Trial Outcomes & Findings for Digital Care Program for Chronic Low Back Pain (NCT NCT04808141)

Last Updated: 2025-05-16

Results Overview

The minimum value of the score is 0% and the maximum is 100%, with lower scores translating into lower disability. In this study, we will be assessing the change between baseline and 8 weeks in Oswestry Disability Index score.

Recruitment status

COMPLETED

Study phase

Target enrollment

140 participants

Primary outcome timeframe

Baseline and 8 weeks after initiation of rehabilitation program

Results posted on

2025-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Digital Rehabilitation Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Overall Study STARTED	70	70
Overall Study COMPLETED	57	45
Overall Study NOT COMPLETED	13	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Digital Care Program for Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.	Total n=140 Participants Total of all reporting groups
Age, Continuous	50.50 years n=5 Participants	54.50 years n=7 Participants	52.00 years n=5 Participants
Age, Customized <25	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Customized 25-40	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants
Age, Customized 41-60	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Age, Customized >60	18 Participants n=5 Participants	25 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	49 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Native American or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	28 Participants n=5 Participants	23 Participants n=7 Participants	51 Participants n=5 Participants
Race/Ethnicity, Customized Multi-racial or biracial	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to answer	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Education level Did not attend school	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Education level Some high school	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Education level High school graduate or GED	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Education level Some colleges (some community colleges, associate degree)	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Education level Four-year college degree or bachelor's degree	17 Participants n=5 Participants	14 Participants n=7 Participants	31 Participants n=5 Participants
Education level Some postgraduate or professional schooling, no postgraduate degree	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Education level Postgraduate or professional degree (including master's, doctorate, medical or law degree)	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Education level Prefer not to answer	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Body Mass Index, categories Normal (18.5-25)	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Body Mass Index, categories Overweight (>25-30)	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Body Mass Index, categories Obese (>30-40)	23 Participants n=5 Participants	21 Participants n=7 Participants	44 Participants n=5 Participants
Body Mass Index, categories Morbidly obese (>40)	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Employment status Employed (part-time or fulltime)	48 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants
Employment status Unemployed (seeking opportunities)	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Employment status Not employed and not seeking work	14 Participants n=5 Participants	18 Participants n=7 Participants	32 Participants n=5 Participants
Employment status Prefer not to answer	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Exercise levels None	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Exercise levels Less than 1 h	20 Participants n=5 Participants	13 Participants n=7 Participants	33 Participants n=5 Participants
Exercise levels Between 1-2.5 h	18 Participants n=5 Participants	24 Participants n=7 Participants	42 Participants n=5 Participants
Exercise levels >2.5 h	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Smoking status	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Low back-related leg pain	34 Participants n=5 Participants	41 Participants n=7 Participants	75 Participants n=5 Participants
Laterality of leg pain Right	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
Laterality of leg pain Left	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Laterality of leg pain Both	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Laterality of leg pain Missing	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Lumbar radicular pain	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Previous physiotherapy	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants
Previous or scheduled low back surgery	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Body Mass Index, continuous	28.26 Kg/m2 n=5 Participants	28.30 Kg/m2 n=7 Participants	28.3 Kg/m2 n=5 Participants
Comorbidities - High Blood Pressure	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Comorbidities - High Blood Sugar or Diabetes	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Comorbidities - Cardiac Conditions	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Comorbidities - Respiratory Conditions	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Comorbidities - None	38 Participants n=5 Participants	37 Participants n=7 Participants	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Oswestry Disability Index Score (ODI) Baseline	24.84 units on a scale Interval 19.93 to 28.75	25.34 units on a scale Interval 21.91 to 28.77
Oswestry Disability Index Score (ODI) 8-weeks	17.94 units on a scale Interval 6.37 to 19.72	18.99 units on a scale Interval 15.2 to 22.78
Oswestry Disability Index Score (ODI) Change baseline-8 weeks	-6.90 units on a scale Interval -19.33 to -1.57	-6.35 units on a scale Interval -10.36 to -3.83

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in pain level 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?" Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing less pain.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Pain Level Baseline	5.40 units on a scale Interval 4.59 to 6.02	5.49 units on a scale Interval 5.05 to 5.94
Pain Level 8-weeks	3.59 units on a scale Interval 2.67 to 4.52	3.38 units on a scale Interval 2.71 to 4.05
Pain Level Change baseline-8 weeks	-1.81 units on a scale Interval -3.51 to -0.25	-2.11 units on a scale Interval -2.82 to -1.49

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Population: This analysis includes only participants who completed the WPAI Overall questionnaire. Participants who did not respond to this questionnaire were excluded from the analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.

Change in WPAI overall scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=45 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=45 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Work Productivity and Activity Impairment (WPAI) Overall Baseline	25.61 units on a scale Interval 13.81 to 30.8	23.79 units on a scale Interval 18.84 to 28.74
Work Productivity and Activity Impairment (WPAI) Overall 8-weeks	16.87 units on a scale Interval 0.0 to 18.98	17.67 units on a scale Interval 10.29 to 25.05
Work Productivity and Activity Impairment (WPAI) Overall Change baseline-8 weeks	-8.74 units on a scale Interval -25.98 to -2.72	-6.12 units on a scale Interval -9.25 to 4.97

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in surgery intent 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"? Minimum and maximum values of the scale are respectively 0 and 10, with lower values representing a lower interest.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Interest in Undergoing Surgery Baseline	6.43 units on a scale Interval 0.0 to 20.68	9.76 units on a scale Interval 4.88 to 14.64
Interest in Undergoing Surgery 8-weeks	0.06 units on a scale Interval 0.0 to 1.49	0.06 units on a scale Interval 0.0 to 4.77
Interest in Undergoing Surgery Change baseline-8 weeks	-6.37 units on a scale Interval -25.06 to -2.92	-9.69 units on a scale Interval -13.6 to -4.38

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Population: This analysis includes only participants who reported medication consumption at baseline. Participants who did not report medication use at baseline were excluded from this analysis. As a result, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.

Change in medication consumption, measured through the following questions: i. "Are you taking any medication for your low back pain?"; binary score ii. "If yes, are you taking opioids for your low back pain?"; binary score iii. "If yes, on how many days in a week, on average, are you taking medication for your low back pain" minimum 0; max 7 days, with 7 being worse.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=34 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=43 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Medication Consumption	9 Participants	7 Participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in Fear avoidance beliefs-Physical Activity questionnaire - Physical Activity subscale. The questionnaire consists of 4 items in which a patient rates their agreement with each statement on a 7-point Likert scale. Where 0= completely disagree, 6=completely agree. There is a maximum score of 24 and a minimum score of 0. Lower scores mean lower fear avoidance.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Fear Avoidance Beliefs - Physical Activity (FABQ-PA) Baseline	14.41 units on a scale Interval 12.06 to 14.78	13.99 units on a scale Interval 12.5 to 15.48
Fear Avoidance Beliefs - Physical Activity (FABQ-PA) 8-weeks	12.48 units on a scale Interval 8.41 to 12.71	12.48 units on a scale Interval 10.65 to 14.32
Fear Avoidance Beliefs - Physical Activity (FABQ-PA) Change baseline-8 weeks	-1.92 units on a scale Interval -5.48 to 2.48	-1.50 units on a scale Interval -3.28 to 0.03

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in the General Anxiety Disorder-7 scale score. Minimum score zero; maximum score 21. Lower scores indicate less severe anxiety.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Anxiety Baseline	3.79 units on a scale Interval 1.32 to 5.88	4.22 units on a scale Interval 2.92 to 5.51
Anxiety 8-weeks	2.51 units on a scale Interval 0.0 to 2.72	2.51 units on a scale Interval 1.36 to 3.67
Anxiety Change baseline-8 weeks	-1.28 units on a scale Interval -4.35 to -0.91	-1.70 units on a scale Interval -2.16 to -0.3

SECONDARY outcome

Timeframe: 8 weeks after initiation of rehabilitation program.

Population: This analysis includes only participants who completed the allocated digital or conventional interventions.

Measured through the following question: "On a scale from 0 to 10, how likely would you recommend this program to a friend or colleague?". Minimum value is zero and maximum is 10. Higher scores translate higher satisfaction.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=57 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=45 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Patient Satisfaction With Intervention	8.4 units on a scale Standard Deviation 2.0	8.4 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in the International Physical Activity Questionnaire- Short Form. The scale scores are calculated to provide a qualitative score: low, moderate and high with higher scores translating into higher activity levels.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=57 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=45 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Physical Activity Levels Baseline · High	17 Participants	14 Participants
Physical Activity Levels Baseline · Moderate	19 Participants	16 Participants
Physical Activity Levels Baseline · Low	21 Participants	15 Participants
Physical Activity Levels 8-weeks · High	23 Participants	17 Participants
Physical Activity Levels 8-weeks · Moderate	20 Participants	15 Participants
Physical Activity Levels 8-weeks · Low	14 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in the Patient Health Questionnaire 9 - 7 scale score. Minimum score zero; maximum score 27. Lower scores indicate less severe depression.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Depression Baseline	4.09 units on a scale Interval 0.45 to 4.87	4.67 units on a scale Interval 3.54 to 5.8
Depression 8-weeks	3.22 units on a scale Interval 1.05 to 3.67	2.48 units on a scale Interval 1.44 to 3.52
Depression Change baseline-8-weeks	-0.87 units on a scale Interval -4.43 to -0.51	-2.19 units on a scale Interval -2.86 to -1.14

SECONDARY outcome

Timeframe: Between baseline and 8 weeks.

Number of participants that complete the 8 week program.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Retention Rate	57 Participants	45 Participants

SECONDARY outcome

Timeframe: Between baseline and 8 weeks.

Population: This analysis includes only participants who received the allocated intervention. Participants who did not receive the intervention were excluded from this analysis. Therefore, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.

Total number of minutes spent doing exercise sessions.

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=63 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=57 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Treatment Intensity	451.78 minutes Standard Deviation 227.36	385.98 minutes Standard Deviation 145.36

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Population: This analysis includes only participants who completed the WPAI Work questionnaire. Participants who did not respond to this questionnaire were excluded from the analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.

Change in WPAI work scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=43 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=44 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Work Productivity and Activity Impairment (WPAI) Work Baseline	23.52 units on a scale Interval 11.32 to 29.49	22.51 units on a scale Interval 17.62 to 27.4
Work Productivity and Activity Impairment (WPAI) Work 8-weeks	15.33 units on a scale Interval 0.0 to 17.62	16.29 units on a scale Interval 8.86 to 23.73
Work Productivity and Activity Impairment (WPAI) Work Change baseline-8 weeks	-8.19 units on a scale Interval -22.87 to 0.03	-6.22 units on a scale Interval -10.14 to 2.68

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Population: This analysis includes only participants who completed the WPAI Time questionnaire. Participants who did not respond to this questionnaire were excluded from the analysis. Consequently, the total number of participants analyzed for this outcome differs from the overall number of participants enrolled in the study.

Change in WPAI time scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=43 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=44 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Work Productivity and Activity Impairment (WPAI) Time Baseline	3.35 units on a scale Interval 0.0 to 13.08	2.63 units on a scale Interval 0.29 to 4.96
Work Productivity and Activity Impairment (WPAI) Time 8-weeks	0.00 units on a scale Interval 0.0 to 13.08	0.00 units on a scale Interval 0.0 to 2.34
Work Productivity and Activity Impairment (WPAI) Time Change baseline-8 weeks	-3.36 units on a scale Interval -9.01 to -1.51	-2.63 units on a scale Interval -4.38 to -1.99

SECONDARY outcome

Timeframe: Baseline and 8 weeks after initiation of rehabilitation program

Change in WPAI Activity scores. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes, with a minimum of 0% and a maximum of 100%

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Work Productivity and Activity Impairment (WPAI) Activity Baseline	35.59 units on a scale Interval 27.39 to 44.1	36.73 units on a scale Interval 29.6 to 43.87
Work Productivity and Activity Impairment (WPAI) Activity 8-week	22.66 units on a scale Interval 1.11 to 28.34	23.45 units on a scale Interval 17.22 to 29.69
Work Productivity and Activity Impairment (WPAI) Activity Change baseline-8 weeks	-12.93 units on a scale Interval -32.09 to -3.11	-13.28 units on a scale Interval -19.27 to -7.38

SECONDARY outcome

Timeframe: Program-end

Rate of patients who dropout from the program

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=70 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=70 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Dropout Rate	11 Participants	24 Participants

SECONDARY outcome

Timeframe: 8 weeks

Number of sessions performed at program-end

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=63 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=57 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Total Sessions	22.32 sessions Standard Deviation 9.46	12.42 sessions Standard Deviation 4.95

SECONDARY outcome

Timeframe: 8-weeks

Number of sessions performed per week in the 8-week rehabilitation program

Outcome measures

Outcome measures
Measure	Digital Rehabilitation n=63 Participants Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=57 Participants Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Frequency of Sessions Per Week	2.79 sessions per week Standard Deviation 1.18	1.55 sessions per week Standard Deviation 0.62

Adverse Events

Digital Rehabilitation

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Conventional Rehabilitation at an Outpatient Clinic

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Digital Rehabilitation n=63 participants at risk Home-based rehabilitation with a digital biofeedback system 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.	Conventional Rehabilitation at an Outpatient Clinic n=57 participants at risk Conventional physical therapy: Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face physical therapy 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 to the specific needs of the participant. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled physical therapy sessions.
Vascular disorders Brain Bleeding	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Musculoskeletal and connective tissue disorders Spine Procedure	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
General disorders Chest Pain	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Injury, poisoning and procedural complications Fall	3.2% 2/63 • Number of events 2 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	1.8% 1/57 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Musculoskeletal and connective tissue disorders Knee Pain	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Infections and infestations Covid-19 infection	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Musculoskeletal and connective tissue disorders Low Back Pain	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	3.5% 2/57 • Number of events 2 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Infections and infestations Arm Cyst	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Musculoskeletal and connective tissue disorders Foot Swelling	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Musculoskeletal and connective tissue disorders Lumbar Spinal Injection Reaction	1.6% 1/63 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	0.00% 0/57 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Musculoskeletal and connective tissue disorders Ankle Sprain	0.00% 0/63 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	1.8% 1/57 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Social circumstances Struck by Car	0.00% 0/63 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	1.8% 1/57 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).
Infections and infestations Cold sickness	0.00% 0/63 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).	1.8% 1/57 • Number of events 1 • 8 weeks The total number of participants at risk for adverse events differs from the overall number of participants enrolled in the study, as only participants who received the allocated interventions were considered. Both participants and physical therapists were instructed to contact the study investigators when adverse events occurred (registered on Castor Electronic Data Capture).

Additional Information

Fernando Dias Correia

Sword Health Inc

Phone: +1 (646) 379-6751

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place