Mechanisms of a Dynamic Stability Approach
Phase: PHASE2
Conditions: Thumb Carpometacarpal Osteoarthritis, Thumb Basal Joint Osteoarthritis
Sponsor: University of Minnesota

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
VERSION DATE: 05/25/2023 
 
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Template Revised On: 11/1/2021 
 
 
ANCILLARY REVIEWS 
 
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n 
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e/ 
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PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
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nucleic acids, toxins, or 
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MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
VERSION DATE: 05/25/2023 
 
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PROTOCOL COVER PAGE 
 
 
Protocol Title 
Mechanisms of a Dynamic Stability Approach 
Principal 
Investigator/Facu
lty Advisor 
Name: Corey McGee 
Department: Occupational Therapy 
Telephone Number: 952-607-6387 
Email Address: mcge0062@umn.edu 
Student 
Investigator 
N/A 
Scientific 
Assessment 
Nationally-based, federal funding organizations 
IND/IDE # (if 
applicable) 
N/A 
IND/IDE Holder 
N/A 
Investigational 
Drug Services # 
(if applicable) 
N/A 
Version 
Number/Date: 
Version 4; 05/25/2023 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
VERSION DATE: 05/25/2023 
 
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REVISION HISTORY 
 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent 
Change? 
1 
12/20/2022 
Changing fluoroscopic methods to 
CAT scans and location of imaging 
to the Center for Clinical Imaging 
Research, U of MN 
Yes 
1.1 
1/22/2023 
Removed 12 week assessment 
and extended treatment period 
to 8 weeks and 1st follow up to 9 
weeks. This addressed 
concerns of radiation exposure 
and recent issues with lower 
interventionist staffing. 
Yes 
2 
4/11/2023 
Added information exchange 
data to the ancillary review grid. 
The use of BPIC is already 
explicitly stated throughout the 
application. We just failed to 
acknowledge this in the 
ancillary review grid. 
No 
3. 
5/25/23 
Amended recruitment efforts to 
include the BPIC/FRA mailing 
service. Composed an invitation 
letter to use for recruitment.  
No 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
VERSION DATE: 05/25/2023 
 
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Table of Contents 
 
1.0 
Objectives ............................................................................................................ 7 
2.0 
Background ......................................................................................................... 8 
3.0 
Study Endpoints/Events/Outcomes ................................................................... 10 
4.0 
Study Intervention(s)/Investigational Agent(s) ................................................... 10 
5.0 
Procedures Involved .......................................................................................... 11 
6.0 
Data and Specimen Banking ............................................................................. 14 
7.0 
Sharing of Results with Participants .................................................................. 14 
8.0 
Study Population ............................................................................................... 15 
9.0 
Vulnerable Populations ...................................................................................... 16 
10.0 Local Number of Participants ............................................................................. 18 
11.0 Local Recruitment Methods ............................................................................... 18 
12.0 Withdrawal of Participants ................................................................................. 19 
13.0 Risks to Participants .......................................................................................... 21 
14.0 Potential Benefits to Participants ....................................................................... 21 
15.0 Statistical Considerations .................................................................................. 21 
16.0 Health Information and Privacy Compliance ...................................................... 22 
17.0 Confidentiality .................................................................................................... 25 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................. 26 
19.0 Provisions to Protect the Privacy Interests of Participants ................................. 27 
20.0 Compensation for Research-Related Injury ....................................................... 27 
21.0 Consent Process ............................................................................................... 27 
22.0 Setting ............................................................................................................... 28 
23.0 Multi-Site Research ........................................................................................... 28 
24.0 Coordinating Center Research .......................................................................... 28 
25.0 Resources Available .......................................................................................... 28 
26.0 References ........................................................................................................ 29 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
VERSION DATE: 05/25/2023 
 
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ABBREVIATIONS/DEFINITIONS 
• 
DS = dynamic stability exercises 
• 
CMC=Carpometacarpal  
• 
OA=Osteoarthritis  
• 
PI=principal investigator 
• 
Subluxation=incomplete joint dislocation 
• 
SC = Standard Care 
• 
DS = Dynamic Stability 
• 
OP = Opponens Pollicis Muscle 
• 
FDI = First Dorsal Interosseus Muscle  
• 
MC = Metacarpal  
• 
CTSI = Clinical Translational Science Institute 
• 
EMR = Electronic Medical Record  
• 
NERS = Non Employee Research Staff 
• 
NIH = National Institute of Health  
• 
CRF = Case Report Form 
 
 
 
 
 
 
 
 
 

MEDICAL PROTOCOL (HRP-590) 
PROTOCOL TITLE: Mechanisms of a Dynamic Stability Approach 
 
VERSION DATE: 05/25/2023 
 
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1.0 
Objectives 
1.1 Purpose:  
Arthritis is our nation’s most common cause of disability1 and an estimated 25.6 million U.S. 
residents are affected by osteoarthritis (OA) of the hand.2 Thumb carpometacarpal (CMC) joint 
OA is the most common and disabling form of symptomatic hand OA.3 Symptoms and 
sequelae associated with thumb CMC OA include acute and chronic pain, grip and pinch 
strength weakness, reduced joint mobility, and difficulty carrying out common manual tasks.4 
Factors associated with the onset of thumb CMC OA include joint instability and concurrent 
misalignment and radiographic changes in these factors predict diminished hand function.5 
Non-operative approaches to reducing joint stress and symptomology are the first course of 
treatment for thumb CMC OA and standard care has taken the form of splint-wear and 
instruction on joint protection when completing manual tasks. Recently, the study of exercise 
as conservative treatment for hand OA has been recommended6 and a novel exercise program 
designed by an occupational therapist, referred to as the “dynamic stability” (DS) program7, has 
been adopted by some rehabilitation therapists and recommended by their surgeon 
counterparts. The DS program, at its core, aims to reduce thumb CMC instability through 
strengthening select muscles known to instantaneously reduce joint instability in the thumb.8  
 
Preliminary retrospective evidence suggests patients who participated in the DS program have 
better pain and disability outcomes than those who received standard care alone.9,10 However, 
major gaps in evidence for DS remain. Although evidence suggests that surgically stabilizing 
the thumb CMC improves hand function11, the hypothesized sustained stabilizing effects of the 
DS exercise program have not been tested in prospective research. It is important to know 
whether a six week course of a DS program can reduce thumb instability and whether these 
benefits are possible for patients with a range of CMC OA severity. Additionally, because the 
gold standard of evaluating thumb instability is not within the scope of practice of rehabilitation 
scientists and therapists, they are limited in their abilities to visualize thumb CMC joint 
mechanics when treating and when evaluating response of treatment. Rehabilitation therapists 
and scientists can, however, be certified in musculoskeletal sonography and sonographic 
methods can be used to quantify thumb CMC alignment.12 However, the agreement between 
sonographic and fluoroscopic or computerized tomography (gold standard) measures for 
assessing thumb CMC instability is unknown and must first be established.  
 
The long term goal of my research is to help mitigate the pain and disability experienced by 
persons with upper limb musculoskeletal disorders through non-invasive and non-
pharmacological approaches. The proposed research aims to prospectively evaluate the 
impact of DS exercises on the thumb instability in persons with thumb CMC osteoarthritis. My 
training plan supports this long-range goal by providing me the background needed to measure 
and/or interpret the outcomes of interest and carry out a single-arm intervention study.  
 
We expect, in part, to achieve our long term and training plan objectives by pursuit of these 
two specific aims:  
 
1. To describe changes in radiographic thumb CMC joint misalignment following a 6-
week clinic-based dynamic stability exercise program. Fifty patients will be enrolled in a 
prospective pre-post interventional study of a 8-week clinic-based dynamic stability program 
and will undergo computerized tomography (CT) measurements   before treatment, and upon 
completion of the program (9 weeks). The primary outcome will be change in CMC subluxation 
in cm from pre-treatment to post-treatment at 9 weeks.  

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1a. To describe the influence of arthritis staging on response to treatment. 
Through the use of a stratified sampling strategy we will seek to enroll equal numbers of 
participants with Eaton Stages 1, 2, and 3 (16-17 participants per strata). Response to 
intervention will be adjusted based on baseline staging via regression.  
1b. To gather preliminary data on treatment adherence and self-reported 
disability for future use when planning a comparative effectiveness trial. 
 
2. To evaluate the accuracy of ultrasound compared with CT (reference standard) for 
quantifying thumb CMC subluxation. Up to 50 participants will undergo  ultrasound (by Dr. 
McGee) during baseline and 9 week CT assessments.. Agreement of ultrasound and CT 
measurements (cm of subluxation) will be assessed by Bland-Altman method. 
 
The proposed study directly aligns with the Centers for Disease Control’s National Public 
Health Agenda for Osteoarthritis12 priorities, which promote evidence-based interventions that 
address self-management and physical activity. The proposed study is innovative because it 
will bring together an interprofessional team of health researchers to prospectively evaluate the 
effects of an exercise-based approach to self-management on change in the instability 
believed to contribute to the onset and progression thumb CMC OA. Additionally, should 
sonography be a suitable proxy for CT assessment of thumb CMC alignment, rehabilitation 
therapists will be better equipped to practice ‘precision’ rehabilitation in this population with 
improved outcomes to follow. Lastly, this project will serve as the foundation for my training 
plan, which will prepare me to design rigorous prospective trials to test the effectiveness of this 
program relative to traditional approaches 
2.0 
Background 
2.1 Significance of Research Question/Purpose:   
The thumb, accounting for 50% of hand function,13 is estimated to be afflicted by OA in 68% of 
adults who are 70 or more years of age.3 Thumb CMC joint OA is the single most common and 
symptomatic form of hand OA and is a substantial source of hand dysfunction.14,15,16 The 
precision, power, and mobility demanded from the thumb to perform precision tasks and grasp 
makes thumb CMC OA particularly debilitating.17 Joint hypermobility is thought to be a major 
etiological factor in the development of thumb OA. An incomplete dislocation of the joint (i.e., 
subluxation) follows this laxity and results in an incongruent joint and subsequently the 
development of OA.18,19 
While surgical approximation of this subluxation results in grip/pinch strength which is 
commiserate with the patient’s unaffected hand,11 it involves invasive ligament reconstruction 
and there is emerging evidence to suggest that exercise may also have a stabilizing 
effect.8,20,21 
Non-operative approaches to reducing joint stress and symptomology are the recommended 
first line of intervention for thumb CMC OA.15 Yet, the recently published results from a survey 
study revealed that only 21% of clients with CMC OA reporting received non-pharmacological 
treatment (i.e., rehabilitation) before a referral to surgical consultation.22 Additionally, recent 
findings suggest that hand surgeons are less likely than other providers to offer non-surgical 
options for treatment23 yet, in a recent study of the outcomes of 701 rehabilitation patients with 
CMC OA, only 15% went on to require surgery at a 2 year follow-up.24 
Historically, non-operative treatment has standardly taken the form of occupational or physical 
therapy and involves wearing a splint and being taught how to protect the joint during daily 

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activities.11 More recently, the European League against Rheumatism’s task force on the 
management of hand osteoarthritis recommended that studies be conducted to “determine the 
most appropriate form or combination of exercise for the different subsets of hand arthritis.”25 In 
response to this call, researchers have published exercises that are based on studies of joint 
biomechanics26 and are intended to address joint instability but were not grounded in outcome 
studies. In a retrospective cohort study, Skye, McGee, Geneva, and O’Brien27 reported 
clinically meaningful reductions in disability and pain in response to these “Dynamic Stability”7 
exercises when combined with standard care. 
Wouters et al.16 took these findings one step further and conducted a retrospective ‘propensity 
score matching’ study where the disability and symptomology of those receiving standard care 
were compared to those who received dynamic stability (DS) exercises in addition to standard 
care (SC). These authors reported that, at 6 weeks, pain outcomes were superior in the 
DS+SC group and at 3 months, both pain and disability outcomes were superior. 
Although these retrospective studies describe significant and clinically meaningful reductions in 
osteoarthritic symptomology and self-reported disability, they do not evaluate for any changes 
in joint mechanics associated with the condition. Changes to the aforementioned subluxation 
must be quantified in order to test assumptions that these exercises alter joint mechanics. 
Moreover, these retrospective studies and their findings lack the rigor of a prospective trial. 
Prospective trials are needed to investigate the added benefit of dynamic stability exercises 
relative to standard rehabilitation and should include the study of joint mechanics in addition to 
measures of symptomology and disability. 
We propose a set of targeted exercises for persons with osteoarthritic thumb CMC joints15 that 
are grounded in theory, thumb biomechanics research,17,18 and recent validation studies.19-21 
This “dynamic stability” program focuses on the neuromuscular/strength training of select 
thumb muscles believed to restore the joint mechanics of the CMC. In this thumb CMC 
dynamic stability (DS) program, the opponens pollicis (OP) and the first dorsal interosseous 
(FDI) thumb muscles are strengthened in order to theoretically center the thumb metacarpal 
(MC) on its fulcrum, the trapezium bone. The ability of these muscles to instantaneously reduce 
a subluxated thumb CMC joint has been validated in cadaveric22,20 and fluoroscopic studies of 
non-arthritic thumbs.19 To date, however, sustained in-vivo mechanical benefits have not yet 
been investigated among persons with thumb OA who have participated in this intervention 
program. 
While fluoroscopic or computerized tomography (CT) measures of joint subluxation are the 
gold standard and should be used as a measure of the thumb CMC’s mechanical response to 
the DS program, due to licensure issues, rehabilitation therapists cannot use such methods to 
evaluate summative or ‘real-time’ changes in joint mechanics that occur in response to 
treatment. Sonography, unlike fluoroscopy or CT, does not omit ionizing radiation, can be used 
to quantify thumb subluxation,12 and rehabilitation therapists can be certified to use 
musculoskeletal sonography. However, the agreement between it and the gold standard must 
first be established before it can be used by rehabilitation therapists and scientists as a safe 
alternative for measurement of thumb instability. 
  
 
2.2 Preliminary Data:   
The proposed study builds on my recent work.8 In this study, we used a non-invasive 
manipulation of the thumb CMC joint and evaluated the instantaneous effect of the maximum 

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VERSION DATE: 05/25/2023 
 
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voluntary contraction of the FDI muscle on thumb CMC joint subluxation in 32 non-arthritic 
hands. The findings illustrated a significantly large effect of FDI loading on subluxation 
[t(31)=10.6(p<.001), d= 2.70] with maximum FDI strength significantly explaining 39% of the 
variance in the subluxation response. Prior to this investigation, none had investigated the 
radiographic in-vivo mechanics of the thumb CMC joint during periods of targeted muscle 
activity as a means of testing the stabilizing effects of exercise on a subluxated thumb joint. 
This study offers data from which we can draw conclusions on the sustained effects of the 
intervention. 
2.3 
Existing Literature:  See section 2.1 
3.0 
Study Endpoints/Events/Outcomes 
3.1 
Primary Endpoint/Event/Outcome: CT assessments before treatment, and upon 
completion of the program (9 weeks). The primary outcome will be change in CMC 
subluxation in cm from pre-treatment to post-treatment at 6 and 12 weeks. 
Secondary Endpoint(s)/Event(s)/Outcome(s): one-time assessment via use of 
musculoskeletal ultrasound during baseline and 9-week CT assessment session.  
Secondary analysis will also include records of treatment adherence and self-reported 
disability before treatment, and upon completion of the 8 week program (week 9). 
4.0 
Study Intervention(s)/Investigational Agent(s) 
4.1 
Description:   
As per O’Brien and Giveans10, the thumb 
CMC DS intervention involves four 45-
minute occupational therapy visits as well as 
a daily home program across a 6-week 
period. Clinic visits focus primarily on home 
program coaching, and progression of the 
exercise regimen (Figure 6). Home 
programs involve daily exercises which 
follow the intensity and duration 
recommended for older adults.31 The home program should require about 15-20 
minutes of the client’s time per day. This intervention program is standard care, 
protocolized and manualized and is summarized by Valdes, Algar, and McGee (2020)32 
summarize. The objective of the DS program is offer patients self-management 
strategies to restore thumb mechanics, delay further joint damage, reduce pain, and 
enable participation in daily activities. This is accomplished through a 3-phased 
approach that includes (1) 
stretching of a muscle which is 
often shortened in thumb CMC 
OA, the adductor pollicis,4 (2) joint 
mobilization to relocate the thumb 
metacarpal and realign the CMC 
joint33, and (3) neuromuscular 
reeducation and strengthening.26 
The latter phase focuses heavily 
on relearning patterns of muscle 
activity that best maintain the 
“stable C” positioning during 
prehension. The “stable C” 

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VERSION DATE: 05/25/2023 
 
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position is one where the ligaments of the CMC are taut and the joint most congruent. 
This position is accomplished through opposing the thumb to the second and third digits 
while keeping the distal joints of the thumb slightly bent (see figure 6a). Once a patient 
can maintain this position during lightly resistive activities, isometric exercise is added 
(Figure 6b) and clients are later progressed into maximally resistive isokinetic exercise 
as pain dictates (Figure 6c). Muscles targeted in the late phase are the first dorsal 
interosseous, opponens pollicis, flexor pollicis brevis, and extensor pollicis brevis; all 
responsible for stabilizing the thumb and maintaining the “C” posture during prehension. 
A summary of this program and intervention parameters is found in Table 1.     
 
4.2 
Drug/Device Handling:  N/A 
4.3 
Biosafety: N/A 
4.4 
Stem Cells: N/A 
4.5 
Fetal Tissue: N/A 
 
5.0 
Procedures Involved 
5.1 
Study Design: aim #1 will be accomplished via a pre-post interventional design 
to evaluate changes in CT measurements of thumb radial subluxation (cm) from pre-
intervention to intervention completion (9 weeks). The 9-week assessment will be the 
primary follow-up. 
Aim #2 will be accomplished with a cross-sectional concurrent validity study design. 
Patients enrolled in the DS exercise intervention study will undergo additional 
assessment of metacarpal subluxation with ultrasound during baseline and week 9 
evaluations. 
5.2 
Study Procedures:  
Aim #1.  
Screening and consenting: Dr. McGee has provided the CTSI’s BPIC service with the 
diagnostic inclusion criteria for the study and will be informed within 3-5 days if a patient 
who meets these criteria is scheduled at the MHealth Clinics and Surgery Center. Dr. 
McGee will be present during the Study Orthopedist’s clinic when these potentially 
eligible patients are scheduled for appointments. The study orthopedist will screen 
patients for pregnancy/risk of pregnancy via interview and present the study to the 
eligible patient and, if interested, the informed consent process will follow. Dr. McGee or 
other IRB-approved personnel will be responsible for informed consent. After 
consenting, baseline assessments will be conducted.  
Assessment: CT will be used at prior to beginning aforementioned rehabilitation 
intervention, and after completing intervention (9 weeks) as per the European guidelines 
on quality criteria for computed tomography.34 A validated positioning jig reproduced by 
our lab35 will be used to maintain standardized joint positioning as the volunteer 
participates in dynamic pinch activities during CT examination. “Radial subluxation” 
(i.e., the displacement of thumb metacarpal base from the lateral border of the 
trapezium)36 is a measure of thumb CMC instability and will be measured in 
centimeters. Subluxation measurements will not be made until after participants 
complete the 8-week protocol. After which, de-identified CT images will be presented to 
study orthopedic surgeon by the PI in a randomized sequence of baseline, and 9 week 
films so as to not introduce bias. Four images will be taken for each affected hand: 

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unloaded lateral pinch, loaded lateral pinch, unloaded 3-point pinch, and loaded 3-point 
pinch. When unilateral thumb OA is present, eight 3-second CT assessments (unloaded 
lateral pinch x2, loaded lateral pinch x 2, unloaded 3 point pinch x 2, and loaded 3-point 
pinch x2) will occur by the time of the 9 week follow-up. In the instance that the 
participant has bilateral CMC OA, 16 three-second assessments will occur. If 
participants have not yet had  an x-ray confirmation of arthritis, through fluoroscopy will 
be billed to participant’s insurance but CT assessments will all be billed to research. 
 
Computerize tomography data will be recorded though use of the Siemens Biograph 
MCT 64 slice PET/CTat U of MN’s Center for Clinical Imaging Research (CCIR). CT 
images will be used to capture ‘kinematic’ data and  and a wireless biometrics digital 
pinch meter will be used to capture the pinch ‘kinetic’ data.     
Intervention: As previously mentioned, the thumb CMC DS intervention will involve four 
45-minute occupational therapy visits as well as a daily home program across an 8-
week period. Clinic visits will focus primarily on home program coaching, and 
progression of the exercise regimen. Home programs involve daily exercises which 
follow the intensity and duration recommended for older adults.31 The home program 
should require about 15-20 minutes of the client’s time per day. This intervention 
program is standard care, protocolized and manualized and is summarized by Valdes, 
Algar, and McGee (2020)32 summarize. The objective of the DS program is to offer 
patients self-management strategies to restore thumb mechanics, delay further joint 
damage, reduce pain, and enable participation in daily activities. This is accomplished 
through a 3-phased approach that includes (1) stretching of a muscle which is often 
shortened in thumb CMC OA, the adductor pollicis,4 (2) joint mobilization to relocate the 
thumb metacarpal and realign the CMC joint33, and (3) neuromuscular reeducation and 
strengthening.26 The latter phase focuses heavily on relearning patterns of muscle 
activity that best maintain the “stable C” positioning during prehension. The “stable C” 
position is one where the ligaments of the CMC are taut and the joint most congruent. 
This position is accomplished through opposing the thumb to the second and third digits 
while keeping the distal joints of the thumb slightly bent (see figure 6a). Once a patient 
can maintain this position during lightly resistive activities, isometric exercise is added 
(Figure 6b) and clients are later progressed into maximally resistive isokinetic exercise 
as pain dictates (Figure 6c). Muscles targeted in the late phase are the first dorsal 
interosseous, opponens pollicis, flexor pollicis brevis, and extensor pollicis brevis; all 
responsible for stabilizing the thumb and maintaining the “C” posture during prehension. 
A summary of this program and intervention parameters is found in Table 1. Table 2 
illustrate the total time commitment expected during the treatment period.   
 
Table 2. Intensity of the intervention.  
 
 
Week 1 
Week 2 
Week 3 
Week 4 
Week 5 
Week 6 
Week 7 
Week 8 
Clinic Visit 
One 60 min 
session 
 
One 60 min 
session 
 
One 60 min 
session 
 
One 60 min 
session 
 
Home 
program 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
15-20 
minutes 
Daily, 5 
days a 
week 
 
Approximate duration of treatment per participant 
 
840-1040 
minutes 
 
For aim #2, ultrasound measures will be obtained using a Sonocite X-Porte 
sonographic device. Sonographic assessment will occur at the time of participants’ 

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baseline and 9-week CT assessments (aim #1). The PI will conduct sonographic 
measures of radial subluxation on all Aim #1 participants (n=49). The same stress view, 
positioning jig and standardized upper limb postures used for Aim #1 will again be 
employed. In addition to these standardized joint postures and forces, the thumb CMC 
joint sonographic procedures described by Oo et al.12 and the general guidelines put 
forth by American Institute of Ultrasound in Medicine37 will be followed. The device is 
the property of Dr. McGee and there will be no charges billed to the participant 
associated with the use of this instrument. Dr. McGee will work with Don McCarty from 
Fairview’s biomedical engineering dept. to ensure the device is approved for use at the 
MHealth Clinics and Surgery Center. 
The PI will quantify radial subluxation (cm) of the thumb metacarpal in the same 
manner as it was in Aim #1. The agreement between these values and those gathered 
through CT in Aim #1 will subsequently be assessed. The PI and the orthopedic 
surgeon evaluator will be blinded to each other’s ultrasonography and CT findings. 
The intervention and baseline diagnostic fluoroscopic assessment are standard care 
and would be conducted even if not for the purposes of this study. Sonography and the 
thee CT measurements would be considered above and beyond standard care. 
Data to be pulled from patient records include age, sex at birth, arthritis staging, 
concomitant health conditions, pain, thumb mobility measurements, and disability 
ratings. Secondary data on treatment adherence via an exercise log and self-reported 
disability will also be captured (Michigan Hand Questionnaire) for secondary analyses. 
Lastly, participants will be asked to report on adverse events during each encounter 
during weeks 1-6.  
Assessment 
Screening
, 
Baseline: 
Visit 1 
(Day 0, 
Week1) 
Treatme
nt Visit 1 
(Week 1) 
Treatment 
Visit 2 
(Week 3) 
Treatment 
Visit 3(Week 
5) 
Treatme
nt Visit 4 
(Week 7) 
Follow-up 
#1 (Week 
9) 
Informed Consent Form  
X 
  
  
  
  
  
Demographics 
X 
  
  
  
  
  
Medical History/Arthritic 
staging 
X 
  
  
  
  
  
Inclusion/Exclusion Criteria 
(Including radiographic 
confirmation of OA via 
fluoroscopy) 
X  
  
  
  
  
  
Attestation of certainty of not 
being pregnant by women 
who are non-post 
menopausal  
X 
 
 
 
 
 
Enrollment 
 X 
  
  
  
  
  
CT Measurements (Aim 1) 
X 
  
  
  
  
 X 
 
 
 
 
 
 
 

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Ultrasound measurements 
(Aim 2) 
X 
 
 
 
 
x 
Self-reported disability 
(Michigan Hand 
Questionnaire) – Aim 1b 
X 
 
 
 
 
X 
Treatment Adherence 
(Exercise Log) – Aim 1b 
  
X 
X 
X 
X 
X 
Adverse Events 
  
X 
X 
X 
X 
X 
Note: “Week” = 7 days +/-3 days 
5.3 
Study Duration:  
● Duration anticipated for an individual participant’s participation in the study: 9 
weeks 
● The duration anticipated to enroll all study participants: 3 years 
● The duration anticipated to complete all study procedures: 4 years 
5.4 Use of radiation: 
Note: the following calculations are based on static radiographic imagining.  
Radiation exposures (Aim#1) will be minimized through, short exposure times, and 
wear of leaded aprons, thyroid shields, and protective eyewear for the participant. 
Leaded aprons, thyroid shields, and leaded eye protection will worn by the evaluators 
and participants throughout each CT assessment. Without the attenuation expected 
from the above protective measures, a conservative estimate of maximal radiation 
exposure per session is 끫殜.끫殜078 끫欜끫欜끫欜 (totaling 0.1248 끫欜끫欜끫欜) when both thumbs are 
measured and 0.0624 끫欜끫欜끫欜 when only measuring one.    
This exposure would respectively equate to 2.3% (unilateral) or 4.6% (bilateral) of the 
radiation one is naturally exposed to each year as a resident of Minnesota (3 
끫欜끫欜끫欜).42Additionally, because investigators will not be working near but not within the 
beam of the CT device so there is no risk to the investigators.   
 
5.5 
Use of Center for Magnetic Resonance Research:  n/a  
6.0 
Data and Specimen Banking 
6.1 
Storage and Access: De-identified data will be stored in Box, for future use by 
other researchers. Data will be available immediately following the first publication with 
no end date following article publication. Researchers (including those outside of the 
study) whose proposed use of the data has been approved by PI will have access to 
the data for individual participant data meta-analysis/to achieve aims in the approved 
proposal. The AHC-IE will be not used.  
 
Publishing of these data may be required. Federal funders (e.g. National Institutes of 
Health), granting agencies (e.g. Bill & Melinda Gates Foundation), and journal 
publishers (e.g. PLoS) increasingly require datasets be made publicly available—often 
immediately upon associated article publication. If this is the case, all data published 
will be fully de-identified. 
  

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6.2 
Data: The following deidentified data may be banked for future analyses and 
compilation into larger datasets: clinical and demographic information, clinical 
assessments, and imaging data. 
6.3 
Release/sharing: Should the investigators pursue data sharing, future studies 
seeking to compile data acquired from this protocol will obtain IRB approval before 
doing so. In the event that this occurs, only investigators or study personnel listed in an 
IRB-approved protocol pertaining to the data compilation will have access to this data. 
The requested will be released to the researchers in a de-identified manner. 
6.4 
Sharing of genetic testing: N/A 
7.0 
Sharing of Results with Participants.  
7.1 
Sharing of results with participants: We plan to share a brief summary of 
aggregated study results with participants either by email or USPS delivery depending 
on the participant’s preference and will include a "thank you" note for participating. We 
plan to use the CTSI Dissemination Toolkit when framing the language.  
8.0 
Study Population 
8.1 
Inclusion Criteria: will include:  
• 
Adults 18 years or older 
• 
having radiographically-confirmed thumb CMC OA 
• 
having been referred to occupational therapy. 
A study orthopedist will use current radiographic evidence to screen and stage thumb 
CMC OA in all prospective candidates to ensure the diagnostic criteria required for 
inclusion are met. The same study orthopedist will screen recruits for pregnancy or risk 
of pregnancy via an interview. Both men and women will be included given the findings 
of Wilder et al.29, who described the prevalence of radiographically confirmed thumb 
carpometacarpal osteoarthritis to be similar in men (20%) and women (21%). 
In addition, should these recruitment efforts prove to be slow we will recruit through the 
existing health records of adults ages 18 and older who have a diagnosis of CMC OA 
and have received care within University of Minnesota Health/Fairview orthopedics/ 
Sports Medicine, or Rheumatology departments from December 2015 to April 30, 2023  
Eligible participants will have any of the following ICD 10 codes: Primary OA CMC joint 
(M18.11, M18.12, M18.2), post-traumatic OA CMC joint (M18.31, M18.32, M18.4) and 
other secondary OA CMC joint (M18.51, M18.52) and will be identified via the I2B2 
Data set and then  run by BPIC and sent to Fairview for mailing. Alternatively, 
Fairview’s Research Recruitment services may perform the same service. 
Those recruited in this fashion will be required to be screened for pregnancy or risk of 
pregnancy via an interview by their preferred medical provider (i.e., women’s health, 
family physician, internal medicine, orthopedic surgeon) prior to enrollment.  
8.2 
Exclusion Criteria will include: 
• 
cortisone treatments to the affected thumb within the prior three months 
• 
thumb CMC joint replacement  
• 
a diagnosis of inflammatory arthritis 
• 
a diagnosis of Ehlers Danlos Syndrome 
• 
a diagnosis of Marfan’s disease  
• 
pregnancy or questionable pregnancy  
• 
mothers who are breastfeeding  

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• 
cognitive disorders which would preclude a client from following the testing 
commands and home program participation  
• 
a diagnosis of a concomitant condition affecting the arthritic thumb (i.e. 
Wartenberg’s syndrome, deQuervain’s, trigger thumb, intersection syndrome) 
• 
grade 4 Eaton29 OA staging  
• 
ongoing hand rehabilitation (i.e., within prior 6 months)  
• 
pain which precludes participants from completing testing 
• 
an EMR flag for not wishing to participate in research  
 
8.3 
Screening: Dr. McGee has provided the CTSI’s BPIC service with the diagnostic 
inclusion criteria for the study and will be informed within 3-5 days if a patient who 
meets these criteria is scheduled at the MHealth Clinics and Surgery Center. Dr. 
McGee will be present during the Study Orthopedist’s clinic when these potentially 
eligible patients are scheduled for appointments. A study orthopedist will use current 
radiographic evidence to screen and stage thumb CMC OA in all prospective 
candidates to ensure the diagnostic criteria required for inclusion are met. The same 
study orthopedist will screen recruits for pregnancy or risk of pregnancy via an interview 
and present the study to the eligible patient. If the recruit is interested, the informed 
consent process will follow and will be conducted by Dr. McGee or other IRB-approved 
personnel.   
9.0 
Vulnerable Populations:   
9.1 
Vulnerable Populations 
 
Population / Group 
Identify whether any of the 
following populations will be 
targeted, included (not necessarily 
targeted) or excluded from 
participation in the study.  
Children 
Excluded from Participation 
Pregnant women/fetuses/neonates 
Excluded from Participation 
Prisoners 
Excluded from Participation 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Excluded from Participation 
Non-English speakers 
Excluded from Participation 
Those unable to read (illiterate) 
Excluded from Participation 

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Employees of the researcher 
Excluded from Participation 
Students of the researcher 
Excluded from Participation 
Undervalued or disenfranchised 
social group 
Included/Allowed to Participate 
Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
Included/Allowed to Participate 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded from Participation 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
Included/Allowed to Participate 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
Excluded from Participation 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
Excluded from Participation 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded from Participation 
 
 
9.2 
Additional Safeguards: All participants will be informed that their participation is 
voluntary, all of the information gathered throughout the course of the study will be kept 
confidential, and that choosing to not participate at any time in the study will not affect 
their relationship with the university or their health care providers. Furthermore, 
participants will be asked, at the time of seeking informed consent, to share their 
comfort with reading the consent form or any other study materials. If the prospective 
participant shares that they are uncomfortable with reading the materials, all materials 
will be read aloud and participants will be asked to do a teach-back to ascertain 
comprehension.   
 
 

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Undervalued or disadvantaged people may not be known, research staff will not be 
asking a direct question about socioeconomic status to potential participants. We do not 
anticipate vulnerability for this group to be increased by participating in this study. 
 
Members of the military may not be known, research staff will not be asking a direct 
question about military status to potential participants. We do not anticipate vulnerability 
for this group to be increased by participating in this study. 
 
Undervalued or disadvantaged people may not be known, research staff will not be 
asking a direct question about socioeconomic status to potential participants. However, 
we have taken special precaution to make sure participants are fairly and adequately 
compensated for their time in this study, yet not coerced by unreasonably high 
compensation amounts. 
 
9.3 
Rationale for exclusion (if potential for direct benefit): We plan to exclude 
expecting mothers/or women who are potentially expecting due to risk of exposure to 
ionizing radiation. This will impact very few potential recruits given that persons with 
thumb CMC OA are primarily post-menopausal women.  We will exclude persons who 
are non-English speaking or illiterate because the Michigan Hand Questionnaire is only 
cross-validated in Brazilian Portuguese, Colombian Spanish and German and requires 
basic literacy to complete.  
 
10.0 Local Number of Participants 
10.1 Local Number of Participants to be consented: we plan to enroll as many as 50 
and as few as 40 participants.  
11.0 Local Recruitment Methods 
11.1 
Recruitment Process: Participants will be recruited from the MHealth Clinics and 
Surgery Center. The PI or research assistant (RA) will be notified by BPIC 3-5 days 
prior to a potential recruit’s visit to orthopedics. The PI will confirm eligibility through 
reviewing the EMR. The PI/RA, as Nonemployee Research Staff (NERS), have 
approved access to such. The study orthopedist will be informed of the client’s eligibility 
by the PI/RA and who will then briefly present the study and ask the patient for 
permission for the PI or study staff to present the study to them in more depth during 
their clinic visit.  If interested, the informed consent process will follow.   
If recruitment efforts through these methods are slow, potential participants will also be 
identified in the i2b2 database then run by BPIC and sent to Fairview for mail-invitation. 
Alternatively, Fairview’s Research Recruitment services may perform the same service. 
These letters or MyChart Messages will be sent to those who qualify via the Fairview 
Recruitment Mailing Service. Patients will then outreach to the PI for additional details 
and, in interested, will proceed with the informed consent process.  
After which, the initial assessment and subsequent therapy sessions will be scheduled. 
We will use selective stratified sampling to enroll equal numbers of persons with 
baseline Eaton30 thumb CMC OA stages 1, 2, and 3 respectively (i.e., 16-17 
participants per strata). The study will be closed to recruitment for those of a strata 
which has achieved 16-17 participants. 

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Successful recruitment appears feasible given the findings of a recent analysis of 
Fairview/UHealth dataset through use of the University of Minnesota CTSI’s “i2b2 
Cohort Discovery tool.” The survey of our participant pool revealed that 4,858 persons 
(3363 women and 1495 men) who met the inclusion criteria for participation were seen 
in Fairview/UHealth Sports and Orthopaedic Clinics from January 1st, 2018 to March 
11th, 2021. 
Although the prevalence of radiographically confirmed thumb CMC OA is similar in men 
and women27, our survey of our participant pool appears to reveal a care-seeking 
gender discrepancy. This discrepancy is consistent with the findings of health service 
research28 and thus, while evidence suggests that women and men are affected equally 
by this condition, we anticipate that the population from which we will recruit will be 
disproportionately female and, in a study of this nature, we will not attempt to selectively 
recruit men. 
In being consistent with the demographics of Minneapolis we will aim to recruit the 
following racial distribution: White: 64%, Black or African American: 19%, Asian: 6%, 
other: 5%, multiracial 5%, and Native American: 1%. Thus we will work to selectively 
recruit approximately 30 white, 9 African American, 5 Latino American, and 5 Asian 
American participants. If this diversity is not met through recruitment on a rolling basis, 
we will work with BPIC to identify those who meet these criteria and selectively recruit 
these persons. 
11.2 
Identification of Potential Participants: The PI or research assistant (RA) will be 
notified by BPIC 3-5 days prior to a potential recruit’s visit to orthopedics. The PI will 
confirm eligibility through reviewing the EMR. The PI/RA, as Nonemployee Research 
Staff (NERS), have approved access to such. The study orthopedist will be informed of 
the client’s eligibility by the PI/RA and who will then briefly present the study and ask 
the patient for permission for the PI or study staff to present the study to them in more 
depth during their clinic visit.   
If recruitment efforts through these methods are slow, potential participants will also be 
identified in the i2b2 database then run by BPIC and sent to Fairview for mail-invitation. 
Alternatively, Fairview’s Research Recruitment services may perform the same service. These 
letters or MyChart Messages will be sent to those who qualify via the Fairview Recruitment 
Mailing Service 
 
11.3 
Recruitment Materials: Recruitment materials will include a brief description of 
the study. This will be provided at the time of the initial encounter with the surgeon. 
Please see the Participant handout provided in the ETHOS application. 
If using health records to identify potential participants, an IRB and Fairview Research 
Administration approved letter will be mailed or sent via MyChart. 
11.4 
Payment: Greenphire ClinCards will be given to each participant to compensate 
for time and parking expenses. Cards will be loaded with a reimbursement of $25.00 
after attending each study-associated therapy and evaluation session (6 sessions x 
25.00 = 150.00).  Additionally, $6.00 per visit will be provided for parking for 6 visits (6 x 
$6.00 = 36.00). In total, participants will receive compensation for attending 4 therapy-
only visits, and 2 evaluation-only visits (i.e., baseline, and 9-week follow-ups). Should 
participants continue with therapy beyond the study period, the remaining therapy costs 
will be billed to participants’ health insurance in the typical fashion. The maximum 
compensation amount for each participant would be $186.00. 
12.0 Withdrawal of Participants 

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12.1 
Withdrawal Circumstances:  
 
An investigator may discontinue a participant from the study for the following reasons: 
• 
Significant study intervention non-compliance 
• 
If any clinical adverse event (AE), laboratory abnormality, or other medical 
condition or situation occurs such that continued participation in the study would 
not be in the best interest of the participant 
• 
If the participant meets an exclusion criterion (either newly developed or not 
previously recognized) that precludes further study participation 
• 
If they are lost to follow up 
• 
If they behave inappropriately toward study staff 
• 
Disease progression which requires discontinuation of the study intervention 
• 
If they show signs of diminished capacity to consent 
• 
Or it is in their best interest, as determined by the PI 
 
Recruits will be informed that participation in this study is voluntary. They will be 
informed that their decision on whether or not to participate in this study will not affect 
their current or future relations with the University, University of Minnesota Medical 
Center, or Fairview. Recruits will be informed that, if they decide to participate, they are 
free to withdraw at any time without affecting those relationships.   
 
12.2 
Withdrawal Procedures: If participants choose to withdraw from the study, data 
collection will be discontinued with no further follow up. Participants who are 
withdrawing from the study will be asked to consider providing consent for subsequent 
data collection to follow up on their medical outcomes related to the project. Thus, 
participants will be presented with the option to sign a “Consent Collection after 
Withdrawal” to enable this future data collection. All data collected up to the point of 
participant withdrawal from the study will continue to be securely stored and analyzed. 
Primary and secondary outcomes will be handled through intent to treat analysis. 
Records will be kept on number of withdrawals as well as the reasoning for such. 
 
12.3 
Termination Procedures: This study may be temporarily suspended or 
prematurely terminated if there is sufficient reasonable cause. Written notification, 
documenting the reason for study suspension or termination, will be provided by the 
suspending or terminating party to the funding agency, and regulatory authorities. If the 
study is prematurely terminated or suspended, the PI will promptly inform the IRB and 
will provide the reason(s) for the termination or suspension. The study team will notify 
the participants of the study termination.  
 
Circumstances that may warrant termination or suspension include, but are not limited 
to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the primary endpoint has been met 
• 
Determination of futility 
Records will be kept on number of withdrawals as well as the reasoning for such. 

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13.0 Risks to Participants 
13.1 
Foreseeable Risks: This proposed study involves human subjects. Human 
subjects are required for this study as we plan to test the effects of an intervention on 
human adults with thumb arthritis.  This study cannot be carried out in an animal model 
nor does it pose any significant risks to the health and wellbeing of human subjects. 1) 
Participants might experience some mild hand fatigue or joint aches for 2-3 days 
following testing and at the onset of the intervention as a result of the repetitive nature 
of the tasks involved, 2) participants will be asked to give some information that you 
may be perceived to be of a personal nature 3) the primary outcome measure for this 
study is CT and this involves the aforementioned minimal amounts of ionizing radiation, 
and 4) at times, it may be necessary for the researchers to physically touch the 
participants’ hands or sides to ensure that you are in the correct positions. This, to 
some, may be uncomfortable. 
 
Radiation exposures will be minimized through short exposure times, and wear of 
leaded aprons, thyroid shields, and protective eyewear for the participant and rater 
alike, and leaded gloves for the rater.39-41  
 
Participants will be allowed frequent rest breaks to limit any amount of fatigue and 
soreness participants may experience in their hands and arms following testing and 
when participating in exercise.  If discomfort increases as a result of testing, participants 
will be instructed on self- managing symptoms through use of physical agents such as 
cryotherapy and rest. In the event that this research activity results in an injury, 
treatment will be available, including first aid, emergency treatment and follow-up care 
as needed. Participants who believe they have suffered a research related injury, will be 
asked to inform the researchers immediately. If participants are physically 
uncomfortable or uncomfortable with the nature of the questions or occasional touch, 
they will be instructed that they are free to withdraw from participation at any time 
without any impact to relationships with the university. 
 
Privacy/Confidentiality Risks: Risk of loss of confidentiality is unlikely, but could possibly 
occur as PHI is utilized as part of this study. This risk would be minimized by 
protections such as de-identification of participants via use of a study identifier, 
locked/secured/limited access to PHI, and electronic data securely stored and 
password-protected. 
 
13.2 
Reproduction Risks: Use of radiographic imaging is contraindicated for pregnant 
women. As such, women who are or could be pregnant will be excluded from this study. 
13.3 Risks to Others: N/A 
14.0 Potential Benefits to Participants 
14.1 Potential Benefits: The occupational therapy services received by all participants 
is known to aid in pain reduction, can assist participants in developing health 
management strategies, and is known to reduce the experience of disability 
15.0 Statistical Considerations 
  

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15.1 
Data Analysis Plan: For aim #1, the within-subjects outcomes will be compared 
primarily on the mean change in degree of subluxation from baseline to 9 week follow-
up (the primary outcome). Additionally, given our recent retrospective findings27 which 
support that advanced arthritic radiographic staging is also a negative predictor of 
response to the DS, mean change scores will be compared and adjusted for according 
to arthritic staging through use of linear regression for added precision of the treatment 
effect estimates. For aim #2, the agreement between baseline radial subluxation 
measurements via CT measurements and those via sonography will be assessed using 
the Bland-Altman method.42 
15.2 
Power Analysis:  
Aim #1: Previous work8 suggested that the mean immediate misalignment change in 
the treatment group will be 0.33 cm, with a standard deviation of 0.18.The proposed 
sample size was estimated a priori assuming a paired t-test of the change in 
misalignment, with two-tailed type I error of 0.05 and power of 90%. We conservatively 
estimate that the minimum clinically important change in misalignment will be between 
0.05cm and 0.40cm, depending on how much the sustained effect is attenuated relative 
to the immediate effect (published value 0.42cm), and that the standard deviation (SD) 
of the misalignment measurement is 0.22cm. The correlation between the pre and post 
measurements is unknown, so we estimate the needed sample size for a range of 
correlation values between 0.20 and 0.80. 
If we conservatively assume that the immediate misalignment change is 0.30cm, that 
the sustained change will be reduced by 50% to 0.15cm, and that the pre and post 
measurements will only be weakly correlated with a correlation coefficient of 0.2, then a 
sample size of 39 people (39 pre and post measurements) will be required. Assuming a 
potential loss-to-follow-up rate of 20%, we will enroll 49 participants. 
Aim #2: A formal sample size estimate is not available for this aim given its novelty. 
However, because a sample of 30 participants is assumed to be adequate for bivariate 
correlational research37, we anticipate that our sample of 49 participants will be 
adequately powered. 
15.3 Statistical Analysis: See section 15.1. 
15.4 
Data Integrity: The PI is responsible for monitoring the integrity of the data. The 
PI will oversee regularly scheduled checks of both our outcome assessors and our 
interventionists. At each check, the PI will use a protocol checklist to document the 
number of evaluation and intervention protocol deviations and provide real-time 
feedback.  
16.0 Health Information and Privacy Compliance 
 
16.1 
Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
 
X I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 

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☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research: As mentioned in section 11.2, the PI or 
research assistant (RA) will be notified by BPIC 3-5 days prior to a potential 
recruit’s visit to orthopedics. The PI will confirm eligibility through reviewing 
the EMR. The PI/RA, as Nonemployee Research Staff (NERS), have 
approved access to such. The study orthopedist will be informed of the 
client’s eligibility by the PI/RA and who will then briefly present the study and 
ask the patient for permission for the PI or study staff to present the study to 
them in more depth during their clinic visit.   
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of 
the authorization language embedded in the template consent form in lieu of 
the U of M stand-alone HIPAA Authorization.  Note: External IRB must be 
serving as the privacy board for this option. 
 
16.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI 
(also referred to as the University's Information Exchange (IE) or data 
shelter) to pull records for me 
x I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) database. 
x I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
 
16.3 
Explain how you will ensure that only records of patients who have agreed to 
have their information used for research will be reviewed: As mentioned in section 11.2, 
the PI or research assistant will confirm eligibility through reviewing the medical record 
and will confirm that the patient has consented to sharing their health information for 
research purposes. 
 
16.4 
Approximate number of records required for review: 50-60 (to account for drop-
outs). 
 
16.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 

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☐ This research involves record review only. There will be no communication 
with research participants. 
X Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
☐ Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication 
and how it will be received by participants.   
16.6 
Explain how the research team has legitimate access to patients/potential 
participants: The research team will be permitted to access sources of private 
information because all participants will be required to sign a HIPAA waiver at the time 
of informed consent. Additionally, the PI and research assistant are Non-Fairview 
Employed Research Staff (NERS) credentialed and thus, have legitimate access to the 
EMR. 
16.7 Location(s) of storage, sharing and analysis of research data, including any links 
to research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In REDCap (recap.ahc.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
X In OnCore (oncore.umn.edu)  
 x Store ☐ Analyze 
☐ Share 
X In the University’s Box Secure Storage (box.umn.edu) 
 X Store 
X Analyze 
X Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
 ☐ Store 
☐ Analyze 
☐ Share 
☐  In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices:  
 ☐ Store 
☐  Analyze 
☐ Share 
☐ Other. Describe:  
☐I will use a server not previously listed to collect/download research data 

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☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
16.8 Consultants. Vendors. Third Parties. N/A 
16.9 
Links to identifiable data:  Two data sets will be maintained until data collection 
is completed. One data set will contain identifiers linked to assigned participant 
numbers. The PHI dataset will link the PHI to participant numbers. Both datasets will be 
stored on university monitored, password protected, encrypted, and secured servers 
(Box data management system). Datasets will be password protected and stored in a 
secure and encrypted repository (Box). Access will only be granted to the PI and IRB 
approved study staff. 
16.10 Sharing of Data with Research Team Members. Access to the datasets stored in 
Box will only be granted to the PI and associated personnel. 
16.11 Storage of Documents: will be stored on university monitored, password 
protected, encrypted, and secured servers (Box data management system). Datasets 
will be password protected and stored in a secure and encrypted repository (Box). 
Access will only be granted to the PI and associated personnel. 
 
16.12 Disposal of Documents:  in compliance with NIH Policy 8.4.2 “Record Retention 
and Access”, records will be retained for 3 years after study completion. At this time, all 
paper copies of research will be shredded and disposed of in PHI-compliant waste 
containers. Electronic records will be purged from the PI’s laptop and Box. The 
recycling bin of the PI’s laptop will also be purged.  
17.0 Confidentiality 
17.1 
Data Security:  Two electronic data sets will be maintained until data collection 
is completed. One data set will contain identifiers linked to assigned participant 
numbers. The PHI data set will link the PHI to participant numbers. Electronic datasets 
will be stored on university monitored, password protected, encrypted, and secured 
servers (Box data management system). Datasets will be password protected and 
stored in a secure and encrypted repository (Box). Access will only be granted to the PI 
and associated personnel. Hard copies of signed consent forms will be kept in a locked 
file cabinet in the PI’s office. Additionally, because this study is occurring within the 
MHealth/Fairview system, a copy of the signed consent/HIPAA form will be sent to 
Health Information Management Services (HIMS) so that it can be entered into the 
participant’s electronic medical record.  
Because this is an NIH-funded project, the National Institutes of Health has granted a 
Certificate of Confidentiality. We will use this Certificate legally to refuse to disclose 
information that may identify participants in any federal, state, or local civil, criminal, 
administrative, legislative, or other proceedings, for example, if there is a court 
subpoena. We will use the Certificate to resist any demands for information that would 
identify participants, except as explained below.  

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It is unclear if the Certificate will work in foreign countries. The Certificate does not 
prevent a researcher from reporting information learned in research when required by 
other state or federal laws, such as mandatory reports to local health authorities for 
abuse or neglect of children/vulnerable adults, or information to the Food and Drug 
Administration (FDA) when required in an FDA audit.  However, the Certificate limits the 
researcher from disclosing such information in follow up civil, criminal, legislative or 
administrative legal proceedings if the information was created or compiled for 
purposes of the research.   
A Certificate of Confidentiality does not prevent participants or a member of their family 
from voluntarily releasing information about participants or their involvement in this 
research. If an insurer, medical care provider, or other person obtains participants’ 
written consent to receive research information, then the researchers will not use the 
Certificate to withhold that information. 
18.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
Clinical site monitoring is conducted to ensure that the rights and well-being of trial 
participants are protected, that the reported trial data are accurate, complete, and 
verifiable, and that the conduct of the trial is in compliance with the currently approved 
protocol/amendment(s), with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP), and with applicable regulatory requirement(s).  
The PI will conduct the monitoring on-site at initial assessment and training and 
periodically throughout the study via a random review of safety data. Independent 
audits will not be conducted. 
18.1 
Data Integrity Monitoring: The PI is responsible for monitoring the integrity of the 
data. The PI will oversee regularly scheduled checks of both our outcome assessors 
and our interventionists. At each check, the PI will use a protocol checklist to document 
the number of evaluation and intervention protocol deviations and provide real-time 
feedback.  
18.2 
Data Safety Monitoring: It will be the responsibility of the Principal Investigator to 
oversee the safety of the study. The PI will review cumulative raw data, trends in AEs, 
SAEs and UPIRTSO on an ongoing basis. Safety data will be captured in the eCRFs for 
each visit. Any safety event meeting the IRB’s urgent reporting criteria will be reported 
to the IRB within its published timelines. 
 
At each contact with the participant, the PI will seek information on adverse events by 
specific questioning and, as appropriate, by examination. Information on all adverse 
events will be recorded immediately in the source document, and also in the 
appropriate adverse event module of the case report form (CRF). All clearly related 
signs, symptoms, and abnormal diagnostic procedures results will be recorded in the 
source document. Reports of all serious adverse events (including follow-up 
information) will be submitted to the IRB within 10 working days if it falls under the 
UPIRTSO guidelines. Copies of each report and documentation of IRB notification and 
receipt will be kept in the Clinical Investigator’s binder.  A second copy will be sent to 
the sponsor. 
 
The PI will be responsible for 1) collecting, reporting, and risk management of adverse 
events, 2) data collection, entry, transmission and analysis, 3) site coordination and 
enrollment, 4) regulatory issues such as IRB actions, and conflict of interest 

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disclosures, and 5) reporting the interim analysis to IRB. All collaborators will be 
immediately notified of any adverse events 
occur. 
 
19.0 Provisions to Protect the Privacy Interests of Participants 
 
19.1 
Protecting Privacy: Information about study subjects will be kept confidential and 
managed according to the requirements of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA).  Those regulations require a signed subject 
authorization informing the subject of the following:  
• 
What protected health information (PHI) will be collected from subjects in this 
study 
• 
Who will have access to that information and why 
• 
Who will use or disclose that information 
• 
The rights of a research subject to revoke their authorization for use of their PHI.  
In the event that a subject revokes authorization to collect or use PHI, the investigator, 
by regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use 
PHI, attempts should be made to obtain permission to collect at least vital status (i.e. 
that the subject is alive) at the end of their scheduled study period. 
Participants who are withdrawing from the study will be asked to consider providing 
consent for subsequent data collection to follow up on their medical outcomes related to 
the project. Thus, participants will be presented with the option to sign a “Consent 
Collection after Withdrawal” to enable this future data collection. 
19.2 
Access to Participants: Participants will be fully informed of the ways in which 
their data will/may be used during the informed consent process. The research team 
has been trained in conducting these conversations and the participants are also 
assessed for their understanding of consent prior to initiating any study procedures. 
20.0 Compensation for Research-Related Injury 
20.1 
Compensation for Research-Related Injury: In the event that this research 
activity results in an injury, treatment will be available, including first aid, emergency 
treatment and follow-up care as needed. Care for such injuries will be billed in the 
ordinary manner to participant’s insurance company. If participants believe they 
suffered a research related injury, they will be encouraged to inform the PI or staff 
immediately. 
20.2 Contract Language: N/A 
21.0 Consent Process 
21.1 
Consent Process: Dr. McGee has provided the CTSI’s BPIC service with the 
diagnostic inclusion criteria for the study and will be informed within 3-5 days if a patient 
who meets these criteria is scheduled at the MHealth Clinics and Surgery Center. Dr. 
McGee will be present during the Study Orthopedist’s clinic when these potentially 
eligible patients are scheduled for appointments. The study orthopedist will present the 
study to the eligible patient and, if interested, the informed consent process will follow. 
Dr. McGee or IRB-approved personnel will be responsible for garnering written consent. 
To ensure that the appropriate consent form is used, we will only print the most recently 

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approved version housed within Ethos. The consent form will be read to recruits. 
Further, recruits will:  
• 
be asked to explain in their own words the details of the study,  
• 
be invited to ask further questions and these questions will be addressed by 
study personnel, 
• 
be invited to discuss with others if uncertain about participating and will be 
provided a written copy of form to facilitate this discussion 
• 
receive a photocopy of the signed copy of their consent/HIPAA form after being 
consented, and 
• 
have the informed consent process witnessed by another, likely a family 
member or interpreter, when non-English speaking 
21.2 
Waiver or Alteration of Consent Process (when consent will not be obtained): 
N/A 
21.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained): N/A  
21.4 
Non-English Speaking Participants:  N/A 
21.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years 
of age): N/A  
21.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: N/A 
21.7 Adults Unable to Consent: N/A 
22.0 Setting 
22.1 
Research Sites: Screening, consenting, and all interventions will be carried out 
at The University of Minnesota Health’s Clinics and Surgery Center. All assessments 
will occur at the Center for Clinical Imaging Research. 
22.2 International Research: N/A 
 
23.0 Multi-Site Research 
N/A 
24.0 Coordinating Center Research 
 
N/A 
 
25.0 Resources Available 
25.1 Resources Available:  
Scientific Environment: The University of Minnesota (U of MN) Academic Health 
Center (AHC) is a major Midwestern academic health care center located directly on 
the University of Minnesota’s Twin Cities Campus. The AHC provides comprehensive 
health care and education to a large population of patients and supports related 
research on such populations. The Program in Occupational Therapy and Department 
of Orthopaedics are all housed within the AHC. 
 

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Space: Dr. McGee has a 120 sq. ft. office space which is equipped to support data 
management, and secured storage of data. Equipment in this lab includes a secured file 
cabinets; a Dell Latitude E6440 Laptop with i5 processor, 500GB hard drive, 8GB 
DDR3 RAM; Dell V725w printer; MS Windows 7; MS Office 2007; and the statistical 
software package, SPSS ver.22. Peripherals include docking station, (2) Dell U2414H 
24 Ultra HD Monitors for split-screen work and a Dell V725w color printer. The office is 
housed in the University of Minnesota - Twin Cities Campus, in the Children’s 
Rehabilitation Center, 3 floors below the Program in Occupational Therapy’s offices and 
two blocks from the CSC and CCIR. 
 
Enrollment, interventions, and data collection will be carried out at the Hand Therapy 
and Surgery Suites at the UHealth Clinical and Surgery Center which possesses 
several designated hand therapy and orthopaedics assessment and treatment areas. 
The interventions and testing for this project will be carried out within this space. 
 
Training: Research Assistants will complete HIPAA and CITI training. 
 
Equipment: The program in occupational therapy and orthopedics therapy center will 
donate 2 calibrated JamarTM Dynamometers for the quantification of maximum grip 
strength, 2 calibrated force gauges for torque-controlled circumferential edema 
measurements, and 2 BaselineTM 180 degree wrist goniometers for wrist and forearm 
range of motion measurements. Dr. McGee uses a Dell Latitude E6440 laptop with i5 
processor, 500GB hard drive, and 8GB DDR3 RAM. Software includes MS Windows 7; 
MS Office 2007; and SAS 9.3 and SPSS ver.22 statistical software packages. Dr. 
McGee also possesses network access to a high capacity Cannon iR2535 black and 
white and color printer. 
 
Recruitment: Successful recruitment appears feasible given the findings of a recent 
analysis of Fairview/UHealth dataset through use of the University of Minnesota CTSI’s 
“i2b2 Cohort Discovery tool.” The survey of our participant pool revealed that 4,858 
persons (3363 women and 1495 men) who met the inclusion criteria for participation 
were seen in Fairview/UHealth Sports and Orthopaedic Clinics from January 1st, 2018 
to March 11th, 2021. 
 
 
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