Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000002381
Ethics application status
Approved
Date submitted
20/12/2007
Date registered
7/01/2008
Date last updated
7/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of Neuro Emotional Technique for chronic low back pain sufferers.
Scientific title
Neuro Emotional technique in comparison to sham Neuro Emotional technique on the effects of pain in chronic low back pain sufferers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 2653 0
Condition category
Condition code
Alternative and Complementary Medicine 2771 2771 0 0
Other alternative and complementary medicine
Musculoskeletal 2793 2793 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Patients shall be given a moderate course of Neuro Emotional Technique (NET) intervention. NET is a mind-body based chiropractic intervention, that utilises muscle testing, semantics and chinese element theory to determine a neuro emotional complex (NEC). A neuroemotional complex is said to be associated with many pain syndromes. The NEC's are assessed through referential statements, through the use of muscle testing. The intervention is created by applying a mechanical mobilisation device (activator) to specific spinal segments whilst the participant contemplates a recalled memory and the recents cause of the pain syndrome. This is believed to help disassociate the emotional content and a pain syndrome to facilitate the return to health. During this time pain is said to be reduced or normalised. Duration of Intervention: The intervention is applied in less than one second mobilising bursts of less than one centimetre amplitude. The burst are repeated 5 times bilaterally at three separate facet joint articulation of the spine. Participants shall receive the intervention at a frequency of 2 sessions per week for one month, followed by one session per month for 5 months (12 sessions).
Intervention code [1] 2394 0
Other interventions
Comparator / control treatment
Sham: Patients shall be given sham NET intervention. This included enthusiastic treatment of muscle testing and semantic testing which does not pertain to any emotional complexed. The referential statements provided were not relevant to the presentation and thus were deemed to have no therapeutic value. Participants shall receive the SHAM treatment at a frequency of 2 sessions per week for one month, followed by one session per month for 5 months (12 sessions).
Control group
Active

Outcomes
Primary outcome [1] 3658 0
Visual Analog Scale (VAS) of how much pain you are experiencing right now. VAS of the typical or average pain you experience. VAS of pain at its best. VAS of pain at its worst.
Timepoint [1] 3658 0
1 month, 3 months and 6 months
Secondary outcome [1] 6181 0
Distress and Risk Assessment Method (DRAM)
Timepoint [1] 6181 0
1 month, 3 months and 6 months
Secondary outcome [2] 6182 0
Oswestry Low Back Pain Questionnaire
Timepoint [2] 6182 0
1 month, 3 months and 6 months

Eligibility
Key inclusion criteria
Participants suffering from low back pain less than three months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Acute low back pain (<3 months duration); < 18 years of age; currently undergoing other manual therapy or psychological intervention; presence of “red flag” conditions; pregnancy; abdominal pain; vascular disease; motor vehicle accident or falls in last 3 months; neurological signs and symptoms; organic kidney, urinary tract or reproductive disease; straight leg raise of < 30°; previous spinal surgery; and bowel, bladder or sexual dysfunction.

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 was completed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 708 0
2000 - 2030

Funding & Sponsors
Funding source category [1] 2907 0
Self funded/Unfunded
Name [1] 2907 0
Mr. Peter Bablis
Country [1] 2907 0
Australia
Primary sponsor type
Individual
Name
Mr. Peter Bablis
Address
8 Patterson Street, Double Bay, NSW 2028
Country
Australia
Secondary sponsor category [1] 2627 0
Individual
Name [1] 2627 0
Assoc. Prof. Henry Pollard
Address [1] 2627 0
84 The Kingsway, Cronulla, NSW 2230
Country [1] 2627 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4850 0
Macquarie University
Ethics committee address [1] 4850 0
Ethics committee country [1] 4850 0
Australia
Date submitted for ethics approval [1] 4850 0
Approval date [1] 4850 0
Ethics approval number [1] 4850 0
HE26SEPT2003-RO2600

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28257 0
Address 28257 0
Country 28257 0
Phone 28257 0
Fax 28257 0
Email 28257 0
Contact person for public queries
Name 11414 0
Assoc Prof Henry Pollard
Address 11414 0
84 The Kingsway, Cronulla. NSW 2230
Country 11414 0
Australia
Phone 11414 0
(02) 9523 4600
Fax 11414 0
Email 11414 0
hpollard@optushome.com.au
Contact person for scientific queries
Name 2342 0
Assoc Prof Henry Pollard
Address 2342 0
84 The Kingsway, Cronulla. NSW 2230
Country 2342 0
Australia
Phone 2342 0
(02) 9523 4600
Fax 2342 0
Email 2342 0
hpollard@optushome.com.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 82488-(Uploaded-11-11-2020-07-40-41)-Basic results summary.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStress reduction via neuro-emotional technique to achieve the simultaneous resolution of chronic low back pain with multiple inflammatory and biobehavioural indicators: A randomized, double-blinded, placebo-controlled trial.2022https://dx.doi.org/10.1016/j.joim.2021.12.001
N.B. These documents automatically identified may not have been verified by the study sponsor.