ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001271796

Ethics application status

Approved

Date submitted

17/11/2013

Date registered

19/11/2013

Date last updated

27/10/2021

Date data sharing statement initially provided

9/02/2021

Date results provided

9/02/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Psychological stress, pain management and the development of a stiff, painful shoulder following rotator cuff or clavicular surgery.

Scientific title

The relationship between pain, depression and sleep and the development of a stiff painful shoulder in patient's undergoing rotator cuff repair, distal clavicular resection or sub-acromial decompression.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1150-3353

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Rotator cuff repair, sub-acromial decompression and distal clavicle resection for rotator cuff tears.

Postoperative Pain

Depressed mood

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

Surgical techniques

Mental Health

Depression

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Observational study.

Procedure - rotator cuff repair, subacromial decompression or distal clavicle resection

Observation - pre and postoperative pain, analgesia, depression and quality of sleep. Observations performed at - preoperative assessment, postoperative days 2, 5 and 7 and weeks 2, 4, 7 and 10

Outcome - development of stiff painful shoulder at 10-12 week postoperative follow up

Intervention code [1]

Not applicable

Comparator / control treatment

Observational study - no comparison or control

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Development of postoperative stiff, painful shoulder following rotator cuff repair, subacromial decompression or distal clavicle resection as assessed by the treating surgeon.

Timepoint [1]

10 to 12 weeks postoperatively.

Secondary outcome [1]

Pre and postoperative pain levels over 24 hours. Average pain, pain at night, worst pain at rest, worst pain with movement. Assessed using a numerical rating scale.

Timepoint [1]

At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.

Secondary outcome [2]

Pre and postoperative analgesia. Enquire as to type and dose in past 24 hours.

Timepoint [2]

At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.

Secondary outcome [3]

Pre and postoperative PHQ-9 depression score.

Timepoint [3]

At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.

Secondary outcome [4]

Pre and postoperative sleep quality. Assessed using a numerical rating scale.

Timepoint [4]

At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.

Eligibility

Key inclusion criteria

Patients of A/Professor Simon Bell who are undergoing rotator cuff repair, distal clavicular resection or subacromial decompression during the recruitment period of November 2013 to April 2014 will be invited to participate.

Minimum age

18 Years

Maximum age

90 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Gleno-humeral arthritis of the operated shoulder.
Preoperative shoulder stiffness
Previous surgery in the same shoulder
Concomitant surgical procedure except for arthroscopic or mini-open rotator cuff repair, subacromial decompression or distal clavicular resection
Inability to answer questions by phone.
Poor English language skills.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

25/11/2013

Actual

28/11/2013

Date of last participant enrolment

Anticipated

Actual

4/06/2014

Date of last data collection

Anticipated

Actual

10/11/2014

Sample size

Target

200

Accrual to date

Final

137

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

A/Professor Simon Bell

Address

Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186

Monash University. A/Professor of Orthopaedic Surgery

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Research Ethics Committee (MUHREC)

Ethics committee address [1]

Human Ethics Office
First Floor, Building 3e
Monash Research Office
Clayton Campus
Monash University VIC 3800

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/10/2013

Ethics approval number [1]

CF10/0376-2010000170

Summary

Brief summary

This study aims to find out whether having a depressed mood or inadequate postoperative pain control are associated with the development of a stiff and painful shoulder following shoulder surgery. 

Surgery to the muscles and tendons (rotator cuff) of the shoulder and surgery to the end of the collar bone (clavicle) are common procedures. However one complication that occurs is the development of a stiff painful shoulder in the first 3 months of the postoperative phase. A number of factors have been associated with the development of postoperative shoulder stiffness. It has been suggested that depressed mood and postoperative pain are associated with the development of postoperative shoulder stiffness but this area has not been studied. The purpose of this study is to look at the relationship between postoperative pain, depressed mood and the development of postoperative shoulder stiffness and determine whether either depressed mood or postoperative pain are important predictors of and possible management targets to decrease the rate of postoperative shoulder stiffness. 

The study will involve 100 to 200 participants who will all be patients of A/Professor Simon Bell undergoing rotator cuff or clavicular surgery

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Simon Bell

Address

Melbourne Shoulder and Elbow Centre.

31 Normanby St Brighton Victoria 3186

Monash University. A/Professor of Orthopaedic surgery.

Country

Australia

Phone

+61, 03, 9592 8028

Fax

[email protected]

Contact person for public queries

Name

Nathaniel Hiscock

Address

Melbourne Shoulder and Elbow Centre.

31 Normanby St Brighton Victoria 3186

Monash University. Co-researcher.

Country

Australia

Phone

+61431215206

Fax

[email protected]

Contact person for scientific queries

Name

Jennifer Coghlan

Address

Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186 Monash University. Research Coordinator

Country

Australia

Phone

+61 3 95928028

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No data dictionaries. SPPS files only available with Ethics approval

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
10516	Study protocol				Pain, depression and the postoperative stiff shoul... [More Details]

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	Pain, depression and the postoperative stiff shoulder Orthopedics and biomechanics.	2015	https://dx.doi.org/10.1186/s12891-015-0841-6

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

Trial Review

Documents added manually

Documents added automatically