Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000358448
Ethics application status
Not yet submitted
Date submitted
28/06/2007
Date registered
4/07/2007
Date last updated
4/07/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treatment of trigger point sensitivity with Neuro Emotional Technique in chronic neck pain sufferers
Scientific title
Treatment of trigger point sensitivity with Neuro Emotional Technique in chronic neck pain sufferers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neck pain
trigger point sensitivty 1915 0
Condition category
Condition code
Musculoskeletal 2006 2006 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Patients were given a 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 (T1, T5 & T8). Participants received the intervention only once. At 3 days post intervention, the participants returned for reassessment of the measures taken at baseline.
Intervention code [1] 1859 0
Treatment: Other
Comparator / control treatment
Control: Patients were given a SHAM NET intervention. This included a process similar to above, however no intervention was applied. The referential statements provided were not relevant to the presentation and thus were deemed to have no therapeutic value.
Control group
Placebo

Outcomes
Primary outcome [1] 2833 0
Reduction in sensitivity of trigger points
Timepoint [1] 2833 0
Assessed 3 days post-intervention.
Secondary outcome [1] 4780 0
Reduction in visual analog scales and increase in pressure gauge algometer readings
Timepoint [1] 4780 0
Assessed 3 days post-intervention.

Eligibility
Key inclusion criteria
Chronic cervical pain (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
Participants that did not have neck pain and headache. Participants who had acute cervical pain, Participants who had undergone recent surgery, Participants suffering any concurrent pathology.

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. Patients were allocated based on patient record numbers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants were blinded to the study, as they were new patients presenting to a clinic who had not previously received the intervention being tested. They were unable to differentiate between the NET or SHAM treatment. The person administering the treatment was not blinded (chiropractor two). The person assessing the outcomes was blinded to each study group (chiropractor one). The persons analysing the data were blinded to the allocation of the groups.
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2150 0
Self funded/Unfunded
Name [1] 2150 0
private practice
Country [1] 2150 0
Australia
Primary sponsor type
Individual
Name
Mr. Peter Bablis
Address
Country
Secondary sponsor category [1] 1951 0
Individual
Name [1] 1951 0
Dr. Henry Pollard
Address [1] 1951 0
Country [1] 1951 0

Ethics approval
Ethics application status
Not yet submitted

Summary
Brief summary
Chronic neck pain sufferers have been found to often suffer from trigger points in neck musculature. Trigger points are bands of hyper-irritable spots in taut muscle, which can cause tenderness, a jump sign, and radiculations of pain. Chronic pain, that greater than 3 months duration, is understood to have significant psychosocial overlay. Very few primary health care therapists have the means to treat this psychosocial overlay and hence reduce associated physical symptoms. Neuro Emotional Technique is a well-established chiropractic intervention which attempts to treat this psychosocial overlay. This study took chronic neck pain sufferers, and measured their presentations of pain on a visual analog scale, and also via a quantified pressure applied to the trigger points with a pressure gauge algometer. The treatment group then received one NET treatment, whilst the control received a SHAM treatment. They both presented 3 days later to see if their symptoms had changed in severity. The primary purpose was to see if NET consultation had a short term effect of the severity of trigger points in neck musculature. The null hypothesis was that NET would not cause a reduction in pain sensitivity in trigger points as measured by pressure algometry.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27673 0
Address 27673 0
Country 27673 0
Phone 27673 0
Fax 27673 0
Email 27673 0
Contact person for public queries
Name 11048 0
Dr. Henry Pollard
Address 11048 0
84 The Kingsway
Cronulla NSW 2230
Country 11048 0
Australia
Phone 11048 0
+61 2 95234600
Fax 11048 0
Email 11048 0
[email protected]
Contact person for scientific queries
Name 1976 0
Dr. Henry Pollard
Address 1976 0
84 The Kingsway
Cronulla NSW 2230
Country 1976 0
Australia
Phone 1976 0
+61 2 95234600
Fax 1976 0
Email 1976 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.