Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial

Background Chronic shoulder pain (CSP) is a common condition with various etiologies, including rotator cuff disorders, adhesive capsulitis, shoulder instability, and shoulder arthritis. It is associated with substantial disability and psychological distress, resulting in poor productivity and quality of life. Physical therapy constitutes the mainstay treatment for CSP, but several barriers exist in accessing care. In recent years, telerehabilitation has gained momentum as a potential solution to overcome such barriers. It has shown numerous benefits, including improving access and convenience, promoting patient adherence, and reducing costs. However, to date, no previous randomized controlled trial has compared fully remote digital physical therapy to in-person rehabilitation for nonoperative CSP. Objective The aim of this study is to compare clinical outcomes between digital physical therapy and conventional in-person physical therapy in patients with CSP. Methods We conducted a single-center, parallel-group, randomized controlled trial involving 82 patients with CSP referred for outpatient physical therapy. Participants were randomized into digital or conventional physical therapy (8-week interventions). The digital intervention consisted of home exercise, education, and cognitive behavioral therapy (CBT), using a device with movement digitalization for biofeedback and asynchronous physical therapist monitoring through a cloud-based portal. The conventional group received in-person physical therapy, including exercises, manual therapy, education, and CBT. The primary outcome was the change (baseline to 8 weeks) in function and symptoms using the short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcome measures included self-reported pain, surgery intent, analgesic intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically. Results A total of 90 participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function measured by the short-form of the Disabilities of the Arm, Shoulder, and Hand questionnaire, with no differences between groups (–1.8, 95% CI –13.5 to 9.8; P=.75). For secondary outcomes, no differences were observed in surgery intent, analgesic intake, and mental health or worst pain. Higher reductions were observed in average and least pain in the conventional group, which, given the small effect sizes (least pain 0.15 and average pain 0.16), are unlikely to be clinically meaningful. High adherence and satisfaction were observed in both groups, with no adverse events. Conclusions This study shows that fully remote digital programs can be viable care delivery models for CSP given their scalability and effectiveness, assessed through comparison with high-dosage in-person rehabilitation. Trial Registration ClinicalTrials.gov (NCT04636528); https://clinicaltrials.gov/study/NCT04636528


1a-i) Identify the mode of delivery in the title
Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if o ine products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms. Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Our intervention is delivered leveraging a medical device that combines a dedicated tablet with a mobile app, motion trackers and a cloud-based portal where all data is stored, enabling the physical therapist monitoring and adjustments prescription. Therefore, we believe that using a single descriptor would be misleading. This information is provided in the Methods: "Asynchronous exercise sessions were performed independently at the participant's convenience using an FDA-listed class II medical device consisting of three inertial motion trackers placed on the chest, upper arm and wrist, a dedicated tablet with a mobile app, and a cloud-based portal

1a-ii) Non-web-based components or important co-interventions in title
Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The digital intervention benefited from chat-based communication between the physical therapist and the patient, which was provided as an ad on, and not as a cointervention. This information is provided in the Methods: "Participants and the physical therapist were able to communicate through a built-in secure chat within a smartphone app for 1a-iii) Primary condition or target group in the title Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "for chronic shoulder pain" 1b) ABSTRACT: Structured summary of trial design, methods, results, and conclusions Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The digital intervention consisted of home exercise, education and cognitive behavioral therapy (CBT), using a device with movement digitalization for biofeedback and asynchronous physical therapist monitoring through a cloud-based portal. The conventional group received in-person physical therapy including exercises, manual therapy, education, and CBT." https://docs.google.com/forms/d/e/1FAIpQLSfZBSUp1bwOc_OimqcS64RdfIAFvmrTSkZQL2-3O8O9hrL5Sw/viewform?hl=en_US&formkey=dGlKd2Z2Q… 12/72 subitem not at all important 1 2 3 4 5 essential 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) C l e a r s e l e c t i o n Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "asynchronous physical therapist monitoring" subitem not at all important 1 2 3 4 5 essential 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "involving 82 patients with CSP referred for outpatient physical therapy." "The digital intervention consisted of home exercise, education and cognitive behavioral therapy (CBT)" "The conventional group received in-person physical therapy" "Primary outcome was the change (baseline to 8-weeks) in function and symptoms using the short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH). Secondary outcome measures included self-reported pain, surgery intent, analgesics intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically." Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Ninety participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function (QuickDASH), with no differences between groups (-1.8, 95%CI -13.5 to 9.8, P=.75). For secondary outcomes, no differences were observed in surgery intent, analgesic intake and mental health or worst pain. Higher reductions were observed in average and least pain in the conventional group, which given the small effect sizes ( METHODS 3a) Description of trial design (such as parallel, factorial) including allocation ratio 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The aim of this study is to compare clinical outcomes between DGPT and conventional inperson PT in patients with CSP. We hypothesized that outcomes would be similar in both interventions." Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "single-center, parallel-group, randomized controlled study" "Randomization was performed by Castor EDC in a 1:1 ratio" Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The inclusion criteria were: a) patients between 18 and 80 years of age; b) intermittent or persistent tendon-related shoulder pain for at least 12 weeks, and/or at least 50% of the time in the past 6 months [35]; c) absence of visual/audio or cognitive impairment interfering with the ability to understand or comply with the program. Exclusion criteria included: a) limited English proficiency; b) residency outside of greater San Francisco area; c) known pregnancy; d) surgery less than 3 months ago; e) symptoms and/or signs indicative of possible infection; f) referred pain from the spine and/or thoracic outlet syndrome; g) active cancer diagnosis or undergoing treatment for cancer; h) known disorder restricting tolerance to more than 20 minutes of light to moderate exercise; i) concomitant neurological disorder that may interfere with participation or confound outcomes (e.g. stroke, multiple sclerosis, Parkinson's disease); j) known cognitive impairment including dementia, psychiatric disorders or other conditions (e.g., visual or auditory impairment) or digital illiteracy precluding patient compliance with home-based exercise or interfering with communication; k) concurrent physical therapy or another outside intervention for shoulder conditions, during the study time."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clari ed. Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "j) known cognitive impairment including dementia, psychiatric disorders or other conditions (e.g., visual or auditory impairment) or digital illiteracy precluding patient compliance with home-based exercise or interfering with communication" 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. o ine), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email con rmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Study participants were conveniently recruited from the UCSF outpatient practice, and were scheduled and screened for PT appointments. An in-person evaluation was conducted to ensure that potential candidates met eligibility criteria."

4a-iii) Information giving during recruitment
Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
C l e a r s e l e c t i o n Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This information is provided in the informed consent included in the study protocol which will be available in clinicaltrials.gov upon publication. Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Exclusion criteria included: (...) b) residency outside of greater San Francisco area;" "Study participants were conveniently recruited from the UCSF outpatient practice, and were scheduled and screened for PT appointments. An in-person evaluation was conducted to ensure that potential candidates met eligibility criteria. Participants provided written informed consent electronically through Castor eConsent (Castor Research Inc.). All studyrelated information (including data from assessments) was stored in Castor electronic data capturing (EDC) platform, which is FDA CFR 21 part 11 compliant."

4b-i) Report if outcomes were (self-)assessed through online questionnaires
Clearly report if outcomes were (self-)assessed through online questionnaires (as common in web-based trials) or otherwise. Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Primary and secondary outcomes were collected at baseline, 4, and 8 weeks in the form of electronic self-reported questionnaires through Castor EDC (except for engagement metrics)." 4b-ii) Report how institutional affiliations are displayed Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Study participants were conveniently recruited from the UCSF outpatient practice, and were scheduled and screened for PT appointments." 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered subitem not at all important 1 2 3 4 5 essential

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, a liations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Con ict of interest" section or mentioned elsewhere in the manuscript).
C l e a r s e l e c t i o n Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The study sponsor, Sword Health, was involved in study design, data collection, and interpretation and writing of the manuscript. " "The authors declare the following competing interests: DJ, F Costa, MM, ACA, VY, and FDC are employees of Sword Health, the sponsor of this study. "

5-ii) Describe the history/development process
Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
C l e a r s e l e c t i o n

Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study This intervention is not solely based on a medical app, but consists on a telerehabilitation service being provided remotely by a physical therapist leveraged by technological aids, namely a dedicated tablet with an app, motion trackers and a cloudbased portal.

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).
C l e a r s e l e c t i o n Does your paper address subitem 5-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The intervention development and/or content was not altered during the trial.

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
C l e a r s e l e c t i o n Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screencapture video, and/or providing owcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scienti c reporting.
C l e a r s e l e c t i o n Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The digital intervention was based on remote physical therapy managed asynchronously by a Physical Therapist that used proprietary technology to monitor and prescribe adjusted exercise protocols (therefore specific algorithms sources can not be shared). We have added a Figure

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of speci c group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
C l e a r s e l e c t i o n Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Study participants were conveniently recruited from the UCSF outpatient practice, and were scheduled and screened for PT appointments." "Study participants received a stipend of $75 after completing the study. " "Asynchronous exercise sessions were performed independently at the participant's convenience using an FDA-listed class II medical device consisting of three inertial motion trackers placed on the chest, upper arm and wrist, a dedicated tablet with a mobile app, and a cloud-based portal (Supplementary Figure S1)." Does your paper address subitem 5-viii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study  Table 1). Patient education was delivered through a smartphone app in the form of short written articles, addressing anatomy and physiology, pain reconceptualization, active coping skills, exercise and fear-avoidance behaviors [14,15]. These topics were also included in the CBT program which was composed of interactive content and sent to participants through email (...) Participants and the physical therapist were able to communicate through a built-in secure chat within a smartphone app for text messages, and video/phone calls conducted on-demand (which was also conducted to motivate patients and increase adherence)." Comparator group: "The conventional intervention was an 8-week program consisting of in-person PT (...). The intervention included therapeutic exercises (similar to the DGPT), but through tactile movement/activity modification and gradual exposure based on McClure's staged approach for shoulder rehabilitation (Figure 1 and Supplementary

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
C l e a r s e l e c t i o n Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Digital intervention group: "It was recommended that participants perform three 20-minute exercise sessions per week (total of 24 sessions)." Comparator group: "Two 30-minutes sessions per week were prescribed (total of 14-16 sessions), allowing for a similar treatment dosage between two groups."

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
C l e a r s e l e c t i o n Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Digital intervention group: "Each participant was assigned and treated by a licensed physical therapist with clinical doctorate credentials." (...) "The motion data was stored in the cloudbased portal (...) accessed and monitored asynchronously by the assigned physical therapist, who adjusted the program accordingly. Three physical therapists were involved in the study with 13 years of experience on average (range 6-23)." (...) "Participants and the physical therapist were able to communicate through a built-in secure chat within a smartphone app for text messages, and video/phone calls conducted on-demand (...)" "Technical and IT support was ensured to patients through several communication channels. When hardware issues could not be resolved remotely, the device was replaced." Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No reminders were used in the digital intervention. Nevertheless, the communication between the physical therapist and participants was also intended to increase adherence to the program: "Participants and the physical therapist were able to communicate through a built-in secure chat within a smartphone app for text messages, and video/phone calls conducted on-demand (which was also conducted to motivate patients and increase adherence)."  Does your paper address subitem 6a-i?

Copy and paste relevant sections from manuscript text
We used standardized questionnaires, whose application online was reported in previous studies.
6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was de ned/measured/monitored (logins, log le analysis, etc.). Use/adoption metrics are important process outcomes that should be reported in any ehealth trial. 6b) Any changes to trial outcomes after the trial commenced, with reasons 6a-iii) Describe whether, how, and when qualitative feedback from participants was obtained Describe whether, how, and when qualitative feedback from participants was obtained (e.g., through emails, feedback forms, interviews, focus groups).
C l e a r s e l e c t i o n

Does your paper address subitem 6a-iii?
Copy and paste relevant sections from manuscript text Qualitative feedback was not obtained, nevertheless patient satisfaction was assessed through a scale: "(6) Patient satisfaction: "On a scale from 0 to 10, how likely is it that you would recommend this intervention to a friend or neighbor?"." Does your paper address CONSORT subitem 6b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Opioid dosage was not systematically recorded across the entire study due to a technical error. No other changes in trial outcomes occurred after trial commencement. Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Considering a power of 80%, a two-sided 0.05 significance level and a 10% dropout rate 82 patients would be necessary to detect a 11.2 point difference between the two groups. The enrollment period was extended to acknowledge the unpredictability brought by the COVID-19 pandemic." 8a) Method used to generate the random allocation sequence NPT: When applicable, how care providers were allocated to each trial group 8b) Type of randomisation; details of any restriction (such as blocking and block size) Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Recruitment ceased once 82 patients were randomized and started the intervention." Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed by Castor EDC in a 1:1 ratio using random permuted blocks of 4-8 participants." Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed by Castor EDC in a 1:1 ratio using random permuted blocks of 4-8 participants. " 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how NPT: Whether or not administering co-interventions were blinded to group assignment Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed by Castor EDC in a 1:1 ratio using random permuted blocks of 4-8 participants. Allocation disclosure was performed after randomization to the principal investigator, who communicated each participant's allocation to those responsible for each study arm, ensuring that the blinding was maintained prior to allocation." Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Randomization was performed by Castor EDC in a 1:1 ratio using random permuted blocks of 4-8 participants. Allocation disclosure was performed after randomization to the principal investigator, who communicated each participant's allocation to those responsible for each study arm, ensuring that the blinding was maintained prior to allocation." subitem not at all important 1 2 3 4 5 essential 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering cointerventions (if any).
C l e a r s e l e c t i o n Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Considering the nature of the intervention, investigators and participants were unblinded to group allocation.However, analyses were conducted independently by two statisticians blinded to group allocation." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
C l e a r s e l e c t i o n Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Considering the nature of the intervention, investigators and participants were unblinded to group allocation." 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The digital intervention consisted of a home exercise program, patient education and CBT ( Figure 1) consistent with current guidelines [14,15]." "The conventional intervention was an 8-week program consisting of in-person PT (...) included therapeutic exercises (similar to the DGPT), but through tactile movement/activity modification and gradual exposure based on McClure's staged approach for shoulder rehabilitation (Figure 1 and Supplementary Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Participants provided written informed consent electronically through Castor eConsent (Castor Research Inc.)." This information is provided in the informed consent included in the study protocol which will be available in clinicaltrials.gov upon publication.

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) C l e a r s e l e c t i o n

Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "All study-related information (including data from assessments) was stored in Castor electronic data capturing (EDC) platform which is FDA CFR 21 part 11 compliant." "Motion data was stored in the cloud-based portal with HITRUST and Google Cloud Platform's SOC2 certifications, and was accessed and monitored asynchronously only by the physical therapist assigned to each participant (...). Personal health information was individually encrypted inside this database." "Safety and adverse events (...) Both participants and physical therapists were instructed to contact the study investigators in case of an adverse event (registered on Castor EDC platform)." 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "A total of 116 participants were screened for eligibility, from which 26 participants (22.4%) were excluded: 4 (3.4%) declined consent, 15 (12.9%) failed to meet eligibility criteria and 7 (6.0%) did not complete their baseline survey or initial visit (Figure 2). Ninety participants were randomized either to the digital group (DGPT, N=46) or the conventional group (CG, N=44), with 41 participants in each group receiving the allocated intervention. At study end, 84.8% (39/46) in the DGPT and 79.5% (35/44) in Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 13b-i?
Copy and paste relevant sections from the manuscript or cite the gure number if applicable (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study The mobile app does not operate by itself. It is fed by the physical therapist action and therefore attrition levels are much lower than the observed with stand-alone apps. "Overall, participants were exposed to a similar treatment dosage in both groups (Table 3) Does your paper address CONSORT subitem 14a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Treatment and follow-up occurred between March 25th, 2021 and December 15th,

14a-i) Indicate if critical "secular events" fell into the study period
Indicate if critical "secular events" fell into the study period, e.g., signi cant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" C l e a r s e l e c t i o n Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No critical "secular events" fell into the study period in regards to changes in Internet resources available, except the COVID-19 pandemic which impacted participants recruitment: "The enrollment period was extended to acknowledge the unpredictability brought by the COVID-19 pandemic." 14b) Why the trial ended or was stopped (early) 15) A Does your paper address CONSORT subitem 14b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Recruitment ceased once 82 patients were randomized and started the intervention." Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "There were no differences between groups in demographic characteristics or clinical scores using an intention-to-treat approach (N=82 , Table 1), except for a higher least pain score in the CG (DGPT: median 1.0, IQR 2.0 and CG: median 2.0, IQR 3.0; Table 1)." subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide de nitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at speci c pre-de ned time points of interest (in absolute and relative numbers per group). Always clearly de ne "use" of the intervention.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
C l e a r s e l e c t i o n Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Outcomes following an intention-to-treat analysis are presented in Table 2  Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Outcomes (...) are presented in Table 2 and respective model estimates in Supplementary  Table S4." "The QuickDASH change between baseline and 8-weeks was similar between groups (difference: -1.8, 95%CI -13.5 to 9.8, P=.75), corresponding to an effect size of 0.01." "Small effect sizes were obtained when comparing the between-group changes in pain variables (worst pain: 0.08; least pain: 0.15; average pain: 0.16) suggesting the absence of a clinically meaningful difference [50]." (...)

17a-i) Presentation of process outcomes such as metrics of use and intensity of use
In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational de nitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is de ned (e.g., timeout after idle time) [1] (report under item 6a). Does your paper address subitem 17a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Overall, participants were exposed to a similar treatment dosage in both groups (Table 3) Does your paper address CONSORT subitem 17b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study Does your paper address CONSORT subitem 18? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study No subgroup or adjusted analyses were conducted in this study.

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
C l e a r s e l e c t i o n Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The purpose of this study was to compare the clinical outcomes between DGPT and conventional, in-person PT for patients with CSP. For the primary outcome (i.e. QuickDASH) we observed a statistically significant change within each group and no difference between groups, along with a similar proportion of treatment responders. For secondary outcomes, no differences were observed in surgery intent, analgesic intake and anxiety between groups, and for these outcomes, within-group pre-post changes were not significant. Similar improvements on depression symptoms were noted in both groups. Higher reductions were observed in average and least pain in the conventional group, but not in worst pain, which were unlikely to be clinically meaningful given the small effect sizes (worst pain: 0.08; least pain: 0.15; average pain: 0.16). Both groups underwent similar treatment dosage, reported high satisfaction scores, low dropout rates, and no adverse events, denoting the acceptance and safety of both care delivery models. Overall, this study demonstrates for the first time the effectiveness of fully-remote DGPT in patients with non-operative CSP compared to inperson PT. These findings suggest that the delivery of PT through digital interventions Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Analgesic intake has been poorly investigated in research focused on non-operative CSP [71], a gap that should be addressed in future trials." "First, this study was undertaken in the context of the COVID-19 pandemic, which may have impacted perceptions, receptivity and compliance with digital and in-person PT programs. Second, the enrolled cohort was composed of predominantly young, physically active, highly educated individuals residing in urban areas, which may limit generalizability. Third, a relatively small proportion of these individuals were receiving regular analgesic medications and were not considering surgery, which again merits caution with extrapolation. Fourth, administration of the CBT and educational components varied between the two groups, even if it was similar in concept. Fifth, both investigators and participants were unblinded to group allocation. Lastly, this study lacked post-treatment follow-up, which prohibits conclusions on long-term benefit and cost-effectiveness. Future research should address these issues and endeavor to identify factors that may influence an individual's decision to partake in digital, in-person or hybrid care and define criteria for appropriate candidate selection.

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
C l e a r s e l e c t i o n Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "First, this study was undertaken in the context of the COVID-19 pandemic, which may have impacted perceptions, receptivity and compliance with digital and in-person PT programs. Second, the enrolled cohort was composed of predominantly young, physically active, highly educated individuals residing in urban areas, which may limit generalizability. Third, a relatively small proportion of these individuals were receiving regular analgesic medications and were not considering surgery, which again merits caution with extrapolation. Fourth, administration of the CBT and educational components varied between the two groups, even if it was similar in concept. Fifth, both investigators and participants were unblinded to group allocation. Lastly, this study lacked post-treatment follow-up, which prohibits conclusions on long-term benefit and cost-effectiveness. " Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Second, the enrolled cohort was composed of predominantly young, physically active, highly educated individuals residing in urban areas, which may limit generalizability. Third, a relatively small proportion of these individuals were receiving regular analgesic medications and were not considering surgery, which again merits caution with extrapolation." Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other cointerventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
C l e a r s e l e c t i o n Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "Future research should address these issues, and endeavor to identify factors that may influence an individual's decision to partake in digital, in-person or hybrid care and define criteria for appropriate candidate selection. The adoption of these new models of care in routine clinical practice also requires competencies by physical therapists, including important changes in training curricula." The human involvement in the digital intervention assessed in this study was similar to the applied in a real-world application setting. Therefore, this was not discussed in the manuscript.

X27) Conflicts of Interest (not a CONSORT item)
subitem not at all important 1 2 3 4 5 essential About the CONSORT EHEALTH checklist X27-i) State the relation of the study team towards the system being evaluated In addition to the usual declaration of interests ( nancial or otherwise), also state the relation of the study team towards the system being evaluated, i.e., state if the authors/evaluators are distinct from or identical with the developers/sponsors of the intervention.
C l e a r s e l e c t i o n Does your paper address subitem X27-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or brie y explain why the item is not applicable/relevant for your study "The authors declare the following competing interests: DJ, F Costa, MM, ACA, VY, and FDC are employees of Sword Health, the sponsor of this study. VB, VY and FDC also hold equity in Sword Health. RM is an independent scientific consultant responsible for statistical analysis. SPC is an independent scientific and clinical consultant who received adviser honorarium from Sword Health." yes, major changes yes, minor changes no yes no Other: As a result of using this checklist, did you make changes in your manuscript? * What were the most important changes you made as a result of using this checklist?
In the methods section.
How much time did you spend on going through the checklist INCLUDING making changes in your manuscript

* 5 hours
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