ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000160639

Ethics application status

Approved

Date submitted

4/02/2014

Date registered

10/02/2014

Date last updated

2/11/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

Effect of low load exercise training on the onset time of deep and superficial neck flexor muscles in people with neck pain

Scientific title

Is the latency in onset of the neck flexor muscles reduced by low load cranio-cervical flexion exercise compared to natural history in persons with idiopathic neck pain?

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

1) Idiopathic neck pain, and

2) Delayed onset of neck muscle activation relative to that of the arm muscles during an arm movement

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The specific exercise involves a low load craniocervical flexion motion (i.e. similar to a “chin nod”) in lying twice per day and a correction of posture for 10 seconds twice per hour during waking hours. For progression the number of repetitions and the target load for the craniocervical flexion task will be incremented as performance improves. The accuracy of exercise will be monitored by a physiotherapist every week. The exercise will be continued for 3 months. Adherence to the exercises will be assessed based on self-reported overall compliance rate.

Intervention code [1]

Treatment: Other

Intervention code [2]

Rehabilitation

Comparator / control treatment

No control

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The onset of activity of the neck flexor muscles in a quick arm movement task will be assessed using surface electromyography (EMG).

Timepoint [1]

At baseline before starting muscle training and every 4 weeks up to 4 months

Secondary outcome [1]

Neck Disability Index

Timepoint [1]

At baseline before starting muscle training and every 4 weeks up to 4 months

Secondary outcome [2]

Patient Specific Functional Scale

Timepoint [2]

At baseline before starting muscle training and every 4 weeks up to 4 months

Eligibility

Key inclusion criteria

Suffering from neck pain which is bothersome and is interrupting daily functions.

Minimum age

18 Years

Maximum age

55 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) No delay of the neck flexor muscles activation when moving the arm; 2) allergies to topical anaesthetic, which will be used for EMG testing only; 3) any nerve tissue mechanosensitivity hindering the movement of the neck or upper limbs; 4) a history of a cervical fracture or dislocation; 5) neurological disorders such as multiple sclerosis, head injury or stroke; 6) upper limb problems hindering arm movement; or 7) major medical problems likely to affect physical performance (e.g. cardiovascular or respiratory)

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

14/05/2013

Actual

15/05/2013

Date of last participant enrolment

Anticipated

Actual

30/04/2015

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council (ID 631717)

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Individual

Name

Hiroshi Takasaki

Address

Division of Physiotherapy, School of Health and Rehabilitation Science, The University of Queensland, St.Lucia, Brisbane, QLD, 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Medical Research Ethics Committee

Ethics committee address [1]

The University of Queensland, St.Lucia, Brisbane, QLD, 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/04/2013

Approval date [1]

14/05/2013

Ethics approval number [1]

2004000654

Summary

Brief summary

Background: The neck muscles support and protect the neck and normally are activated as soon as arm muscles are activated when we move our arms. However, the onset of the neck muscles including the deep and superficial neck flexor muscles in comparison to the onset of deltoid muscles (relative latency) is delayed in people with neck pain relative to pain-free individuals. In a previous study it was shown that the relative latency of the onset of the deep neck flexors was improved by a specific low load neck exercise, which was practised for six weeks. However, the relative latency of the onset of deep neck flexors remained delayed in comparison to asymptomatic subjects. This was interpreted to indicate a persistent deficit in timing of activation of these muscles. We therefore question whether the onset of the neck muscles can be further improved to match that of pain-free individuals if the exercise is continued for a longer time. This information is very important for ideal prescription of exercises for people with neck pain and could be relevant for prevention of further episodes of neck pain. The purpose of this study is to investigate whether the onset of activation of the neck flexor muscles can be further improved, than has been shown previously, by extension of the period of training with the specific low load neck exercise.
Subjects: Nine individuals with idiopathic neck pain has been included.
Measures: Myoelectric activity of the deep and superficial neck flexor muscles have been recorded using surface electromyography (EMG). The onset of activity of the neck muscles in a quick arm movement task has been assessed as the primary outcome measure. 
Procedures: EMG measures have been assessed at baseline before starting 3-month exercise training and then every 4 weeks up to 4 months. Participants have been taught a low load home exercise that is designed to gently and precisely activate the deep neck flexor muscles. The exercise training involves a low intensity upper cervical flexion motion (i.e. similar to a chin nod) in lying twice a day and correcting posture twice per hour. For progression of the exercise the number of repetitions and the target load has been  increased as the patients were able. The accuracy of the home exercise has been  checked every week by a specialist physiotherapist.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Hiroshi Takasaki

Address

Division of Physical Therapy,
Saitama Prefectural University,
Sannomiya 820, Kosigaya, Saitama, 343-8540, Japan.

Country

Japan

Phone

+81489734706

Fax

takasaki-hiroshi@spu.ac.jp

Contact person for public queries

Name

Hiroshi Takasaki

Address

Division of Physical Therapy,
Saitama Prefectural University,
Sannomiya 820, Kosigaya, Saitama, 343-8540, Japan.

Country

Japan

Phone

+81489734706

Fax

takasaki-hiroshi@spu.ac.jp

Contact person for scientific queries

Name

Hiroshi Takasaki

Address

Division of Physical Therapy,
Saitama Prefectural University,
Sannomiya 820, Kosigaya, Saitama, 343-8540, Japan.

Country

Japan

Phone

+81489734706

Fax

takasaki-hiroshi@spu.ac.jp

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.

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