Jet Therapy and Clinical Trials

 "dilation of micro vessels"

 "better circulation" 

"reduction in hospital time of up to 44.1%"

 "less reversible tissue damage" 

"safe massage"

Jet Therapy is a product introduced into the South African market some five years ago and involves the application of purified air under pressure to the skin.  It is said to be effective in hastening healing of diabetic ulcers, and alleviating symptoms with diabetic feet and in patients with rest pain.

If, as anecdotal reports suggested, it hastened the healing of diabetic ulcers, improved peripheral circulation and symptoms in diabetic patients, this needed to be confirmed clinically and the mechanism of action established.

Possible mechanisms are:

In addition, anecdotal reports obtained from many of the clinics using the Jet Therapy system in various parts of the world indicate that there is a reduction in the appearance of cellulite and body-fat in the area that has been treated after a course of 10 Jet Therapy Treatments. 

To date, the Department of Physiology at the University of Natal, Nelson Mandela Medical School and the University of Durban-Westville have performed the following scientific evaluations of this treatment, summarised below:

This initial phase was broken down into four separate investigations

1. The acute effect of Jet Therapy on skin blood flow as measured by the Laser Doppler Fluxmetry.   

Skin blood flow was measured in healthy volunteers, after 30 and 60 seconds of Jet Therapy using two different applicator heads and unheated air at 1 atmosphere pressure.  With the unheated Laser Doppler Fluxmetry probe sited on the dorsum of the foot, treatment at various sites on the foot resulted in a 5-7 fold increases in Laser Doppler derived skin blood flow.  Similar results were obtained when the probe was placed on the anterior compartment of the leg.  The increase in skin blood flow rate measured appears to decay with distance of treatment from the probe. Significant increases were noted as much as 5 cm away from the measuring site.  Skin cooling of about 4c occurred.

With the measuring probes placed on the left foot and treatment performed on the right foot, no increase in skin blood flow inn the left foot was obtained.  This would suggest that it is unlikely that the effects of Jet Therapy are centrally mediated or carry over from one side of the body to the other.

 2.The effect of 45 minutes of Jet Therapy on skin blood flow as measured by Laser Doppler Fluxmetry.

Skin blood flow and skin temperature was measured in healthy volunteers, before treatment and every 5 minutes during Jet Therapy treatment, at 1 atmosphere pressure, on the footing using the "sport" and "agitator" applicator heads and unheated air.  With the probe sited on the dorsum of the foot, the foot was treated continuously for 45 minutes.  Measurements were taken during treatment at different sites on the dorsum and medial arch. No readings were taken with the Jet within 5 cms of the Laser Doppler probe.  Again, a sustained 5-10 fold increase in skin blood flow was noted throughout the treatment. On cessation of treatment it was noted that skin blood flow rapidly returned to normal values.  Skin blood flow and skin temperature was measured every minute for fifteen minutes after the 45 minute treatment of the foot.  The skin temperature rose slowly but after 15 minutes was still lower than the pre-treatment value.  Skin blood flow, which returned to normal immediately after treatment, did not rise significantly during this period.

3.The effect of Jet Therapy on subcutaneous and intracompartmental muscle pressure.

This study measures the pressure generated by the air jet in subcutaneous fat and in the underlying muscle. Subcutaneous pressure and intracompartmental (ICP) muscle pressures were measured using the Stryker pressure transducer and monitor. An 18 gauge needle was inserted either subcutaneously or into the muscle of the anterior thigh of 10 healthy volunteers. Pressure measurements were made with the air Jet over the ICR needle and repeated with the jet 2, 4, 6, 8 and 10 cm proximal to the needle. Air pressures raging from 0.5 - 4 atmospheres were used in 0.5 atmosphere increments. Substantial increases in both intracompartmental and subcutaneous pressure were recorded, with pressures of up to 8OmmHg recorded at 4 atmospheres. At high applied pressure, the pressure decays within 4 cm of the Jet. The data has not yet been fully analysed. These pressures can result in muscle cell damage, and care should be taken not to treat over a confined area, but rather to move the probe around to reduce the risk. As stated earlier, no evidence of cell damage could be inferred from the blood results.

4.The effects of Jet Therapy on blood parameters.   

Two pilot studies have been conducted on a limited number of subjects, to investigate the possibility that Jet Therapy caused muscle cell damage and or damage to blood cells passing the air jet.

Venous blood was drawn from 5 subjects before and after a 'cellulite' treatment, and in a further 5 healthy subjects before and after a 45 minute treatment of the foot. No demonstrable changes were noted in the full and differential blood counts and no morphological changes were noted in the cells. Urea and electrolyte results were all within normal range before and after treatment. There was no increase in creatine kinase or lactate dehydrogenase. While these results indicate that there is no evidence of damage to blood cells or muscle, further work is required to increase the sample size, and to specifically investigate diabetic patients.

In addition, minor studies looked at the following:  

The effect of Jet Therapy on blood flow in major arteries and veins.

This study aims to use Duplex Doppler Ultrasound imaging and spectral analysis to quantify changes in blood flow velocity and blood flow volume in major axial arteries and veins when the air jet is applied directly over them. Data on 1 subject suggests that changes do occur. Further work is required.

The effect of Jet Therapy on delayed onset muscle soreness

Delayed onset muscle soreness is used as a model of muscle injury. A project on the effect of Jet Therapy on the resolution of the pain of delayed onset muscle soreness is being planned.  

Temperature changes during Jet Therapy Treatment.

The temperature of the air leaving the Jet was measured using the "sport" and "agitator" applicator heads at .5, 1 and 1.5 atmosphere pressure. The temperature of the air entering the compressor is the ambient air temperature.  With an external ambient air temperature of 26.3 c and a room temperature averaging 19.75 (+- 0.16c) during the course of taking temperatures of the air leaving the applicator heads, the average Jet air temperature measured 5 cm from the applicator heads was 18.93 c (+-0.28c).

Skin temperature on the dorsum of the foot was measured during 25 treatments of the foot using the "sport" and "agitator" applicator heads at a treatment pressure of 1 atmosphere.  Skin temperature was reduced by 4c after 20 minutes of treatment and by 5.05c after 45 minutes of treatment.   

The effect of Jet Therapy on muscle pain

This involved a test of pain ratings and "range of movement" readings before and after Jet Therapy treatment in a sample of sportsmen that had just completed a gruelling endurance event over a three-day period. Statistical analysis was performed using the two-tailed Mann- Whitney test.

Conclusion

All the subjects in the sample recorded significant improvements. An associated study of changes in the pain free range of movement following the treatment of muscle pain has not yet been analysed.

Subsequently, 

The following studies were done by the Department of Physiology in conjunction with Prof. M.Gregory from the Electron Microscopy unit of the University of Durban Westville.

Clinical Trial Diabetic Foot Ulcers

At the present time the fieldwork of a pilot clinical study on the effects of Jet Therapy treatment of diabetic foot ulcers has just been completed at the R.K Khan Hospital Chatsworth, Durban under the supervision of the chief surgeon Mr. Y. Desai and the consulting surgeon, Mr. U.K. Naidoo. The results show that the addition of the Jet Therapy massage to the conventional treatment for foot ulcers provided a reduction of 49.8 days (or 44.1%) in hospital stay. 

It is intended to follow-up this study with a second study dealing with neuropathic feet where higher patient numbers will be attainable.

Clinical Trial Cellulite

A further pilot study is underway to confirm or repudiate the anecdotal claims for cellulite reduction and to establish the reliability of measurement of body fat using three different measuring devices and to establish the mechanism whereby the purported reduction in body measurement is achieved.

Plan Of Investigation

A group of 40 volunteer women, all within the ages of 30-50, are selected to undergo a course of 10 Jet Therapy cellulite removal treatments. The treatments are for one hour at a time, applied every third day by the same operator.

The volunteers are requested to make no material changes to their lifestyles and in a particular their eating habits and their normal exercise patterns. 

At the commencement of the study each person will be weighed, and measurements will be taken at a fixed point of both thighs, established by a measurement in height by the subject standing in an upright position, bare footed. 

ll participants will be measured using CT scan sections.

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