Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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 information initially 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] 283614 0
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. 290512 0
Postoperative Pain 290538 0
Depressed mood 290539 0
Condition category
Condition code
Musculoskeletal 290899 290899 0 0
Other muscular and skeletal disorders
Surgery 290900 290900 0 0
Surgical techniques
Mental Health 290901 290901 0 0
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] 288279 0
Not applicable
Comparator / control treatment
Observational study - no comparison or control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290884 0
Development of postoperative stiff, painful shoulder following rotator cuff repair, subacromial decompression or distal clavicle resection as assessed by the treating surgeon.
Timepoint [1] 290884 0
10 to 12 weeks postoperatively.
Secondary outcome [1] 305537 0
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] 305537 0
At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.
Secondary outcome [2] 305597 0
Pre and postoperative analgesia. Enquire as to type and dose in past 24 hours.
Timepoint [2] 305597 0
At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.
Secondary outcome [3] 305598 0
Pre and postoperative PHQ-9 depression score.
Timepoint [3] 305598 0
At the preoperative consultation.

Postoperatively on day 2, 5, 7 and week 2, 4, 7 and 10.
Secondary outcome [4] 305599 0
Pre and postoperative sleep quality. Assessed using a numerical rating scale.
Timepoint [4] 305599 0
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?
No
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] 288289 0
Self funded/Unfunded
Name [1] 288289 0
Country [1] 288289 0
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] 287010 0
None
Name [1] 287010 0
Address [1] 287010 0
Country [1] 287010 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290184 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 290184 0
Human Ethics Office
First Floor, Building 3e
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 290184 0
Australia
Date submitted for ethics approval [1] 290184 0
Approval date [1] 290184 0
28/10/2013
Ethics approval number [1] 290184 0
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 44314 0
A/Prof Simon Bell
Address 44314 0
Melbourne Shoulder and Elbow Centre.

31 Normanby St Brighton Victoria 3186

Monash University. A/Professor of Orthopaedic surgery.
Country 44314 0
Australia
Phone 44314 0
+61, 03, 9592 8028
Fax 44314 0
Email 44314 0
[email protected]
Contact person for public queries
Name 44315 0
Dr Nathaniel Hiscock
Address 44315 0
Melbourne Shoulder and Elbow Centre.

31 Normanby St Brighton Victoria 3186

Monash University. Co-researcher.
Country 44315 0
Australia
Phone 44315 0
+61431215206
Fax 44315 0
Email 44315 0
[email protected]
Contact person for scientific queries
Name 44316 0
Dr Jennifer Coghlan
Address 44316 0
Melbourne Shoulder and Elbow Centre. 31 Normanby St Brighton Victoria 3186 Monash University. Research Coordinator
Country 44316 0
Australia
Phone 44316 0
+61 3 95928028
Fax 44316 0
Email 44316 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
10516Study protocol    Pain, depression and the postoperative stiff shoul... [More Details]



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePain, depression and the postoperative stiff shoulder Orthopedics and biomechanics.2015https://dx.doi.org/10.1186/s12891-015-0841-6
N.B. These documents automatically identified may not have been verified by the study sponsor.