Trial Review

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
ACTRN12607000469415
Ethics application status
Not yet submitted
Date submitted
23/08/2007
Date registered
19/09/2007
Date last updated
19/09/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of Triggerpoint sensitivity with neuroemotional technique in chronic neck pain sufferers
Scientific title
Triggerpoint sufferer response to Neuro Emotional Technique (NET) treatment for pain and tenderness reduction
Universal Trial Number (UTN)
Trial acronym
NET for TPs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trigger point tenderness 2289 0
Condition category
Condition code
Musculoskeletal 2383 2383 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NET treatment is a mind-body approach which uses applies physical stimulus whilst a participant thinks about a key emotional event. The physical stimulus in this case is a gentle percussion on the back in the thoracic region. In this trial participants will receive a single treatment session of approximately 15 minutes.
Intervention code [1] 2003 0
Treatment: Other
Comparator / control treatment
A sham treatment will be employed
Control group
Placebo

Outcomes
Primary outcome [1] 3286 0
Change in trigger point sensitivity measured by visual analog scale
Timepoint [1] 3286 0
Outcome measured once, 3 days following treatment
Secondary outcome [1] 5466 0
Change in trigger point sensitivity measured by algometer
Timepoint [1] 5466 0
Outcome measured once, 3 days following treatment

Eligibility
Key inclusion criteria
Chronic neck pain ie greater than 3 months duration
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Red flag conditions
Vascular disease
Acute onset pain
Injury, fall or motor vehicle accident in last 6 months
Yellow lags
Pregnancy
Anticoagulant therapy
Easy bruising
Organic disease
History of neck or arm surgery
Bowel, bladder or kidney dysfunction
Currently undergoing other treatments which may impinge on participation

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)
Allocation concealment. The person who determined if the participant was eligible for inclusion in the trial was unaware, at the time the decision was made, as to which group the participant would be allocated. Numbered containers were used in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocated by dice throw as each person attended place of treatment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 394 0
2109

Funding & Sponsors
Funding source category [1] 2545 0
University
Name [1] 2545 0
Macquarie University
Country [1] 2545 0
Australia
Funding source category [2] 2627 0
Self funded/Unfunded
Name [2] 2627 0
Mr Peter bablis
Country [2] 2627 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Balaclava Rd North Ryde
Sydney
New South Wales 2109
Country
Australia
Secondary sponsor category [1] 2303 0
None
Name [1] 2303 0
Address [1] 2303 0
Country [1] 2303 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4461 0
Macquarie University Ethics Review Committee (Human Subjects)
Ethics committee address [1] 4461 0
Macquarie University
Balaclava Rd North Ryde
Sydney
New South Wales 2109
Ethics committee country [1] 4461 0
Australia
Date submitted for ethics approval [1] 4461 0
08/08/2007
Approval date [1] 4461 0
Ethics approval number [1] 4461 0
Ethics committee name [2] 4546 0
Ethics committee address [2] 4546 0
Ethics committee country [2] 4546 0
Date submitted for ethics approval [2] 4546 0
08/08/2007
Approval date [2] 4546 0
Ethics approval number [2] 4546 0

Summary
Brief summary
This study investigates whether a new form of treatment (NET) has a beneficial effect on tender or painful trigger points. Trigger points are locations on a muscle surface which are abnormally tender and are a source of self-perpetuating and continuing pain. This study looks at trigger points in the neck region. Participants will be assessed for the presence of trigger points. They will be given one course of NET treatment. They will return after 3 days to have their trigger points assessed for any change in their tenderness and the degree of neck pain. The treatment group results will be compared to a control group who receive a sham treatment which has no therapeutic value.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28000 0
Address 28000 0
Country 28000 0
Phone 28000 0
Fax 28000 0
Email 28000 0
Contact person for public queries
Name 11157 0
A/Prof Rod Bonello
Address 11157 0
Department of Health & Chiropractic
Macquarie University NSW 2109
Country 11157 0
Australia
Phone 11157 0
612 9850 6383
Fax 11157 0
612 9850 9389
Email 11157 0
[email protected]
Contact person for scientific queries
Name 2085 0
A/Prof Rod Bonello
Address 2085 0
Department of Health & Chiropractic
Macquarie University NSW 2109
Country 2085 0
Australia
Phone 2085 0
612 9850 6383
Fax 2085 0
612 9850 9389
Email 2085 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.