ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

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]

None

Comparator / control treatment

Mobility Training

Control group

Active

Outcomes

Primary outcome [1]

Neck Disability Index (NDI) score (score/100)

Timepoint [1]

Measured at baseline, after 10 weeks of intervention and at 6 months follow up.

Secondary outcome [1]

1.Visual analogue scale pain measures.

Timepoint [1]

Secondary outcome [2]

2.Ultrasound Imaging: cross-sectional area of muscles.

Timepoint [2]

Secondary outcome [3]

3.Electromyography measures.

Timepoint [3]

Secondary outcome [4]

4.Cranio-cervical muscle strength and endurance measures.

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Development Grant # 301239

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

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]

Government body

Name [1]

NHMRC Development Grant

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Ethics Committee, the University of Queensland

Ethics committee address [1]

The University of Queensland
St Lucia Campus
Queensland 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2003

Approval date [1]

01/11/2003

Ethics approval number [1]

Summary

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

Publication
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

Contacts

Principal investigator

Name

Prof Gwendolen Jull

Address

School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia Campus
Qld 4072

Country

Australia

Phone

61 7 336 57139

Fax

g.jull@uq.edu.au

Contact person for public queries

Name

Shaun O'Leary

Address

Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 7 33654587

Fax

+61 7 33652775

s.oleary@shrs.uq.edu.au

Contact person for scientific queries

Name

Shaun O'Leary

Address

Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 7 33654587

Fax

+61 7 33652775

s.oleary@uq.edu.au

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.

Trial Review

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