Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12608000185369
Ethics application status
Approved
Date submitted
6/04/2008
Date registered
10/04/2008
Date last updated
23/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevalence of Musculoskeletal Pain and Shoulder Disability in Open Heart Surgical Patients pre-operatively and at six and twelve weeks post-operatively: a prospective longitudinal observation study.
Scientific title
Prevalence of Musculoskeletal Pain and Shoulder Disability in Open Heart Surgical Patients pre-operatively and at six and twelve weeks post-operatively: a prospective longitudinal observation study.
Secondary ID [1] 288363 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Heart Surgery 3007 0
Condition category
Condition code
Cardiovascular 3157 3157 0 0
Coronary heart disease
Musculoskeletal 3158 3158 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A written survey was conducted pre-operatively, at six and 12 weeks post-open heart surgery. Questions related to postoperative musculoskeletal pain of the spine, thoracic cage and shoulder, sternal clicking, a disability scale and compliance with the home exercise and walking program.
Intervention code [1] 2772 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4042 0
Visual Analogue Scale for pain for each of the following nine areas of the body: neck, left shoulder, right shoulder, upper back, front of chest, ribcage, lower back, left elbow/hand and right elbow/hand. These values were then added for each patient to give a total pain score (on a scale of 0?90). A higher score indicated greater pain.
Timepoint [1] 4042 0
pre-operatively, 6 weeks post-operatively and 12 weeks post-operatively
Secondary outcome [1] 6803 0
Closed Questions included age, sex, hand dominance, pre-existing musculoskeletal pain and conditions
Timepoint [1] 6803 0
pre-operatively
Secondary outcome [2] 6804 0
Shoulder Disability Scale -obtained on a scale of 0?80. A higher score indicated more disability.
Timepoint [2] 6804 0
pre-operatively, 6 weeks post-operatively and 12 weeks post-operatively
Secondary outcome [3] 6841 0
Closed Questions on distance walked and use of anti-inflammatory/pain medication.
Timepoint [3] 6841 0
pre-operatively, 6 weeks post-operatively and 12 weeks post-operatively
Secondary outcome [4] 6842 0
Data collected from the medical record: included patient demographics, a locally devised pre-operative surgical risk score, surgery type and details, complications and length of stay
Timepoint [4] 6842 0
pre-operatively and immediately post-operatively.

Eligibility
Key inclusion criteria
Subjects awaiting elective open-heart surgery attending pre-admission clinic following informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusions: if subjects unable to understand written or spoken English, had a history of cerebral vascular accident with resultant upper limb neurological dysfunction, or development of significant complications preventing participation in usual postoperative physiotherapy.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2004
Actual
5/05/2004
Date of last participant enrolment
Anticipated
Actual
8/03/2005
Date of last data collection
Anticipated
Actual
7/06/2005
Sample size
Target
100
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3266 0
Self funded/Unfunded
Name [1] 3266 0
R Nicole Bellet
Country [1] 3266 0
Australia
Primary sponsor type
Hospital
Name
Physiotherapy Department The Prince Charles Hospital
Address
Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside 4032
Country
Australia
Secondary sponsor category [1] 2920 0
None
Name [1] 2920 0
Address [1] 2920 0
Country [1] 2920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5252 0
Human Research Ethics Committee
The Prince Charles Hospital Health Service District
Ethics committee address [1] 5252 0
The Prince Charles Hospital
Rode Rd
Chermside 4032
Ethics committee country [1] 5252 0
Australia
Date submitted for ethics approval [1] 5252 0
Approval date [1] 5252 0
26/02/2004
Ethics approval number [1] 5252 0
EC2373

Summary
Brief summary
This study aims to determine the extent of muscular and joint pain and shoulder disability in patients who have undergone open-heart surgery. Resarch questions are: what is the prevalence, type and area of musculsoskeletal pain, and shoulder disability pre-operatively, at six and at 12 weeks post-operatively? What is the prevalence of sternal clicking at 6 and 12 weeks post-operation. What is the level of patient compliance with home exercise advice? What are the variables associated with the development of post-operative musculoskeletal complications? Hypothesis is that 30% patients develop new musculoskeletal pain post-open heart surgery which is apparent at 6 weeks post operation and that this pain will return to pre-operative levels by 12 weeks post-operation.
Trial website
Trial related presentations / publications
Bellet, R. N., Lamb, R.L., Gould, T,D., Bartlett, H.J. "Prevalence of neuro-musculoskeletal pain and dysfunction in open-heart surgical patients preoperatively and at 6 and 12 weeks postoperatively: a prospective longitudinal observation study." Pragmatic and Observational Research 2017 Oct 10; 8: 211-222. doi: 10.2147/POR.S131060. eCollection 2017
Public notes

Contacts
Principal investigator
Name 28498 0
Dr R. Nicole Bellet
Address 28498 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside 4032
Country 28498 0
Australia
Phone 28498 0
61 7 31395445
Fax 28498 0
Email 28498 0
[email protected]
Contact person for public queries
Name 11655 0
R Nicole Bellet
Address 11655 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside 4032
Country 11655 0
Australia
Phone 11655 0
07 3139 4445
Fax 11655 0
Email 11655 0
[email protected]
Contact person for scientific queries
Name 2583 0
R Nicole Bellet
Address 2583 0
Physiotherapy Department
The Prince Charles Hospital
Rode Rd
Chermside 4032
Country 2583 0
Australia
Phone 2583 0
07 3139 4445
Fax 2583 0
Email 2583 0
[email protected]

No information has been provided regarding IPD availability


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.