Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000066987
Ethics application status
Approved
Date submitted
21/10/2010
Date registered
19/01/2011
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Date results provided
8/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Maximising shoulder function following accessory nerve damage (neurapraxia) after neck dissection surgery for cancer
Scientific title
Effect of a progressive resisted exercise program on shoulder pain and function following accessory nerve neurapraxia after neck dissection surgery for cancer
Secondary ID [1] 252930 0
Nil secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder function resulting from accessory nerve injury after surgery for head and neck cancer 258464 0
Condition category
Condition code
Musculoskeletal 258626 258626 0 0
Other muscular and skeletal disorders
Cancer 258627 258627 0 0
Head and neck
Surgery 258628 258628 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants eligible are those that have undergone neck dissection surgery for cancer within eight weeks, that present with clinical signs of accessory nerve injury; dropped scapula, winged scapula, and reduced active abduction on the operated side. Participation in the intervention group will involve attending the physiotherapy department at the study sites for a supervised exercise program. This involves progressive strengthening exercises using hand weights, active-assisted range of movement exercises of the shoulder, active range of movement exercises of the neck, and stretches of the shoulder and neck. The supervising physiotherapist ensures no worsening of pain or fatigue occurs during sessions. This will take half an hour, once a week for 12 weeks. The same exercises will be
performed at home twice a week. Exercise diaries are utilised to ensure compliance and no self upgrading of exercises.
Intervention code [1] 257453 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive current usual care, which is referral to physiotherapy only if they report
pain or problems in their shoulder after surgery. If they report shoulder pain and problems with movement, they are given a handout of generalised shoulder and neck exercises and advice about scar care. Participants may receive physiotherapy elsewhere, and what they receive will be up to the treating physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 259474 0
Shoulder pain and disability index (SPADI) . A one page validated questionnaire.
Timepoint [1] 259474 0
All participants will be required to attend assessments at the study sites at the start of the study (within eight weeks of surgery), and at 3 months, 6 months and 12 months.
Secondary outcome [1] 266055 0
Active shoulder range of motion, in particular abduction and flexion movement directions. Measured by a blinded assessor at each study site with a digital inclinometer.
Timepoint [1] 266055 0
All participants will be required to attend assessments at the study sites at the start of the study (within eight weeks of surgery), and at 3 months, 6 months and 12 months.
Secondary outcome [2] 266056 0
Neck dissection impairment index (NDII). A one page validated questionnaire, that is region specific.
Timepoint [2] 266056 0
All participants will be required to attend assessments at the study sites at the start of the study (within eight weeks of surgery), and at 3 months, 6 months and 12 months.
Secondary outcome [3] 266057 0
Global perceived effect scale (GPES). To ascertain participants' perceived effect of control or intervention.
Timepoint [3] 266057 0
All participants will be required to attend assessments at the study sites at the start of the study (within eight weeks of surgery), and at 3 months, 6 months and 12 months.

Eligibility
Key inclusion criteria
Must be within 8 weeks of neck dissection surgery, with accessory nerve preservation and scar fully healed.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking, that requires an interpreter.
Metastases to other areas.
Does not possess ability to give informed consent.
Nil cognitive impairment, intellectual disability or significant mental illness.
Not pregnant.

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)
Allocation is concealed. The statistician emailed the sequence generation to a staff member not involved in the study, who then placed the sequential numbers into opaque envelopes. The intervention physiotherapist opens each envelope in order, when the participant has been assessed and informed consent has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block design stratified by hospital and neck dissection surgery type (modified radical or selective neck dissection). A computer generated sequence was obtained from a statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
1/04/2009
Date of last participant enrolment
Anticipated
Actual
15/09/2012
Date of last data collection
Anticipated
Actual
15/12/2013
Sample size
Target
60
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 3395 0
2298
Recruitment postcode(s) [2] 3396 0
2170

Funding & Sponsors
Funding source category [1] 257905 0
Hospital
Name [1] 257905 0
Calvary Mater Newcastle
Country [1] 257905 0
Australia
Primary sponsor type
Hospital
Name
Calvary Mater Newcastle
Address
Edith St
Waratah 2298
NSW
Country
Australia
Secondary sponsor category [1] 257100 0
University
Name [1] 257100 0
University of Newcastle
Address [1] 257100 0
School of Health Sciences
University Drive
Callaghan 2308
NSW
Country [1] 257100 0
Australia
Other collaborator category [1] 251620 0
Individual
Name [1] 251620 0
Ms Aoife McGarvey
Address [1] 251620 0
Physiotherapy department
Calvary Mater Newcastle hospital
Edith St
Waratah 2298
NSW
Country [1] 251620 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259926 0
HNEHREC
Ethics committee address [1] 259926 0
Ethics committee country [1] 259926 0
Australia
Date submitted for ethics approval [1] 259926 0
18/02/2009
Approval date [1] 259926 0
04/03/2009
Ethics approval number [1] 259926 0
09/02/18/5.07

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

Contacts
Principal investigator
Name 31814 0
Ms Aoife McGarvey
Address 31814 0
Calvary Mater Newcastle Hospital, Waratah, 2298
Country 31814 0
Australia
Phone 31814 0
+61 249211211
Fax 31814 0
Email 31814 0
[email protected]
Contact person for public queries
Name 15061 0
Ms Aoife McGarvey
Address 15061 0
Emergency department Calvary Mater Newcastle Hospital Edith St Waratah 2298 NSW
Country 15061 0
Australia
Phone 15061 0
+61 249211211
Fax 15061 0
Email 15061 0
[email protected]
Contact person for scientific queries
Name 5989 0
A/Prof Pauline Chiarelli
Address 5989 0
School of Health Sciences
University of Newcastle
University Drive
Callaghan NSW 2308
Country 5989 0
Australia
Phone 5989 0
+61249216046
Fax 5989 0
Email 5989 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
Nil


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.