Background
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Our primary research aim is to investigate the clinical effectiveness of the Stratified Blended Approach for patients with neck and/or shoulder complaints on pain and disability over 9 months, compared to usual physiotherapy care.
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to investigate the effectiveness of the Stratified Blended Approach for patients with neck and/or shoulder complaints on pain intensity, health-related quality of life, illness perceptions, self-management skills, physical activity, exercise adherence, self-perceived effect and satisfaction at 3 and 9 months, compared to usual physiotherapy care;
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to investigate the cost-effectiveness and cost-utility of the Stratified Blended Approach for patients with neck and/or shoulder complaints, compared to usual physiotherapy care.
Methods
Trial design and setting
Participants
Physiotherapists
Patients
Intervention
The stratified blended approach
Phase 1: Stratification | |||
Content and intensity of treatment will be matched to the patient’s risk of persistent disabling pain (low, medium or high, assessed with the Keele STarT MSK Tool) | Mode of care delivery will be matched to the patient’s suitability for blended care (yes or no, assessed with the Dutch Blended Physiotherapy Checklist) | ||
Phase 2: Matched treatment per risk profile | |||
Low risk | Medium risk | High risk | |
Physiotherapy sessions (either face-to-face or video consults) | |||
Aim | Improvement of a patient’s pain and disability | ||
Intensity | 3–4 sessions (3 weeks) | 6–9 sessions (12 weeks) | 8–12 sessions (12 weeks) |
Content | Reassurance, provide information on neck/shoulder complaints, personal etiology, self-management options and the importance of adequate physical activity/exercise behavior | Similar to low risk and additionally: consider to provide passive or active joint mobilization techniques, in combination with functional exercise therapy | Similar to medium risk and additionally: consider to address patient’s specific physical and psychosocial obstacles to recovery, using a combination of physical and psychological approaches, including pain education |
Integration | Motivate to read information modules and do home-based exercises independently | Per session evaluation of progress with e-Exercise app or paper-based workbook to optimize physiotherapy treatment | |
Evaluation | A final session to evaluate the progress and give recommendations to prevent recurrent episodes of neck/shoulder complaints and maintain or improve the physical activity level | ||
Patient’s home setting: e-Exercise app or paper-based workbook | |||
Information module | 3 weekly varying information themes, including assignments to stimulate self-reflection | 12 weekly varying information themes, including assignments to stimulate self-reflection, about the etiology of neck/shoulder complaints, physical activity, patient experiences, pain management, and psychosocial factors related to neck/shoulder complaints. The information and order of the information provided will differ per risk profile and working status | |
Exercise module | 3–4 personalized exercises to fit the patient’s specific functional status. | ||
Physical activity module | Recommendations | The patient chooses one physical activity and sets a goal to maintain or enhance the level of that physical activity. A graded activity functionality can be activated. | The patient chooses one physical activity and sets a goal to enhance the level of that physical activity, by using a graded activity functionality. |
Matched treatment: content and intensity of physiotherapy care
Low risk
Medium risk
High risk
Matched treatment: mode of care delivery
Blended care
Paper-based workbook
Usual physiotherapy
Measurements
Primary outcome
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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) [29‐33] for patients with primarily neck complaints and by the Shoulder Pain and Disability Index (SPADI) [34‐38] for patients with primarily shoulder complaints. A higher total score (0–100 for both outcome measures) indicates increased pain and functional limitations [29‐38].
Secondary outcomes
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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 [41‐45].
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Patients’ self-management skills are assessed with the Dutch version of the short form Patient Activation Measure (PAM13-Dutch) [49, 50]. 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 [49, 50].
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Physical activity will be objectively measured with an Actigraph accelerometer [51, 52]. 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 [51, 52]. Average amount of moderate or vigorous physical activity (MVPA) per day will be calculated.
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Exercise adherence will be measured with the Exercise Adherence Rating Scale (EARS) [53]. 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 [53].
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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) [56].
Demographic and clinical characteristics
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Patient characteristics are only collected in the first questionnaire and include various demographic and clinical variables, including: age, sex, education level, duration of complaints, weight, height and co-morbidities.
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The risk of persistent disabling pain will be assessed with the Keele STarT MSK Tool (i.e. low, medium or high risk) [13]. The Keele STarT MSK Tool is part of the Stratified Blended Approach and is additionally included in the data collection.
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As part of the data collection, patients’ suitability for e-Exercise (blended care) will be measured by two self-developed questions as substitute for the Dutch Blended Physiotherapy Checklist. It is not possible to use the Dutch Blended Physiotherapy Checklist as a measurement instrument, because it is a tool to guide physiotherapists in their clinical reasoning while setting up a personalized blended physiotherapy treatment, thus not a patient reported outcome measure [16]. Therefore, this cannot be measured in the control arm. The following questions will be assessed in the first questionnaire: ‘Do you own a smartphone or tablet? (yes/no)’ and ‘How many apps do you use regularly (weekly) on your smartphone or tablet? (none/1-3 per week/4-10 per week/more than 10 per week)’.
Other outcomes
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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.
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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. Additionally, all patients will be asked in the first follow-up questionnaire whether they received and used an app or paper-based workbook as part of their physiotherapy treatment.