Feasibility, Acceptability, and Preliminary Efficacy of Combined Transcranial Direct Current Stimulation and Mindfulness for Pain After Total Knee Arthroplasty
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Florida State University

PROTOCOL TITLE: 
 
Page 1 of 14 
Revised: December 1, 2018 
PROTOCOL TITLE: 
Feasibility, acceptability, and preliminary efficacy of combined transcranial direct current 
stimulation and mindfulness for pain after total knee arthroplasty    
PRINCIPAL INVESTIGATOR: 
Name: Geraldine Martorella 
College of Nursing 
Telephone Number: 850-644-6028 cell: 850-443-2723 
Email Address: gmartorella@fsu.edu 
VERSION NUMBER/DATE: 
05-10-2022 (version 1). 
 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
6/7/23 
Removing fNIRS data collection  
Yes  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives* .............................................................................................................. 3 
3.0 
Background* ............................................................................................................ 4 
4.0 
Study Endpoints* ..................................................................................................... 4 
5.0 
Study Intervention/Investigational Agent ................................................................ 5 
6.0 
Procedures Involved* ............................................................................................... 5 
7.0 
Data and Specimen Banking* .................................................................................. 8 
8.0 
Sharing of Results with Subjects* ........................................................................... 8 
9.0 
Study Timelines* ..................................................................................................... 8 
10.0 Inclusion and Exclusion Criteria* ............................................................................ 9 
11.0 Vulnerable Populations* .......................................................................................... 9 
12.0 Local Number of Subjects ....................................................................................... 9 
13.0 Recruitment Methods ............................................................................................... 9 
14.0 Withdrawal of Subjects* ........................................................................................ 10 
15.0 Risks to Subjects* .................................................................................................. 10 
16.0 Potential Benefits to Subjects* .............................................................................. 10 
17.0 Data Management* and Confidentiality ................................................................ 10 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 11 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
20.0 Compensation for Research-Related Injury ........................................................... 12 
21.0 Economic Burden to Subjects ................................................................................ 12 
22.0 Consent Process ..................................................................................................... 12 
23.0 Process to Document Consent in Writing .............................................................. 13 
24.0 Setting .................................................................................................................... 13 
25.0 Resources Available ............................................................................................... 14 
26.0 Multi-Site Research* ............................................................................................. 14 
 
 
 

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1.0 
Study Summary 
 
Study Title 
Feasibility, acceptability, and preliminary efficacy of 
combined transcranial direct current stimulation and 
mindfulness for pain after total knee arthroplasty    
Study Design 
Pilot randomized controlled trial 
Primary Objective 
Assess feasibility/acceptability of the intervention 
Secondary 
Objective(s) 
Assess preliminary effectiveness on pain intensity and pain 
interference with activities 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Combined Mindfulness-based intervention (MBI) + 
transcranial direct current stimulation (tDCS) vs sham 
MBI+sham tDCS 
IND/IDE #  
 
Study Population 
Preoperative patients undergoing total knee replacement 
(TKR) 
Sample Size 
40 
Study Duration for 
individual 
participants 
1 month 
Study Specific 
Abbreviations/ 
Definitions  
CPSP: chronic post-surgical pain 
MBI: mindfulness-based intervention 
tDCS: transcranial direct current stimulation 
EG: experimental group 
CG: control group 
 
2.0 
Objectives* 
2.1 The goal of this project is to assess the preliminary feasibility, acceptability, 
and efficacy of self-administered preoperative tDCS+MBI in older adults (50+) 
undergoing TKR. The central hypothesis is that combined preoperative tDCS+MBI 
will decrease postoperative analgesic consumption, postoperative clinical pain 
severity, as well as preoperative pain-related cortical response. We will accomplish 
three aims using a randomized controlled trial. 
2.2 Hypotheses:  
To determine the effects of 5, 20-minute preoperative self-administered tDCS 
sessions combined with brief MBI on analgesic medication consumption following 
TKR 
Hypothesis 1: participants receiving preoperative active tDCS+MBI will show reduced 
postoperative analgesic consumption. 
To determine the effects of 5, 20-minute preoperative self-administered tDCS 
sessions combined with brief MBI on postoperative pain severity following TKR  
Hypothesis 2: participants receiving preoperative active tDCS+MBI will show reduced 
postoperative pain intensity and pain interference with physical and emotional function 5 
days and 1 month after TKR. 
To explore the effects of 5, 20-minute preoperative self-administered tDCS 
sessions combined with brief MBI on preoperative endogenous pain modulation  

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Hypothesis 3: participants receiving preoperative active tDCS+MBI will 
show improved preoperative endogenous pain modulation. 
 
3.0 
Background* 
Osteoarthritis (OA) is a leading cause of disability with 32.5 million adults 
diagnosed in the United States (US)1 and the number of people affected is 
predicted to climb conjointly with life expectancy2. TKR is among the three most 
common inpatient surgeries performed in the US3, and patients undergoing TKR 
commonly experience acute pain and consume analgesic medications after 
surgery, more importantly in the first 48-72 hours4,5. While acute pain in the 
surgical context is expected, greater pain predicts worse outcomes for TKR 
patients, including chronic post-surgical pain (CPSP)4,6 in up to 44% of patients, 
thus impacting their quality of life6-8. Opioid analgesics have traditionally been 
used to manage pain related to a TKR procedure13,14. However, the iatrogenic 
potential of opioids in the perioperative (e.g., respiratory depression, delirium) 
and postoperative phases (e.g., misuse, addiction, cognitive impairment, 
decreased level of activity)15, particularly in older adults, has led to efforts in 
examining non-pharmacological pain management strategies 16,17. Moreover, the 
current biopsychosocial framework for pain management calls for a multimodal 
approach18. 
4.0 
Study Endpoints* 
4.1 Measures will be taken by a research assistant via a telephone 
interview using a Qualtrics® survey. Outcome measures will be 
taken at 4 time points: 1) baseline (before preoperative active/sham 
tDCS+MBI), 2) after 5 sessions of preoperative active/sham 
tDCS+MBI, 3) after surgery, and 4) 1 month after surgery (see table 
below) 
4.2 Primary endpoint: Analgesic consumption. The dose of every opioid 
received within 5 days postoperatively will be transcribed and 
converted into standardized parenteral morphine equivalents using 
the Centers for Disease and Control Prevention Guidelines on 
opioids 42. A total in milligrams will be calculated for each day and 
means will be obtained for all groups. 
4.3 Secondary endpoints: pain severity (numeric rating scale 0-100), 
pain interference with activities (numeric rating scale 0-10), 
depression and anxiety (PHQ-4), pain catastrophizing (Pain 
Catastrophizing Scale), multimodal quantitative sensory testing 
(QST) including heat pain (e.g., threshold, tolerance), pressure pain 
threshold, punctate mechanical pain (e.g., suprathreshold ratings 
and temporal summation), and Conditioned Pain Modulation (CPM), 
acceptability and feasibility 
 
 
 
Day/month  
B 
Preoperative phase 
Postoperative phase 

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Day 
1 
Day 
2 
Day 
3 
Day 
4 
Day 5 
Day 1 
 
Day 2 
Day 
3 
Month 
1 
Medical History 
Questionnaire 
X 
 
 
 
 
 
 
 
 
 
Analgesic 
consumption 
(primary outcome) 
 
 
 
 
 
 
X 
X 
X 
X 
Clinical Pain 
severity 
(secondary 
outcome) 
 
   NRS  
X 
 
 
 
 
X 
 
 
 
 
X 
X 
   BPI 
X 
 
 
 
 
X 
 
 
X 
X 
   PHQ-4 
X 
 
 
 
 
X 
 
 
X 
X 
   PCS 
X 
 
 
 
 
X 
 
 
X 
X 
Pain-related 
Cortical Response 
(secondary 
outcome) 
 
 QST measures 
X 
 
 
 
 
X 
 
 
 
 
Acceptability and 
feasibility 
 
 
 
 
 
 
 
 
 
 
   tDCS + MBI 
experience 
questionnaire  
 
 
 
 
 
X 
 
 
 
 
   Side effects 
questionnaire  
 
X 
X 
X 
X 
X 
 
 
 
 
 
 
5.0 
Study Intervention/Investigational Agent 
5.1 Dr Ahn’s laboratory research coordinator, Lindsey Park, who is the research 
coordinator for previous and ongoing tDCS studies (R01NR019051 and R15NR018050), 
will be responsible for coordinating and supervising the intervention sessions. Equipment 
will also be provided by Dr Ahn’s lab. Participants will receive a brief training at the lab to 
explain the procedure and how to use the device at the time of enrollment (after their 
preoperative visit at the clinic). Participants will go home with the tDCS device and 
videoconference meetings will be scheduled for the monitoring of sessions. Each 
session will start with tDCS and end with a brief mindfulness meditation using audio 
recording, i.e., 3-minute breathing space. This exercise is a well-established strategy 
that is being used in MBI for acute pain19 and chronic pain35. 
 
6.0 
Procedures Involved* 
6.1 
This study will use double-blind randomized sham-controlled design with 
an allocation ratio of 1:1 with repeated measures at 4 time points. Participants 
will be randomly assigned to one of 2 arms as follows: 1) preoperative active 
tDCS+MBI or 2) preoperative sham tDCS+MBI. Participants will be recruited at 
their preoperative visit (see letter of collaboration). A clinician (registered nurse or 
surgeon) or a research coordinator from the clinic will review the preoperative 

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clinic schedule, conduct a pre-screening of potentially eligible participants, and 
introduce the study to potential participants at their preoperative visit by using a 
flyer. If the individual agrees to learn more, the PI or RA (Katherine Lewis) will 
enter the room to discuss study, answer questions and sign the consent. If they 
agree to participate, after signing the consent, they will be invited to come to the 
brain stimulation laboratory (FSU innovation park) where a baseline assessment 
will be done before randomization by the RA or lab research coordinator (Lindsey 
Park). The tDCS device along with instructions will then be provided. The 
baseline visit will take approximately 2 hours. The preop procedures will be as 
follows with T = day of surgery: 
 
T-7: Recruitment/Consent 
T-6: Baseline lab measurements & tDCS fitting and training 
T-5: AM & PM remote tDCS/MBI 
T-4: AM & PM remote tDCS/MBI 
T-3: AM remote tDCS/MBI + Post-intervention lab measurement & collect tDCS 
equipment 
 
6.2 Measures:  
Usual sociodemographic variables (i.e., age, sex, civil status, living conditions, 
education level, and employment status) will be assessed. Relevant medico-
surgical information during hospitalization will be collected: type of surgery, 
postoperative complications, and current involvement in a rehabilitation program. 
The presence of chronic pain before surgery will also be documented.  
Outcome measures will be taken at 4 time points: 1) baseline (before preoperative 
active/sham tDCS+MBI), 2) after 5 sessions of preoperative active/sham tDCS+MBI, 3) 
after surgery, and 4) 1 month after surgery. Table 1 gives an overview of all measures 
for the preoperative and postoperative phases. 
Analgesic consumption. The dose of every opioid received within 5 days postoperatively 
will be transcribed and converted into standardized parenteral morphine equivalents 
using the Centers for Disease and Control Prevention Guidelines on opioids 42. A total in 
milligrams will be calculated for each day and means will be obtained for all groups. 
Pain severity. Pain intensity is a global indicator of the pain experience. It will be 
assessed with a numerical rating scale (NRS) (0-100) with the anchors being no pain at 
all (0) and worst possible pain (100).  This type of scale is recognized for its reliability, 
validity and sensitivity in various clienteles and settings 41,43,44 and is a reliable and well-
validated measure with good ability to detect pain change in adults with knee OA 45. Four 
different measures of pain intensity will be taken: 1) average pain upon movement in the 
past 7 days, 2) worst pain upon movement in the past 7 days, 3) present pain upon 
movement, and 4) present pain at rest. As suggested by the IMMPACT group in regard 
to pain core domains in clinical trials 41,46, the impact of pain on various aspects of daily 
living will be assessed with interference items of the Brief Pain Inventory (BPI) 47. The 
BPI has been successfully validated patients suffering from OA and undergoing TKR 6,48. 
It includes seven items and evaluates the impact of pain on general activity, mood, 
walking, work, relationships, sleep, and enjoyment of life via a NRS (0-10). Each item 
represents a subscale and can be scored and analyzed individually (0-10), with the 
anchors being “does not interfere” (0) and “completely interferes” (10). A total 
interference score can also be calculated by taking the sum of all the items. Additionally, 

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with regards to emotional function, considering established relations between pain, 
anxiety, and depression 49, measures of anxiety and depression will be taken with the 
Patient Health Questionnaire-4 (PHQ-4) for depression and anxiety at all time points 50. 
Total score is determined by adding together the scores of each of the 4 items. Scores 
are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 
for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests 
depression. The validity and reliability of the Patient Health Questionnaire-4 has been 
well established including with surgical clienteles 51,52. The Pain Catastrophizing Scale 53 
will be used to assess patients’ pain-related catastrophic thoughts. It includes 13 items 
divided into three subscales: rumination (4 items), magnification (3 items), and 
helplessness (6 items). Each item is rated on a 5-point scale with the end points not at 
all (score=0) and all the time (score=4). The total score and scores for each subscale 
can be calculated by taking the sum of the items. The Pain Catastrophizing Scale has 
demonstrated an excellent internal consistency, and its sensitivity in the context of 
chronic pain has been established 54,55. Pain severity will also be measured 1 month 
after surgery to explore sustained efficacy of combined tDCS+MBI on the incidence and 
severity of persistent post-surgical pain. 
A multimodal Quantitative Sensory Testing (QST) battery will be completed: heat pain 
(e.g., threshold, tolerance), pressure pain threshold, punctate mechanical pain (e.g., 
suprathreshold ratings and temporal summation), and Conditioned Pain Modulation 
(CPM). These measures, which were utilized in our previous and ongoing study 
(R01NR019051 and R15NR018050), will be assessed using equipment and methods 
available at the Dr. Ahn’s laboratory, including a Medoc TSA-II Neurosensory Analyzer 
and Wagner pressure algometer. 
Acceptability and feasibility. We will collect data on participants’ tDCS experience via a 
questionnaire, at the conclusion of tDCS treatment on a 0 (strongly disagree) to 10 
(strongly agree) scale: 1) It was easy to prepare the device and accessories; 2) The 
device was unnecessarily complex; 3) The device was easy to use; 4) I felt the video 
conferences with a technical person were helpful; 5) I would imagine that most people 
would learn to use this device quickly; 6) The device was cumbersome to use; 7) I felt 
confident using the device; 8) I needed to learn a lot of things before I could get going 
with this device; 9) The effectiveness of the treatment increased over the course of 
treatment; 10) Overall, I felt that transcranial electrical stimulation treatment benefited 
me. Moreover, we will evaluate the presence and severity of possible side effects of 
treatment at the end of each session on a 0 (not at all) to 10 (highest degree) scale. By 
using open-ended questions, the participants will be asked whether they experienced 
any side effects, and they will then be asked specifically about tingling, itching sensation, 
burning sensation, pain at the stimulation site, fatigue, nervousness, headache, difficulty 
concentrating, mood change, and changes in vision or visual perception. If any side 
effects are reported, the degree of relatedness to the intervention will be assessed on a 
5-point scale. This approach has been used in our previous study and frequently in other 
studies 58-60. Regarding feasibility, we will calculate the percentage of participants who a) 
met the inclusion criteria, b) agreed to be randomly assigned, c) completed the full 
tDCS+MBI protocol, and d) attended the follow-up assessment. 
 
 
6.3 Treatment conditions:  
The Food and Drug Administration (FDA) has ruled that the aforementioned 
tDCS stimulator is a “non-significant risk” device, a requirement for 
Investigational Device Exceptions. For pain treatment, tDCS is typically delivered 

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with the anode electrode placed over the primary motor cortex (M1) and with the 
cathode electrode placed over the supraorbital region (SO)36,37. A panel of 
experts from the European Chapter of the International Federation of Clinical 
Neurophysiology recommends 20-minute M1-SO stimulation using 2 mA 
electrical current intensity for possible efficacy among populations with chronic 
pain38. tDCS with a constant current intensity of 2 mA will be applied for 20 
minutes per session twice a day for 2.5 days before surgery (preop tDCS) via the 
Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY; 6.5 inches 
long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked 
surface sponge electrodes. The sponge electrodes snap into the custom 
headgear, which is secured to the participant’s head for simple and fail-safe 
electrode preparation. This single-position headgear with clearly labeled sponge 
markers eliminates room for user error and helps conserve the placement of the 
montage. Participants can only administer a stimulation session via the Soterix 
1x1 tDCS mini-CT Stimulator device after being provided a single-use unlock 
code by the research staff once proper contact quality is achieved (only the on/off 
button is adjustable by the study participants; they will not able to adjust the 
device settings). After the participant enters the unlock code, the screen on the 
device will show a timer that counts down the minutes until the end of the 
session. At 20 minutes, the device will turn off automatically, and study staff will 
instruct the participant to remove the headset and discard the sponges and to 
safely store all materials for the next session. 
For preoperative sham stimulation, the electrodes will also be placed twice a day 
for 2.5 days in the same positions as for active stimulation, but the stimulator will 
only deliver 2 mA current for 30 seconds. This sham stimulation method has 
been shown to be reliable and indistinguishable from active treatment39,40. 
Regarding sham brief MBI, participants will be invited to practice a standard 
relaxation exercise for 3 minutes by listening to an audio recording. 
 
7.0 
Data and Specimen Banking* 
7.1 Data (questionnaires, sociodemographic and clinical info) will have 
identifiers removed and banked indefinitely. Data will be available 
to research team, PI, RA, statistician. Data will be stored on a 
password-protected computer. The computer will be stored in a 
locked room. 
 
8.0 
Sharing of Results with Subjects* 
8.1 Data will be released to participants upon request and approval by 
PI (HIPAA). De-identified datasets will be available to the scientific 
community upon request (depending on the journal policy in which 
results will be published). 
 
9.0 
Study Timelines* 

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• 
The duration of an individual subject’s participation in the 
study: 1 month 
• 
The duration anticipated to enroll all study subjects: 6 months 
• 
The estimated date for the investigators to complete this study: 
7 months 
 
10.0 Inclusion and Exclusion Criteria* 
 
Inclusion criteria: elective unilateral knee total replacement, (4) mentally capable 
of reading, giving consent and following instructions, (5) being able to answer 
questions in English, (6) not pregnant. Exclusion criteria include: (1) history of 
brain surgery, brain tumor, seizure, stroke, or intracranial metal implantation, (2) 
systemic rheumatic disorders, including rheumatoid arthritis, systemic lupus 
erythematosus, and fibromyalgia, (3) alcohol/substance abuse, (4) current use of 
sodium channel blockers, calcium channel blockers and NMDS receptor 
antagonists, (5) hospitalization within the preceding year for psychiatric illness, 
and (6) no access to a device with internet access that can be used for secure 
videoconferencing for real-time remote supervision. 
 
Following populations will not be included: 
• 
Adults unable to consent 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women 
• 
Prisoners 
11.0 Vulnerable Populations* 
11.1 N/A 
 
12.0 Local Number of Subjects 
12.1 N=40 (completers) 
 
13.0 Recruitment Methods 
An experienced research assistant (RA) and/or the PI will be responsible of 
participants’ recruitment and informed consent procedures.  
The research coordinator (Phillip Worts) will review the preoperative clinic 
schedule. The individual will conduct a pre-screening of potentially eligible 
participants (see attached HIPAA waiver). A clinician (Registered nurse, Victoria 
Haley) will introduce the study to potential participants at their preoperative visit 
by using a flyer. If the individual agrees to learn more, the PI or RA will enter the 
room to discuss study, answer questions, sign the consent and schedule the visit to 
the lab. Before any in-person interaction, COVID-19 screening will be conducted. 

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The PI and RA are fully vaccinated, they will use the CDC self-checker tool and 
wear a mask at all times, as well as respect the clinic’s current policies. Patients 
usually receive a COVID screening before starting their visit at the clinic and the 
clinician will inform them about FSU COVID-19 precautions and distribute the 
FSU Information sheet. 
13.1 Source of subjects: community/outpatient clinics 
13.2 Participants in both groups will receive gift cards of $100 at the end 
of the study. 
14.0 Withdrawal of Subjects* 
14.1 Participants will be withdrawn without their consent if 
complications occur during their postoperative recovery and they 
need to be re-admitted to the hospital. 
 
15.0 Risks to Subjects* 
15.1 No adverse events have been reported in relation to mindfulness-
based intervention or tDCS. We have conducted several studies on 
tDCS and patients minimal side effects such as slight itching 
(present in 30% of people as reported by systematic reviews) or 
tingling on the scalp (present in 70% of people as reported in 
systematic reviews). Although we have not observed other side 
effects. Systematic reviews report the possibility of dizziness in 10% 
of people, nausea in 3% and headache in 11% of people. The Food 
and Drug Administration (FDA) has ruled that the aforementioned 
tDCS stimulator is a “non-significant risk” device, a requirement for 
Investigational Device Exceptions.  
15.2 Patients may feel tired while completing questionnaires, but they can 
pause and resume at any time. Individual interviews and some items 
from questionnaires may allow emotions related to the experience of 
a major surgery to emerge. If psychological distress becomes 
obvious (verbatim or score on a questionnaire), the provider will be 
informed for follow-up and the patient will be encouraged to 
communicate with the clinic.  
 
16.0 Potential Benefits to Subjects* 
16.1 Based on previous studies, participants may use less opioids and 
experience less pain and anxiety. This reduction may allow for a 
better recovery and return to activities. 
 
17.0 Data Management* and Confidentiality 
17.1 The protocol will favor an intention-to-treat approach for the analysis of results.  

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Data analysis will be performed with R (Vienna, Austria) version 4.1+. Baseline 
demographic information will be summarized using descriptive statistics. Continuous 
variables will be summarized with means and standard deviations. Categorical variables 
will be summarized with counts, proportions, and medians (interquartile range). The 
distribution of all variables will be examined before any analysis, using appropriate 
statistical tests like Shapiro’s test for normality checking. If the assumption of normality is 
not met, equivalent non-parametric approaches or data transformation will be employed. 
The multiple testing problem will be accounted for using Bonferroni correction. All testing 
will be two-sided and 0.05 will be used as the familywise significance level. If needed, 
statistical analysis will also be conducted after controlling for baseline demographics and 
clinical characteristics (e.g., age, sex, and race). 
For Aim 1, analgesic consumption measured on 3 consecutive days will be summarized 
into one number for each subject. Two-sample t-test (or non-parametric alternative) will 
be employed to determine the significance of the difference between the active and the 
sham tDCS+MBI groups. Multivariate linear regression will be further employed to 
account for potential confounding factors, including selected baseline demographics and 
clinical characteristics (e.g., age, sex, race, and body mass index). For Aim 2, we will 
conduct multivariable regression analysis to compare the change in clinical pain intensity 
(NRS, BPI, PHQ-4, PCS) from baseline to Day 3 in the postoperative phase after 
controlling for baseline and other confounding factors (e.g., age, race, sex, baseline 
NRS, consumption of pain medications). We will also determine whether the 
improvement conferred by active tDCS+MBI can be sustained by comparing the clinical 
pain intensity changes from baseline to 1 month between the active and the sham 
groups. We will also conduct sex-stratified analysis and explore whether there exists sex 
difference in these effects. For Aim 3, the QST dataset for endogenous pain modulation 
will be analyzed using multivariate linear regression for changes in each of the QST 
measures against potential confounding factors, and backward stepwise variable 
selection will then be performed to identify the parsimonious model structures. 
Spearman rank-order correlation will be used to quantify the association between 
changes in each of the QST measures and the changes in clinical pain intensity (NRS).   
17.2. The PI, RA and research coordinator received the CITI training. Data will 
be de-identified and a code will be assigned to each participant.  
17.3 
Data entry will be validated at random. 
17.4 
Data (questionnaires, sociodemographic and clinical info) will 
have identifiers removed and banked for a minimum of 3 years per 
Federal regulations. Deidentified data will be available to research team: 
PI, co-I (Dr Ahn and Dr Johnson), RA, statistician (Dr Miao, CON). Data 
will be stored on a password-protected computer. The computer will be 
stored in a locked room. Any data collected online will be stored on an 
encrypted data server at the CON. Any downloaded data will be stored on 
a password protected computer. The RA supervised by the PI will be 
responsible for data receipt. Dr Ahn and Dr Johnson will assist with 
results interpretation. 
 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 

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Dr Martorella has the primary responsibility for monitoring study 
research staff. Research team will receive training on the study design, 
recruitment and protocol. Weekly meetings will take place with study staff 
to ensure protocol adherence and monthly meetings with co-investigators 
to discuss any issues. Patients’ experiences and any potential adverse 
events will be reviewed and discussed. Each treatment session will be 
remotely supervised via zoom and after each session any potential side 
effects will be investigated and documented by the research coordinator 
(see questionnaires), Lindsey Park. This monitoring will be continued 
after surgery for the remainder of the data collection (up to 1 month).  
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Privacy interest protection is increased by the use of online data 
collection and intervention tools. Regarding individual interviews, 
we believe that the questions will not be perceived as intrusive as 
they only address the intervention and its convenience for patients. 
However, we will highlight that there is no obligation to answer. 
Also, if participants prefer not to be recorded, we will take notes on 
their response and not use the recorder. 
19.2 We will explain to the participants that they can complete 
questionnaires and strategies at their own pace and that if they feel 
that a question is making them uncomfortable, they have no 
obligation to respond.  
 
20.0 Compensation for Research-Related Injury 
20.1 N/A 
 
21.0 Economic Burden to Subjects 
21.1 N/A The intervention is provided remotely. All necessary materials 
and equipment will be provided. Data collection will be remotely as 
well. The only time participants will travel to the lab is at the time of 
the preoperative visit so they can get equipment and baseline data 
can be collected. 
 
22.0 Consent Process 
22.1 If the patients are interested in participating,  
A clinician/research coordinator from TOC will introduce the study to 
potential participants at their preoperative visit by using a flyer, and if the 
individual agrees to learn more, the PI or RA will enter the room to 
discuss study, answer questions and have the participant sign the consent 

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on a printed copy. Once the study team member will have countersigned 
the consent, a copy will be provided to the participant and a copy will be 
kept by the study team in a locked cabinet in the PI’s office. the Before 
any in-person interaction, COVID-19 screening will be conducted. 
Although, the PI and RA are fully vaccinated, they will use the CDC self-
checker tool and wear a mask at all times. Patients usually receive a 
COVID screening before starting their visit at the clinic and the clinician 
will inform them about FSU COVID-19 precautions. An FSU information 
sheet on FSU COVID-19 precautions will also be distributed at the time of 
consent. 
We believe that the study will be perceived as being independent 
from the clinical setting and that participants will not experience 
undue influence. Moreover, it will be underlined that participating in 
the study or not will not affect the care they receive. 
22.2 Participants will be adults, not cognitively impaired, who can 
understand and read English and able to consent. No vulnerable 
populations will be involved. 
23.0 Process to Document Consent in Writing 
23.1 The consent will be obtained and signed on paper at the 
preoperative clinic or at the lab baseline visit. 
 
24.0 Setting 
24.1 Participants will be recruited in the community during their 
preoperative visit. All intervention and assessment procedures will 
be performed remotely, online or via telephone, except for the 
consent and baseline questionnaire (baseline visit) and one follow-
up visit before surgery (after the preoperative intervention). 
Telephone/zoom interviews will be done from Dr Ahn’s lab at 
innovation park. 
24.2 The FSU CON is well equipped for any size research project. The 
CON provides significant research resources for faculty including, 
1) computers and computer technical support; 2) day-to-day 
financial oversight of grants; 3) assistance with financial reporting 
for project annual and final reports; and 4) consultation on research 
design, data analysis and dissemination. Dr. Martorella (PI) 
maintains individual office in the center. Each office contains a 
computer and laser printer. The center also houses a research 
conference room that can be used to meet with members of the 
research team. Telephone and video-conferencing equipment and 
programs (i.e., Skype, GoToMeeting) are also available in each of 
the research team member’s offices. Designated office space for 
federally funded research is available within the TMH Center for 
Research and Evidenced-Based Practice, in addition to a dedicated 

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file room to store study-related documents and participant files. The 
College of Nursing provides staff experienced in processing (i.e., 
collecting, inputting, coding and cleaning) high volumes of data 
including a dedicated data analyst who works solely on CON 
research, systems for instrument development and piloting including 
large scale distribution of surveys, servers and clusters for high 
demand computing, and network bandwidth to accommodate high 
volume Internet traffic.  
 
25.0 Resources Available 
25.1 Dr David Bellamy (TOC) does an average of 4 knee surgeries per 
week. Considering a potential refusal rate of 30%, it is anticipated 
that the recruitment will require at least 14 weeks if they meet all 
criteria. 
25.2 A RA will be trained and fully devoted to the project 
25.3 Participants are being followed by a team of clinicians (clinic and/or 
rehab) because of their recent major surgery, thus they have access 
to medical resources. 
 
26.0 Multi-Site Research* 
This is not a multicenter study.