The Ad-Shoulder intervention
The Ad-Shoulder intervention was developed by DHM and YR on the basis of the self-managed single exercise programme by Littlewood and colleagues (26–30) and informed by recent research on subacromial shoulder pain (11, 13) and adherence to exercises for patients with persistent musculoskeletal pain (31). The behavioural component of the Ad-Shoulder intervention was based on the self-management framework, provided by Lorig and Holman (32), A key component in this framework is to target patients’ self-efficacy, defined as the confidence to perform a specific task or behaviour (33). In Bandura’s Social Cognitive Theory the person’s perceived self-efficacy is thought to mediate behaviour change (33), which in this self-management intervention is closely linked to adherence to home exercises and physical activity. In the self-management framework suggested by Lorig and Holman (34), the ability to self-manage is achieved based on learning five core self-management skills. These are: Problem-solving, decision making, resource utilization, the forming of a patient/health care provider partnership and taking action. These core self-management skills are elaborated according to the intervention in Appendix 2. The intervention consisted of 1–5 individual sessions over 3 months, where the first session had a duration of 1 hour and the following sessions about 45 minutes. The self-management strategy emphasises dynamic, progressively loaded exercises for the shoulder (Appendix 3). To enhance exercise adherence, we used behaviour change techniques such as social support, goal setting, demonstration of behaviour, graded tasks and self-monitoring of behaviour (Appendix 2). For specific content reporting of the home based exercises we have followed the Certificate on Exercise Reporting Template (Appendix 4) (35, 36). The participants had the option to contact the physiotherapist by phone, text message or e-mail for advice for up to 12 weeks, the duration of the intervention. Patients were allowed to continue with their usual medication, but were asked not to receive other treatment. The intervention was delivered by a PhD student (DHM) and a master student (HVG), both qualified physiotherapists’, with a special interest in shoulder pain and at least 4 years’ experience with assessment and management of musculoskeletal pain conditions.
Measurements
The participants filled in a self-reported questionnaire at baseline (right before the first consultation) and at Week 12. In addition, three self-reported measures (Pain Self-Efficacy Questionnaire 2-item, Numeric Pain Rating Scale and Self-Efficacy) were collected repeatedly, and data on objective physical activity was collected with accelerometers one week before baseline, at Week 6 and at Week 12.
The questionnaire package consisted of sociodemographic variables (age, sex, duration of shoulder pain, education level, work status, relationship status, smoking status, height and weight) and patient reported outcome measures. An overview of the self-reported measures and time-points is provided in Table 1 and a description of these are provided in Appendix 5.
Table 1
Overview of self-reported measures and the time points for the measurements
|
Baseline
|
Week 6
|
Week 12
|
Shoulder Pain and Disability Index (41)
|
X
|
|
X
|
Patient Specific Function Scale (42, 43)
|
X
|
|
X
|
Numeric Pain Rating Scale* (44)
|
X
|
X
|
X
|
Self-efficacy* (45)
|
X
|
X
|
X
|
Pain Self-Efficacy Questionnaire 2-item* (46)
|
X
|
X
|
X
|
Work ability index (47)
|
X
|
|
X
|
EQ-5D-5L (48)
|
X
|
|
X
|
Bergen Insomnia Scale (49)
|
X
|
|
X
|
Kinesiophobia (50)
|
X
|
|
X
|
Patient reported physical activity (51)
|
X
|
|
X
|
Hopkins Symptom Checklist 25 (52)
|
X
|
|
|
Expectations of recovery (53)
|
X
|
|
|
Global Perceived Effect Scale (54)
|
|
|
X
|
Adverse events
|
|
|
X
|
*Also measured with repeated measurements (total of 30 measures) |
Table 2
Patient demographics and patient characteristics (n = 11)
Variables
|
n
|
Median (IQR)
|
Gender, woman
|
7
|
|
Age
|
|
47 (14)
|
Body Mass Index
|
|
22.8 (2)
|
Smoking status, no
|
11
|
|
Duration of symptoms (months)
|
|
18 (15)
|
Hopkins Symptom Checklist 25
|
|
1,2 (0.6)
|
Working status
|
|
Working
|
9
|
|
Sick leave
|
2
|
|
Educational level
|
|
|
Primary School
|
0
|
|
High School
|
0
|
|
Higher education ≤ 4 years
|
4
|
|
Higher education > 4 years
|
7
|
|
Relationship status
|
|
Married/in a relationship
|
7
|
|
Divorced
|
2
|
|
Widow/widower
|
0
|
|
Single
|
2
|
|
Expectations of recovery
|
|
Complete recovery
|
4
|
|
Much improved
|
6
|
|
Slightly improved
|
1
|
|
No change or worse
|
0
|
|
Table 3
Measurements at baseline and 12 weeks follow-up (n = 11)
|
SPADI Week 0/12
|
PSFS Week 0/12
|
NPRS Week 0/12
|
Kinesiophobia Week 0/12
|
WAI Week 0/12
|
Self-Efficacy Week 0/12
|
PSEQ-2 Week 0/12
|
BIS Week 0/12
|
EQ5D-5L Week 0/12
|
Physical activity Week 0/6/12
|
GPE Week 12
|
CASE 1
|
56/3
|
5/9.7
|
5/0
|
1/1
|
5/9
|
4/1
|
9/12
|
22/13
|
0.67/1
|
37/48/23
|
1
|
CASE 2
|
19/0
|
2.7/10
|
5/0
|
6/0
|
10/10
|
2/1
|
12/12
|
6/0
|
0,82/1
|
31/-/52
|
1
|
CASE 3
|
67/46
|
0.3/2.3
|
9/6
|
2/1
|
4/7
|
5/5
|
7/7
|
35/32
|
0.73/0.52
|
58/-/-
|
4
|
CASE 4
|
43/32
|
3/5.3
|
7/3
|
7/4
|
9/10
|
2/2
|
9/11
|
9/11
|
0.73/0.75
|
293/358/215
|
3
|
CASE 5
|
20/5
|
6.3/6.3
|
3/1
|
5/1
|
10/10
|
2/2
|
11/11
|
10/4
|
0.86/0.86
|
120/-/217
|
2
|
CASE 6
|
57/21
|
8.7/8.3
|
8/2
|
8/7
|
7/8
|
3/2
|
9/8
|
25/16
|
0.59/0.73
|
217/323/323
|
2
|
CASE 7
|
19/5
|
6.3/7.7
|
3/1
|
7/1
|
8/9
|
4/2
|
11/10
|
10/4
|
0.79/0.86
|
216/204/158
|
3
|
CASE 8
|
22/23
|
2.7/3.3
|
2/3
|
0/0
|
5/6
|
2/1
|
12/11
|
7/2
|
0.64/0.82
|
343/617/348
|
3
|
CASE 9
|
38/22
|
3.3/7.3
|
5/3
|
2/2
|
6/7
|
3/2
|
9/9
|
12/6
|
0.67/0.79
|
120/137/202
|
2
|
CASE 10
|
22/3
|
5/10
|
2/0
|
0/0
|
10/10
|
2/1
|
12/12
|
10/9
|
0.86/1
|
132/84/41
|
1
|
CASE 11
|
65/-
|
7/-
|
6/-
|
7/-
|
7/-
|
4/-
|
8/-
|
14/-
|
0,73/-
|
110/-/-
|
-
|
Median (range)
|
38 (19–67)/ 21 (0–46)
|
3.3 (0.3–8.7)/8 (2.3–10)
|
5 (2–9)/ 2 (0–6)
|
3,5 (0–8)/ 1
(0–7)
|
7 (0–10)/ 9 (6–10)
|
2,5 (2–5)/ 2 (1–5)
|
9 (7–12)/ 11 (7–12)
|
10 (6–35)/ 6 (2–32)
|
0,73 (0,59 − 0,86)/ 0,84 (0,52 − 1)
|
132 (31–343)/ 170 (48–617)/ 158 (23–323)
|
2 (1–4)
|
Median change Week 0/12
(n = 10)
|
18 (-1-53)
|
2.2 (-0.4-7.33)
|
2.5 (-1-6)
|
1 (0–6)
|
1 (0–4)
|
1 (0–3)
|
0 (-1-3)
|
6(-2-9)
|
0.13 (-0.21-0.33)
|
14 (-91-107)
|
-
|
Missing data
|
-/1
|
-/1
|
-/1
|
-/1
|
-/1
|
-/1
|
-/1
|
-/1
|
-/1
|
-/4/2
|
1
|
Floor effect*
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
Ceiling effect**
|
-
|
-
|
-
|
2
|
3
|
-
|
3
|
-
|
-
|
-
|
-
|
SPADI: Shoulder Pain and Disability Index (0-100, 100 worst score); PSFS: Patient Specific Function Scale (0–10, 0 = Unable to perform activity); NPRS: Numeric pain rating scale (0–10, 10 = most intense pain imaginable); Kinesiophobia (0–10, 10 = very much fear); PSEQ2: Pain Self-Efficacy Questionnaire 2 item (0–12, 0 = not at all confident); Self-efficacy: “How confident have you felt about managing your shoulder pain by yourself (1–5, 5 = not at all confident); BIS: Bergen Insomnia Scale, 0–42 (42 = worst score); WAI: Working Ability Index, 0–10 (0 = Can not work at all); EQ5D-5L: 1 = perfect health. Physical activity: Minutes of moderate physical activity (MET ≥ 3) during three consecutive days measured using an accelerometer. GPE: Global perceived effect scale, 1–6, 1 = Very much better, 6 = Very much worse. *Number of patients with the worst score at baseline. **Number of patients with the best score at baseline |
The participants also responded to SMS text messages containing three measurements (Numeric Pain Rating Scale, Self-efficacy and Pain Self-Efficacy Questionnaire 2-item) before, during, and after the intervention period to explore the process of change on an individual level. During the first week pre-treatment phase (A), 3 text messages including the three measurements were collected. During the 12-week treatment phase (B) the text messages were collected twice every week (total of 24), and during the one week post-treatment phase (A) the text messages were collected 3 times.
Physical activity was objectively measured, using four accelerometers (AX3, 3-axis Logging Accelerometer, Axivity, United Kingdom) attached to the chest, upper arm, hip and wrist for three consecutive days one week before baseline, at Week 6 and at Week 12. This accelerometer provides information about movement and enabled us to objectively measure the amount of general physical activity (minutes of ≥ moderate activity, defined as Metabolic equivalent (MET) value ≥ 3).
Feasibility outcomes and progression criteria
1. The recruitment rate – measured by how many people that were eligible and how many people that were recruited per week
Progression criteria: Ten participants would be enrolled in the study within a 12 week period.
2. Follow-up rate - measured by the percentage of participants who were followed up successfully until the three months follow-up.
Progression criteria: Follow up rates ≥ 80% for the questionnaire at 12 weeks and the repeated measures.
3. Feasibility of Actigraph assessment of physical activity - measured by percentage of participants with valid data at each time point (baseline, 6 weeks and 12 months). Validity of data was defined as successful measurement of a participant’s physical activity for at least 20 hours per day for three consecutive days.
Progression criteria: At least 80% of participants would contribute valid physical activity (actigraph) data at each time point.
4. Adherence with the self-managed exercises – measured by percentage of patients maintaining at least 80% adherence to the self-managed exercises measured by self-reported exercise logbook.
Progression criteria: At least 80% of the participants would adhere to at least 80% of the assigned home exercise program (self-reported).
5. Fidelity of the delivery of the intervention – measured by whether the physiotherapist delivered the components of the intervention or added other components to the intervention using a physiotherapist completed logbook at 3 months.
Progression criteria: The therapists would deliver the intervention according to the protocol.
6. Number and nature of adverse events - measured by self-report questionnaire.
Progression criteria: No more than 30% would report adverse events (including mild), such as increased short term pain with home exercises.
7. Data collection procedure - assessed by exploring data from the self-report outcomes with respect to missing data and scoring pattern at baseline (floor/ceiling effect, median, variation).
In terms of decision making against the progression criteria, should we have fallen below/above any of these rates in our feasibility study we would consider whether protocol modification or close monitoring during a main RCT would address any failure to meet these criteria, or decide that the main RCT would not be feasible (21).