Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000650493
Ethics application status
Approved
Date submitted
17/12/2007
Date registered
20/12/2007
Date last updated
20/12/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled pilot study of Neuro Emotional technique for low back pain
Scientific title
Chronic low back pain sufferers receiving Neuro Emotional technique in comparison to sham Neuro Emotional technique measured via Visual Analog Scale (VAS).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 2635 0
Condition category
Condition code
Alternative and Complementary Medicine 2750 2750 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Patients were given a short 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 received the intervention at a frequency of 2 sessions per week for one month (8 sessions).
Intervention code [1] 2370 0
Other interventions
Comparator / control treatment
Control: Patients were given a sham NET intervention. This included enthusiastic treatment of muscle testing and semantic testing which did 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.
Control group
Active

Outcomes
Primary outcome [1] 3639 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] 3639 0
1 month
Secondary outcome [1] 6106 0
Distress and Risk Assessment Method (DRAM)
Timepoint [1] 6106 0
1 month
Secondary outcome [2] 6107 0
Oswestry Low Back Pain Questionnaire
Timepoint [2] 6107 0
1 month

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 phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to intervention is simple randomisation using quasi-randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
17
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 344 0
2000 - 2030

Funding & Sponsors
Funding source category [1] 2890 0
Self funded/Unfunded
Name [1] 2890 0
Mr. Peter Bablis, Chiropractor
Country [1] 2890 0
Australia
Primary sponsor type
Individual
Name
Mr. Peter Bablis
Address
8 Patterson Street
Double Bay NSW 2028
Country
Australia
Secondary sponsor category [1] 2611 0
Individual
Name [1] 2611 0
Associate Professor Henry Pollard
Address [1] 2611 0
84 The Kingsway
Cronulla NSW 2230
Country [1] 2611 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4832 0
Macquarie University
Ethics committee address [1] 4832 0
Ethics committee country [1] 4832 0
Australia
Date submitted for ethics approval [1] 4832 0
Approval date [1] 4832 0
Ethics approval number [1] 4832 0
HE26SEPT2003-RO2600

Summary
Brief summary
Low back pain is the most common presentation to chiropractic practitioners. Recent evidence suggests that chronic LBP may be associated with physical and psychosocial components. The biopsychosocial model of pain acknowledges the biological, psychological and social dimensions of the pain experience. This model recognizes disability often results from an inability to perform activities due to the pain, or due to the fear of future pain. The mind-body approach attempts to integrate the psychosocial dimensions of the person into therapy. It is for these reasons that manual medicine has begun to embrace the concept of "mind-body" treatments. These treatments attempt in various ways to integrate the function of the mind with the body in both assessment and therapy. Despite these lofty goals, very few of these treatments have been scrutinized under controlled conditions. This pilot study provides preliminary evidence that a mind-body approach, identified as Neuro Emotional Technique, may be beneficial in the treatment of chronic low back pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28245 0
Address 28245 0
Country 28245 0
Phone 28245 0
Fax 28245 0
Email 28245 0
Contact person for public queries
Name 11402 0
Associate Professor Henry Pollard
Address 11402 0
84 The Kingsway
Cronulla NSW 2230
Country 11402 0
Australia
Phone 11402 0
+61 2 95234600
Fax 11402 0
Email 11402 0
[email protected]
Contact person for scientific queries
Name 2330 0
Associate Professor Henry Pollard
Address 2330 0
84 The Kingsway
Cronulla NSW 2230
Country 2330 0
Australia
Phone 2330 0
+61 2 95234600
Fax 2330 0
Email 2330 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.