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Trial registered on ANZCTR


Registration number
ACTRN12618001507279p
Ethics application status
Submitted, not yet approved
Date submitted
25/08/2018
Date registered
7/09/2018
Date last updated
7/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
'My shoulder has a brain': physiotherapy for persistent shoulder pain: taking control of your shoulder pain
Scientific title
'My shoulder has a brain': feasibility of neuroscience-informed physiotherapy for persistent shoulder pain
Secondary ID [1] 295908 0
None
Universal Trial Number (UTN)
U1111-1216-3011
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 309381 0
Rotator cuff related pain 309382 0
Condition category
Condition code
Musculoskeletal 308242 308242 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 308243 308243 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive pragmatic individualised physiotherapy treatment, based on their baseline assessment. Following the baseline assessment, they will have up to 7 sessions, expected to last one hour for the first two sessions, and thereafter ½ hr. The frequency of the sessions will be based on the individual patient-specific context, over a maximum time period of 3 months. Thus, a total of 8 sessions (including the baseline assessment) will be provided over 3 months.
The intervention will be based on a symptom-modification and cognitive therapy approach using 5 phases. For Phase 1, symptom-modification will focus on reduction of pain and/or stiffness using manual therapy, active movements of the shoulder and low-intensity shoulder exercises. Cognitive training (Phase 2) will be adapted from approaches used for patients with chronic low back pain, and informed by our previous study. The cognitive training will be supported by patient resources (online video clips) developed during Stage 1 and 2 of our research. These will include knowledge regarding shoulder anatomy; interpretation of imaging findings; pain physiology; cognitive/psychologically-informed exercises; and the role of specific and general physical exercises, relaxation and general health. The explicit inclusion of Phase 2 ‘Cognitive training’ and Phase 5 ‘Physical activity’ are the main points of differences to current regular physiotherapy for rotator cuff syndrome and constitute, specifically, the ‘neuroscience’-informed approach.
Phases 3 to 5 will be progressive exercises to increase loading ability of the shoulder, muscle strength and graded general physical activity. Specific exercises will be based on the patient’s individual goals, functional level and requirements in terms of daily life, occupation-related tasks, recreation and sports. Cognitive training will underpin all 5 phases, and the phases may be concurrent, rather than strictly sequential. There will be emphasis on reflective communication, goal orientation, functional enhancement and self-management throughout the treatment series.
Participants will complete a daily online exercise diary of their (1) shoulder-specific exercises and (2) general physical activities. Participants will also be asked to complete a diary of costs related to the shoulder pain during the course of the physiotherapy programme.
All treatments will be provided by physiotherapists.
Intervention code [1] 312232 0
Rehabilitation
Intervention code [2] 312233 0
Behaviour
Intervention code [3] 312234 0
Lifestyle
Comparator / control treatment
This is a one-group feasibility study and no control treatment will be included.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307206 0
Shoulder Pain And Disability Index (SPADI), total score: indicating overall daily function related to shoulder activity
Timepoint [1] 307206 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [1] 351126 0
Patient Specific Functional Scale (PSFS)
Timepoint [1] 351126 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [2] 351127 0
Fear-Avoidance Beliefs Questionnaire (FABQ);
Timepoint [2] 351127 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [3] 351128 0
Pain Catastrophizing Scale (PCS)
Timepoint [3] 351128 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [4] 351129 0
SF-12
Timepoint [4] 351129 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [5] 351130 0
EQ-5D
Timepoint [5] 351130 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [6] 351131 0
Health literacy: Neurophysiology of Pain Questionnaire
Timepoint [6] 351131 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [7] 351132 0
Self-efficacy Questionnaire
Timepoint [7] 351132 0
Baseline; Discharge from intervention; 3-month follow-up
Secondary outcome [8] 351133 0
Range of motion of composite internal and external rotation, measured with inclinometer with arm in 90 degrees abduction,
Timepoint [8] 351133 0
Baseline; Discharge from intervention.
Secondary outcome [9] 351134 0
Isometric external rotation muscle strength of the shoulder using a handheld dynamometer
Timepoint [9] 351134 0
Baseline; Discharge from intervention.
Secondary outcome [10] 351379 0
Range of motion of shoulder flexion (inclinometer)
Timepoint [10] 351379 0
Baseline; Discharge from intervention.
Secondary outcome [11] 351380 0
Isometric internal rotation muscle strength of the shoulder using a handheld dynamometer
Timepoint [11] 351380 0
Baseline; Discharge from intervention.
Secondary outcome [12] 351381 0
Health care-related costs: self-reported costs of treatment, visits to other health care professionals, and over-the-counter or prescribed medicines for the shoulder pain
Timepoint [12] 351381 0
Discharge from Intervention
Secondary outcome [13] 351382 0
Productivity costs: Self-reported data on employment status, occupation, time off work and reduced productivity at work
Timepoint [13] 351382 0
Discharge from Intervention
Secondary outcome [14] 351383 0
Patient-incurred costs associated with the physiotherapy treatment sessions (travel costs, time off work and child care costs) via self-reported patient diary.
Timepoint [14] 351383 0
Discharge

Eligibility
Key inclusion criteria
i) men and women, age 40 years and greater; (ii) primary complaint of shoulder pain with or without referral in the upper limb for 3 months or longer, (iii) shoulder pain provoked with resisted contractions into abduction and/or lateral rotation and/or (iv) range of motion largely preserved.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) shoulder surgery in the last 6 months, (ii) known systemic inflammatory disorders, (iii) cervical repeated movement testing affecting shoulder pain and/or range of movement, (iv) severe depressive symptoms, suicidal ideation or psychotic illness (PHQ-9, score >23)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Non-randomised trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Feasibility
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Objective 1: Descriptive statistics will be used for recruitment frequency and the number of eligible participants, the drop-out rate, and degree of missing data for the patient-rated outcomes measures. The programme will be considered feasible if 80% of patients complete the programme until formal discharge.
Objective 2: Descriptive statistics will be used to summarise key clinical outcomes. Estimates of the treatment effect will be calculated with change scores (mean differences and 95% confidence intervals) from baseline to follow-up for each of the clinical outcome variables.
The primary outcome will be the SPADI, the remaining patient-outcome measures and the physical measures will be secondary outcomes. These will be compared with clinical meaningful differences for the variables.
The main adverse event will be increased levels of pain (change >3/10, not subsiding within 24 hours following treatment and/or exercise).
Objective 3: Clinical fidelity: adherence to the intervention by auditing and summarising patients’ log-books and the physiotherapists’ assessment and treatment documentation. An assistant research fellow will audit the documentation.
Objective 4: Economic outcome measure: costs will be summarised descriptively (frequency; mean/SD for parametric distributions; median/ranges for non-parametric).


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20800 0
New Zealand
State/province [1] 20800 0
Otago and Cantebury

Funding & Sponsors
Funding source category [1] 300500 0
Other
Name [1] 300500 0
Jack Thomson Arthritis Grant
Address [1] 300500 0
Otago Medical Research Foundation
Deloitte, Secretaries
PO Box 1245
Dunedin
Country [1] 300500 0
New Zealand
Funding source category [2] 300501 0
Other
Name [2] 300501 0
Physiotherapy New Zealand Scholarship Trust
Address [2] 300501 0
PO Box 27 386
Marion Square
Wellington
6141
Country [2] 300501 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Center of Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 300047 0
None
Name [1] 300047 0
Address [1] 300047 0
Country [1] 300047 0
Other collaborator category [1] 280322 0
Individual
Name [1] 280322 0
Dr Craig Wassinger
Address [1] 280322 0
Department of Physical Therapy
East Tennessee State University
1276 Gilbreath Dr
Johnson City, TN 37604

Country [1] 280322 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301297 0
Health and Disability Ethics Committee
Ethics committee address [1] 301297 0
Ministry of Health
PO Box 5013
Wellington
6011
Ethics committee country [1] 301297 0
New Zealand
Date submitted for ethics approval [1] 301297 0
06/08/2018
Approval date [1] 301297 0
Ethics approval number [1] 301297 0

Summary
Brief summary
This will be one-group feasibility trial. Patients with persistent shoulder pain will receive a physiotherapy programme that includes pain education, self-management skills and graded general physical activity, in addition to usual physiotherapy. The programme will include 8 sessions (including the baseline assessment) over 3 months. We will: (1) define the number of participants, and how many participants complete the questionnaires and the physiotherapy sessions; (2) measure clinical outcomes of the programme; (3) determine adherence to the programme, and (4) determine direct and indirect costs of the shoulder pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86538 0
Dr Gisela Sole
Address 86538 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 86538 0
New Zealand
Phone 86538 0
+64 3 4797936
Fax 86538 0
Email 86538 0
gisela.sole@otago.ac.nz
Contact person for public queries
Name 86539 0
Dr Gisela Sole
Address 86539 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 86539 0
New Zealand
Phone 86539 0
+64 3 4797936
Fax 86539 0
Email 86539 0
gisela.sole@otago.ac.nz
Contact person for scientific queries
Name 86540 0
Dr Gisela Sole
Address 86540 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
Box 56
Dunedin
9054
Country 86540 0
New Zealand
Phone 86540 0
+64 3 4797936
Fax 86540 0
Email 86540 0
gisela.sole@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable