Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000034639
Ethics application status
Approved
Date submitted
12/10/2022
Date registered
12/01/2023
Date last updated
23/02/2023
Date data sharing statement initially provided
12/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of manual therapy as an adjunct to physiotherapy for persistent shoulder pain: a feasibility study
Scientific title
The effectiveness of manual therapy with individualised multi-modal physiotherapy for rotator cuff related shoulder pain (RCRSP): a pilot randomized, non-inferiority controlled trial
Secondary ID [1] 308148 0
Nil
Universal Trial Number (UTN)
U1111-1279-2251
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
shoulder pain 327867 0
Rotator cuff related shoulder pain 327868 0
Condition category
Condition code
Musculoskeletal 324948 324948 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 325532 325532 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants of the Manual Therapy Group will receive up to 8 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 8 sessions. Manual therapy will be applied for at least 4 of the 8 sessions using a pragmatic approach based on clinical reasoning. The techniques may include the following:
• Passive joint mobilisations (Maitland concept)
• Mobilisations-with-movement (Mulligan concept)
• The symptom-modification approach (Lewis)
• Thoracic manipulations
• 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: Guided by resources developed and collated by the research team:
• Website https://shoulderpain.org.nz/
• Set of two Microsoft® Powerpoint files developed by the research team – (1) pain neurophysiology; (2) reasons for undertaking exercise and physical activity.
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 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. Websites and Powerpoint files will guide provision of information. Topic sequencing will be individualised to each patient. The therapist will send a link to applicable videos 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://youtu.be/yw0NCIb73Bc
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://youtu.be/Ucao9wcl81Y

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 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 Psychology researcher (Swain) will train the clinicians for the therapeutic relationship/cognitive skills. Follow-up sessions will be held with the principal investigator via Zoom or in person.
D. How
Face-to-face physiotherapy care and self-directed home exercises.
E. Where
University of Otago School of Physiotherapy clinics, Dunedin and Christchurch, New Zealand.
F. When and how much
Recruitment is planned from February to August 2023. Physiotherapy care will be provided with up to 8 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.

Intervention code [1] 324616 0
Treatment: Other
Intervention code [2] 324617 0
Rehabilitation
Comparator / control treatment
The Control group will also receive up to 8 physiotherapy sessions, including patient education (using the same resrouces as the Intervention group), exercise and physical activity prescription, and completion of patient diaries. These participants will not receive any manual therapy during the 8 sessions.

The duration (two one-hour sessions, thereafter half-hour sessions), number of sessions and 3-month period will be the same as for the intervention group,

Physiotherapists will provide both the Intervention and the Control treatment.
Control group
Active

Outcomes
Primary outcome [1] 332782 0
Participant retention assessed using physiotherapists' clinical checklist.
Timepoint [1] 332782 0
Completion of physiotherapy sessions up to formal discharge
Primary outcome [2] 333489 0
Fidelity: physiotherapists' checklist of treatments provided each session.
Timepoint [2] 333489 0
Throughout treatment (intervention or control) period.
Primary outcome [3] 333490 0
Fidelity: Clinicians will be asked (with patient’s consent) to audio record the physiotherapy sessions. These will be analysed qualitatively.
Timepoint [3] 333490 0
Start, midway and before completion of treatment period
Secondary outcome [1] 414701 0
Fear-avoidance beliefs Questionnaire (FABQ)
Timepoint [1] 414701 0
3-month, 6-month follow-up
Secondary outcome [2] 414702 0
Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [2] 414702 0
8 week, 3-month, 6-month follow-up
Secondary outcome [3] 414703 0
Patient Acceptable Symptom State (PASS)
Timepoint [3] 414703 0
3-month, 6-month follow-up
Secondary outcome [4] 414705 0
Patient satisfaction with treatment and duration (3-point Likert Scale)
Timepoint [4] 414705 0
3-month follow-up
Secondary outcome [5] 414706 0
Global Rating of Change Score (GROC)
Timepoint [5] 414706 0
3-month and 6-month follow-up
Secondary outcome [6] 417273 0
Clinical adherence
Timepoint [6] 417273 0
Audit of clinical notes at start, mid-way and treatment period completion.
Secondary outcome [7] 417274 0
Patient adherence for exercise and physical activity: audit of patient diaries
Timepoint [7] 417274 0
Following discharge.
Secondary outcome [8] 417275 0
Adverse events (pain flare-up that does not settle within 24 hours, delayed onset muscle soreness): number of events and severity (mild, moderate, severe as per Common Terminology Criteria for Adverse Events, 10033425, Musculoskeletal disorders, pain in the extremities).
Timepoint [8] 417275 0
3 months follow-up
Secondary outcome [9] 417276 0
Patient perspectives and experiences: qualitative semi-structured individual interviews using a study-specific question guide. The interviews will be undertaken by a research team member (Swain) and will be maximally 1 hour each. Interviews will be audio-recorded and transcribed verbatim.
Timepoint [9] 417276 0
3 months (following discharge)
Secondary outcome [10] 417277 0
Physical function assessed with the Short Disabilities of the Arm, Shoulder and Hand scale (QuickDASH)
Timepoint [10] 417277 0
8 weeks, 3-month, 6-month follow-up

Eligibility
Key inclusion criteria
Inclusion criteria will be: (i) men and women, aged 35 years and older; (ii) primary complaint of shoulder pain with or without referral in the upper limb for a minimum of 3 months, (iii) shoulder pain attributed to a RCRSP using the diagnostic guidelines of the British Elbow and Shoulder Society (BESS). The middle aged and older adults are included as those are more likely to have recurrent or persistent RCRSP than younger adults.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be: (i) any shoulder surgery in the past, (ii) known systemic inflammatory disorders, (iii) cervical repeated movement testing affecting shoulder pain and/or range of movement, (iv) severe depressive symptoms, suicidal or psychotic illness (PHQ-9, score >23).

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)
Allocation will be concealed in sealed and opaque envelopes that are sequentially numbered. The envelope will be opened by physiotherapy clinician prior to the first appointment with the participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated list, stratified by sex (male/female) and ethnicity (Maori/Pacifika versus all others).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
As this is a pilot study a formal sample size calculation is not required, but can be based on practicalities and estimating rates. To fully describe fidelity of the complex interventions, we suggest recruiting 30 participants in each group (‘Manual Therapy’ versus ‘No Manual Therapy’; total, 60). Twenty-four will be recruited in Christchurch and 36 in Dunedin.
Feasibility: Aim 1: Feasibility will be determined by descriptive statistics of recruitment, retention, and clinical audit. Clinical fidelity and adherence (treatment recordings/ediary’s) will be described qualitatively with a focus on the therapeutic engagement and alliance. The physiotherapists’ checklists will be audited and summarised. The number of physiotherapy sessions, duration and frequency will be summarised. Adverse events will be reported descriptively, and compared by group.
Aim 2: Preliminary estimates of treatment effects: We will use descriptive statistics for outcome measures at each measurement time. We will compare baseline characteristics (independent t-tests and Chi-squared tests) to establish the comparability of groups. All data will be assessed for underlying assumptions before using statistical analyses. Mixed model linear regression (or variations as determined by the preliminary analyses) will be used to compare each outcome between the two groups. The results will be interpreted within the context of a pilot study. Treatment effect sizes will be used to calculate the sample sizes needed for a full RCT.
Aim 3: Patient experiences and perspectives: qualitative analysis of interviews using Thematic Analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
31/08/2023
Actual
Date of last data collection
Anticipated
29/02/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25060 0
New Zealand
State/province [1] 25060 0
Otago
Country [2] 25061 0
New Zealand
State/province [2] 25061 0
Canterbury

Funding & Sponsors
Funding source category [1] 312412 0
University
Name [1] 312412 0
University of Otago (Stanley Paris Fellowship)
Country [1] 312412 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 314006 0
None
Name [1] 314006 0
Address [1] 314006 0
Country [1] 314006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311759 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 311759 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 311759 0
New Zealand
Date submitted for ethics approval [1] 311759 0
06/10/2022
Approval date [1] 311759 0
30/01/2023
Ethics approval number [1] 311759 0
2022 FULL 13022

Summary
Brief summary
The primary aim of this pilot RCT is to determine the feasibility, adherence, and treatment fidelity and adverse responses for a full RCT evaluating whether multi-modal physiotherapy without manual therapy (No Manual therapy group) is as effective as multi-modal physiotherapy with manual therapy (Manual therapy group).
The second aim will be to determine preliminary estimates of treatment effects for patient-reported function, pain, self-efficacy and satisfaction.
The third aim is to explore patient perspectives and experiences of the interventions and of the research process.

This will be a two-arm, single-blinded pilot randomised clinical trial using a non-inferiority design. We hypothesise that there will not be a difference in primary outcome (QuickDASH) at 3 months and 6 months after entry into the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122266 0
Prof Gisela Sole
Address 122266 0
Centre for Heatlh, Activity and Rehabilitation Reserach
School of Physiotherapy
Box 56
Dunedin
9054
Country 122266 0
New Zealand
Phone 122266 0
+64 034797466
Fax 122266 0
Email 122266 0
[email protected]
Contact person for public queries
Name 122267 0
Prof Gisela Sole
Address 122267 0
Centre for Heatlh, Activity and Rehabilitation Reserach
School of Physiotherapy
Box 56
Dunedin
9054
Country 122267 0
New Zealand
Phone 122267 0
+64 034797466
Fax 122267 0
Email 122267 0
[email protected]
Contact person for scientific queries
Name 122268 0
Prof Gisela Sole
Address 122268 0
Centre for Heatlh, Activity and Rehabilitation Reserach
School of Physiotherapy
Box 56
Dunedin
9054
Country 122268 0
New Zealand
Phone 122268 0
+64 034797466
Fax 122268 0
Email 122268 0
[email protected]

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
When will data be available (start and end dates)?
Following publication in a peer reviewed article, planned for 2024, 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. [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17345Study protocol  [email protected]
17346Ethical approval  [email protected]



Results publications and other study-related documents

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