AUGUST 2008

SONOTRON

HEALTH TECHNOLOGY ASSESSMENT UNIT

MEDICAL DEVELOPMENT DIVISION
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MINISTRY OF HEALTH MALAYSIA
010/08
DISCLAIMER

Technology review is a brief report, prepared on an urgent basis, which draws on restricted
reviews from analysis of pertinent literature, on expert opinion and / or regulatory status where
appropriate. It is not subjected to an external review process. While effort has been made to do
so, this document may not fully reflect all scientific research available. Additionally, other
relevant scientific findings may have been reported since completion of this review.

Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS),

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Federal Government Administrative Centre
62590 Putrajaya

Tel: 603 88831246

Fax: 603 8883 1230

Available at the following website: http://www.moh.gov.my

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Prepared by:

Dr Izzuna Mudla bt Mohamed Ghazali

Principal Assistant Director
Health Technology Assessment Section
Ministry of Health Malaysia

Norkiah Ujang
Nursing Sister
Health Technology Assessment Section
Ministry of Health Malaysia

Reviewed by:
Datin Dr Rugayah bt Bakri
Deputy Director
Health Technology Assessment Unit
Ministry of Health Malaysia

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EXECUTIVE SUMMARY

Sonotron Therapy is a non-invasive alternative medical therapy used by some medical

practitioners for patient with chronic and acute pain of joints and other soft tissues.

This technology review was requested by the Senior Consultant Paediatrician, Malacca Hospital,
following a newspaper write-up on Sonotron as a panacea for a host of paediatric and medical
ailments.

Sonotron acts by means of Corona Discharge Beam that is produced when a low frequency radio
wave is applied to an electrode situated inside a hand-held applicator. The device does not touch
the skin during treatment.

There were insufficient evidence on the safety, effectiveness and cost-effectiveness of Sonotron.
There was no literature on properly designed clinical trials retrieved.

Based on this review, Sonotron is not recommended as a standard treatment for patients with
diabetics wound, arthritis or post stroke. More clinical research is warranted to provide good
quality evidence such as randomized clinical trials for each indication as claimed by the
manufacturer and Sonotron users.

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 SONOTRON

1. INTRODUCTION

Sonotron therapy has been used as an alternative therapy for chronic ailments. This therapy is
performed by the use of a Sonotron which is a non-invasive, patented device that was
invented by Dr. Alfonso Di Mino of the United States of America in 1987. It is claimed to
be the quickest, safest and most effective, totally non-invasive therapeutic medical device for
patients with chronic and acute pain in the joints, muscles and other soft tissues, without the
use of drugs.1 In Asia, Japanese doctors were the first to use Sonotron in 1993. In 1994, few
units of it were sold in Malaysia.2

This technology review was requested by the Senior Consultant Paediatrician, Malacca
Hospital, following a newspaper write-up on Sonotron as a panacea for a host of paediatric
and medical ailments.

2. OBJECTIVES

To determine the safety, effectiveness and cost effectiveness of Sonotron in treating patients
with diabetics wound, arthritis and post stroke.

3. TECHNICAL FEATURES

Sonotron is manufactured by ADM Tronics Unlimited, Inc. of USA. It consists of a base unit
and a hair dryer-like applicator and operates on single phase 240, 230, 100, 110 VAC, like
any household applicator. Sonotron is portable and the base measures 19.7cm x 53.3cm x
38.1cm. The applicator is 27.9 cm in length and 6.17 cm in diameter.3

Sonotron acts by means of Corona Discharge Beam that is produced when a low frequency
radio wave of 430 kHz which is pulsed at a low sound frequency of 1 kHz. It is applied to an
electrode situated inside a hand-held applicator. This unique electro-magnetic energy travels
through the air and impinges on the skin, under which is the problem area. The device does

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not touch the skin at all during treatment. The area to be treated can be an arthritic joint, a set
of muscles or any site underlying the skin that is causing difficulty.

Sonotron Therapy has been postulated to work by many mechanisms of action;4

I. YMT’s Free Radical Hypotesis – the inactivation of free radicals in the area of
patient’s body by the energy from the Sonotron, thereby reducing pain and reversing
the process of destruction in body tissues. This mechanism could most likely sound
logical for explaining why in a total of about 14 minutes, a diabetic sore, with
horizontal size of 40mm, can be healed completely with only 2 minutes of net
exposure time per session from the Sonotron and needing only 7 treatment sessions ,
in total.

II. Nerve Function Hypothesis – Sonotron was shown to reduce swelling and increase
the range of motion of 49 horses with induced arthritis. It may have something to do
with the nerve function, in that it reduces sensitivity to sensory nerves, or it change
the permeability of the membranes.

III. Collagen Protein Hypothesis – the Sonotron reduces pain associated with the
osteoarthritic response in joint due to its ability to reduce collagen protein levels.

According to the manufacturer and sonotron users, it can be used to treat various conditions
such as:

-Oesteoarthritis-Arthrosis

-Carpal Tunnel Syndrome

-Tarsal Tunnel Syndrome

- Temporamandibular Joint

-Tendinitis

-Bursitis

-Sports Injuries

-Other Joint Conditions

-Diabetic ulcer

-Eczema

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4. METHODOLOGY

4.1 SEARCH METHODS

Literature were searched through electronic databases which included Pubmed, Cochrane
Library, Ovid, Science Direct, Proquest and general databases such as Google and Yahoo.

The search strategy used the terms, which were either used singly or in various combinations:
sonotron OR “sonotron therapy” OR “corona discharge beam”, effectiveness OR efficacy,
safety OR safe OR “adverse effect*” OR “harm* effect*” OR toxicity, “cost effectiveness”
OR “cost analysis” OR econom*. There was no limitation in the search.

4.2 SELECTION OF STUDIES INCLUDED /EXCLUDED

All primary papers, systematic reviews or meta-analysis pertaining to safety, effectiveness

and cost effectiveness of sonotron were included in this study.
Critical appraisal of all relevant literature was performed using Critical Appraisal Checklist
Project (CASP) checklists and the evidence graded according to the US/Canadian Preventive
Services Task Force Level of Evidence.

5. RESULTS AND DISCUSSION

There was no published paper retrieved on Sonotron. According to Panmedic Sdn. Bhd., the
distributor of Sonotron in Malaysia, a pilot study was conducted in 1999-2000 by nine
doctors from various parts of Malaysia involving 555 patients. Following the pilot study, a
larger study was conducted in 2003-2004. Sixteen doctors who owned Sonotron in Malaysia
participated in the study. They reviewed 1054 clinical cases treated with Sonotron. The
results were compiled in a book.2 The discussion below will be based on the 2003-2004 study
and anecdotal claims.

5.1 SAFETY

Sonotron is a non-invasive device. During therapy the device does not touch the patient at all.
According to Sonotron website, safety studies have been conducted by the Biomedical
Engineering Staff of the Instrumentation Systems Center in the College of Engineering of the
University of Wisconsin to quantify and classify the output signals of the Sonotron Device.
Output signals were found to resemble the frequency spectra of electrosurgical units, but with
approximately 1/60th the current power. The amount of power dissipated within the tissue
was claimed to be smaller, similar in magnitude to the power of a pocket calculator which is
small enough to preclude a burn hazard even in the event of an inadvertent ground contact.5

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There was no adverse event pertaining to Sonotron usage reported in the 2003-2004 study. It
was reported that all the respondents felt that Sonotron is a safe procedure.

Sonotron has not received FDA 510(k) clearance or CE mark.

5.2 EFFICACY/EFFECTIVENESS

In the study conducted by Panmedic Sdn Bhd, among the 1054 cases, 33% received single
session and 67% received multiple sessions. For musculoskeletal disorders, all the 225
patients who received single session reported to have at least 50% improvement where 40%
of them reported 91-100% improvement. The trend of the reported improvement for other
disorders studied; namely neurologic disorders, ENT disorders, dermatological disorders,
gastrointestinal disorders, ophthalmologic disorders, dental and oral disorders,
gynaecological/genitourinary disorders and pulmonary disorders were similar. However, the
number of cases in each group (disorders) was small ranging from 4 cases to 33 cases.

All the patients who received multiple treatments reported improvement of their condition
where 20% of them reported 50-80% improvement and 80% reported 80% to 100%
improvement. An average of 2-3 sessions were needed to achieve an improvement of 90%
and above for all disorders except dermatological problems which took between 4-5 sessions.

There were anecdotal claims regarding the effectiveness of Sonotron.

A patient with first degree spondylolisthesis L4 over L5 with pain score of 7 out of 10 after
15-20 minutes of walking claimed that his pain score reduced to 1-2 out of 10 after fifth
therapy session.6

Two cases aged 67 and 55 years old with chronic neck pain who initially have pain score of
10 and 5.6 out of 10 respectively claimed that their pain score reduced to 1-2 and 0.5-1 out of
10 respectively.7,8

Two cases with chronic knee pain with initial pain score of 7-9 out of 10 claimed that the
pain reduced immediately after the first treatment and after the third treatment the pain score
reduced further to a score of 1-2.9,10

5.3 COST EFFECTIVENESS

There was no evidence retrieved on cost-effectiveness of Sonotron. Each session costs about
RM40 to RM60 depending on the illness. Most chronic problems usually need 5 to 10
sessions.

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6. CONCLUSION

There were insufficient evidence on the safety, effectiveness and cost-effectiveness of

Sonotron.

7. RECOMMENDATION

Based on this review, sonotron is not recommended as a standard treatment for patients with
diabetics wound, arthritis and post stroke. More clinical research is warranted to provide
good quality evidence such as randomized clinical trials for each indication as claimed by the
manufacturer and sonotron users.

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8. REFERENCES

1. Sonotron. Retrieved from http://www.panmedic.com/sonotron.htm on 12/6/2008.

2 . Panmedic Sdn. Bhd. 1054 Sonotron case reports of doctors:For the remarkable healer
in You!. Panmedic Sdn Bhd. Kuala Lumpur, 2008.

3. Sonotron:Electronic medical device. Retrieved from

http://www.indiapaper.com/sonotron.htm on 12/6/2008.

4. Sonotron Research Center. How does Sonotron Therapy work? Retrieved from
http://webm91a9.tabnet.vwh.net/srcweb-JUNE99/SWM99-How/How-Does-It-Work.htm
on 12/6/2008.

5 . Sonotron:Electronic medical device. Retrieved from

http://www.indiapaper.com/sonotron.htm on 12/6/2008.

6. Sonotron therapy on spondylolisthesis. Sonotron Research Centre. Retrieved from

http://webm91a9.tabnet.vwh.net/srcweb-JUNE99/SWM99-
PatientsResponses/Spondylolisthesis.htm

7. Sonotron therapy on Chronic Neck pain. Sonotron Research Centre. Retrieved from
http://webm91a9.tabnet.vwh.net/srcweb-JUNE99/SWM99-patient Responses/Chronic-
Neck-Pain-Case1 on 7/8/2008

8. Sonotron therapy on Chronic Neck pain. Sonotron Research Centre. Retrieved from
http://webm91a9.tabnet.vwh.net/srcweb-JUNE99/SWM99-patient Responses/Chronic-
Neck-Pain-Case2 on 7/8/2008

9. Sonotron therapy on Chronic Knee Pain. Sonotron Research Centre. Retrieved from
http://webm91a9.tabnet.vwh.net/srcweb-JUNE99/SWM99-patient Responses/Chronic-
Knee-Pain-Case1 on 7/8/2008

10. Sonotron therapy on Chronic Knee Pain. Sonotron Research Centre. Retrieved from
http://webm91a9.tabnet.vwh.net/srcweb-JUNE99/SWM99-patient Responses/Chronic-
Knee-Pain-Case2 on 7/8/2008