Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000500651
Ethics application status
Approved
Date submitted
19/09/2005
Date registered
23/09/2005
Date last updated
5/11/2018
Date data sharing statement initially provided
5/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cranio-Cervical dynamometry in the rehabilitation of neck pain
Scientific title
The efficacy of cranio-cervical dynamometry in the management of chronic neck pain and retraining of neck muscle impairment
Secondary ID [1] 287812 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Nil used
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neck pain 625 0
Condition category
Condition code
Musculoskeletal 697 697 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of a new method of cranio-cervical dynamometry (strength and endurance training) to two other common forms of neck exercise therapy (cranio-cervical flexion retraining, active
range of motion.All 3 exercise programs are supervised by physiotherapists over a 10 week period.
Intervention code [1] 649 0
None
Comparator / control treatment
Mobility Training
Control group
Active

Outcomes
Primary outcome [1] 849 0
Neck Disability Index (NDI) score (score/100)
Timepoint [1] 849 0
Measured at baseline, after 10 weeks of intervention and at 6 months follow up.
Secondary outcome [1] 1687 0
1.Visual analogue scale pain measures.
Timepoint [1] 1687 0
NA
Secondary outcome [2] 1688 0
2.Ultrasound Imaging: cross-sectional area of muscles.
Timepoint [2] 1688 0
NA
Secondary outcome [3] 1689 0
3.Electromyography measures.
Timepoint [3] 1689 0
NA
Secondary outcome [4] 1690 0
4.Cranio-cervical muscle strength and endurance measures.
Timepoint [4] 1690 0
10 weeks and 6 months post intervention

Eligibility
Key inclusion criteria
Neck pain of 6 months duration or greater;NPQ score of greater than 20%;Demonstrable poor muscle performance on the clinical test of cranio-cervical flexion.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neck pain from non-musculoskeletal causes;Neurological signs;Any medical disorder which contra-indicates physical exercise.

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)
Concealed Allocation by randomisation by an independent investigator
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with no restriction
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2004
Actual
31/01/2004
Date of last participant enrolment
Anticipated
Actual
30/06/2005
Date of last data collection
Anticipated
Actual
30/01/2006
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 772 0
Government body
Name [1] 772 0
NHMRC Development Grant # 301239
Country [1] 772 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Campus
Qld 4072
Country
Australia
Secondary sponsor category [1] 634 0
Government body
Name [1] 634 0
NHMRC Development Grant
Address [1] 634 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 634 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293801 0
Medical Ethics Committee, the University of Queensland
Ethics committee address [1] 293801 0
Ethics committee country [1] 293801 0
Australia
Date submitted for ethics approval [1] 293801 0
01/10/2003
Approval date [1] 293801 0
01/11/2003
Ethics approval number [1] 293801 0
NA

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

Contacts
Principal investigator
Name 36008 0
Prof Gwendolen Jull
Address 36008 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Campus
Qld 4072
Country 36008 0
Australia
Phone 36008 0
61 7 336 57139
Fax 36008 0
Email 36008 0
[email protected]
Contact person for public queries
Name 9838 0
Shaun O'Leary
Address 9838 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 9838 0
Australia
Phone 9838 0
+61 7 33654587
Fax 9838 0
+61 7 33652775
Email 9838 0
[email protected]
Contact person for scientific queries
Name 766 0
Shaun O'Leary
Address 766 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072
Country 766 0
Australia
Phone 766 0
+61 7 33654587
Fax 766 0
+61 7 33652775
Email 766 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.