A study of the effectiveness of ENAR® over TENS and Placebo therapies for the treatment of chronic neck pain in an Australian adult population

A study of the effectiveness of Electro-Neuro-Adaptive-Regulator (ENAR)® in reducing pain for the treatment of chronic neck pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000438550

Enrollment

Registered

2006-10-11

Start date

2004-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The ENAR® therapy device is said to combine Western biofeedback with Eastern energy medicine. It is an emerging technology which uses a varying frequency waveform similar TENS, and it alters its resultant frequency spectra according to areas of greater skin resistance. This pilot study investigates the effects of ENAR, TENS and a Sham protocol on 24 non-complicated, chronic neck pain sufferers is conducted.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Adults from Sydney, Australia.Chronic neck pain minimum 6 weeks duration.No sign or symptom implying cervical spine discogenic disease or radiculopathy.

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.

Outcome results