Digital Care Program for Chronic Shoulder Tendinopathy Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study
Phase: NA
Conditions: Musculoskeletal Pain, Chronic Shoulder Pain, Shoulder Tendinopathy
Sponsor: Sword Health, SA

SH-RCT-CS-US-01 
 
 
 
 
 
 
 
 
 
Clinical Investigation Plan for Medical Device Studies 
 
 
 
 
Full title of investigation: 
Digital care program for chronic shoulder 
tendinopathy versus conventional physical 
therapy: a prospective, randomized 
controlled study 
Version and date of Clinical 
Investigation Plan (CIP): 
Version 1.4, 8 October 2020 
Sponsor: 
SWORD Health 
Sponsor CIP number: 
SH-RCT-CS-US-01 
 
 

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REVISION HISTORY 
 
Version 
Date 
Description 
Author 
1.0 
07/13/2020 
Original 
FC and MM 
1.1 
08/05/2020 
Content revision. Clarified procedures related to 
participant intake and assessment. 
FC and MM 
1.2 
08/26/2020 
Reviewed outcome measures and participant 
assessment procedures 
FC 
1.3 
09/22/2020 
Reviewed outcome measures, participant 
assessment procedures and clarified 
inclusion/Exclusion criteria 
FC 
1.4 
10/08/20202 
Reviewed exclusion criteria and conventional 
PT treatment protocol 
FC and SP 
 
 

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SIGNATURES 
 
The Principal Investigator (PI) and other personnel involved in the agree to perform the 
investigations and to abide by this CIP. The investigators agree to conduct the Investigation in 
compliance with all applicable laws and FDA Regulations Relating to Good Clinical Practice and 
Clinical Trials. 
 
 
Principal Investigator 
Sang (Sam) Pak, PT, DPT 
Assistant Professor, UCSF 
 
_________________________________ 
Signature 
Date: 
 
Sponsor Chief Medical Officer 
Fernando Correia, MD 
Chief Medical Officer, SWORD Health Technologies, Inc 
_________________________________ 
Signature 
Date: 
 
Sponsor Representative 
Virgílio Bento, PhD 
Chief Executive Officer, SWORD Health Technologies, Inc 
_________________________________ 
Signature 
Date: 
 
 
 

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SPONSOR 
 
Sponsor representative 
Virgílio Bento 
 
SWORD Health Technologies, Inc 
1209 Orange Street 
Wilmington, County of New Castle 
Delaware 19801 
Contact:  +1 646-519-0638 
Email: hello@swordhealth.com 
 
STUDY INVESTIGATORS 
 
Principal Investigator 
Sam Pak 
 
University of California San Francisco 
Box 0736 
San Francisco 
California 94158 
Contact:  +1 646-519-0638 
Email: sam.pak@ucsf.edu 
 
 
 
 
 

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TABLE OF CONTENTS 
REVISION HISTORY .................................................................................................................................................................... II 
SIGNATURES ................................................................................................................................................................................ III 
SPONSOR ........................................................................................................................................................................................ IV 
STUDY INVESTIGATORS ........................................................................................................................................................... IV 
1. 
BACKGROUND ..................................................................................................................................................................... 1 
1. 
SWORD HEALTH DIGITAL CARE PROGRAMS .......................................................................................................... 3 
2. 
SYSTEM TECHNICAL SPECIFICATIONS ...................................................................................................................... 4 
3. 
SECURITY AND DATA STORAGE ................................................................................................................................... 5 
3.1 
DATABASE ........................................................................................................................................................................ 5 
3.2 
WEB PORTAL ................................................................................................................................................................... 5 
3.3 
WEBSITE ........................................................................................................................................................................... 5 
3.4 
MOBILE APP ..................................................................................................................................................................... 6 
4. 
STUDY OBJECTIVE ............................................................................................................................................................. 6 
5. 
STUDY HYPOTHESIS .......................................................................................................................................................... 6 
6. 
STUDY DESIGN ..................................................................................................................................................................... 6 
7. 
STUDY OUTCOMES ............................................................................................................................................................. 6 
8. 
SAMPLE SIZE ESTIMATION ............................................................................................................................................. 8 
9. 
INCLUSION/EXCLUSION CRITERIA .............................................................................................................................. 8 
9.1. 
INCLUSION CRITERIA .................................................................................................................................................. 8 
9.2. 
EXCLUSION CRITERIA ................................................................................................................................................. 9 
10. 
CANDIDATE IDENTIFICATION AND PROCEEDINGS .......................................................................................... 9 
11. 
PROCESS OF CONSENT .............................................................................................................................................. 10 
12. 
ALLOCATION & BLINDING ....................................................................................................................................... 10 
13. 
INTERVENTION ............................................................................................................................................................ 11 
13.1. 
DIGITAL PROGRAM .................................................................................................................................................... 11 
13.2. 
CONVENTIONAL PT ..................................................................................................................................................... 12 
14. 
ASSESSMENTS ............................................................................................................................................................... 12 
15. 
STATISTICAL ANALYSIS PLAN ................................................................................................................................ 16 
16. 
RISKS AND BENEFITS ................................................................................................................................................. 16 
17. 
CONFIDENTIALITY ...................................................................................................................................................... 17 
18. 
REFERENCES ................................................................................................................................................................. 18 
ANNEX 1 - INFORMED CONSENT FORM .............................................................................................................................. 24 
ANNEX 2- DIGITAL THERAPEUTIC EXERCISE PROTOCOL ............................................................................................ 6 
ANNEX 3- CONVENTIONAL THERAPEUTIC EXERCISE PROTOCOL .......................................................................... 14 
 

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1. BACKGROUND 
 
Shoulder pain is highly prevalent, being the third main complaint in primary care settings.1–3 There 
is a wide range of reported incidence and prevalence rates, with a median of 24.8% of adults 
reporting shoulder pain every month.4 In developed countries, 1% of adults annually consult a 
primary care provider due to shoulder pain.2,5  
 
Around 65 to 70% of shoulder pain complaints involve problems in the rotator cuff (RTC) 
tendons,1,6 with incidence rising higher after the 4th decade of life.1,7–9 Abundant data from across 
the world is available on the prevalence of RTC pathologies.6,10–16 
 
RTC dysfunction represent a huge burden for healthcare systems, insurance companies and 
employers alike.1,17 Shoulder problems account for 2.4% of all general practitioner consultations 
in the UK,18 and 4.5 million visits to physicians annually in the USA.19 One study in the UK20 
estimated that nearly £310 million is spent on medical appointments in the first 6 months of 
shoulder pain onset, and additional costs of surgical procedures are estimated at 
approximately £30 million/year, with up to 50% of these costs related to sick leave from paid 
employment. More than 300,000 surgical repairs for RTC pathologies are performed annually in 
the USA, and the annual financial burden of RTC management was also estimated at $3 billion.21 
 
A myriad of international clinical practice guidelines have been put forth over the years, outlining 
the management of pain-causing shoulder disorders.22–26 Most causes of mild-to-moderate and 
gradual onset shoulder pain are treated initially with conservative care. Indeed, many recent studies 
and systematic reviews, as well as the American Academy of Orthopaedic Surgeons guidelines, 
support that firstly the patient should be directed to a physical therapy (PT) program and not 
surgery. 26–30 For some specific conditions (e.g., symptomatic small to medium full-thickness RTC 
tears), strong evidence further supports that both PT and operative treatment attain significant 
improvements in patient-reported outcomes.26 Of note, another systematic review on treatment 
options for shoulder pain suggests that passive modalities, such as manual therapy, electrotherapy 
and taping should be avoided as mono-therapy but that they could, in specific cases, provide 

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additional benefit when utilized in conjunction with therapeutic exercise programs.31 This suggests 
that the exercise component of PT is fundamental in the treatment of painful shoulder disorders. 
 
Regarding rehabilitation setting, some studies show that home-based therapy, based on exercise, could be 
as effective as conventional PT interventions.32,33 This is in line with the recent trends in healthcare delivery, 
moving away from inpatient care and towards home-based care with the intent of improving cost-
effectiveness. Furthermore, the need for home-based digital solutions is now felt more acutely than ever, in 
the face of the current pandemic.34–36  In this context, solutions enabling home-based rehabilitation without 
requiring real-time human supervision can be key to improving effectiveness and lowering costs, while 
keeping all stakeholders safe. Indeed, there are studies demonstrating the potential37–39 and cost-
effectiveness40 of shoulder postoperative care and rehabilitation through telehealth solutions.  
 
However, while evidence is growing that digital therapeutics (DTx) can improve outcomes, personalize 
care and decrease costs,41 there is still much ground to be explored in the field of digital therapy following 
RCR.42,43 Several studies can be found on the validation/development of systems/algorithms for monitoring 
shoulder motion to assist clinicians on patient evaluation44,45 but these do not meet the aforementioned needs 
and cannot be considered digital therapeutics. 
 
There have been some advances on new technologies for shoulder rehabilitation, namely using wearable 
sensors43 and augmented reality.46 Of note, some of these studies focus on systems based on inertial motion 
trackers that can be used by the patient at home, under remote monitoring from the physical therapist. 
However, these are either in very preliminary stages of development or validation,47–51 with no clinical 
validation studies performed, or are directed at rehabilitation after stroke.43,46  
 
SWORD Health has developed a novel motion tracking-based digital biofeedback system for 
home-based physical rehabilitation - SWORD PhoenixÒ- which is an FDA-listed class II medical 
device. The company has previously conducted two pilot studies (NCT03047252; NCT03045549) 
comparing a digital therapy program using this device against conventional face-to-face physical 
therapy. These studies have proven the feasibility, safety and effectiveness of this digital 
therapeutic on rehabilitation after total knee and hip arthroplasty.52–54  
This is a single-center, prospective, randomised, controlled study, with two parallel groups, 
designed to assess the clinical impact of a digital exercise program against conventional 
rehabilitation for shoulder tendonitis. The hypothesis is that all the clinical outcomes measured 

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will significantly improve after the program, and patients using this novel system will attain at 
least the same outcomes than the ones attained by the conventional PT group. 
 
2. SWORD HEALTH DIGITAL CARE PROGRAMS 
 
SWORD Health’s Digital Care programs address the three pillars of musculoskeletal care: 
therapeutic exercise, patient education and cognitive behavioural therapy (CBT).  
 
The exercise component is delivered through a digital feedback system - SWORD PhoenixÒ- 
which is an FDA-listed class II medical device. This device uses motion tracking technology to 
digitize motion and provide real-time biofeedback on performance during exercise execution (see 
more below). This allows individuals to perform independent exercise sessions at home without 
the need for constant face-to-face therapist supervision, while still being remotely monitored 
(asynchronously) through a cloud-based Portal. 
The safety and effectiveness of digital exercise programs performed with this device, in a home-
based scenario, have already been demonstrated for recovery after total knee and hip 
arthroplasty.53–55 In these studies, where digital programs based on this device were compared with 
conventional PT, the clinical outcomes were superior in the digital group. These results were 
explained by (a) the positive impact of a kinematic biofeedback tool on patient performance, 
especially regarding error correction and stimulation of a greater range of motion; (b) patient 
empowerment regarding their rehabilitation process; (c) high patient engagement through the use 
of gamification strategies; (d) the positive effect of remote monitoring on patient effort and (e) the 
availability of objective data for clinical review, enabling data-driven decisions. 
 
The education component is delivered through a smartphone app. Through this app, each 
individual is presented with educational content on their condition, in the form of small articles 
curated by SWORD’s clinical team, focusing on subjects ranging from anatomy and physiology, 
pain, exercise and fear avoidant behaviours. 
 
The CBT component takes the form of an 8-week program based on third-generation CBT 
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Therapy and Compassion-based therapy. The program is presented to individuals through email, 
with links to short, pre-recorded, self-guided, meditation sessions, as well as written mindfulness 
exercises called “habit releasers”. 
 
3. SYSTEM TECHNICAL SPECIFICATIONS 
 
SWORD Phoenix® is a proprietary, 510(K) exempt, class I medical device, with CE mark, which 
is composed of the following three interconnected components: 
 
§ 
Motion trackers, placed on body segments using Velcro® straps. Each motion tracker is placed in a 
specific position. To assist in the correct placement of the motion trackers, both the trackers and the 
matching straps are color-coded. The motion trackers' setup varies according to each therapy. 
 
§ 
Mobile App, that comes pre-installed on a tablet, that guides the patient in each exercise session. Before 
each exercise, the patient is presented with a real-life video and audio explanation of that exercise. The 
execution interface is subsequently shown. This screen features: a) a progress bar; b) a repetition 
counter; c) a star counter and d) a timer displaying time left in the exercise. A correct repetition is 
defined as a movement starting at the baseline and reaching or surpassing the specified target, without 
violating movement or posture constraints. In case the patient violates a constraint, a message is 
prompted showing which movement error was performed, so that the patient can correct the movement 
in the following attempts. For each correct repetition, the patient earns from 1 to 5 stars, depending on 
the range of motion of that specific movement in comparison to normative values for that movement. 
At the end of each session, the patient is presented with a summary of the number of completed 
repetitions and stars, as well as with badges rewarding him for the progresses achieved in each exercise. 
 
§ 
Web-based Portal that allows the clinical team to generate new patient profiles and create exercise 
sessions for each patient. To prescribe a session, the clinician needs to select the exercises, number of 
sets and number of repetitions.  When a patient performs a session, the results are uploaded to the 
platform and available for review. Based on this information, the clinical team can edit the parameters 
of each exercise according to patient performance and progress. 
 
 

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4. SECURITY AND DATA STORAGE 
 
4.1 DATABASE 
The networks where SWORD Health’s infrastructure is hosted are maintained by Google and are 
included in Google Cloud Platform’s SOC2 and HITRUST certifications. Security-related 
configurations are registered and verified periodically. 
Collected data is stored in databases that are only accessible to SWORD’s Application 
Programming Interface (API), and Personal Health Information (PHI) is individually encrypted 
inside this database. Separate databases are used for development, QA, and production 
environments. 
 
4.2 WEB PORTAL 
Data is secured in transit to SWORD's Application Programming Interface (APIs) due to enforced 
application of TLS 1.2 or above. Additionally, a web application firewall protects our servers from 
Cross-site Scripting (XSS) and SQL Injection attacks. 
Access to SWORD's Web Portal is provided only to individuals who have a valid work contract 
with SWORD Health and have a role within the company that allows them to use the platform (i.e. 
PTs and IT support). 
Access control mechanisms ensure that only authorized users have access to PHI and different 
functions are mapped to different roles within the platform (i.e. IT support personnel only have 
access to de-identified data). 
 
4.3 WEBSITE 
SWORD's Onboarding Website does not have a login function as it works only as a registry 
platform and user accounts are created in SWORD's Web Portal. Data is secured in transit to 
SWORD's Application Programming Interface (APIs) due to enforced application of TLS 1.2 or 
above. Additionally, a web application firewall protects our servers from Cross-site Scripting 
(XSS) and SQL Injection attacks. 
 

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4.4 MOBILE APP 
For an individual to access the mobile app in the medical device, their profile must be created in 
SWORD's Web Portal. Upon profile creation, the individual is attributed a unique QR card that is 
shipped together with the medical device kit. Upon the first usage, the individual is required to set 
a personal pin code (two-factor authentication is employed, as the user must scan their QR code 
and input a confirmation code sent by text message. This is required for the first login, with 
subsequent logins being done by presenting the pin and the QR card. Each session expires within 
24 hours, requiring the individual to present these again if >24 hours have passed since the last 
usage. 
Transport Layer Security (TLS) protocols are applied on every connection to ensure secure data 
transmission between the mobile app and the Database. Additionally, data stored in the device is 
also encrypted. 
 
5. STUDY OBJECTIVE 
To assess the clinical outcomes of a digital program for chronic shoulder tendonitis versus 
conventional. PT. 
 
6. STUDY HYPOTHESIS 
The digital program will be associated with at least the same outcomes as conventional PT. 
 
7. STUDY DESIGN 
Prospective, single-center, parallel-group, randomised controlled study. 
 
8. STUDY OUTCOMES 
 
8.1 Primary Outcome 
Impact on physical function and symptoms measured through the shortened Disabilities of the 
Arm, Shoulder and Hand questionnaire (QuickDASH) between baseline and 8 weeks. 
 
 
 

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8.2 Secondary Outcomes 
The secondary outcomes will include the following: 
 
a) Impact on shoulder range of motion 
Shoulder range of motion will be measured in the following exercises: shoulder flexion; shoulder 
abduction and external shoulder rotation at 90 degrees of abduction. 
 
b) Impact on Pain 
Measured through the following question: “On a scale of 0 to 10, where 0 is no pain and 10 the 
worst pain imaginable, how would you rate your pain in the last 24 hours?” 
 
c) Interest in undergoing surgery 
Measured through the following question: “On a scale of 0 to 10, where 0 is not at all and 10 is 
extremely interested, how interested are you in undergoing shoulder surgery in the next 12 
months”? 
 
d) Medication consumption 
Measured through the following questions:  
i. 
“Are you taking any medication for your shoulder pain?”;  
ii. 
 “If yes, on how many days in a week, on average, are you taking medication for your shoulder 
pain" 
 
e) Impact on fear avoidance beliefs 
Measured by: Patient-reported questionnaire (Fear Avoidance Beliefs Questionnaire- FABQ) 
 
f) Impact on anxiety and depression 
Measured by the General Anxiety Disorder-7 scale and Patient Health Questionnaire-9 scale 
 
g) Impact on work productivity and activity impairment  
Measured through Work Productivity and Activity Impairment Questionnaire: Specific Health 
Problem v2.0 (WPAI:SHP) 
 

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h) Satisfaction with social roles and discretional social activities 
Measured through the Patient Reported Outcomes Measurement Information System 
Computerized Adaptive Test (PROMIS-CAT) scales: Ability to participate in social roles and 
activities (version 2.0) and satisfaction with social roles and activities (version 2.0). 
 
i) Patient engagement 
Measured through:  g.1) adherence to exercise sessions; g.2) drop-out rates; g.3) treatment 
intensity (i.e. total number of exercise minutes) 
 
j) Patient satisfaction 
Measured through the Net Promoter Score, by asking participants the following question: “On a scale 
from 0 to 10, how likely are you to recommend this program to a friend or colleague?” 
 
9. SAMPLE SIZE ESTIMATION 
Sample size estimation calculations were performed taking into consideration the primary outcome 
measure – the QuickDASH. In a sample of 57 patients with shoulder tendon disorders treated with 
SWORD Health’s medical device in the context of work-related conditions, the mean and standard 
deviation of the QuickDASH scale at baseline was of 59 and 19 points respectively. A Minimal 
Detectable Difference (MDD) of 11.2 points was considered, based on the psychometric properties 
of the scale.56 Considering a power of 80%, a two-sided 0.05 significance level and a 10% dropout 
rate, 80 (40+40) patients would be necessary to detect a 11.2 points difference between the two 
groups. 
 
 
10. INCLUSION/EXCLUSION CRITERIA 
 
a.  Inclusion Criteria 
a) Subjects aged between 18 and 80 years of age at enrolment 
b) Reporting intermittent or persistent shoulder pain for at least 6 weeks, and/or present at least 
50% of the time in the past 6 months 
c) Lack of visual/audio or cognitive impairment interfering with the ability to understand or 
comply with the program 

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b. Exclusion Criteria 
a) Non-English speaking 
b) Residing outside greater SF area 
c) Known pregnancy 
d) Submitted to spinal surgery less than 3 months ago 
e) Symptoms and/or signs indicative of possible infectious disorder 
f) Referred pain from spine and/or thoracic outlet syndrome 
g) Active cancer diagnosis or undergoing treatment for cancer 
h) Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of light 
to moderate physical activity 
i) Concomitant neurological disorder (e.g. stroke, multiple sclerosis, Parkinson’s disease) 
j) Dementia or psychiatric disorders precluding patient from complying with a home-based 
exercise program 
k) Illiteracy and/or serious visual or auditory impairment interfering with communication or 
compliance 
 
Additionally, any patient undergoing a PT program for shoulder pain will be required to stop 
ongoing programs to enroll in the study. 
 
11. CANDIDATE IDENTIFICATION AND PROCEEDINGS 
 
Patient recruitment will primarily be done through the use of UCSF electronic health record (EHR) 
recruitment services from the Clinical and Translational Service Institute (CTSI) to assist with 
targeting and identification of potentially eligible participants. As an “honest broker” of the EHR 
data, the service is designed to protect patient privacy and offer more efficient way to recruit 
eligible participants that meets the study’s inclusion/exclusion criteria. The cohort of patients 
scheduled to receive physical therapy services will be identified and pre-screened by CTSI to 
ensure potential participants are eligible to meet the initial study’s criteria. Once patients have been 
identified, they are flagged from their appointments for physical therapy services at the UCSF 
Outpatient Patient Faculty, and will be evaluated in-person as part of their regular initial scheduled 
visit (i.e. evaluation visit). At the time of this visit, potential participants will be assessed by one 
of the co-investigators to also ensure that participants meet the cognitive and mental capacity 

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requirements. Once the criteria are met, investigator will present the study and invite the patient to 
participate and provide consent. The participant’s screening survey data will be collected and be 
randomized to one of the two arms, coordinated by the study coordinator. All study-related 
information will be stored by electronic data capturing (EDC) system.  
 
To centralize all study-related information, a commercially available electronic data capturing 
(EDC) system will be used.  
 
Following the identification of a potential candidate, the investigator will enter the EDC portal and 
fill the screening survey. If the patient is eligible (i.e. meets inclusion criteria and does not have 
any exclusion criteria) the investigator will present the study and invite the patient to participate 
and provide consent. 
 
12. PROCESS OF CONSENT 
 
The study will be presented verbally to potential participants by a study investigator, in a face-to-
face meeting. Adequate time will be allowed for the candidate to clarify any doubts about the 
study, following which the eConsent form will be sent through the EDC platform to the participant 
and investigator, for signature. The study consent form (Annex 1) will then be signed by the 
participant and the investigator collecting consent, and stored in the EDC platform. 
 
13. ALLOCATION & BLINDING 
 
Patients will be randomly allocated to one of two groups, using random permuted blocks of 6. 
After eConsent collection, the investigator will enter the EDC portal and proceed with 
randomisation (also built into the EDC). Following randomisation, the investigator will contact 
the person responsible for the rehabilitation program in each group to allocate the participant to 
the respective study arm. Blinding of investigators and patients regarding allocation arm will not 
be possible, given the nature of the intervention. Analysis of study results will be performed by an 
independent statistician at UCSF. 
 

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14. INTERVENTION  
 
a. Digital program 
Patients in the digital intervention group will benefit from an 8-week program composed of 
therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by 
SWORD Health. These patients will be referred to SWORD Health by the investigator who 
identified the candidate. SWORD Health will then assign a physical therapist to each patient. The 
physical therapist will contact the patient for onboarding and will manage the case. 
 
Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, 
under remote monitoring by a physical therapist. Participants will be provided with a tablet 
computer with a SWORD mobile app installed, along with two inertial motion trackers (each 
comprised of a gyroscope, an accelerometer and a magnetometer) to be placed on chest, upper arm 
and wrist, respectively. These trackers enable precise movement quantification, feeding the mobile 
app, which guides the patient through the session, providing video and audio instructions before 
each exercise, as well as real-time audio and video biofeedback during the exercise. On the other 
end, the clinical teams are allowed to remotely monitor results and prescribe/edit exercise sessions 
through a web-based portal.  
  
The exercise component will follow the protocol outlined in Annex 2, which can however be 
adapted by the physical therapist to the specific needs of the participant. Participants will be asked 
to start with three 20 min sessions per week, building gradually to three 30 min sessions per week. 
Participants will not be excluded from the study in case of lower adherence, but will not be 
included in the per-protocol analysis if they perform less than 21 sessions over the course of 8 
weeks.  
Participants in this group will be considered as dropouts if they: a) choose to abandon the study; 
b) do not engage in any exercise session for at least fourteen consecutive days. 
 
The educational component will be delivered automatically through a smartphone app (available 
for iOS and Android), and will take the form of small educational texts that will be released 

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periodically to the participant. This component is not mandatory per protocol, but metrics on user 
engagement will be measured. 
 
The CBT program will take the form of a self-paced program consisting of written and pre-
recorded audio materials. An email will be sent weekly by the physical therapist to the participant, 
during the 8 weeks of the program. Each email will contain an introductory text describing the 
objectives for that week, as well as a link to that week’s audio session and a PDF attachment with 
self-guided exercises. The CBT component is not mandatory per protocol, but metrics on user 
engagement will be measured. 
 
 
 
b. Conventional PT 
 
Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face 
PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will 
follow the principles outlined in Annex 3, which includes commonly used interventions adapted 
by the physical therapist to the specific needs of the participant. 
 
Participants in this group will be excluded from the per protocol analysis if they complete less than 
14 sessions over 8 weeks. Participants in this group will be considered as dropouts if they: a) 
choose to abandon the study; b) miss four consecutive scheduled PT sessions. 
 
In addition to the face-to-face sessions, PTs will also be communicating with participants in this 
group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a 
telephone check-ins (10-15 min calls, up to twice per week).  
 
15. PARTICIPANT ASSESSMENTS 
 
Patients will be assessed at baseline, 4 and 8 weeks.  
 
Baseline Assessment 

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This assessment will involve a face-to-face visit, where the following information will be 
collected: 
a) date of birth 
b) gender 
c) height & weight 
d) body mass index 
e) formal education (years of schooling) 
f) job type 
g) previous shoulder surgery (> 3 months ago) 
h) Working status 
i) Geocodes/zip  
j) Race/ethnicity  
k) Age 
 
The following outcomes will also be assessed in this visit: a) Shoulder Range of Motion; b) 
PROMIS CAT measures. 
 
Shoulder Range of Motion will be measured in the following movements: 1) shoulder flexion; 2) 
shoulder abduction; 3) external rotations with shoulder abducted at 90 degrees. The participant 
will be asked to perform three non-painful repetitions of each movement, in a standing position. 
The investigator will measure the maximum joint angle attained by the participant, using a digital 
goniometer in each repetitions. The highest of the three values will be considered. 
 
Regarding satisfaction with social role and ability to participate in social roles and activities, these 
will be collected through PROMIS CAT v2.0. These will be collected onsite, and the results will 
then be transferred by the investigator to the eCRF. 
 
Assessment of primary outcome, as well as the remaining secondary outcomes will be performed 
through an electronic questionnaire to be filled by participants, through the EDC system. These 
will need to be filled within 5 consecutive days, counting from the date they are sent to the 
participant. To promote compliance with this schedule, whenever the deadline is approaching, 
automatic email reminders will be sent to participants. Participants will be excluded from the study 

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for protocol breach in case they don’t fill in the assessment forms. Upon completion of the baseline 
form, participants in the study will receive a stipend of $25. 
 
Additional measurements of upper limb function and tri-dimensional motion will also be 
performed at the onsite visit by the clinician, using a motion capture system. These will not be 
considered in the outcomes of this study, but will be made available for post-hoc analysis. 
 
 
Interim assessment (4 weeks) 
Participants will be required to complete a questionnaire similar to the baseline assessment, within 
a 5-day window beginning at the start of week 4. These assessments will include all the information 
pertaining to the primary and secondary outcomes, except for those that are collected through a 
face-to-face assessment. These (shoulder range of motion and PROMIS CAT measures) will not 
be collected on this assessment. Upon completion of this form, participants in the study will receive 
a stipend of $25. 
 
Final assessment (8 weeks) 
 
This assessment will involve a face-to-face visit, where the following outcomes will be assesed: 
a) shoulder Range of Motion; b) PROMIS CAT measures and c) Participant satisfaction (Net 
Promoter Score). Shoulder Range of Motion and PROMIS CAT measures will be assessed using 
a similar methodology to the one descried for the baseline assessment. 
 
Participants will also be required to complete a questionnaire similar to the baseline and interim 
assessments, within a 5-day window beginning at the start of week 4. These assessments will 
include all the information pertaining to the primary and secondary outcomes, except for those that 
are collected in the face-to-face visit. Upon completion of this form, participants in the study will 
receive a stipend of $25. 
 

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Additional measurements of upper limb function and tri-dimensional motion will also be 
performed at the onsite visit by the clinician, using a motion capture system. These will not be 
considered in the outcomes of this study, but will be made available for post-hoc analysis. 
 
 
Engagement assessment 
 
For participants on the digital group, engagement and usage metrics of the educational and CBT 
components will also be collected automatically. 
 
Additionally, the following activity log will be collected from patient’s Electronic medical records 
and time stamps, as well as paper survey (or, in the case of the digital group, sent to the study 
coordinator via email, with the participant identified only by the study ID), to be entered into EDC 
portal by study coordinator: 
1. Face-to-face visits registry (dates, times and duration) 
2. Remote sessions registry (dates, times and duration) 
3. Number and duration of contacts between PT and participant (emails, text messages, phone and 
videocalls) 
4. Total time spent on remote monitoring of the patient (digital group only) 
 
Adverse events 
In any event during the course of the study if subjects experience adverse effects of both internal 
(on-site) and external (off-site) events, a prompt reporting to the UCSF Human Research 
Protection Program (HRPP)/institutional review board (IRB) and to the sponsor of the study will 
take place. This includes any unanticipated problems involving risk to subjects noted in the study. 
The safety plan in IRB will contain protocol to help with communication and procedures that are 
in place to monitor and report adverse events should they occur. The investigators will accurately 
document causality assessment to their best knowledge and follow-up of all definite, probable, or 
unrelated adverse events to the study and safety-related information.  
 
Care continuity 
To ensure that quality of care is not compromised throughout the study, all subjects from both 

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groups will be assessed at the final appointment to determine whether further care is warranted. If 
subjects require additional physical therapy services or follow-up back to the physician, the 
primary investigator will coordinate with UCSF physical therapist to ensure continuity of care or 
proper closure of their care are complete. 
 
 
16. STATISTICAL ANALYSIS PLAN 
 
To assess differences in clinical and demographic variables of the patients allocated to the two 
study groups, independent samples t test or Mann–Whitney U test will be used for quantitative 
variables. For categorical variables, Chi-square test or Fisher’s exact test will be used.  
Outcome analysis will be performed using both an intention to treat analysis and a per-protocol 
analysis.  
The overall impact of the intervention on the primary and secondary outcomes will be assessed 
considering both the results at the 8-week assessment as well as change from baseline.  
Differences between interventions will be evaluated using independent samples t test or Mann-
Whitney U test. For non-normally distributed variables, the magnitude of the difference in the 
medians will be assessed using Hodges-Lehman estimator. Additionally, a repeated measures 
ANOVA will also be performed, with group as an independent factor and time as a within-subjects 
factor. When necessary, logarithmic transformation will be performed to obtain normally 
distributed variables. In all analysis, a significant level of 0.05 will be considered. 
 
17. RISKS AND BENEFITS 
 
Participants in this clinical study will be allocated to one of two treatment groups. In any case, they 
will be receiving an evidence-based treatment program tailored to their condition, overseen by 
physicians and physical therapists. Participants in the digital care program will be performing the 
exercise component using a certified medical device for its intended purpose. Therefore, 
participants are not running additional risks by participating in this study.  
Exercise programs can, however, be associated with temporary pain or discomfort as expected 
from the typical treatment. In the digital care group, pain and fatigue scores will be asked at the 
end of each session, and this information is relayed to the physical therapist assigned to the 

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participant, who will contact the patient in case of excessive pain or fatigue. In the conventional 
PT group, sessions will be performed under direct supervision from a physical therapist. In any 
case, both participants and physical therapists will be instructed to contact the study investigators 
in case of an adverse event. 
As to the benefits, by participating in this study, participants may experience reduction in pain, 
improvement in function, mood and general well-being. However, the effects may vary from 
person to person, and therefore substantial improvements cannot be guaranteed. 
 
18. CONFIDENTIALITY 
 
PHI will be shared with individuals and organizations that conduct or watch over this research, 
including: 
- 
The research sponsor 
- 
People who work with the research sponsor 
- 
Government agencies, such as the Food and Drug Administration 
- 
The Institutional Review Board (IRB) that reviewed this research 
Data used for dissemination of study results will be de-identified before publication. 
 
 
 

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19. REFERENCES 
 
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25.  
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after shoulder joint replacement. J Telemed Telecare. 2011. doi:10.1258/jtt.2010.100317 
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Schizophrenia. JMIR mHealth uHealth. 2017. doi:10.2196/mhealth.7030 
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019-2930-4 
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Smartphone applications for the evaluation of pathologic shoulder range of motion and 
shoulder scores—a comparative study. JSES Open Access. 2018. 
doi:10.1016/j.jses.2017.10.001 
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exercises to support clinical decision on treatment process using smartphone. In: Procedia 
Computer Science. ; 2017. doi:10.1016/j.procs.2017.06.019 
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56.  
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ANNEX 1 - INFORMED CONSENT FORM

SH-RCT-CS-US-01 
 
1 
RESEARCH SUBJECT CONSENT FORM 
 
 
 
Title: 
Digital care program for chronic shoulder tendinopathy versus 
conventional physical therapy: a prospective, randomized 
controlled study 
 
Protocol No.: 
SH-SA-MSK-US-01 
 
Sponsor: 
SWORD Health Technologies, Inc. 
 
Investigator:  
 
Sang (Sam) Pak, PT, DPT 
Assistant Professor, UCSF 
 
Study-Related 
Phone Number(s): 
650-776-5514 
 
Study-Related 
Email Contact: 
sam.pak@ucsf.edu 
 
Ethical Approval: 
 
 
DETAILED RESEARCH CONSENT 
You were asked for your verbal consent to take part in a research study. This document provides 
a concise summary of this research. It describes the key information that we believe most people 
need to decide whether to take part in this research. Later sections of this document will provide 
all relevant details. 
 
What should I know about this research? 
Your physician explained this research to you. This form sums up that explanation. 

SH-RCT-CS-US-01 
 
2 
Taking part in this research is voluntary. Whether you take part is up to you. You can choose not 
to take part. There will be no penalty or loss of benefits to which you are otherwise entitled. 
You can agree to take part and later change your mind. There will be no penalty or loss of benefits 
to which you are otherwise entitled. 
This research study has been thoroughly reviewed by an independent group called an Institutional 
Review Board (“IRB”). An IRB is a group of people who perform independent review of research 
studies. The protocol number given by the committee for this study is shown at the top of this 
information sheet. 
If you don’t understand, ask questions. Ask all the questions you want before you decide. 
 
Why is this research being done? 
The purpose of this study, which is looking to enroll about 144 subjects, is to assess the clinical 
impact of a digital program for chronic low back pain versus conventional physical therapy. 
 
How long will I be in this research? 
We expect that your taking part in this research will last 8 weeks. You will be asked to fill in a 
reassessment questionnaire once every four weeks. 
 
What happens to me if I agree to take part in this research? 
If you decide to take part in this research study, you will be assigned at random (i.e., as if tossing 
a coin) to one of two groups, which we have named digital or conventional. 
If you are assigned to the digital group, you will be receiving a kit with a tablet and sensors in the 
next few days. A mobile app on the tablet, together with the sensors, will be guiding you through 
exercise sessions according to a protocol specific for your condition. You will be assigned a 
Physical Therapist that will be monitoring your performance and progress through an online portal, 
and adapting the program accordingly.  
You will also have access to educational texts prepared by SWORD’s clinical team, which are 
available through a smartphone app which you have to download.  
You will also have access to a cognitive behavioural therapy program. This program was designed 
to help you relax and give you mental tools to deal better with your condition. This program will 
be delivered through a weekly email, which contains a description of the objectives for the week 

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3 
and a link to a pre-recorded audio session. It may also have one additional file with mental 
exercises to complement the sessions. 
If you are assigned to the conventional group, you will be receiving two 30-minute sessions for 8 
weeks, face-to-face with a Physical Therapist. These sessions will take place at the Outpatient 
faculty practice at UCSF. In addition, your assigned PT will also be communicating with you 
through a secure messaging system  (Mychart) used at UCSF or, alternatively, through telephone 
check-ins (10-15 min calls, up to twice per week).  
 
Could being in this research hurt me? 
Exercise programs can be associated with temporary pain and discomfort. If, at any point during 
the program, you unexpectedly experience any ill effects, contact the research team through the 
provided contacts: sam.pak@ucsf.edu or 650-776-5514. 
 
Will it cost me money to take part in this research? 
You will have access to this program at no cost to you. 
 
Will being in this research benefit me? 
You may experience a reduction in pain, improvement in function, mood and general well-being. 
However, the effects vary from person to person, and we cannot promise any definite benefits to 
you for taking part in this research. 
We cannot promise any benefits to others from your taking part in this research. However, possible 
benefits to others include the development of more effective evidence-based rehabilitation 
therapies for chronic musculoskeletal disorders. 
 
What other choices do I have besides taking part in this research? 
Your alternative is to not take part in the research, and discuss other alternatives with your 
physician. 
 
What happens to the information collected for this research? 
Your private information and your medical record will be shared with individuals and 
organizations that conduct or watch over this research, including: 

SH-RCT-CS-US-01 
 
4 
- 
The research sponsor 
- 
People who work with the research sponsor including the physical therapist 
- 
Government agencies, such as the Food and Drug Administration 
- 
The Institutional Review Board (IRB) that reviewed this research 
 
We may publish the results of this research. However, we will keep your name and other 
identifying information confidential. 
We protect your information from disclosure to others to the extent required by law. We cannot 
promise complete secrecy. 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. At most, the website 
will include a summary of the results. You can search this website at any time. 
Data collected in this research might be deidentified and used for future research or distributed to 
another investigator for future research without your consent. 
 
Who can answer my questions about this research? 
If you have questions, concerns, or complaints, or think this research has hurt you or made you 
sick, talk to the research team at the phone number listed above on the first page. 
 
Can I be removed from this research without my approval? 
The person in charge of this research can remove you from this research without your approval. 
Possible reasons for removal include: 
- 
It is in your best interest 
- 
The research is canceled by the FDA or the sponsor 
We will tell you about any new information that may affect your health, welfare, or choice to stay 
in this research. 
 
What happens if I agree to be in this research, but I change my mind later? 
If you decide to leave this research, contact the research team through the following contact: 
sam.pak@ucsf.edu or 650-776-5514. This will not affect your access to medical care, impact your 
legal rights or lead to any penalty or loss of benefits to which you are otherwise entitled. 

SH-RCT-CS-US-01 
 
5 
 
Will I be paid for taking part in this research? 
You will be paid a financial incentive of 25$ for each electronic questionnaire you fill out and 
hand over to your physician. 
 
Statement of Consent 
 
Your signature documents your consent to take part in this research. 
 
 
 
Signature of adult subject capable of consent 
 
Date 
 
 
 
Signature of person obtaining consent 
 
Date 
 
 
 
 
Signature of testimony in case subject is unable to sign 
 
Date 
 
 
 

SH-RCT-CS-US-01 
 
6 
 
 
 
 
 
 
 
ANNEX 2- DIGITAL THERAPEUTIC EXERCISE PROTOCOL 
 
 

SH-RCT-CS-US-01 
 
7 
 
Shoulder Pain Exercise Protocol. Phase 1 (week 1) 
Goals 
Precautions 
Recovery of full range of motion (passive and active) 
Decrease pain and inflammatory signs 
Gradually increase muscular strength 
Do not perform loaded exercises above 70º 
flexion / abduction 
Intervention 
Daily Digital Therapist Sessions 
Remote session – Assessment/Deploy 
Digital Therapist Exercises  
Mobility 
Strength 1 (External Load – RPE >8) 
Standing Position 
Shoulder Flexion 
2 sets of 8 reps 
(alternating) 
2 sets of 8 reps (2/5 lbs.) (alternating) 
Shoulder Hyperextension 
2 sets of 8 reps 
(alternating) 
 
Shoulder Abduction 
2 sets of 8 reps 
(alternating) 
2 sets of 8 reps (5/7 lbs.) (alternating) 
Scapular Plane Elevation 
2 sets of 8 reps 
(alternating) 
2 sets of 8 reps (2/5 lbs.) (alternating) 
Diagonal 1 Flexion 
 
 
Diagonal 2 Flexion 
2 sets of 8 reps 
(alternating) 
2 sets of 8 reps (2/5 lbs.) (alternating) 
Shoulder External Rotation 
2 sets of 8 reps 
(alternating) 
2 sets of 8 reps – Theraband (alternating) 
Shoulder Internal Rotation 
 
 
Hand to Back 
2 sets of 8 reps 
(alternating) 
 
Shoulder Horizontal Abduction 
 
2 sets of 8 reps (alternating) 
Shoulder Horizontal Adduction 
 
 

SH-RCT-CS-US-01 
 
8 
Shoulder External Rotation in 
Abduction 
 
3 sets of 8 reps (5/7 lbs.) (alternating) 
Shoulder Internal Rotation in 
Abduction 
 
 
Scapulae Retraction with Shoulder 
Flexion 
2 sets of 8 reps 
(alternating) 
 
Scapulae Protraction with Shoulder 
Flexion 
 
 
Arm Circles with Shoulder Flexion 
 
 
Arm Circles with Shoulder 
Abduction 
 
2 sets of 8 reps (2/5 lbs.) (alternating) 
Chair Press-Up 
 
 
Push-Up Against the Wall 
 
 
Pendulum 
 
 
Estimated Therapy Time 
20 min 
20 min 
 
 
 
 

SH-RCT-CS-US-01 
 
9 
 
Shoulder Pain Exercise Protocol. Phase 1 (weeks 2 to 4) 
Goals 
Precautions 
Recovery of full range of motion (passive and active) 
Decrease pain and inflammatory signs 
Gradually increase muscular strength 
Do not perform loaded exercises above 70º 
flexion / abduction 
Intervention 
Daily Digital Therapist Sessions 
4-Week Remote Assessment 
Digital Therapist 
Exercises  
Mobility 
Strength 1 (External 
Load – RPE >8) 
Strength 2 (External Load – 
RPE >8) 
Standing Position 
Forearm Supination 
2 sets of 10 reps 
(alternating) 
 
 
Elbow Flexion 
 
2 sets of 10 reps 
(alternating) 
 
Shoulder Flexion 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps (2/5 
lbs.) (alternating) 
 
Shoulder Hyperextension 
2 sets of 10 reps 
(alternating) 
 
2 sets of 10 reps – Theraband 
(alternating) 
Shoulder Abduction 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Scapular Plane Elevation 
2 sets of 10 reps 
(alternating) 
 
2 sets of 10 reps (2/5 lbs.) 
(alternating) 
Diagonal 1 Flexion 
 
2 sets of 10 reps (2/5 
lbs.) (alternating) 
 
Diagonal 2 Flexion 
2 sets of 10 reps 
(alternating) 
 
2 sets of 10 reps (2/5 lbs.) 
(alternating) 
Shoulder External Rotation 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps – 
Theraband (alternating) 
 

SH-RCT-CS-US-01 
 10 
Shoulder Internal Rotation 
2 sets of 10 reps 
(alternating) 
 
3 sets of 8 reps – Theraband 
(alternating) 
Hand to Back 
2 sets of 10 reps 
(alternating) 
 
 
Shoulder Horizontal 
Abduction 
 
2 sets of 10 reps 
(alternating) 
 
Shoulder Horizontal 
Adduction 
 
 
2 sets of 10 reps (alternating) 
Shoulder External Rotation 
in Abduction 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Shoulder Internal Rotation 
in Abduction 
 
 
2 sets of 10 reps (5/7 lbs.) 
(alternating) 
Scapulae Retraction with 
Shoulder Flexion 
2 sets of 10 reps 
(alternating) 
 
 
Arm Circles with Shoulder 
Flexion 
 
2 sets of 10 reps (2/5 
lbs.) (alternating) 
 
Arm Circles with Shoulder 
Abduction 
 
 
2 sets of 10 reps (2/5 lbs.) 
(alternating) 
Chair Press-Up 
 
 
2 sets of 10 reps (alternating) 
Push-Up Against the Wall 
 
 
2 sets of 10 reps (alternating) 
Pendulum 
 
 
 
Lying Position 
Shoulder Flexion 
 
2 sets of 10 reps (2/5 
lbs.) (alternating) 
 
Shoulder External Rotation 
 
 
2 sets of 10 reps (2/5 lbs.) 
(alternating) 
Shoulder Internal Rotation 
 
2 sets of 10 reps (2/5 
lbs.) (alternating) 
 
Estimated Training Time 
29 min 
29 min 
28 min 
 

SH-RCT-CS-US-01 
 11 
Shoulder Pain Exercise Protocol. Phase 2 (Weeks 5 to 8) 
Goals 
Precautions 
Range of motion conservation 
Global muscular strengthening in 
asymptomatic range of movement, focusing 
on: 
- 
Rotator cuff 
- 
Scapular stabilizers 
- 
Deltoids 
Do not perform push-ups on the floor in case of complete 
rotator cuff tears (use inclined planes) 
Intervention 
Daily Digital Therapist Sessions  
8 Week Remote Assessment 
Digital Therapist Exercises  
Mobility 
Strength 1 (External 
Load – RPE >8) 
Strength 2 (External 
Load – RPE >8) 
Standing Position 
Shoulder Flexion 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Shoulder Hyperextension 
 
 
2 sets of 10 reps 
(Theraband) 
(alternating) 
Shoulder Abduction 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Scapular Plane Elevation 
2 sets of 10 reps 
(alternating) 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
Diagonal 1 Flexion 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Diagonal 2 Flexion 
2 sets of 10 reps 
(alternating) 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 

SH-RCT-CS-US-01 
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Shoulder External Rotation 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps 
(Theraband) 
(alternating) 
 
Shoulder Internal Rotation 
 
 
2 sets of 10 reps 
(Theraband) 
(alternating) 
Hand to Back 
2 sets of 10 reps 
(alternating) 
 
 
Shoulder Horizontal Abduction 
 
2 sets of 10 reps 
(Theraband) 
(alternating) 
 
Shoulder Horizontal Adduction 
 
 
2 sets of 10 reps 
(Theraband) 
(alternating) 
Shoulder External Rotation in 
Abduction 
2 sets of 10 reps 
(alternating) 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Shoulder Internal Rotation in 
Abduction 
2 sets of 10 reps 
(alternating) 
 
 
Scapulae Retraction with 
Shoulder Flexion 
2 sets of 10 reps 
(alternating) 
 
 
Scapulae Protraction with 
Shoulder Flexion 
 
 
 
Arm Circles with Shoulder 
Flexion 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Arm Circles with Shoulder 
Abduction 
 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
Chair Press-Up 
 
 
2 sets of 10 reps 
(consecutive) 
Push-Up Against the Wall 
 
 
2 sets of 10 reps 
(alternating) 
Pendulum 
 
 
 

SH-RCT-CS-US-01 
 13 
Lying Position 
Shoulder Flexion 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Shoulder Abduction 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Shoulder External Rotation 
 
 
 
Shoulder Internal Rotation 
 
 
 
Shoulder Horizontal Abduction 
 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
Arm Circle with Shoulder 
Flexion 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
 
Arm Circle with Shoulder 
Abduction 
 
 
2 sets of 10 reps (5/7 
lbs.) (alternating) 
Estimated Training Time 
29 min 
 29 min 
 27 min 
 
 
 
 
 
 

SH-RCT-CS-US-01 
 14 
 
 
 
 
 
 
 
 
ANNEX 3- CONVENTIONAL PT INTERVENTION PROTOCOL 
 
 

SH-RCT-CS-US-01 
 15 
 
The co-investigators are encouraged to use the McClure's staged based rehabilitation therapy 
(STAR) classification (see Table 1) as a guide but not necessarily as a prescriptive manner to select 
interventions. Instead, the co-investigators will reference their use interventions categorized based 
on commonly practiced in an outpatient physical therapy setting (see Table 2).  
McClure's stage-based rehabilitation therapy (STAR) intervention approach is based on the 
Irritability of the patient's condition. Assessments of symptoms of Irritability are gathered from 
the patient's history and findings from the examination. Table 1 represents a guided approach to 
STAR for the chronic shoulder pain population and the type of interventions used. Table 2 
describes the type of commonly used physical therapy interventions that could be used in the 
cohorts.  
 
Guideline to help determine the stage of Irritability is based on both history and 
examination findings* 
 
High 
Moderate 
Low 
• Pain >= 7/10  
• Consistent night or 
resting pain  
• Pain before end of range  
• AROM < PROM 
• High disability  
 
• Pain (4-6/10) 
• Intermittent night or rest pain  
• Pain at end of range  
• AROM and PROM close 
• Moderate disability  
• Pain (<= 3/10) 
• Absent night or rest pain  
• Minimal pain with overhead  
• AROM = PROM  
• Low disability  
Approach: Minimize 
physical stress  
• Activity 
modification  
Approach: Mild-moderate physical 
stress  
• Basic-level functional 
activity restoration  
Approach: Mod-high physical 
stress  
• High-demand functional 
activities  
*Taken from Staged approach (STAR) for rehabilitation classification by McClure et al.  
 

SH-RCT-CS-US-01 
 16 
Table 1. McClure's staged approach to shoulder intervention based on different 
impairments 
 
Impairments 
Irritability  
Intervention 
Approaches 
Examples of 
Intervention**  
Restricted passive mobility 
due to joint/muscle/neural 
tissues 
Low   
• ROM 
• Stretching 
• manual therapy: 
tolerable stretch 
sensation at end-
range 
• Hold longer 
duration and 
frequency  
• Aggressive active and 
passive stretches (e.g., 
sleeper stretches; 
foam roller T's, Y's, 
I's; Doorway stretch)  
Restricted passive mobility 
due to joint/muscle/neural 
tissues 
Moderate  
• ROM 
• Stretching 
• Comfortable end-
range manual 
therapy 
• Active and passive 
stretches (e.g., gentle 
sleeper stretches; 
Foam roller T's, Y's, 
I's; modified to ½ to 
full foam roller T's, 
Y's, I's; Modified 
doorway stretch)  
Restricted passive mobility 
due to joint/muscle/neural 
tissues 
High 
• ROM 
• Stretching 
• Pain-free manual 
therapy 
• Avoid end-range 
• AAROM/PROM 
(e.g., ½ roller; towel 
rolls; wall crawl)  
Excessive passive mobility  High 
• Protect joint/tissue 
from end-range 
• Gentle isometrics  

SH-RCT-CS-US-01 
 17 
Impairments 
Irritability  
Intervention 
Approaches 
Examples of 
Intervention**  
• Manual therapy to 
reduce pain  
• Parascapular 
strengthening  
Excessive passive mobility 
Mod 
• Develop active 
control in mid-range 
while avoiding end-
range in basic 
activity 
Address 
hypomobility of 
adjacent joints or 
tissues  
• Isometrics to 
isokinetic (e.g., 
ER/IR/ABD/Flex, 
parascapular stabs)  
 
Excessive passive mobility 
Low 
• Develop active 
control during full-
range, high-level 
functional activity 
Address 
hypomobility of 
adjacent joints or 
tissues  
• Isokinetic to dynamic 
(e.g., 
ER/IR/ABD/Flex, 
parascapular stabs) 
Neuromuscular weakness 
due to atrophy, disuse, 
and/or deconditioning  
High 
• AROM within pain-
free ranges  
• AAROM/AROMS via 
Pulleys, table slides   
• Isometrics (e.g. 
ER/IR/ABD/Flex, 
parascapular stabs) 
 

SH-RCT-CS-US-01 
 18 
Impairments 
Irritability  
Intervention 
Approaches 
Examples of 
Intervention**  
Neuromuscular weakness 
due to atrophy, disuse, 
and/or deconditioning 
Mod 
• Light or moderate 
resistance to fatigue 
Mid-ranges  
• Isometrics to 
isokinetic  
• Rotator cuff 
strengthening (ER/IR) 
in neutral to variations 
of ABD via weights 
or T-band (i.e., 
ER/IR/ABD/Flex, 
parascapular stabs) 
Neuromuscular weakness 
due to atrophy, disuse, 
and/or deconditioning 
Low 
• Moderate or high 
resistance to fatigue 
Include end-ranges  
• Isokinetic to dynamic 
resistive movements  
• Rotator cuff 
strengthening 
(ER/IR/Flex/ABD) in 
progression from 
neutral to variations 
of movements via 
weights or T-band 
Neuromuscular weakness 
associated with poor motor 
control or neural 
activation  
High 
• AROM within pain-
free ranges 
• Biofeedback, 
• Neuromuscular 
electrical 
stimulation, or other 
activation strategies  
• Isometrics (e.g., 
ER/IR, parascapular 
stabs)  
• Mirror/manual cue 
feedback for 
AROM/AAROM; 
Scapular 
clock exercises 

SH-RCT-CS-US-01 
 19 
Impairments 
Irritability  
Intervention 
Approaches 
Examples of 
Intervention**  
Neuromuscular weakness 
associated with poor motor 
control or neural 
activation  
Mod 
• Basic movement 
training with 
emphasis on 
quality/precision 
rather than 
resistance according 
to motor learning 
principles  
• Isometrics to 
isokinetic (e.g., 
ER/IR, parascapular 
stabs) 
• loaded motor control 
exercises with mirror 
feedback 
Neuromuscular weakness 
associated with poor motor 
control or neural 
activation  
Low 
• High-demand 
movement training 
with emphasis on 
quality rather than 
resistance according 
to motor learning 
principles  
• Isokinetic to 
dynamics (e.g., 
ER/IR, parascapular 
stabs) 
• Progressive loaded 
motor control 
exercises with mirror 
feedback 
Restricted tolerance to 
functional activity  
High 
• Maximum joint or 
tissue protection 
from end-range 
• Advocate use of 
unaffected regions  
• Patient education 
(e.g., anatomy; 
biomechanics; 
supplemental 
youtube videos; 
Tissue healing 
timelines; Pain 
science)   
• CBT  
• Graded activity and 
graded exposure 

SH-RCT-CS-US-01 
 20 
Impairments 
Irritability  
Intervention 
Approaches 
Examples of 
Intervention**  
exercises / functional 
activities  
Restricted tolerance to 
functional activity 
Mod 
• Progressively 
engage in basic 
functional activity  
• Patient education 
(e.g., anatomy; 
biomechanics; 
supplemental 
youtube videos; 
Tissue healing 
timelines; Pain 
science)   
• CBT 
• Progress graded 
activity and graded 
exposure exercises / 
functional activities 
Restricted tolerance to 
functional activity 
Low  
• Progressively 
engage in basic 
functional activity 
• Patient education 
(e.g., anatomy; 
biomechanics; 
supplemental 
youtube videos; 
Tissue healing 
timelines; Pain 
science)   
• CBT 
• Progress graded 
activity and graded 

SH-RCT-CS-US-01 
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Impairments 
Irritability  
Intervention 
Approaches 
Examples of 
Intervention**  
exposure exercises / 
functional activities 
Limited patient 
understanding of condition 
leading to inappropriate or 
avoidance of activity  
Low/Mod/High • Select appropriate 
patient education  
• Patient education 
(e.g., anatomy; 
biomechanics; 
supplemental 
youtube videos; 
Tissue healing 
timelines; Pain 
science)   
• CBT  
• Motivational 
interviews   
**Not a comprehensive list of interventions/exercises  
 
 
 

SH-RCT-CS-US-01 
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Table 2. General Category of Physical Therapy Interventions  
Intervention 
Categories  
Description  
Type of Interventions 
Examples of 
Intervention**  
Therapeutic 
Exercises 
Systematically planned 
performance of bodily 
movement, postures, 
physical activities 
relevant to patient's 
condition* 
• Flexibility  
• Strengthening 
• Endurance   
• Neuromuscular 
reeducation  
• Functional task 
training  
• Strengthening - ER/IR 
in neutral position with 
T-band  
• Flexibility - Wall slides 
in standing  
• Functional activities 
training 
 
Patient Education  Informing, educating, 
training patients 
related to their 
condition  
• Disease condition  
• Anatomy  
• Activity modification  
• Ergonomics  
• Cognitive Behavior 
Therapy/Motivational 
Interview  
• Symptom 
management  
• Patient education on 
glenohumeral joint and 
surrounding tissues  
• Precautions of 
activities for shoulder 
joint 
Manual Therapy  
Skilled passive 
movements of 
joints/soft tissue  
• Joint mobilization  
• Soft tissue 
mobilization  
• Neural tissue 
mobilization  
• Therapeutic massage  
• Passive accessory 
motion of anterior-
posterior of 
glenohumeral joint  
• Passive physiological 
motion of 
glenohumeral joint 

SH-RCT-CS-US-01 
 23 
• Myofascial 
decompression 
(Cupping) 
Biophysical 
Agents/Modalities 
Use of a broad group 
of modalities for 
therapeutic purposes  
• Electric Stimulation  
• Ultrasound 
• Heat/Ice  
• Taping 
• Biofeedback  
• Electrical muscle 
stimulation (EMS) 
• Neuromuscular 
electrical stimulation 
(NMES) 
*Definition is taken from APTA Guide to Physical Therapists Practice  
**Not a comprehensive list of interventions/exercises  
 
 
 
 

SH-RCT-CS-US-01 
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