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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]

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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Other

Intervention code [2]

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]

Angular onset of pain during shoulder abduction, measured in degrees with a digital inclinometer.

Timepoint [1]

(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]

Pain during shoulder abduction as measured with a numeric pain rating scale (score range from 0 to 10 points).

Timepoint [1]

Secondary outcome [2]

Maximum range of motion for shoulder abduction, measured in degrees with a digital inclinometer.

Timepoint [2]

(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.

Secondary outcome [3]

Pain at rest, as measured with a numeric pain rating scale (score range from 0 to 10 points).

Timepoint [3]

Secondary outcome [4]

Pressure pain threshold (PPT), measured with an algometer.

Timepoint [4]

(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.

Secondary outcome [5]

Temporal summation of pain will be assessed using a nylon monofilament.

Timepoint [5]

(1) Baseline, and (2) immediately after receiving the 3rd set of 10 repetitions of MWM or sham MWM intervention.

Secondary outcome [6]

Adverse event, as reported by participants, in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0).

Timepoint [6]

48 hours after participants received the intervention.

Secondary outcome [7]

Brief pain inventory (short form)

Timepoint [7]

Baseline, 1 day, 3, 5 and 7 days after intervention.

Secondary outcome [8]

Global rating of change scale

Timepoint [8]

(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]

Pain during maximum shoulder abduction as measured with a numeric pain rating scale (score range from 0 to 10 points).

Timepoint [9]

(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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Dunedin

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

325 Great King Street,
Postcode: 9054
PO Box 56
Dunedin

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee

Ethics committee address [1]

University of Otago Council, PO Box 56, Dunedin 9054, New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

20/07/2021

Approval date [1]

02/08/2021

Ethics approval number [1]

H21/117

Summary

Brief summary

This is a double-blinded (participant and outcome assessor) randomised, sham-controlled trial. Sixty participants with subacromial shoulder pain will be recruited and randomly allocated into the mobilization with movement (MWM) or sham MWM group. The initial treatment effects of MWM and sham MWM on shoulder pain-free range of motion (ROM), pain during movement, maximum ROM, pain at rest, pressure pain threshold, temporal summation of pain and global rating of change scale will be assessed before and after participants received the treatment. The purpose of this study is to explore whether the MWM alone improves clinical outcomes in patients with subacromial shoulder pain, and further explore whether a high-volume MWM leads to better clinical outcomes compared to low-volume MWM. We hypothesize that MWM will lead to better clinical outcomes compared to sham MWM and that high-volume MWM will be more effective than low-volume MWM.

Trial website

Trial related presentations / publications

Public notes

In addition, to be included, participants need to have been vaccinated for COVID-19.

Contacts

Principal investigator

Name

Dr Daniel Cury Ribeiro

Address

School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin, New Zealand

Country

New Zealand

Phone

+64 3 479 7455

Fax

daniel.ribeiro@otago.ac.nz

Contact person for public queries

Name

Daniel Cury Ribeiro

Address

School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin, New Zealand

Country

New Zealand

Phone

+64 3 479 7455

Fax

daniel.ribeiro@otago.ac.nz

Contact person for scientific queries

Name

Daniel Cury Ribeiro

Address

School of Physiotherapy - University of Otago 325 Great King Street, Postcode: 9054, PO Box 56, Dunedin, New Zealand

Country

New Zealand

Phone

+64 3 479 7455

Fax

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 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

Source	Title	Year of Publication	DOI
Embase	Initial 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).	2023	https://dx.doi.org/10.1136/bmjopen-2022-069919

N.B. These documents automatically identified may not have been verified by the study sponsor.

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