Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000438550
Ethics application status
Approved
Date submitted
9/10/2006
Date registered
11/10/2006
Date last updated
11/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study of the effectiveness of ENAR® over TENS and Placebo therapies for the treatment of chronic neck pain in an Australian adult population
Scientific title
A study of the effectiveness of Electro-Neuro-Adaptive-Regulator (ENAR)® in reducing pain for the treatment of chronic neck pain
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic neck pain. 1410 0
Condition category
Condition code
Musculoskeletal 1505 1505 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Electro-Neuro-Adaptive-Regulator (ENAR) electrotherapy (experimental) 15 minutes moving contact of the device on the skin of the neck and shoulders.
Transcutaneous Electrical Nerve Stimulation (TENS) electrotherapy (comparison) 15 minutes moving contact of the device on the skin of the neck and shoulders.

All 3 treatment group participants received twelve, 15-minute treatment sessions over a six week period
Intervention code [1] 1395 0
Treatment: Devices
Comparator / control treatment
Sham (detuned ENAR) as placebo control strategy.
Control group
Placebo

Outcomes
Primary outcome [1] 2082 0
Visual Analogue Scale (VAS) pain
Timepoint [1] 2082 0
Five assessments points at 1, 6, 12, 18 and 24 weeks following commencement of the trial.
Primary outcome [2] 2083 0
Neck Disability Index (NDI)
Timepoint [2] 2083 0
Five assessments points at 1, 6, 12, 18 and 24 weeks following commencement of the trial.
Secondary outcome [1] 3597 0
Patient Specific Functional Scale (PSFS).
Timepoint [1] 3597 0
Five assessments points at 1, 6, 12, 18 and 24 weeks following commencement of the trial.
Secondary outcome [2] 3598 0
Short Form 36 (SF-36).
Timepoint [2] 3598 0
Five assessments points at 1, 6, 12, 18 and 24 weeks following commencement of the trial.

Eligibility
Key inclusion criteria
Adults from Sydney, Australia.Chronic neck pain minimum 6 weeks duration.No sign or symptom implying cervical spine discogenic disease or radiculopathy.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suspicion of Red Flag Conditions such as; Spinal fractures, Osseous and Cartilaginous infections, Inflammatory Arthritic conditions, and Malignancy.Yellow Flag Conditions such as; Non-finalised Workers Compensation or Third Party Insurance Claim, Any other non-finalised compensatory litigation.Whiplash Associated Disorder (WAD) grade 1-4 whiplash injury within the last six months.Presence of significant vascular disease.Severe or acute relapse of neck pain within the last three months.Motor vehicle accident, serious falls or any other accident requiring medical/hospital treatment within the last three months.Current neurological signs, symptoms or syndromes, e.g. muscle wasting or nerve root signs, epilepsy or paraplegia.Pregnancy or likelihood of pregnancy within the trial period.Spinal or orthopaedic surgery within the past two years.Bowel, or bladder/sexual dysfunction as a result of either lumbar spine or prostate dysfunctionCurrently undergoing a course of manual therapy or psychological intervention.Participants not prepared to attend 12 treatment sessions within the first six weeks and a further three assessment sessions over the next 18 weeks.

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)
central randomisation by phone computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants (subjects) were blinded as to their treatment allocation. Analysts were blinded as to the nature of intervention.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1642 0
Commercial sector/Industry
Name [1] 1642 0
Enlightened Therapies P/L
Country [1] 1642 0
Primary sponsor type
Commercial sector/Industry
Name
Enlightened Therapies P/L
Address
Country
Australia
Secondary sponsor category [1] 1450 0
None
Name [1] 1450 0
Nil
Address [1] 1450 0
Country [1] 1450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3087 0
Macquarie University
Ethics committee address [1] 3087 0
Ethics committee country [1] 3087 0
Australia
Date submitted for ethics approval [1] 3087 0
Approval date [1] 3087 0
04/04/2003
Ethics approval number [1] 3087 0
HE28MAR2003-R02192CM

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

Contacts
Principal investigator
Name 27622 0
Address 27622 0
Country 27622 0
Phone 27622 0
Fax 27622 0
Email 27622 0
Contact person for public queries
Name 10584 0
Andrew Vitiello
Address 10584 0
Department of Health & Chiropractic
Macquarie University
North Ryde NSW 2109
Country 10584 0
Australia
Phone 10584 0
+61 2 98506383
Fax 10584 0
+61 2 98509389
Email 10584 0
[email protected]
Contact person for scientific queries
Name 1512 0
Andrew Vitiello
Address 1512 0
Department of Health & Chiropractic
Macquarie University
North Ryde NSW 2109
Country 1512 0
Australia
Phone 1512 0
+61 2 98506383
Fax 1512 0
+61 2 98509389
Email 1512 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.