Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001723875
Ethics application status
Approved
Date submitted
5/11/2021
Date registered
16/12/2021
Date last updated
5/05/2023
Date data sharing statement initially provided
16/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of high-volume mobilization with movement on shoulder range of motion and pain in patients with shoulder pain
Scientific title
The initial effect of high-volume mobilization with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: a randomized controlled trial
Secondary ID [1] 305478 0
None
Universal Trial Number (UTN)
U1111-1270-2324
Trial acronym
Evolution Trial (The initial Effect of high-VOLUme mobilizaTION with movement on shoulder range of motion and pain in patients with shoulder pain: a randomized controlled TRIAL)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacromial shoulder pain 323877 0
Condition category
Condition code
Musculoskeletal 321390 321390 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobilization with movement (MWM):

Participants will attend one session at the the university research-clinic. A registered physiotherapist will deliver this intervention, face-to-face.

Participants allocated to the MWM group will receive 3 sets of 10 repetitions of sustained posterolateral glide MWM technique on the glenohumeral joint. The MWM technique will be applied to the joint while participants perform 3 sets of 10 repetitions of shoulder abduction. We expect participants will take approximately 20 seconds to perform 10 repetitions of shoulder abduction. Participants will rest for 60s between each set. The duration of intervention is expected to last for 5 minutes.

Participants will sit on a chair while the physiotherapist will stand on the contralateral side of the painful shoulder. The physiotherapist will stabilise the scapula with one hand and place the other hand over the anterior aspect of the head of the humerus. The physiotherapist will sustain the posterolateral glide applied to the gleno-humeral joint while the participant performs shoulder abduction movements.

Participants will be informed that the MWM procedure must be pain-free and the technique should be stopped if any painful symptom is experienced during the procedure.

If participants present a complete pain-free range of motion in response to the technique, participants will be asked to apply over pressure at the tenth repetition. The overpressure will be performed by having the participant applying pressure on their elbow (on the affected side) using their opposite hand, and sustaining this pressure for 10 seconds.

Treatment fidelity will be monitored by clinicians' notes and session attendance checklist.
Intervention code [1] 321892 0
Treatment: Other
Intervention code [2] 321893 0
Rehabilitation
Comparator / control treatment
Sham mobilization with movement (MWM):

Participants will attend one session at the the university research-clinic. A registered physiotherapist will deliver this intervention, face-to-face.

The sham MWM will replicate the MWM condition, except for the posterolateral glide applied at the glenohumeral joint. During the sham condition, no pressure will be applied to the glenohumeral joint. The physiotherapist will stand on the contralateral side of the painful shoulder and place one hand along the clavicle and sternum and the other hand on the posterior aspect of the humeral head of the painful shoulder. The physiotherapists will maintain the placement of the hands, simulating the MWM technique (but without pressure) while the participant performs shoulder abduction movements.

Participants will be instructed to abduct their painful shoulder through their available pain-free range of motion until the onset of pain or, if pain is present at rest, until pain increases. The number of sets, repetitions, and the time interval between sets will be identical to the MWM condition.

Participants will be informed that the sham MWM procedure must be pain-free and the technique should be stopped if any painful symptom is experienced during the procedure.
Control group
Placebo

Outcomes
Primary outcome [1] 329200 0
Angular onset of pain during shoulder abduction, measured in degrees with a digital inclinometer.
Timepoint [1] 329200 0
(1) Baseline, (2) immediately after receiving the 1st set of 10 repetitions of MWM or sham MWM intervention, and (3) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.
Secondary outcome [1] 401754 0
Pain during shoulder abduction as measured with a numeric pain rating scale (score range from 0 to 10 points).

Timepoint [1] 401754 0
(1) Baseline, (2) immediately after receiving the 1st set of 10 repetitions of MWM or sham MWM intervention, and (3) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.
Secondary outcome [2] 401755 0
Maximum range of motion for shoulder abduction, measured in degrees with a digital inclinometer.
Timepoint [2] 401755 0
(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.
Secondary outcome [3] 401756 0
Pain at rest, as measured with a numeric pain rating scale (score range from 0 to 10 points).
Timepoint [3] 401756 0
(1) Baseline, (2) immediately after receiving the 1st set of 10 repetitions of MWM or sham MWM intervention, and (3) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.
Secondary outcome [4] 401757 0
Pressure pain threshold (PPT), measured with an algometer.
Timepoint [4] 401757 0
(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.
Secondary outcome [5] 401758 0
Temporal summation of pain will be assessed using a nylon monofilament.
Timepoint [5] 401758 0
(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.
Secondary outcome [6] 401766 0
Adverse event, as reported by participants, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0).
Timepoint [6] 401766 0
48 hours after participants received the intervention.
Secondary outcome [7] 402569 0
Brief pain inventory (short form)
Timepoint [7] 402569 0
Baseline, 1 day, 3, 5 and 7 days after intervention.
Secondary outcome [8] 402720 0
Global rating of change scale
Timepoint [8] 402720 0
(1) Immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention, and (2) 3 days after participants received the intervention.
Secondary outcome [9] 409624 0
Pain during maximum shoulder abduction as measured with a numeric pain rating scale (score range from 0 to 10 points).
Timepoint [9] 409624 0
(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.

Eligibility
Key inclusion criteria
Participants will be included if they present with painful arc movement during shoulder flexion or abduction; or pain on resisted lateral rotation or abduction; or positive Jobe’s test.

To be included, participants also need to respond positively to the application of a posterolateral glide MWM on the shoulder at initial screening. For the purpose of this study, a positive response to MWM is defined as a perceived improvement in pain-free movement by the participant during the application of MWM.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they present signs or symptoms suggesting: acute rotator cuff tear, massive rotator cuff tears (defined by gross shoulder muscle weakness in the absence of pain), history of shoulder or cervical surgery in the past 6 months, corticosteroid injection in the last 6 weeks, other shoulder disorders (i.e., glenohumeral osteoarthritis, history of shoulder subluxation or dislocation, acromioclavicular joint pain, adhesive capsulitis), signs of paresthesia in the upper extremity, systemic inflammation or disease, neurological disease affecting the shoulder, or tumor.

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 will be concealed in numbered opaque and sealed envelopes prepared by a researcher who will not be involved in screening participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to either MWM or sham MWM group with an allocation ratio of 1:1. We will use blocked randomization with varying size. The statistician will be responsible for the sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed-effects model with a random intercept will be used to compare the changes in outcome measures (from baseline to the time after receiving 1 set, and 3 sets of treatments, respectively) between the MWM and sham MWM groups (Objectives 1 and 2). The model includes time, treatment and an interaction between time and treatment as covariates. All the outcome measures (baseline, after 1 set of treatments and after 3 sets of treatments) will be retained as part of the outcome variable. We will also estimate the difference in changes in the outcome measures from time 1 (after receiving one set) to time 2 (after receiving three sets) between the MWM and sham MWM groups (Objective 3). The 95% confidence intervals of the estimates will also be reported. Sensitivity analyses will include adjustments for the baseline value of the outcome measure (treating baseline value of the outcome as a covariate in the model) and any baseline imbalance. We will also assess the difference in changes in BPI-SF over time (1 day, 3 days, 5 days, and 7 days after treatment) between the MWM and sham MWM interventions (Objective 4). An intention-to-treat (ITT) analysis will be used. All statistical analyses will be performed using Stata 12.0 software (Stata Corporation, College Station, TX, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2022
Actual
1/04/2022
Date of last participant enrolment
Anticipated
8/12/2023
Actual
21/07/2022
Date of last data collection
Anticipated
15/12/2023
Actual
4/08/2022
Sample size
Target
60
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 24193 0
New Zealand
State/province [1] 24193 0
Dunedin

Funding & Sponsors
Funding source category [1] 309835 0
University
Name [1] 309835 0
University of Otago
Country [1] 309835 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
325 Great King Street,
Postcode: 9054
PO Box 56
Dunedin
Country
New Zealand
Secondary sponsor category [1] 310916 0
None
Name [1] 310916 0
Address [1] 310916 0
Country [1] 310916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309576 0
University of Otago Human Ethics Committee
Ethics committee address [1] 309576 0
Ethics committee country [1] 309576 0
New Zealand
Date submitted for ethics approval [1] 309576 0
20/07/2021
Approval date [1] 309576 0
02/08/2021
Ethics approval number [1] 309576 0
H21/117

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

Contacts
Principal investigator
Name 114642 0
Dr Daniel Cury Ribeiro
Address 114642 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin, New Zealand
Country 114642 0
New Zealand
Phone 114642 0
+64 3 479 7455
Fax 114642 0
Email 114642 0
[email protected]
Contact person for public queries
Name 114643 0
Daniel Cury Ribeiro
Address 114643 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin, New Zealand
Country 114643 0
New Zealand
Phone 114643 0
+64 3 479 7455
Fax 114643 0
Email 114643 0
[email protected]
Contact person for scientific queries
Name 114644 0
Daniel Cury Ribeiro
Address 114644 0
School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin, New Zealand
Country 114644 0
New Zealand
Phone 114644 0
+64 3 479 7455
Fax 114644 0
Email 114644 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?
Individual participant data underlying published results only
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?
To achieve the aims in the approved proposal, for IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (provide email or other contact details).


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
SourceTitleYear of PublicationDOI
EmbaseInitial effect of high-volume mobilisation with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: Protocol for a randomised controlled trial (Evolution Trial).2023https://dx.doi.org/10.1136/bmjopen-2022-069919
N.B. These documents automatically identified may not have been verified by the study sponsor.