Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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] 284027 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
1) Idiopathic neck pain, and

291073 0
2) Delayed onset of neck muscle activation relative to that of the arm muscles during an arm movement
 291074 0
Condition category
Condition code
Musculoskeletal 291417 291417 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 291441 291441 0 0
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] 288718 0
Treatment: Other
Intervention code [2] 288735 0
Rehabilitation
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291407 0
The onset of activity of the neck flexor muscles in a quick arm movement task will be assessed using surface electromyography (EMG).
Timepoint [1] 291407 0
At baseline before starting muscle training and every 4 weeks up to 4 months
Secondary outcome [1] 306701 0
Neck Disability Index
Timepoint [1] 306701 0
At baseline before starting muscle training and every 4 weeks up to 4 months
Secondary outcome [2] 306740 0
Patient Specific Functional Scale
Timepoint [2] 306740 0
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?
No
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
20
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288655 0
Government body
Name [1] 288655 0
National Health and Medical Research Council (ID 631717)
Country [1] 288655 0
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] 287366 0
None
Name [1] 287366 0
Address [1] 287366 0
Country [1] 287366 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290507 0
Medical Research Ethics Committee
Ethics committee address [1] 290507 0
The University of Queensland, St.Lucia, Brisbane, QLD, 4072
Ethics committee country [1] 290507 0
Australia
Date submitted for ethics approval [1] 290507 0
30/04/2013
Approval date [1] 290507 0
14/05/2013
Ethics approval number [1] 290507 0
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 46002 0
Dr Hiroshi Takasaki
Address 46002 0
Division of Physical Therapy,
Saitama Prefectural University,
Sannomiya 820, Kosigaya, Saitama, 343-8540, Japan.
Country 46002 0
Japan
Phone 46002 0
+81489734706
Fax 46002 0
Email 46002 0
[email protected]
Contact person for public queries
Name 46003 0
Hiroshi Takasaki
Address 46003 0
Division of Physical Therapy,
Saitama Prefectural University,
Sannomiya 820, Kosigaya, Saitama, 343-8540, Japan.
Country 46003 0
Japan
Phone 46003 0
+81489734706
Fax 46003 0
Email 46003 0
[email protected]
Contact person for scientific queries
Name 46004 0
Hiroshi Takasaki
Address 46004 0
Division of Physical Therapy,
Saitama Prefectural University,
Sannomiya 820, Kosigaya, Saitama, 343-8540, Japan.
Country 46004 0
Japan
Phone 46004 0
+81489734706
Fax 46004 0
Email 46004 0
[email protected]

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.