Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000163505
Ethics application status
Approved
Date submitted
22/01/2024
Date registered
21/02/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
21/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepped physiotherapy for persistent shoulder pain
Scientific title
Stepped physiotherapy for persistent shoulder pain in adults with persistent rotator cuff related shoulder pain
Secondary ID [1] 311034 0
Health Research Council project grant 23-257
Universal Trial Number (UTN)
U1111-1298-4087
Trial acronym
StePS-NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 332547 0
Rotator cuff related shoulder pain 332548 0
Rotator cuff tendinopathy 332794 0
Condition category
Condition code
Physical Medicine / Rehabilitation 329236 329236 0 0
Physiotherapy
Musculoskeletal 329653 329653 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stepped Care will include two one-on-one one-hour physiotherapy sessions of a Self-management programme. The first session will include a ~20-minute clinical assessment of the participant’s pain and their goals and preferences. Shared information will relate to their condition/injury; basic pain neuroscience; pain self-management and lifestyle factors (including relaxation, sleep management). General information about exercise and staying active will be provided. A general physical activity (e.g., walking, cycling or gym training) will be recommended (150–300 minutes of moderate-intensity activity per week as per WHO recommendations).
During the second session (2-3 weeks later), the physiotherapist will review the participant’s status and physical activity. Person-specific long-term advice will be provided for shoulder health.
At 6-week follow-up those no longer experiencing clinically important symptoms at that timepoint (QuickDASH less than 11) will have no further physiotherapy. Those with remaining symptoms (QuickDASH equal or greater than 11) will receive follow-up interventions by the physiotherapist as for Group 2, with up to 8 sessions over 6 weeks (total maximum: 10 sessions).
A. What (materials)
Patient education: Guided by resources developed and collated by the research team:
• Website https://shoulderpain.org.nz/
Exercise prescription: Strength training equipment (free weights, resistance bands).
Patient diaries to document goals; progress; physical activity and exercise; pain medication; visits to other health professionals; direct and indirect treatment costs.
B. What (procedures):
Communication, advice and education
The physiotherapist will use a person-centered approach, using a culturally responsive approach to explore the patient’s pain experience, goals and devising a rehabilitation plan; motivational interviewing and reflective listening. The ‘shoulder pain’ website developed at the University of Otago will guide provision of information. Topic sequencing will be individualised to each patient. The therapist will send a link to applicable videos embedded on the website (and others) to patients who will be able to watch them as often as they find helpful.
Topics:
• Anatomy of the shoulder
Surface anatomy of trapezius, deltoid, biceps and triceps muscles; rotator cuff; tendinopathy, partial and full tear; common age-related changes of the rotator cuff. https://shoulderpain.org.nz/your-shoulder/shoulder-anatomy
• Connecting with our nervous system
The messenger system: neurons, nervous system; the alarm system: sensitivity of the nervous system; factors influencing the alarm system and pain; patterns in the brain (‘neurotags’); factors influenced by the ‘alarm system’ (stress, memory, sleep, concentration, digestion, immunity). https://shoulderpain.org.nz/pain-management/pain-types-and-causes
• Managing shoulder pain and wellness with movement: exercise and general physical activity
Role of exercise and physical activity towards general health and wellness and desensitising the nervous system; role of specific exercises to strengthen the shoulder; pacing, ‘walking the line’. https://shoulderpain.org.nz/your-shoulder/whole-body-health
C. Providers
The intervention will be provided by registered physiotherapists (any experience level). They will be trained by the researchers at a one-day workshop, within the month prior to start of recruitment. The Health Behavioural Psychology researcher (Swain), a Maori researcher (Bell), and the principal investigator (Sole) will train the clinicians for the therapeutic relationship/cognitive skills, cultural responsiveness and the manual therapy/exercise and physical activity programme. Follow-up sessions will be held with the principal investigator via Zoom or in person.
D. How
Two face-to-face, one-on-one physiotherapy sessions and self-directed physical activity.
E. Where
• University of Otago School of Physiotherapy clinics, Dunedin
• Christchurch Physiotherapy and Sports Clinic, Christchurch
• Auckland Shoulder Clinic, Auckland
• Focused Physiotherapy, Waikato
F. When and how much
Recruitment is planned from April 2024 to April 2025. Physiotherapy care will be provided 2 one-hour sessions within three weeks. Patients will be followed up at 6 weeks those with remaining symptoms (based on the threshold QuickDASH score) will be offered physiotherapy, as for the ‘Pragmatic Physiotherapy’ Group (see below).
and across a three-month period: two of them will be one hour, and the remaining ones ½-hour duration. The frequency of the sessions across the three-month period will be based on the physiotherapist’s and patients’ collaborative decision.
G. Tailoring
A pragmatic approach will be used, tailored to the patients’ clinical presentation and approach.
Education: the information provided to the patient will be dependent on the line of the conversations and questions asked by the patient.
Prescription of general physical activity (e.g. walking, cycling, gym training) will be based on the patient’s interest, past activity level, as well as current tolerance, for example, walking 15 minutes daily. The goal will be to achieve WHO guidelines for physical activity (150-300 minutes of moderate-intensity activity per week). Participants will be asked to record their physical activity in an electronic or hard copy diary on a weekly basis.
H. Modifications
Any modifications to the protocol will be documented and reported.
I. Safety
• Pain flare ups. The physiotherapist will discuss with the participant what level of discomfort or pain might be expected during physical activity. In most cases such acvitiy-related discomfort/pain settles within 24 hours. If it lasts longer than 24 hours and the participant considers the discomfort/pain excessive, they will be asked to avoid the specific activity and report that back to the physiotherapist. The Physiotherapist will record such response in the clinical notes during the second session, and modify the physical at a lower intensity. If participants have severe or untolerable pain at any time during the three months following the first session, they will be able to contact the physiotherapist and be offered to enter the ‘Pragmatic Physiotherapy’ programme, as below.
Intervention code [1] 327747 0
Lifestyle
Intervention code [2] 327748 0
Rehabilitation
Comparator / control treatment
Participants of the Pragmatic Physiotherapy group will receive up to 10 individual physiotherapy sessions within a 3-month period. Two of the sessions will be one hour duration, and the remaining sessions will be half-hour. The weekly frequency will vary, negotiated individually between the physiotherapist and the patient.
Patients will receive manual therapy, exercise prescription, patient education and guidance for physical activity during the 10 sessions. Manual therapy will be applied using a pragmatic approach based on clinical reasoning. The techniques may include the following:
• Passive joint mobilisations of the shoulder girdle, and cervical/thoracic spine (Maitland concept)
• Mobilisations-with-movement (Mulligan concept)
• The symptom-modification approach (Lewis)
• Thoracic manipulations (high-velocity thrusts)
• Soft tissue mobilisations of the cervical spine, axio-scapular and glenohumeral muscles.
Techniques will be based on the patient’s specific impairments (e.g. loss of range of movement or pain during a specific movement) and their functional goals. The dosage will be dependent on the pain intensity and the patient’s tolerance. Considerations will be the starting position (e.g. supine or prone, and angle of the arm), the direction of the mobilisation, and the grade of the oscillatory mobilisation [‘depth’ and amplitude]. For the Mulligan and symptom-modification approaches, articular glides that reduce the patient’s pain during a specific movement will be applied. The glides will be applied either manually (physiotherapist’s hands) or with a manual therapy belt, during 6 to 8 repetitions of the active movement. Progressions will be based on the patient’s pain/symptom responses immediately after the application (within session) and on return for the next appointment (between sessions).
A. What (materials)
Patient education: Access to the same website as the ‘Stepped Care Group’ (see above).
Exercise prescription: Strength training equipment (free weights, resistance bands).
Patient diaries to document goals; progress; physical activity and exercise; pain medication; visits to other health professionals; direct and indirect treatment costs.
Belts used for mobilisations-with-movement.
B. What (procedures):
Communication, advice and education
The same style of communication and content for the advice and education as for the ‘Stepped Care’ Group will be provided (see above). The education may be spread across the 10 sessions, rather just in the first two sessions.
Exercise prescription
Exercises are designed to progressively load the shoulder and to promote general physical activity. We will follow the following processes:
Stage 1: Early stage rehabilitation and shoulder symptom modification
Low-level exercises (motor control exercises), slow, controlled movements, focussing on quality.
Stage 2: Eccentric and heavy slow resistance exercises
Progress shoulder-specific exercises using the Shape-Up-My-Shoulder (SUMS) approach considering potential variables such as increasing range, load (weight), frequency, speed.
Stage 3: Functional programme
Progressively returning to function in terms of individual-specific work, sports, daily activities and recreation. This phase overlaps with Stage 1 and 2, and consists of a general exercise programme, including general physical activity. The programme is individualised to the patient’s requirements and goals, and progressed
C. Providers
The intervention will be provided by the same registered physiotherapists as for the ‘Stepped Care’ Group (See above).
D. How
Face-to-face physiotherapy care and self-directed home exercises.
E. Where
• The same locations as for the ‘Stepped Care’ group (see above).
F. When and how much
Recruitment will be concurrent as for the ‘Stepped Care’ group, planned from April 2024 to April 2025. Physiotherapy care will be provided with up to 10 sessions across a three-month period: two of them will be one hour, and the remaining ones ½-hour duration. The frequency of the sessions across the three-month period will be based on the physiotherapist’s and patients’ collaborative decision.
G. Tailoring
A pragmatic approach will be used, tailored to the patients’ clinical presentation and approach.
Education: sequencing of information provided to the patient will be dependent on the line of the conversations and questions asked by the patient.
Exercise prescription: Starting dosage of exercises will be dependent on the assessment of their ability and tolerance during specific exercises. The load (weight), repetitions, sets and frequency will be assessed to be within the patient’s tolerance of discomfort/pain. In general, exercises will be prescribed with 15 repetitions with 2 or 3 sets on a daily basis. Progression will include the number of exercises (1 exercise to up to 6 exercises), body starting position, load, number of repetitions/sets/frequency, and speed. Prescription of general physical activity (e.g. walking) will also be based on the patient’s interest, past activity level, as well as current tolerance, for example, walking 15 minutes daily.
H. Modifications
Any modifications to the protocol will be documented and reported.
I. Safety
• Physical risks may include delayed onset muscle soreness (muscle stiffness) as a normal consequence of exercise. Participants will be asked to record these in their diary and report back to the physiotherapist. The physiotherapist will be asked to record the symptoms in their clinical notes. Exercises will be modified if the muscle stiffness is considered excessive by the participant.
• Exercise or manual therapy may also flare up pain. The physiotherapist will discuss with the participant what level of discomfort or pain might be expected during the exercises. In most cases such exercise-related discomfort/pain settles within 24 hours. If it lasts longer than 24 hours and the participant considers the discomfort/pain excessive, they will be asked to avoid the specific exercise and report that back to the physiotherapist. The Physiotherapist will record such response in the clinical notes, and modify the exercises at a lower intensity.
• Manual Therapy: there may be discomfort and pain during the application of manual therapy. The physiotherapist will continuously ask the participant to report such discomfort while applying the technique. Their response immediately following application will be assessed, following routine physiotherapy processes. The participant will be asked to report back at the next session what the symptom response following the treatment was. The physiotherapist will record their self-reported response, and will modify manual therapy applications accordingly.
Control group
Active

Outcomes
Primary outcome [1] 337072 0
Shoulder-related pain & disability (composite)
Timepoint [1] 337072 0
Baseline;
6 weeks, 3 months (primary outcome), 6 months, 12 months following the first physiotherapy session
Secondary outcome [1] 430559 0
Pain severity
Timepoint [1] 430559 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [2] 430560 0
Pain beliefs and behaviour (composite)
Timepoint [2] 430560 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [3] 430561 0
Pain beliefs and behaviour (composite)
Timepoint [3] 430561 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [4] 430562 0
Anxiety and Depression (composite)
Timepoint [4] 430562 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [5] 430563 0
Self-confidence in living with pain
Timepoint [5] 430563 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [6] 430566 0
Patient satisfaction with their condition
Timepoint [6] 430566 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [7] 430567 0
Patient satisfaction with the physiotherapy
Timepoint [7] 430567 0
6 weeks and 3 months following the first physiotherapy session
Secondary outcome [8] 430568 0
Patient-reported change
Timepoint [8] 430568 0
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [9] 430569 0
Health-related quality of life
Timepoint [9] 430569 0
Baseline;
6 weeks, 3 months, 6 months, 12 months following the first physiotherapy session
Secondary outcome [10] 430570 0
Direct and indirect costs of healthcare for the shoulder pain (composite)
Timepoint [10] 430570 0
3, 6 and 12 months following first physiotherapy session
Secondary outcome [11] 430571 0
Treatment fidelity
Timepoint [11] 430571 0
At completion of the physiotherapy sessions.
Secondary outcome [12] 430572 0
Treatment fidelity of person-centered communication and interaction with the patient (composite)
Timepoint [12] 430572 0
During a two-week block at the start of the intervention delivery, mid-way and towars the end of the intervention delivery.
Secondary outcome [13] 430573 0
Patient experiences
Timepoint [13] 430573 0
3 months following the first physiotherapy session.

Eligibility
Key inclusion criteria
(i) Men and women, age greater or equal to 18 years; (ii) pain duration 3 months or greater (as those with persistent pain account for most of the health system costs for shoulder pain); (iii) shoulder pain attributed to a rotator cuff related shoulder pain (rotator cuff syndrome) using valid diagnostic criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Past shoulder surgery, glenohumeral dislocation or fracture; (ii) known systemic inflammatory disorders, for example rheumatoid arthritis; (iii) cervical movement affecting shoulder pain; (iv) clinically suspected massive full thickness rotator cuff tears or frozen shoulder; (v) steroid injection for shoulder pain within the past 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone or email
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
REDCap’s concealled sequence generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Statistical Analysis
We will use descriptive statistics and frequentist quantitative measures at each measurement time point to explore relationships of outcomes with patient characteristics and interventions. We will use a repeated measures version of two one-sided test approach to assess equivalence of outcome(s) in the groups (Group 1 and Group 2), considering possible clustering by clinic. In addition to per-protocol analysis (restricted to participants who adhered to the interventions, namely those that attended physiotherapy until formal discontinuation), principles underlying intention-to-treat analysis will be followed depending on the level of attrition.

Economic Analysis
A cost-effectiveness analysis will be conducted on an intention-to-treat basis at the individual level and reported from a societal perspective. The outcome measures will be QuickDASH scores and Quality-Adjusted Life Years (QALYs). To calculate QALYs, each participant’s health profile (i.e. their self-reported health on the five dimensions and levels of the EQ5D, e.g. 12321) will be converted to a utility value using the NZ EQ-5D-5L social value set. Direct medical costs will include physiotherapy costs, dispensed pharmaceutical costs, diagnostic imaging, GP, and orthopaedic surgery costs. Direct and indirect shoulder-related costs incurred by participants, such as transport costs, over-the-counter medication, carer support and time off work will be included. Incremental cost effectiveness ratios (QuickDASH) and cost utility ratios (QALYs) will be calculated; specifically, the incremental cost per QuickDASH/QALY for Group 1 (Stepped Care, including both arms) compared to Group 2 (Pragmatic Physiotherapy). Bootstrapping will be used to generate cost-effectiveness acceptability curves which estimate the probability the intervention is cost-effective across a range of willingness-to-pay thresholds. Sensitivity analyses will be conducted to assess the sensitivity of the results to variation in key parameters.

Qualitative study of patients' experiences using Interpretive Description.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
21/05/2024
Date of last participant enrolment
Anticipated
30/05/2025
Actual
Date of last data collection
Anticipated
30/05/2026
Actual
Sample size
Target
200
Accrual to date
33
Final
Recruitment outside Australia
Country [1] 26072 0
New Zealand
State/province [1] 26072 0

Funding & Sponsors
Funding source category [1] 315295 0
Government body
Name [1] 315295 0
Health Research Council
Country [1] 315295 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Box 56, Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 317340 0
None
Name [1] 317340 0
Address [1] 317340 0
Country [1] 317340 0
Other collaborator category [1] 282915 0
Other Collaborative groups
Name [1] 282915 0
Christchurch Physiotherapy and Sports Clinic
Address [1] 282915 0
22 Moorhouse Ave, Addington, Christchurch, 8011
Country [1] 282915 0
New Zealand
Other collaborator category [2] 282916 0
Other Collaborative groups
Name [2] 282916 0
Acukland Shoulder Clinic
Address [2] 282916 0
7/88 Cook st, Auckland CBD, Auckland
Country [2] 282916 0
New Zealand
Other collaborator category [3] 282917 0
Other Collaborative groups
Name [3] 282917 0
Focussed Physiotherapy
Address [3] 282917 0
78 Maniapoto Street, Otorohanga
Country [3] 282917 0
New Zealand
Other collaborator category [4] 282918 0
Individual
Name [4] 282918 0
A/Prof Nicola Swain
Address [4] 282918 0
University of Otago, Dunedin
Country [4] 282918 0
New Zealand
Other collaborator category [5] 282919 0
Individual
Name [5] 282919 0
Dr Ricky Bell
Address [5] 282919 0
Physiotherapy Ltd, 55 Blackbridge Rd, Karaka, Auckland, 2580
Country [5] 282919 0
New Zealand
Other collaborator category [6] 282920 0
Individual
Name [6] 282920 0
Dr Margie Olds
Address [6] 282920 0
Auckland Shoulder Clinic, 7/88 Cook Street, Auckland CBD, Auckland 1010
Country [6] 282920 0
New Zealand
Other collaborator category [7] 282921 0
Individual
Name [7] 282921 0
A/Prof Ari Samaranayaka
Address [7] 282921 0
Biostatistics Centre, Health Sciences Division, University of Otago, Dunedin
Country [7] 282921 0
New Zealand
Other collaborator category [8] 282922 0
Individual
Name [8] 282922 0
A/Prof Trudy Sullivan
Address [8] 282922 0
Department of Preventive and Social Medicine, University of Otago, Dunedin
Country [8] 282922 0
New Zealand
Other collaborator category [9] 282923 0
Individual
Name [9] 282923 0
Prof Jean-Sébastien Roy
Address [9] 282923 0
Centre for Interdisciplinary Research in Rehabilitation and Social Integration (Cirris) & Laval University, Canada
Country [9] 282923 0
Canada
Other collaborator category [10] 282924 0
Individual
Name [10] 282924 0
Prof François Desmeules
Address [10] 282924 0
Maisonneuve-Rosemont Hospital Research Centre, University of Montreal
Country [10] 282924 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314219 0
Central Health and Disability Ethics Committees
Ethics committee address [1] 314219 0
Ethics committee country [1] 314219 0
New Zealand
Date submitted for ethics approval [1] 314219 0
28/11/2023
Approval date [1] 314219 0
04/12/2023
Ethics approval number [1] 314219 0
2023 FULL 18871

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130826 0
Prof Gisela Sole
Address 130826 0
Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Box 56, Dunedin, 9054
Country 130826 0
New Zealand
Phone 130826 0
+64 034797466
Fax 130826 0
Email 130826 0
gisela.sole@otago.ac.nz
Contact person for public queries
Name 130827 0
Gisela Sole
Address 130827 0
Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Box 56, Dunedin, 9054
Country 130827 0
New Zealand
Phone 130827 0
+64 034797466
Fax 130827 0
Email 130827 0
gisela.sole@otago.ac.nz
Contact person for scientific queries
Name 130828 0
Gisela Sole
Address 130828 0
Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Box 56, Dunedin, 9054
Country 130828 0
New Zealand
Phone 130828 0
+64 034797466
Fax 130828 0
Email 130828 0
gisela.sole@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only, on reasonable request
When will data be available (start and end dates)?
Following publication in a peer reviewed article, planned for 2026, for 10 years following publication
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator. gisela.sole@otago.ac.nz or shoulder@otago.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21364Study protocol  gisela.sole@otago.ac.nz
21365Ethical approval  gisela.sole@otago.ac.nz



Results publications and other study-related documents

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