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Trial registered on ANZCTR


Registration number
ACTRN12623000783628
Ethics application status
Approved
Date submitted
16/06/2023
Date registered
18/07/2023
Date last updated
18/07/2023
Date data sharing statement initially provided
18/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of mobilization with movement plus best care advice versus best care advice for patients with subacromial shoulder pain: a pilot randomized controlled trial
Scientific title
Mobilization with movement versus best care advice for patients with subacromial shoulder pain: a pilot randomized controlled trial
Secondary ID [1] 309238 0
Nil Know
Universal Trial Number (UTN)
U1111-1289-9959
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder pain 329396 0
Condition category
Condition code
Musculoskeletal 326340 326340 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to this group will receive a best practice advice plus tailored Mobilization With Movement (MWM).

The best practice advice will consists of a one-off clinician consultation session, with the session lasting for approximately 40 min. During that session, the clinician will provide brief information about shoulder pain and will discuss strategies to avoid aggravating their shoulder pain and to self-manage pain. The clinician will answer any questions participants may have and will re-assure participants that their condition should improve over time. Participants will receive a pamphlet with information about their condition and basic self-management strategies. The pamphlet will be developed for this study based on the literature and after consulting with clinicians. In that same session, the clinician will deliver the first intervention of MWM.

After the first session, participants will receive 15 additional MWM interventions. Those interventions will last approximately 10 min. The MWM technique will be applied over 8 weeks, with two treatment sessions per week (i.e., 1st session lasting for 40 min, followed by 15 sessions lasting 10 min).

During each treatment session, 3-5 sets of 6-10 repetitions will be applied, with a rest interval of 1 minute between sets. Information about the MWM technique used will be recorded on a customized sheet by the clinician and will include participants’ position (e.g. sitting, lying, or standing), the MWM techniques used, and the number of sets and repetitions performed.
Intervention code [1] 325679 0
Rehabilitation
Comparator / control treatment
Participants allocated to this group will receive best practice advice.

The best practice advice will consists of a one-off clinician consultation session during which the clinician will provide brief information about shoulder pain and will discuss strategies to avoid aggravating their shoulder pain and to self-manage pain. The clinician will answer any questions participants may have and will re-assure participants that their condition should improve over time. Participants will receive a pamphlet with information about their condition and basic self-management strategies. This one-off consultation will last approximately 30 min.
Control group
Active

Outcomes
Primary outcome [1] 334194 0
Participant’s recruitment rate (number of participants per month)
Data collected from study database.
Timepoint [1] 334194 0
Baseline
Primary outcome [2] 335330 0
Proportion of participants enrolled from the total number screened (number of enrolled participants /total number of screened participants, with reasons).
Data collected from study database.
Timepoint [2] 335330 0
Baseline
Primary outcome [3] 335331 0
Adherence to the allocated intervention (number of sessions attended, expressed as a percentage of the total number of sessions).
Data collected from study database.
Timepoint [3] 335331 0
12th week after baseline.
Secondary outcome [1] 419793 0
Patient Specific Functional Scale (PSFS);
Timepoint [1] 419793 0
Baseline, 4th, 8th, and 12th week after baseline.
Secondary outcome [2] 421546 0
Shoulder Pain and Disability Index (SPADI);
Timepoint [2] 421546 0
Baseline, 4th, 8th, and 12th week after baseline.
Secondary outcome [3] 421547 0
Average pain in the last 7 days: numeric rating pain scale (NRPS);
Timepoint [3] 421547 0
Baseline, 4th, 8th, and 12th week after baseline.
Secondary outcome [4] 421548 0
Pain-free active shoulder abduction range of motion (ROM).
Timepoint [4] 421548 0
Baseline, 4th, 8th, and 12th week after baseline.
Secondary outcome [5] 423979 0
Drop-out rate (number of participants who withdrew from the study).
Timepoint [5] 423979 0
12th week after baseline.
Data collected from study database.

Eligibility
Key inclusion criteria
We will include participants aged 18-75 years old with subacromial shoulder pain, who present immediate reduction in shoulder pain following the application of MWM to the shoulder complex (glenohumeral, sternoclavicular, acromioclavicular, and scapulothoracic), cervical spine, or thoracic region.

We have defined subacromial shoulder pain and we will screen participants following the British Elbow and Shoulder Society (BESS) guidelines. We will include participants who present with a painful arc movement during shoulder flexion or abduction; or pain on resisted lateral rotation or abduction; or positive Jobe’s test.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude participants who have acute rotator cuff tear, unreduced dislocation, tumour or infection; or the history of shoulder, cervical surgeries, shoulder subluxation and dislocation; or localised acromioclavicular joint pain, frozen shoulder, hemiplegic shoulder pain, systematic inflammation or disease; or clinical signs of full thickness of rotator cuff tear.

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)
The allocation schedule will be concealed by a research administrator (not involved with recruitment, assessment, or intervention) who will inform the research team about treatment allocation once screening is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule will be computer-generated by a research administrator (not involved with recruitment, assessment, or intervention).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcomes (recruitment rates, adherence to the rehabilitation program, proportion of participants enrolled from the total number screened, and drop-out rate) will be presented using descriptive statistics.

To obtain estimates of intervention effects, we will compare changes in pain and shoulder-related disability scores between the two intervention groups using a mixed-effects model with a random intercept will be used to compare the changes in outcome measures (from baseline to 12 weeks after baseline) between the MWM and best practice advice. The model will include baseline scores, time, treatment and an interaction between time and treatment as covariates. Outcome measures at follow-up (4th, 8th, and 12th week after baseline) will be retained as part of the outcome variable.

Since this is a pilot study, we will not adjust alpha for multiple comparisons. This will decrease the chance of Type II error, increasing the chance of identifying potentially important differences between groups. This statistical approach is considered appropriate for feasibility, pilot or exploratory studies. Alpha will be set at 0.05, and power at 80% for all statistical analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/08/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 25330 0
New Zealand
State/province [1] 25330 0
Otago

Funding & Sponsors
Funding source category [1] 313428 0
University
Name [1] 313428 0
School of Physiotherapy - University of Otago
Country [1] 313428 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street, Dunedin North, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 315196 0
None
Name [1] 315196 0
Address [1] 315196 0
Country [1] 315196 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312640 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 312640 0
325 Great King StreetDunedin North, Dunedin 9016
Ethics committee country [1] 312640 0
New Zealand
Date submitted for ethics approval [1] 312640 0
13/03/2023
Approval date [1] 312640 0
27/03/2023
Ethics approval number [1] 312640 0
H23/042

Summary
Brief summary
Shoulder pain is a common musculoskeletal condition, affecting one third of the world population. The conservative treatment is the first-line intervention, with mobilization with movement being a commonly used intervention in the clinical setting. However, evidence on the effects of mobilization with movement are lacking in the literature. Previous laboratory-based studies have shown that: (1) clinician-administrated sustained shoulder posterolateral glide mobilization offloads shoulder muscles, providing mechanical support to the shoulder; (2) self-administrated sustained shoulder mobilizations lead to similar changes in muscle activity level as clinician-administrated mobilization, supporting the use of home-based mobilization for shoulder rehabilitation; (3) patients with shoulder pain present immediate reduction in pain levels, increased range of motion, and increased muscle activity levels in response to mobilization with movement. Those findings suggest that sustained mobilization temporarily changes the control of scapular and shoulder muscles in asymptomatic and individuals with subacromial shoulder pain.
The present proposal aims to advance the current knowledge further by piloting the design of a full trial to test the effectiveness of mobilization with movement on the management of patients with shoulder subacromial pain.
This study is a prospective, assessor-blind, parallel-group randomized controlled pilot trial. A total sample size of 24 participants with subacromial shoulder pain will be allocated to mobilization with movement group or a minimal intervention group. Patients in the mobilization with movement group will receive a tailored mobilization with movement technique over 8 weeks, with two treatment sessions per week. Primary outcomes will be participant’s recruitment rate; proportion of participants enrolled from the total number screened; adherence to the allocated intervention; drop-out rate, and treatment fidelity. Participants will be assessed 4 times over 12 weeks (baseline, 4, 8, and 12 weeks). An intention-to-treat analysis approach will be applied for all analyses. Primary outcomes will be presented using descriptive statistics. An independent mixed-model will be conducted for each outcome measure. An implementation-based process evaluation will be assessed by interviewing participants who take part in the study with a thematic qualitative analysis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125386 0
Prof Daniel Cury Ribeiro
Address 125386 0
325 Great King Street, Dunedin North, Dunedin 9016
School of Physiotherapy, University of Otago
Country 125386 0
New Zealand
Phone 125386 0
+64 3 479 7455
Fax 125386 0
Email 125386 0
daniel.ribeiro@otago.ac.nz
Contact person for public queries
Name 125387 0
Prof Daniel Cury Ribeiro
Address 125387 0
325 Great King Street, Dunedin North, Dunedin 9016
School of Physiotherapy, University of Otago
Country 125387 0
New Zealand
Phone 125387 0
+64 3 479 7455
Fax 125387 0
Email 125387 0
daniel.ribeiro@otago.ac.nz
Contact person for scientific queries
Name 125388 0
A/Prof Daniel Cury Ribeiro
Address 125388 0
325 Great King Street, Dunedin North, Dunedin 9016
School of Physiotherapy, University of Otago
Country 125388 0
New Zealand
Phone 125388 0
+64 3 479 7455
Fax 125388 0
Email 125388 0
daniel.ribeiro@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?
Individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (e-mail: Daniel.ribeiro@otago.ac.nz).


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.