeks and Level 2 activities for the last two weeks. (see Appendix. 
Supplements - Home exercise programs for both groups). Both groups will receive handouts with pictures and 
detailed instructions for each of their exercises.  
a. Home exercise program (HEP): Both protocols were modelled after current literature for a standard 
lower extremity exercise program for GTPS and a load modification program. The load modification program 
from Mellor and colleagues (2016) was further adapted to include exercise dosage shown to be effective in 

Load Modification Hip Study (2017H0450)               Version: 5 
PI: Stephanie Di Stasi Roewer 
IRB Approved: 1/31/2022 
 
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patellar tendinopathy trials.29,30 The HEP will be instructed and guided by the physical therapist, in combination 
with practice by the patient, and demonstration by the therapist, if needed. It is expected that program instruction 
will take about 15-20 minutes in both groups and that the home programs themselves will take between 15-20 
minutes. The physical therapist will provide standardized cueing to optimize technique. Participants will be 
provided opportunities to ask questions during the session and provided a written home program with text and 
pictures for the patient to follow. These instructions, including the pictures will be made available online through 
REDCapTM, along with instructional videos to provide the participant an additional resource to clarify technique. 
b. Activity modifications instructions for the load modification group: This instruction will take 
approximately 5 additional minutes based on our use of this handout in our physical therapy clinic with patients 
with GTPS for the past 2 years.  
i. 
Posture and movement handouts: The physical therapist will share the handout (Appendix 2. 
Supplements – Lateral Hip Pain Activity Modifications) with the participant, asking them to identify any of 
the movements or postures (ie. sitting with legs crossed, iliotibial band stretching) that are common to 
their daily activities. Patients will be educated as to how each contributes to increased pressure on the 
lateral structures of hip and can cause pain. The physical therapist will review, demonstrate, and provide 
feedback on all items relevant to the participants’ daily routine. 
ii. 
Using pain as a load modification guide: Participants in the load modification group will be 
instructed not to exceed 5 out of 10 on the NPRS during the exercises, and proceed with training as long 
as this pain intensity during exercise does not increase their pain in within the next 24 hours.13  
iii. 
Changes to activity level: participants in the load modification group who report >5/10 pain with 
exercise that does not change or is worse the next day will be advised to reduce their physical exercise 
activity (ie. walking, hiking, running).13 Participants in the load modification group will also be instructed 
to modify activity level as needed to avoid increasing pain or stiffness each week. Participants 
randomized to the standard exercise group will be instructed to avoid the painful physical exercise activity 
for the duration of the 4-week program (ie. “If it hurts, don’t continue to do it. Focus on these few exercises 
for the 4 weeks). Activity level will be monitored using the Tegner Activity Level Scale on a weekly basis 
over the 4-week intervention.43 
 
F. Weekly online/telephone surveys: Participants will be asked to complete a REDCapTM survey (Appendix 
2. Supplements – Weekly Survey) each week until their follow-up visit to the Jameson Crane Sports Medicine 
Institute for study testing and their clinical visit. This weekly survey will include the GROC, the NPRS, and home 
exercise program compliance questions. It will also include questions about any treatment they have received 
or injuries they have had that may affect the outcomes of interest. 
 
Though not the primary focus of this feasibility trial, we will invite all participants to complete follow-up 
REDCapTM surveys at 3 and 6 months post initial intervention to gather information about current pain level, 
function, and activity level. Participants will not be asked to complete any home exercise program compliance 
data or report changes to their care or any new injuries. With IRB approval, we will obtain information regarding 
subsequent treatments and procedures from the participants’ electronic health record with the goal of providing 
us relevant preliminary data to inform the variables of interest for the future clinical trial.  
 
Safety stopping rules:  
We anticipate a small proportion of the participants in each group (<15%) may experience an increase in 
symptoms with participation in this trial. Thus, we will employ safety stopping rules as described in detail in the 
Human Subjects document.  
 
G. Data management  
a. Personal Health Information (PHI): The participant’s medical chart information, REDCapTM data, and 
2D videos all contain PHI. All PHI relevant to the patient’s hip condition is collected and maintained within the 
participant’s medical chart (IHIS). These PHI data are accessible only by the approved, unblinded researchers 
who have undergone IHIS training within OSUWMC. REDCapTM data is encrypted and sits behind OSUWMC’s 
firewall. Data will be coded with a unique-identifier (UID) and the file which links the UID to the patient’s personal 

Load Modification Hip Study (2017H0450)               Version: 5 
PI: Stephanie Di Stasi Roewer 
IRB Approved: 1/31/2022 
 
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health information (PHI) will be kept on a secure server behind the OSUWMC firewall and password-protected. 
Only research team members with user privileges (approved by the PI) have access to this database via 
username and password. When REDCapTM data are exported to files for analysis, they will be exported without 
PHI data unless the analysis requires it and the PI approves. These files will be maintained on our secure 
laboratory server behind OSUWMC firewall; it is accessible only to members of the research team. 2D video will 
be collected with a GoPro. All videos will be transferred within 24 hours from the GoPro to the (1) laboratory 
server within a separate, password-protected folder on our server, accessible only to investigators blinded to 
treatment group, and (2) REDCap. 2D videos will be deleted from the GoPro after successful transfer to the 
server. As part of the 2D video collection, we will use REDCap to document NPRS scores with the matching 
video recordings with each task.  
Post collection data storage and analysis: A blinded study team member will be responsible for 2D video quality 
control and creating trial clips for subsequent analysis. Video analysis will begin after the last participant 
completes their 4-week follow-up. These data will be used to determine measurement variability (intraclass 
correlation coefficients, standard error of the measurement, and minimal detectable change values) and provide 
information with regard to changes in movement patterns as a result of program participation. Frontal plane 
kinematics (peaks and excursions) of the trunk, pelvis, hip, and knee will be calculated (Kinovea version 0.8.15) 
for each task. Analysis will include the double and single leg static starting postures and peak frontal plane 
motion (as identified using the joint position tracking function). Lines will be drawn through the long axes of the 
bones for the shank and thigh, through the ASIS for the pelvis, and from the sternum to the midpoint of the ASIS 
line (Figure 2). Horizontal and vertical ‘lab axes’ will be applied to the image to allow calculations relative to pure 
horizontal (ie. pelvic drop) and pure vertical (ie. trunk lean). Angles will also be calculated with respect to the 
proximal segment.  
Statistical analysis plan: 
An intention to treat approach is planned for all analyses, using all participants who were randomized 
who have available data at 4 week follow-up. Where appropriate, normality will be assessed and non-parametric 
approaches will be used when assumptions are violated. Demographics and clinical characteristics (ie. age, sex 
distribution, BMI, baseline pain scores, etc) will be summarized for SE and LM groups, respectively, and 
compared between the groups using two-sample t-test for continuous outcomes or Fisher’s exact test for discrete 
outcomes.  
To evaluate the effect of treatment group allocation on dichotomized treatment success (Aim 1, 
Hypothesis 1), defined as either: 1) at least ‘moderately better’ on the Global Rating of Change scale or 2) ≥2 
point decrease on the Numeric Pain Rating Scale, we will use Fisher’s exact test to compare the success rate 
between SE and LM group. Frontal plane kinematics are a secondary variable of interest (Aim 1, Hypothesis 2). 
With the available 2D data set, we will compare change scores between groups using independent t-tests and/or 
effect sizes. These data may serve as preliminary data for future grant applications. 
To evaluate study retention rates and treatment adherence (Aim 2) we will use descriptive statistics. We 
will calculate the number of participants in each treatment group who report completing the home program “most 
(4+) days of the week” and “mostly as directed” on each of the four (4) follow-up REDCapTM surveys.  The 
retention rate and compliance rate will be calculated with 95% confidence interval using exact binomial for each 
treatment at each follow-up. 
 
H. Feasibility: We will evaluate the feasibility of a future clinical trial to determine the efficacy of load modification 
exercises and education in improving post-operative function in patients with GTPS by quantifying:  
1. The proportion of recruited participants from the total number (a) screened and (b) eligible  
2. Participant adherence as measured by: (1) number of weekly surveys completed (ie. number of surveys 
completed/total number of surveys, (2) weekly home exercise program compliance (self-reported) over 
the duration of the study, (3) participation retention/attendance at the 4-week follow-up session, and (5) 
reasons for drop-out and when it occurred (e.g. participant moved out of the area prior to 4-week follow-
up) 
 
I. Potential Problems/Alternative Strategies 

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IRB Approved: 1/31/2022 
 
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1. MRI will not be used to confirm gluteal tendinopathy. Grimaldi and colleagues (2017)31 performed a 
diagnostic utility study of 65 individuals with GTPS that showed pain during a 30 second single limb 
stance was strongly associated with MRI-confirmed gluteal tendinopathy (+LR = 12.2). Importantly, 
literature also confirms the high prevalence of MRI-confirmed gluteal tendinopathy in asymptomatic 
individuals,31,44,45 highlighting the absence of a strong association between imaging-identified tissue 
pathology and the clinical syndrome of GTPS. For the aims of this study, this and other validated clinical 
tests will be used to identify individuals with GTPS. We accept that a small, but insignificant proportion of 
enrolled participants with clinical indicators of GTPS may not have radiologically-confirmed gluteal 
tendinopathy. We do not anticipate this will affect the results of this study. 
2. Treatment success is no different between groups (ie. equally effective or ineffective). Compressive 
forces of the gluteal tendons onto the greater trochanter increase with poor frontal plane control of the 
hip and pelvis. If is unexpected that modification of these loads through postural and activity modifications 
and targeted exercises would not be significantly more effective than exercises that disregard this 
mechanism. However, the lack of effect may indicate the need for more frequent, supervised intervention. 
If both groups demonstrate equal success, these data would still support our proposed model of a 
‘physical therapy first’ approach. 
3. Hip abduction weakness is a clinical feature of GTPS and strength gains may be a critical metric of 
program success. Hip abduction strength will not be measured, but is associated with poor frontal plane 
pelvic and hip control during a squatting task. We concede that movement changes may be associated 
with strength improvements, but contend that improvements in strength do not ubiquitously translate to 
better movement. Thus, we opted to evaluate movement in this preliminary efficacy and feasibility trial. 
4. We may be underpowered to see an effect over the 4 week period. The 4-week follow-up period is 
consistent with clinical practice and the approach to previous studies6,22 evaluating the effect of 
corticosteroid injections. Further, we modelled our treatment approach on robustly designed RCTs14,29,30 
in other lower extremity tendinopathy that suggest this 4-week period is enough time to see an effect if 
one exists. 
 
Benchmarks for success 
The first benchmark will be full participant enrollment (N=60) within the first 15 months of the study The second 
benchmark will be to maintain 80% 4-week follow-up retention rate; we will assess this at the midpoint of 
recruitment and testing (N=30) and again at final testing of all participants. Finally, our third benchmark of 
success will be to have <15% adverse events rates as defined per GROC (see Protection of Human Subjects 
section) 
 
 
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