ANZCTR - Registration

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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

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Musculoskeletal

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]

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]

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]

1 month, 3 months and 6 months

Secondary outcome [1]

Distress and Risk Assessment Method (DRAM)

Timepoint [1]

1 month, 3 months and 6 months

Secondary outcome [2]

Oswestry Low Back Pain Questionnaire

Timepoint [2]

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]

2000 - 2030

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Mr. Peter Bablis

Address [1]

8 Patterson Street, Double Bay, NSW 2028

Country [1]

Australia

Primary sponsor type

Individual

Name

Mr. Peter Bablis

Address

8 Patterson Street, Double Bay, NSW 2028

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Assoc. Prof. Henry Pollard

Address [1]

84 The Kingsway, Cronulla, NSW 2230

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

HE26SEPT2003-RO2600

Summary

Brief summary

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Assoc Prof Henry Pollard

Address

84 The Kingsway, Cronulla. NSW 2230

Country

Australia

Phone

(02) 9523 4600

Fax

[email protected]

Contact person for scientific queries

Name

Assoc Prof Henry Pollard

Address

84 The Kingsway, Cronulla. NSW 2230

Country

Australia

Phone

(02) 9523 4600

Fax

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			82488-(Uploaded-11-11-2020-07-40-41)-Basic results summary.pdf

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Stress 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.	2022	https://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.

Trial Review

Documents added manually

Documents added automatically