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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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

Study type
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
Comparator / control treatment
Mobility Training
Control group

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
Secondary outcome [2] 1688 0
2.Ultrasound Imaging: cross-sectional area of muscles.
Timepoint [2] 1688 0
Secondary outcome [3] 1689 0
3.Electromyography measures.
Timepoint [3] 1689 0
Secondary outcome [4] 1690 0
4.Cranio-cervical muscle strength and endurance measures.
Timepoint [4] 1690 0
10 weeks and 6 months post intervention

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Ethics committee name [1] 293801 0
Medical Ethics Committee, the University of Queensland
Ethics committee address [1] 293801 0
The University of Queensland
St Lucia Campus
Queensland 4072
Ethics committee country [1] 293801 0
Date submitted for ethics approval [1] 293801 0
Approval date [1] 293801 0
Ethics approval number [1] 293801 0

Brief summary
Objectives: To determine if changes in motor performance following a course of exercise in patients with mechanical neck pain (MNP) were dependent on the primary behavioral demand of the exercise performed.
Design: Randomised clinical trial
Setting: University laboratory.
Participants: Sixty volunteers with chronic MNP were randomly allocated into either an endurance training group (ETr) (n=20), a coordination training group (CTr) (n=20), or an active mobility training group (MTr) (n = 20).
Intervention: Exercise targeted to improve cervical motor performance
Main Outcome Measures: Changes in cervical motor performance (strength, endurance, coordination, active mobility) following the training program were evaluated immediately following the 10 week training program, and at a 26 week follow-up.
Results: Between group comparisons revealed significantly greater gains in endurance (P = 0.01) by the ETr group, and significantly greater gains in coordination (P = 0.02) by the CTr group. All three groups experienced improvement in pain (P < 0.05) and disability (P < 0.01).
Conclusions: Changes in motor performance in individuals with MNP in response to an exercise program were dependent on the specific mode of exercise performed, with minimal improvement in other domains of motor performance
Trial website
Trial related presentations / publications
O’Leary S, Jull G, Kim M, Uthaikhup S, Vicenzino B (2012). Training mode dependent changes in motor performance in neck pain. Archives of Physical Medicine and Rehabilitation 93(7):1225-33
Public notes

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
Phone 36008 0
61 7 336 57139
Fax 36008 0
Email 36008 0
Contact person for public queries
Name 9838 0
Dr 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
Phone 9838 0
+61 7 33654587
Fax 9838 0
+61 7 33652775
Email 9838 0
Contact person for scientific queries
Name 766 0
Dr 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
Phone 766 0
+61 7 33654587
Fax 766 0
+61 7 33652775
Email 766 0

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?
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary