Stratified Physiotherapeutic (Blended) Care in Neck and Shoulder Complaints

The primary outcome is the combined region-specific pain and disability score over 9 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.

The primary outcome is the combined region-specific pain and disability score over 9 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.

The average neck and/or shoulder pain intensity in the last week will be measured with an 11-point Numeric Rating Scale (NRS) (0 = no pain; 10 = worst pain imaginable)

The average neck and/or shoulder pain intensity in the last week will be measured with an 11-point Numeric Rating Scale (NRS) (0 = no pain; 10 = worst pain imaginable)

Health-related quality of life will be measured with the 36-Item Short Form Health Survey (SF-36). The questionnaire consists of eight subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain (over the last 4 weeks) and general health). Scores for each subscale will be calculated (0-100). Higher scores indicate a better health-related quality of life.

Health-related quality of life will be measured with the 36-Item Short Form Health Survey (SF-36). The questionnaire consists of eight subscales (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain (over the last 4 weeks) and general health). Scores for each subscale will be calculated (0-100). Higher scores indicate a better health-related quality of life.

Illness perceptions will be measured with the Brief Illness Perception Questionnaire (IPQ-K). This questionnaire is an eight-item scale designed to assess cognitive and emotional representations of illness on an ordinal scale (0-10)

Illness perceptions will be measured with the Brief Illness Perception Questionnaire (IPQ-K). This questionnaire is an eight-item scale designed to assess cognitive and emotional representations of illness on an ordinal scale (0-10)

Patients' self-management skills are assessed with the Dutch version of the short form Patient Activation Measure (PAM13-Dutch). The PAM 13-Dutch is a reliable 13-item instrument and assesses patient (or consumer) self-reported knowledge, skills and confidence for self-management of one's health or chronic condition. The answering categories per item are 4-point Likert scales, ranging from totally disagree to totally agree and 'non applicable'. A higher score (range 1-100) indicates a higher level of self-management.

Patients' self-management skills are assessed with the Dutch version of the short form Patient Activation Measure (PAM13-Dutch). The PAM 13-Dutch is a reliable 13-item instrument and assesses patient (or consumer) self-reported knowledge, skills and confidence for self-management of one's health or chronic condition. The answering categories per item are 4-point Likert scales, ranging from totally disagree to totally agree and 'non applicable'. A higher score (range 1-100) indicates a higher level of self-management.

Physical activity will be objectively measured with an Actigraph accelerometer. The Actigraph accelerometer is a reliable tool for measuring physical activity in adults. Participants will be instructed to wear the accelerometer on their waist for five consecutive days, except when sleeping, showering, bathing or swimming. Average amount of moderate or vigorous physical activity (MVPA) per day will be calculated.

Physical activity will be objectively measured with an Actigraph accelerometer. The Actigraph accelerometer is a reliable tool for measuring physical activity in adults. Participants will be instructed to wear the accelerometer on their waist for five consecutive days, except when sleeping, showering, bathing or swimming. Average amount of moderate or vigorous physical activity (MVPA) per day will be calculated.

Exercise adherence will be measured with the Exercise Adherence Rating Scale (EARS). The EARS is a 6 item self-reported questionnaire with items scored on a 5-point Likert scale (0 = completely agree; 4 = completely disagree). A higher score (0-24) indicates better adherence to prescribed home-exercises.

Exercise adherence will be measured with the Exercise Adherence Rating Scale (EARS). The EARS is a 6 item self-reported questionnaire with items scored on a 5-point Likert scale (0 = completely agree; 4 = completely disagree). A higher score (0-24) indicates better adherence to prescribed home-exercises.

Global perceived effect will be measured with the 7-point Likert global perceived effect score (GPE). Categories 1 (very much improved) to 3 (a little improved) are classified as 'improved'. Categories 4 (no change) to 7 (very much worse) are classified as 'not improved'.

Global perceived effect will be measured with the 7-point Likert global perceived effect score (GPE). Categories 1 (very much improved) to 3 (a little improved) are classified as 'improved'. Categories 4 (no change) to 7 (very much worse) are classified as 'not improved'.

Satisfaction with treatment outcome will be measured with an 8-point Likert scale question: 'All things considered, how satisfied are you with the results of the treatment for your neck and/or shoulder complaints? (1 = extremely satisfied, 7 = extremely dissatisfied, 8 = not sure/no opinion)

This outcome will be combined to a region-specific pain and disability score over 3 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.

This outcome will be combined to a region-specific pain and disability score over 3 months follow-up, assessed by the Neck Pain and Disability Scale (NPAD) for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) for patients with primarily shoulder complaints. A higher total score (0-100 for both outcome measures) indicates increased pain and functional limitations.

A cost-utility analysis (CUA) will be performed for QALYs and a cost-effectiveness analysis (CEA) for the combined region-specific pain and disability score, both of which will be performed from the societal and the healthcare perspective. From the societal perspective all costs will be taken into account, irrespective of who pays or benefits, whereas solely those borne by the healthcare sector will be included if the healthcare perspective is applied.

A cost-utility analysis (CUA) will be performed for QALYs and a cost-effectiveness analysis (CEA) for the combined region-specific pain and disability score, both of which will be performed from the societal and the healthcare perspective. From the societal perspective all costs will be taken into account, irrespective of who pays or benefits, whereas solely those borne by the healthcare sector will be included if the healthcare perspective is applied.

The content and intensity of physiotherapy care will be measured by a case report form, filled out by the physiotherapist at the end of the treatment period or after 3 months. Information of the risk of persistent disabling pain, the suitability for blended care, the physiotherapists diagnosis of the presenting problem, the number of physiotherapy sessions, deviations from the study protocol, and content of the physiotherapy sessions will be collected.

The content and intensity of physiotherapy care will be measured by a case report form, filled out by the physiotherapist at the end of the treatment period or after 3 months. Information of the risk of persistent disabling pain, the suitability for blended care, the physiotherapists diagnosis of the presenting problem, the number of physiotherapy sessions, deviations from the study protocol, and content of the physiotherapy sessions will be collected.

Adherence to the smartphone app with e-Exercise modules in the Stratified Blended Approach arm will be assessed by quantitative data on the usage. These data will automatically be stored on the backend of the app.