Digital Care Program for Chronic Low Back Pain Versus Conventional Physical Therapy: a Prospective, Randomized Controlled Study
Phase: NA
Conditions: Chronic Low-back Pain
Sponsor: Sword Health, SA

 
 
 
CLINICAL INVESTIGATION PLAN FOR MEDICAL DEVICE STUDIES 
 
 
Full title of investigation: 
Digital care program for chronic low back 
pain versus conventional physical therapy: 
a prospective, randomized controlled study 
Version and date of Clinical 
Investigation Plan (CIP): 
Version 1.5, 26 August 2020 
Sponsor: 
SWORD Health 
Sponsor CIP number: 
SH-RCT-LBP-US-01 
 
 
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I 
REVISION HISTORY 
 
Version 
Date 
Description 
Author 
1.0 
06/10/2020 
Original 
FC and CD 
1.1 
07/22/2020 
Content revision. Clarified procedures of 
participant and data intake. 
FC and MM 
1.2 
08/05/2020 
Content revision. Added intervention program 
for digital PT group. 
FC and MM 
1.3 
08/19/2020 
Content revision. Added intervention program 
for conventional PT group. 
CD and FC 
1.4 
08/24/2020 
Content revision. Clarification of method to 
collect session by session information, Added 
study contacts. 
FC 
1.5 
08/26/2020 
Updated patient stipend section. Updated 
intervention program for conventional PT. 
CD and FC 
 
 
 
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II 
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 
Cui Di, MD 
Assistant Professor of Physical and Rehabilitation Medicine, Emory University, Atlanta, Georgia 
 
_________________________________ 
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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III 
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 
Cui Di, MD 
59 Executive Park,  
Atlanta, GA 30324 
Contact: +1 6783717422 
E-mail: di.cui@emoryhealthcare.org 
 
 
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TABLE OF CONTENTS 
 
CLINICAL INVESTIGATION PLAN FOR MEDICAL DEVICE STUDIES ....................................................................... I 
REVISION HISTORY ............................................................................................................................................................ I 
SIGNATURES ....................................................................................................................................................................... II 
SPONSOR ............................................................................................................................................................................. III 
STUDY INVESTIGATORS .................................................................................................................................................. III 
1. 
BACKGROUND .......................................................................................................................................................... 1 
2. 
SWORD HEALTH DIGITAL CARE PROGRAMS ................................................................................................... 2 
3. 
SYSTEM TECHNICAL SPECIFICATIONS .............................................................................................................. 3 
4. 
SECURITY AND DATA STORAGE........................................................................................................................... 4 
4.1 
DATABASE ............................................................................................................................................................ 4 
4.2 
WEB PORTAL........................................................................................................................................................ 4 
4.3 
WEBSITE................................................................................................................................................................ 5 
4.4 
MOBILE APP ......................................................................................................................................................... 5 
5. 
STUDY OBJECTIVE................................................................................................................................................... 5 
6. 
STUDY HYPOTHESIS ................................................................................................................................................ 5 
7. 
STUDY DESIGN .......................................................................................................................................................... 6 
8. 
STUDY OUTCOMES .................................................................................................................................................. 6 
9. 
SAMPLE SIZE ESTIMATION ................................................................................................................................... 7 
10. 
INCLUSION/EXCLUSION CRITERIA................................................................................................................. 7 
11. 
CANDIDATE IDENTIFICATION AND PROCEEDINGS .................................................................................... 8 
12. 
PROCESS OF CONSENT ...................................................................................................................................... 8 
13. 
ALLOCATION & BLINDING ............................................................................................................................... 9 
14. 
INTERVENTION ................................................................................................................................................... 9 
15. 
ASSESSMENTS .................................................................................................................................................... 11 
16. 
STATISTICAL ANALYSIS PLAN....................................................................................................................... 12 
17. 
RISKS AND BENEFITS ....................................................................................................................................... 12 
18. 
CONFIDENTIALITY ........................................................................................................................................... 13 
19. 
REFERENCES ...................................................................................................................................................... 14 
ANNEX 1 - INFORMED CONSENT FORM ...................................................................................................................... 18 
ANNEX 2- THERAPEUTIC EXERCISE PROTOCOL........................................................................................................ 6 
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SH-RCT-LBP-US-01 Clinical Investigation Protocol 
 
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1. BACKGROUND 
 
Low back pain (LBP) has for long been the world’s leading cause of years leaved with disability,1 
and, considering that the overall life expectancy is rising, this pandemic only tends to get worse. 
Nearly everyone is affected by LBP at some moment in life (70-80% of lifetime prevalence).2–4 
As a consequence, LBP is also presented as a leading cause of work absenteeism worldwide.5–7 
Thus, although the estimate costs of LBP may be difficult to compare between different countries, 
its overwhelming socio-economic impact in modern society is evident.8 
 
In the absence of an effective treatment, LBP can become chronic, causing a huge impact in 
patients’ daily life,9,10 and ultimately promoting a high consumption of healthcare resources.2,8,11 
In the US alone, health expenditures for adults with spinal problems were estimated at $6000 per 
person, representing a total cost of $102 billion each year.12 
 
The dim picture described above highlights the urgent need for effective interventions that 
minimize disability, improve quality of life and decrease productivity losses.13  
 
Current guidelines on CLBP management recommend patient education, exercise, physical 
therapy (PT), and behavioural therapy as the mainstay treatments for this condition.14  
 
Despite some discrepancy in the type of exercise program (e.g. aquatic exercises, stretching, back 
schools, McKenzie exercise approach, yoga, tai-chi) and mode of delivery (e.g., individually 
designed programs, supervised home exercise, and group exercise), exercise therapy is 
recommended nearly transversally,14–17 with most studies concluding that exercise intervention 
programs should include a combination of muscular strength, flexibility and aerobic fitness 
exercises.18–20 Moreover, home exercises with a regular therapist follow-up has proven highly 
effective.21–25  
 
This is not, however, how LBP is currently managed. Appropriate patient education and structured 
behavioural training are rarely provided, and opioid prescription is also a common practice,14,26 
despite known opioid-related morbidity and mortality rates.27 Because the prevalence of CLBP is 
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continuously rising, and opioid misuse is an issue of great concern globally, identifying effective 
nonopioid alternatives for CLBP is of paramount importance. 
 
Further compounding this problem, from the patients who are directed to PT, almost half give up 
after just 4 sessions, and only 30% complete their programs.28 
 
In this context, new ways of delivering care are much needed. Crucially, these need to: a) address 
the three pillars of care to achieve good and sustained clinical outcomes; b) overcome barriers to 
access; c) ensure patients are engaged throughout the programs; d) be scalable and cost-efficient. 
 
Thus, SWORD Health has developed a digital care program to address these needs.  
 
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 I 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.29–31 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 
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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 educational component is  delivered through a smartphone 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. 
 
A dedicated third-generation Cognitive Behavioural Therapy (CBT) program, which takes the 
form of a self-paced program consisting of written and pre-recorded audio materials, is also made 
available to the individual, through a secure email platform. 
 
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 
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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.  
 
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). 
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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. 
 
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 low back pain versus conventional 
PT. 
 
6. STUDY HYPOTHESIS 
 
The digital program will be associated with at least the same outcomes as conventional PT. 
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7. STUDY DESIGN 
 
Prospective, single-center, parallel-group, randomised controlled study. 
 
8. STUDY OUTCOMES 
 
8.1 Primary Outcome 
Impact on functional disability measured through the Oswestry Disability Index score (patient 
reported outcome measure) between baseline and 8 weeks. 
 
8.2 Secondary Outcomes 
The secondary outcomes will include the following, measured between baseline and 8 weeks: 
 
a) 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?” 
b) Impact on work productivity and activity impairment  
Measured through Work Productivity and Activity Impairment Questionnaire: Specific Health 
Problem v2.0 (WPAI:SHP) 
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 back surgery in the next 12 
months”? 
d) Medication consumption 
Measured through the following questions:  
i. 
“Are you taking any medication for your low back pain?”;  
ii. 
“If yes, are you taking opioids for your low back pain?”;  
iii. 
“If yes, on how many days in a week, on average, are you taking medication for your 
low back pain" 
e) Impact on fear avoidance beliefs 
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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) 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) 
h) Patient satisfaction 
Measured through the Net Promoter Score 
i) Impact on physical activity levels 
Measured through the International Physical Activity Questionnaire- Short Form. 
 
 
9. SAMPLE SIZE ESTIMATION 
 
Sample size estimation calculations were performed taking into consideration the primary outcome 
measure – The Oswestry Disability Index (ODI). In the absence of similar studies, the calculations 
were made considering the study by Stankovic et al. (2012). This was a large study (n=160 
patients), which compared two different rehabilitation protocols for CLBP and which used the 
same primary outcome as the present study. In this study, the standard deviation of the ODI at 
baseline was 17.83 points. A Minimal Clinically Important Change (MCIC) of 10 points was 
considered, based on the study by Ostelo et al.32 Considering a power of 80% and a two-sided 0.05 
significance level, 102 individuals will be necessary to detect a 10-point difference between the 
two groups. 
 
10. INCLUSION/EXCLUSION CRITERIA 
 
10.1 Inclusion Criteria 
a) Subjects aged between 18 and 80 years of age at enrolment 
b) Reporting intermittent or persistent low back pain for at least 12 weeks, and/or present at 
least 50% of the time in the past 6 months 
c) Ability to understand complex motor tasks 
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d) Ability to interact with a tablet 
 
10.2 Exclusion Criteria 
a) Known pregnancy 
b) Submitted to spinal surgery less than 3 months ago 
c) Symptoms and/or signs indicative of possible infectious disorder 
d) Known disorder with indication for spine surgery (i.e., tumor, cauda equina syndrome) 
e) Cancer diagnosis or undergoing treatment for cancer 
f) Cardiac, respiratory or other known disorder incompatible with at least 20 minutes of 
light to moderate physical activity 
g) Concomitant neurological disorder (e.g. Stroke, multiple sclerosis, Parkinson’s disease) 
h) Dementia or psychiatric disorders precluding patient from complying with a home-based 
exercise program 
i) Illiteracy and/or serious visual or auditory impairment interfering with communication or 
compliance 
 
Additionally, any patient undergoing a PT program for low back pain will be required to stop 
ongoing programs to enroll in the study. 
 
11. CANDIDATE IDENTIFICATION AND PROCEEDINGS 
 
Candidates will be evaluated at the outpatient musculoskeletal clinic at Emory Orthopaedic and 
Spine Center (Atlanta, Ga). 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 
 
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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 a 
statistician blinded to allocation groups. 
 
 
14. INTERVENTION  
 
14.1 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 PT. 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 the upper and lower back, 
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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. 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 
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. 
 
 
 
14.2 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 protocol outlined in Annex 3, which can however be adapted by the physical therapist 
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will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive 
scheduled PT sessions. 
 
15. ASSESSMENTS AND SPECIFIC DATA COLLECTION 
 
Patients will be assessed at baseline, 4 and 8 weeks. All questionnaires will be collected through 
the EDC system. These will need to be filled within 5 consecutive days. 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 for protocol breach in case they don’t 
fill in the assessment forms.  
 
Regarding the baseline assessment, participants will be asked to complete the survey before the 
start of the program. This assessment will include all the information pertaining to the primary and 
secondary outcomes, as well as the following information: 
a) date of birth 
b) gender 
c) height & weight 
d) body mass index 
e) formal education (years of schooling) 
f) job type 
g) baseline physical activity level 
h) previous back surgery (> 3 months ago)  
i) risk factors: working status, smoking status 
 
For the 4- and 8-week assessment, participants will be required to complete the questionnaire 
within a 5-day window beginning at the start of week 4 and 8. These assessments will include all 
the information pertaining to the primary and secondary outcomes. Physical activity will be 
measured only at baseline and 8 week assessment. 
 
For participants on the digital group, engagement and usage metrics of the educational and CBT 
components will also be collected automatically. 
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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. Total time spent on remote monitoring of the patient (digital group only) 
 
When applicable, adverse events reporting will also be made through this portal and annexed to 
patient’s file (beginning date, resolution date (if applicable), resolution state, severity, description). 
 
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 12-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 
 
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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. 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 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 
 
1.  
Vos T, Barber RM, Bell B, et al. Global, regional, and national incidence, prevalence, and 
years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 
1990-2013: A systematic analysis for the Global Burden of Disease Study 2013. Lancet. 
2015;386(9995):743-800. doi:10.1016/S0140-6736(15)60692-4 
2.  
Andersson GBJ. Epidemiological features of chronic low-back pain. Lancet. 1999. 
doi:10.1016/S0140-6736(99)01312-4 
3.  
Hoy D, Brooks P, Blyth F, Buchbinder R. The Epidemiology of low back pain. Best Pract 
Res Clin Rheumatol. 2010. doi:10.1016/j.berh.2010.10.002 
4.  
Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health 
Organ. 2003. doi:S0042-96862003000900007 [pii] 
5.  
Ihlebæk C, Hansson TH, Lærum E, et al. Prevalence of low back pain and sickness 
absence: A “borderline” study in Norway and Sweden. Scand J Public Health. 2006. 
doi:10.1080/14034940600552051 
6.  
Besen E, Young AE, Shaw WS. Returning to Work Following Low Back Pain: Towards a 
Model of Individual Psychosocial Factors. J Occup Rehabil. 2015. doi:10.1007/s10926-
014-9522-9 
7.  
Kool J, Oesch P, De Bie R. Predictive tests for non-return to work in patients with chronic 
low back pain. Eur Spine J. 2002. doi:10.1007/s005860100335 
8.  
Maher C, Underwood M, Buchbinder R. Non-specific low back pain. Lancet. 2017. 
doi:10.1016/S0140-6736(16)30970-9 
9.  
Froud R, Patterson S, Eldridge S, et al. A systematic review and meta-synthesis of the 
impact of low back pain on people’s lives. BMC Musculoskelet Disord. 2014. 
doi:10.1186/1471-2474-15-50 
10.  
Gore M, Sadosky A, Stacey BR, Tai K-S, Leslie D. The Burden of Chronic Low Back 
Pain. Spine (Phila Pa 1976). 2012;37(11):E668-E677. 
doi:10.1097/BRS.0b013e318241e5de 
11.  
Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: 
Data From the 2009–2010 National Health and Nutrition Examination Survey. Arthritis 
Care Res. 2016. doi:10.1002/acr.22890 
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SH-RCT-LBP-US-01 Clinical Investigation Protocol 
 
15 
12.  
Martin BI, Deyo RA, Mirza SK, et al. Expenditures and health status among adults with 
back and neck problems. JAMA - J Am Med Assoc. 2008. doi:10.1001/jama.299.6.656 
13.  
Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness 
studies in the United States and internationally. Spine J. 2008;8(1):8-20. 
doi:10.1016/j.spinee.2007.10.005 
14.  
Oliveira CB, Maher CG, Pinto RZ, et al. Clinical practice guidelines for the management 
of non-specific low back pain in primary care: an updated overview. European Spine 
Journal. 2018. 
15.  
Chou R, Côté P, Randhawa K, et al. The Global Spine Care Initiative: applying evidence-
based guidelines on the non-invasive management of back and neck pain to low- and 
middle-income communities. Eur Spine J. 2018. doi:10.1007/s00586-017-5433-8 
16.  
Qaseem A, Wilt TJ, McLean RM, Forciea MA. Noninvasive treatments for acute, 
subacute, and chronic low back pain: A clinical practice guideline from the American 
College of Physicians. Ann Intern Med. 2017;166(7):514-530. doi:10.7326/M16-2367 
17.  
Wong JJ, Côté P, Sutton DA, et al. Clinical practice guidelines for the noninvasive 
management of low back pain: A systematic review by the Ontario Protocol for Traffic 
Injury Management (OPTIMa) Collaboration. Eur J Pain (United Kingdom). 2017. 
doi:10.1002/ejp.931 
18.  
Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical 
Activity on Non-Specific Chronic Low Back Pain. Healthcare. 2016;4(2):22. 
doi:10.3390/healthcare4020022 
19.  
Delitto A, Sciences R, George SZ, et al. Low Back Pain: Clinical Practice Guidelines 
Linked to the International Classification of Functioning, Disability, and Health from the 
Orthopaedic Section of the American Physical Therapy Association.”. J Orthop Sport 
Phys Ther. 2012;42(4):1-81. doi:10.2519/jospt.2012.42.4.A1.Low 
20.  
Heidari P, Farahbakhsh F, Rostami M, Noormohammadpour P, Kordi R. The role of 
ultrasound in diagnosis of the causes of low back pain: A review of the literature. Asian J 
Sports Med. 2015;6(1):1-235. doi:10.5812/asjsm.23803 
21.  
van Middelkoop M, Rubinstein SM, Verhagen AP, Ostelo RW, Koes BW, van Tulder 
MW. Exercise therapy for chronic nonspecific low-back pain. Best Pract Res Clin 
Rheumatol. 2010;24(2):193-204. doi:10.1016/j.berh.2010.01.002 
         

SH-RCT-LBP-US-01 Clinical Investigation Protocol 
 
16 
22.  
Hayden JA, Van Tulder MW, Tomlinson G. Systematic review: Strategies for using 
exercise therapy to improve outcomes in chronic low back pain. Ann Intern Med. 
2005;142(9):776-785. doi:10.7326/0003-4819-142-9-200505030-00014 
23.  
Savigny P, Kuntze S, Watson P, et al. Low Back Pain: Early Management of Persistent 
Non-Specific Low Back Pain. NICE Clini. London: National Collaborating Centre for 
Primary Care and Royal College of General Practitioners; 2009. 
https://www.ncbi.nlm.nih.gov/books/NBK11702/. 
24.  
Airaksinen O, Hildebrandt J, Mannion A, et al. European guidelines for the management 
of chronic non-specific low back pain. Eur Spine J. 2004;(November):1-204. 
doi:10.1007/s00586-006-1072-1 
25.  
Anar SÖ. The effectiveness of home-based exercise programs for low back pain patients. 
J Phys Ther Sci. 2016;28(10):2727-2730. doi:10.1589/jpts.28.2727 
26.  
Shmagel A, Ngo L, Ensrud K, Foley R. Prescription Medication Use Among Community-
Based U.S. Adults With Chronic Low Back Pain: A Cross-Sectional Population Based 
Study. J Pain. 2018. doi:10.1016/j.jpain.2018.04.004 
27.  
Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, Van Der Goes DN. Rates of 
opioid misuse, abuse, and addiction in chronic pain: A systematic review and data 
synthesis. Pain. 2015. doi:10.1097/01.j.pain.0000460357.01998.f1 
28.  
Company, Moran. Physical Therapy Episodes for Low Back Pain : Medicare Spending 
and Intensity of Physical Therapy Services. 2017;(October). 
29.  
Correia FD, Nogueira A, Magalhães I, et al. Home-based Rehabilitation With A Novel 
Digital Biofeedback System versus Conventional In-person Rehabilitation after Total 
Knee Replacement: a feasibility study. Sci Rep. 2018. doi:10.1038/s41598-018-29668-0 
30.  
Correia FD, Nogueira A, Magalhães I, et al. Medium-Term Outcomes of Digital Versus 
Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, 
Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019. doi:10.2196/13111 
31.  
Dias Correia F, Nogueira A, Magalhães I, et al. Digital Versus Conventional 
Rehabilitation After Total Hip Arthroplasty: A Single-Center, Parallel-Group Pilot Study. 
JMIR Rehabil Assist Technol. 2019;6(1):e14523. doi:10.2196/14523 
32.  
Ostelo RWJG, de Vet HCW. Clinically important outcomes in low back pain. Best Pract 
Res Clin Rheumatol. 2005;19(4):593-607. doi:10.1016/j.berh.2005.03.003 
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SH-RCT-LBP-US-01 Clinical Investigation Protocol 
 
17 
 
 
 
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SH-RCT-LBP-US-01 Clinical Investigation Protocol 
 
18 
ANNEX 1 - INFORMED CONSENT FORM
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RESEARCH SUBJECT CONSENT FORM 
 
 
 
Title: 
Digital care program for chronic low back pain versus 
conventional physical therapy: a prospective, randomized 
controlled study 
 
Protocol No.: 
SH-SA-MSK-US-01 
 
Sponsor: 
SWORD Health Technologies, Inc. 
 
Investigator:  
 
Cui Di, MD 
Assistant Professor of Physical and Rehabilitation Medicine 
Emory University  
Atlanta, Georgia 
 
Study-Related 
Phone Number(s): 
404-778-6857 
 
Study-Related 
Email Contact: 
lauren.glenney@emory.edu 
 
Ethical Approval: 
 
 
 
 
 
 
 
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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. 
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.  
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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 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 Emory 
Spine Center Outpatient Clinic. 
 
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: 404-778-6857 or lauren.glenney@emory.edu. 
 
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: 
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- 
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 contacts: 
phone 404-778-6857 or lauren.glenney@emory.edu. 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. 
 
Will I be paid for taking part in this research? 
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You will be paid a financial incentive equivalent of 50$ for each electronic milestone 
questionnaire you complete and hand over to your physician. There are 3 milestone 
questionnaires, for a total of $150.00 
 
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 
 
 
 
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ANNEX 2- DIGITAL THERAPEUTIC EXERCISE PROTOCOL 
 
 
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Low Back Pain Program – Initial Phase  
Week 1 
Goals 
Increase exercise complexity  
Gradually return to avoided movements 
Normalize movement patterns 
Increase trust in movement 
Intervention 
Daily Digital Therapist Sessions 
Assessment/Deploy 
Digital Therapist Exercises 
Mobility / Endurance 
Session A 
Mobility / Endurance Session B 
Cat-camel 
2 sets of 10 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
Child’s pose 
2 sets of 1 repetitions (alternating) 
2 sets of 1 repetitions (alternating) 
Prone press ups 
2 sets of 1 repetitions (alternating) 
2 sets of 1 repetitions (alternating) 
Plank 
 
 
Plank with trunk rotation 
 
 
Plank and hand walking 
 
 
Sitting trunk flexion 
2 sets of 10 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
Sitting trunk flexion with rotation 
2 sets of 12 repetitions 
(alternating) 
 
Sitting trunk rotation 
 
2 sets of 12 repetitions 
(alternating) 
Sitting trunk extension 
2 sets of 10 repetitions 
(alternating) 
 
Sitting trunk side bend 
2 sets of 12 repetitions 
(alternating) 
2 sets of 12 repetitions 
(alternating) 
Siting trunk extension with 
rotation 
 
2 sets of 8 repetitions (alternating) 
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Standing trunk flexion 
 
 
Standing trunk flexion with 
rotation 
 
 
Standing trunk rotation 
 
 
Standing trunk side bend 
 
 
Standing trunk extention 
 
 
Pelvic anterior-posterior tilt 
1 sets of 10 repetitions 
(alternating) 
1 sets of 10 repetitions 
(alternating) 
Pelvic side tilt 
1 sets of 10 repetitions 
(alternating) 
1 sets of 10 repetitions 
(alternating) 
Estimated Training Time 
20 min 
20 min 
 
Low Back Pain Program – Intermediate Phase  
Week 2 to 3 
Goals 
Increase exercise complexity  
Gradually return to avoided movements 
Normalize movement patterns 
Increase trust in movement 
Intervention 
Daily Digital Therapist Sessions 
Digital Therapist 
Exercises 
Mobility / Endurance 
Session A 
Mobility / Endurance 
Session B 
Strength Session 
Cat-camel 
2 sets of 10 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
 
Child’s pose 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Prone press ups 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Plank 
 
 
2 sets of 1 repetitions 
(alternating) 
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Plank with trunk rotation 
 
 
 
Plank and hand walking 
 
 
 
Sitting trunk flexion 
2 sets of 12 repetitions 
(alternating) 
2 sets of 12 repetitions 
(alternating) 
2 sets of 8 repetitions 
(alternating) 
Sitting trunk flexion 
with rotation 
 
2 sets of 16 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
Sitting trunk rotation 
 
 
 
Sitting trunk extension 
2 sets of 12 repetitions 
(alternating) 
 
 
Sitting trunk side bend 
 
 
 
Siting trunk extension 
with rotation 
 
2 sets of 10 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
Standing trunk flexion 
 
 
2 sets of 8 repetitions 
(alternating) 
Standing trunk flexion 
with rotation 
2 sets of 14 repetitions 
(alternating) 
 
2 sets of 16 repetitions 
(alternating) 
Standing trunk rotation 
 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
Standing trunk side bend 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
Standing trunk extention 
2 sets of 12 repetitions 
(alternating) 
 
2 sets of 8 repetitions 
(alternating) 
Pelvic anterior-posterior 
tilt 
2 sets of 10 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
 
Pelvic side tilt 
2 sets of 10 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
 
Estimated Training 
Time 
27 min 
28 min 
30 min 
 
Low Back Pain Program – Intermediate Phase  
Week 4 to 5 
Goals 
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Increase exercise complexity  
Gradually return to avoided movements 
Normalize movement patterns 
Increase trust in movement 
Intervention 
Daily Digital Therapist Sessions 
4-week Remote Assessment 
Digital Therapist 
Exercises 
Mobility / Endurance 
Session A 
Mobility / Endurance 
Session B 
Strength Session 
Cat-camel 
2 sets of 12 repetitions 
(alternating) 
2 sets of 12 repetitions 
(alternating) 
 
Child’s pose 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Prone press ups 
2 sets of 1 repetitions 
(alternating) 
 
2 sets of 1 repetitions 
(alternating) 
Isometric cat pose 
2 sets of 1 repetitions 
(alternating) 
 
 
Plank 
 
 
2 sets of 1 repetitions 
(alternating) 
Plank with trunk rotation 
 
 
1 sets of 6 repetitions 
(alternating) 
Plank and hand walking 
 
 
 
Sitting trunk flexion 
 
 
 
Sitting trunk flexion 
with rotation 
 
2 sets of 16 repetitions 
(alternating) 
2 sets of 8 repetitions 
(alternating) 
Sitting trunk rotation 
 
2 sets of 10 repetitions 
(alternating) 
 
Sitting trunk extension 
 
 
 
Sitting trunk side bend 
 
 
 
Siting trunk extension 
with rotation 
 
2 sets of 12 repetitions 
(alternating) 
2 sets of 6 repetitions 
(alternating) 
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Standing trunk flexion 
 
3 sets of 10 repetitions 
(alternating) 
3 sets of 6 repetitions 
(alternating) 
Standing trunk flexion 
with rotation 
3 sets of 16 repetitions 
(alternating) 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk rotation 
 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk side bend 
3 sets of 16 repetitions 
(alternating) 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk extention 
3 sets of 12 repetitions 
(alternating) 
 
3 sets of 6 repetitions 
(alternating) 
Pelvic anterior-posterior 
tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
Pelvic side tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
Estimated Training 
Time 
30 min 
25 min 
30 min 
 
Low Back Pain Program – Final Phase 
Week 6 
Goals 
Increase external load 
Explosion / Power exercises 
Return to all daily activities 
Maximum complexity on the exercises 
Specific activities training 
Focus on education and prevention of chronic 
Intervention 
Daily Digital Therapist Sessions 
Digital Therapist 
Exercises 
Mobility / Endurance 
Session A 
Mobility / Endurance 
Session B 
Strength Session 
Cat-camel 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
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Child’s pose 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Prone press ups 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Isometric cat pose 
2 sets of 1 repetitions 
(alternating) 
 
 
Plank 
 
 
2 sets of 1 repetitions 
(alternating) 
Plank with trunk rotation 
 
 
2 sets of 6 repetitions 
(alternating) 
Plank and hand walking 
 
 
1 sets of 2 repetitions 
(alternating) 
Sitting trunk flexion 
1 sets of 10 repetitions 
 
 
Sitting trunk flexion 
with rotation 
 
2 sets of 18 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
Sitting trunk rotation 
 
 
 
Sitting trunk extension 
 
 
 
Sitting trunk side bend 
 
 
 
Siting trunk extension 
with rotation 
 
2 sets of 14 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternating) 
Standing trunk flexion 
 
2 sets of 14 repetitions 
(alternating) 
2 sets of 10 repetitions 
(alternated) 
Standing trunk flexion 
with rotation 
2 sets of 20 repetitions 
(alternating) 
 
2 sets of 16 repetitions 
(alternated) 
Standing trunk rotation 
 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
Standing trunk side bend 
2 sets of 20 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
Standing trunk extention 
2 sets of 14 repetitions 
(alternating) 
 
2 sets of 10 repetitions 
(alternating) 
Pelvic anterior-posterior 
tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
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Pelvic side tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
Estimated Training 
Time 
28 min 
27 min 
30 min 
 
 
 
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Low Back Pain Program – Final Phase 
Week 7 
Goals 
Increase external load 
Explosion / Power exercises 
Return to all daily activities 
Maximum complexity on the exercises 
Specific activities training 
Focus on education and prevention of chronic 
Intervention 
Daily Digital Therapist Sessions 
Digital Therapist 
Exercises 
Mobility / Endurance 
Session A 
Mobility / Endurance 
Session B 
Strength Session 
Cat-camel 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
 
Child’s pose 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Prone press ups 
2 sets of 1 repetitions 
(alternating) 
 
2 sets of 1 repetitions 
(alternating) 
Isometric cat pose 
2 sets of 1 repetitions 
(alternating) 
 
 
Plank 
 
 
2 sets of 1 repetitions 
(alternating) 
Plank with trunk rotation 
 
 
 2 sets of 8 repetitions 
(alternating) 
Plank and hand walking 
 
 
1 sets of 4 repetitions 
(alternating) 
Side Plank 
 
 
1 sets of 4 repetitions 
(alternating) 
Sitting trunk flexion 
 
1 sets of 10 repetitions 
(alternating) 
 
         

 
Sitting trunk flexion 
with rotation 
 
2 sets of 14 repetitions 
(alternating) 
 
Sitting trunk rotation 
 
 
 
Sitting trunk extension 
 
 
 
Sitting trunk side bend 
 
 
 
Siting trunk extension 
with rotation 
 
2 sets of 12 repetitions 
(alternating) 
 
Standing trunk flexion 
 
 
3 sets of 10 repetitions 
(alternating) 
Standing trunk flexion 
with rotation 
2 sets of 22 repetitions 
(alternating) 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk rotation 
 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk side bend 
2 sets of 22 repetitions 
(alternating) 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk extention 
2 sets of 14 repetitions 
(alternating) 
 
3 sets of 10 repetitions 
(alternating) 
Pelvic anterior-posterior 
tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
Pelvic side tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 14 repetitions 
(alternating) 
 
Estimated Training 
Time 
28 min 
28 min 
31 min 
 
 
 
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Low Back Pain Program – Final Phase 
Week 8 
Goals 
Increase external load 
Explosion / Power exercises 
Return to all daily activities 
Maximum complexity on the exercises 
Specific activities training 
Focus on education and prevention of chronic 
Intervention 
Daily Digital Therapist Sessions 
8-week Remote Assessment 
SWORD exercises 
Mobility / Endurance 
Session A 
Mobility / Endurance 
Session B 
Strength Session 
Cat-camel 
2 sets of 16 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
 
Child’s pose 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Prone press ups 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
2 sets of 1 repetitions 
(alternating) 
Isometric cat pose 
2 sets of 1 repetitions 
(alternating) 
 
 
Plank 
 
 
2 sets of 1 repetitions 
(alternating) 
Plank with trunk rotation 
 
 
2 sets of 8 repetitions 
(alternating) 
Plank and hand walking 
 
 
2 sets of 4 repetitions 
(alternating) 
Side plank 
 
 
1 sets of 4 repetitions 
(alternating) 
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Isometric side plank 
 
 
1 sets of 2 repetitions 
(alternating) 
Sitting trunk flexion 
 
 
 
Sitting trunk flexion 
with rotation 
 
 
 
Sitting trunk rotation 
 
1 set of 10 repetitions 
(alternating) 
 
Sitting trunk extension 
 
 
 
Sitting trunk side bend 
 
 
 
Siting trunk extension 
with rotation 
 
 
 
Standing trunk flexion 
 
3 sets of 12 repetitions 
(alternating) 
 3 sets of 8 repetitions 
(alternating) 
Standing trunk flexion 
with rotation 
3 sets of 14 repetitions 
(alternating) 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk rotation 
3 sets of 14 repetitions 
(alternating) 
 
3 sets of 12 repetitions 
(alternating) 
Standing trunk side bend 
3 sets of 14 repetitions 
(alternating) 
3 sets of 16 repetitions 
(alternating) 
3 sets of 12 repetitions 
(alternating) 
Standing trunk extention 
 
3 sets of 12 repetitions 
(alternating) 
3 sets of 8 repetitions 
(alternating) 
Pelvic anterior-posterior 
tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
 
Pelvic side tilt 
2 sets of 14 repetitions 
(alternating) 
2 sets of 16 repetitions 
(alternating) 
 
Estimated Training 
Time 
31 min 
30 min 
31 min 
 
 
 
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ANNEX 3- CONVENTIONAL THERAPEUTIC EXERCISE PROTOCOL 
 
 
 
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Conventional Physical Therapy will be individualized according to the patient’s symptoms 
and baseline physical capabilities. The therapy will include the following components 
 
1) Therapeutic Exercises 
These execises will be initiated by the physical therapist, with instruction to continue 
at home. Patient may progress along intensity level as tolerated under the guidance of 
the physical therapist. Additional sports/activity specific exercises maybe included 
and not listed below.  
 
Conventional PT 
Exercises 
Low Intensity 
Medium Intensity 
High Intensity 
Dead Bugs 
(Supported Arm) 
2-4 sets of 2 min 
set  
 
 
Dead Bugs 
(Unsupported Arm) 
 
3-5 sets of 3 min Rep 
(alternating) 
3-5 sets of 5 min Rep with weight in 
hands(alternating) 
Partial sit up 
Arm Reaching 
between the thighs  
10 reps x 2 sets 
Arm crossed at chest 
10 rep x 3 sets 
Hand behind head 
20 rep x 3 sets 
Bridging  
Both foot on the 
floor 
10 reps x 2-3 sets 
Single Leg on the 
floor 
20 reps x 2-4 sets 
Balance on stability ball 
20 reps x 5 sets 
Plank 
(Forearm) 
10 second hold  
 3 sets 
30 second hold 
3 sets 
60 second hold 
3 sets 
Prone 
Opposite Arm/leg 
lift 
10 reps x 1-2 sets 
Opposite Arm/leg lift 
(On balance ball) 
10 reps x 1-2 sets 
Opposite Arm/leg lift 
(On balance ball) 
20 reps x 1-2 sets 
Quadruped 
Opposite Arm/leg 
lift 
10 reps x 1-2 sets 
Opposite Arm and 
leg lift 
10 reps x 1-2 sets 
Opposite Arm and leg lift (with 
weight in hand and ankle weight) 
10 reps x 1-2 sets 
Side plank 
(From Knee) 
10 second hold  
 3 sets 
30 second hold 
3 sets 
60 second hold 
3 sets 
Wall Slide  
(Or Ball slide 
against wall) 
45 degree 
10 -20 reps 
90 degree 
10 reps with 30 sec 
hold 
90 degree, with weights and arm 
extended 
10 reps with 30 sec hold 
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2) Manual Therapy: During the patient’s physical therapy treatment manual therapy may be 
applied by skilled physical therapists as necessary for the patient’s condition. 
•         Soft tissue mobilization 
•         Joint mobilization/manipulation 
•         Myofascial release 
•         Trigger point dry needling 
•         Cupping 
 
3) Active and Passive Stretches 
All stretches maybe completed by patient alone or be assisted/augmented by the 
physical therapist 
•         Hip flexor/quad stretch 
•         Hamstring stretch 
•         Glute/piriformis stretch 
•         QL stretch 
 
4) Range of Motion exercises 
These will be both active and passive under the assistance of the physical therapists and 
will be progress under the instruction by the physical therapist.  
• 
Single knee to chest/double knee to chest 
• 
Lumbar rotation in hook-lying 
• 
Seated flexion 
• 
Prone extension 
• 
Book opening for rotation 
 
 
5) Modalities 
During patient’s physical therapy treatment, patient may receive the following 
modalities as seen fit by the physical therapist.  
•         Heat/cold therapy 
•         Electrical stimulation/TENs 
•         Thermal ultrasound 
Mechanical traction 
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