The effect of foot massage with Clove Essential Oil on enhancing Vibration Perception Threshold(VPT) in individuals with Diabetic Peripheral Neuropathy - A Randomized controlled trial

Diabetes mellitus is a chronic, metabolic disease characterized by elevated blood glucose levels (or blood sugar), which over time causes a serious damage to the heart, blood vessels, eyes, kidneys and nerves. Type 2 diabetes mellitus (T2DM), occurs usually in adults and is a common type, which occurs when there is insulin resistance or when the body fails to produce sufficient insulin. In the past 3 decades the prevalence of type 2 diabetes has risen dramatically in almost all the developed and developing countries.

The International Diabetes Federation estimates that 425 million people around the world are suffering from diabetes diagnosed, making diabetes the largest global epidemic of the 21st century. According to Indian Council of Medical Research, India is known as the ‘diabetes capital of the world’. In India, approximately 101 million people are diabetics and 136 million people are prediabetic.

The most concerning complication of T2DM at present is diabetic neuropathy. It can be peripheral, focal, proximal or autonomic. Globally, more than 40 million people suffer from neuropathy as a complication of T2DM. According to the American Diabetes Association (ADA), diabetic peripheral neuropathy (DPN) is defined as “the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causes”. Common symptoms of DPN include significant deficits in tactile and pain sensitivity, kinesthesia, lower-limb proprioception, and vibration sense, caused by promotion of neuronal apoptosis and inhibition of nerve regeneration in diabetes. The nervous system is affected in DPN, which may lead to morbidity, thereby economic burden for diabetes care should be increased. DPN also accounts to about 40– 60% of lower extremity amputations. DPN symptoms can be subjective and short-term, so may go undetected. It is dominantly denoted by sensory changes in the “glove-and- stocking” distribution. The DPN prevalence cannot be fully studied, yet studies show a variation of about 10% to 90% in diabetic patients, depending on the criteria and methods used to define neuropathy. DPN has been almost discovered in 26% to 31% of surveys in T2DM patients in India. Treatment of DPN is challenging and the drugs available are scarce. The Gold standard method for diagnosing the DPN is Nerve Conduction Study (NCS) and the other diagnostic methods for assessing Quantitative sensory testing (QST) is CASE IV (WR Medical Electronics), Biothesiometer, Thermoaesthesiometer, TSA Neurosensory Analyser (Medoc Ltd), due to its feasibility and validity biothesiometer/Neurothesiometer  is being used as an assessment tool for my study.

The Daily functioning and sleep of approximately 25% of people with Diabetic Neuropathy gets interfered and it affects their Quality of Life.

In DPN, there is a redox balance disruption of NADP+ and NADPH in T2DM due to aldose reductase enzyme. This causes an increase in sorbitol in our body which has been explained as a cause for the complications of T2DM. The sorbitol accumulation mainly occurs in the tissues like Retina, Kidney and Schwann cells which also lacks the enzyme Sorbitol dehydrogenase causes cell damage in T2DM patients.

Tolrestat, Sorbinil and Zenerastat are aldose reductase inhibitors which had been used as drug in allopathy medication for the treatment of DPN. Due to its increased side effects, at present NSAIDS has been used as a drug of choice for DPN. Aldose reductase inhibitors that block the polyol pathway are the class of Medication given to slow or reverse the progression of neuropathy in Diabetes patients.

Naturopathy is a cost-effective treatment, and a distinctive primary care medicine which promotes an overall well-being and the ability to overcome the disease.

Naturopathy employs various therapies to treat the patient based on Panchamahabhuta theory. In my study, Massage and Aromatherapy are the therapies used for the intervention of DPN. Massage is the systemic rubbing and manipulation of the soft tissues of the body that produce effects on Vascular, Muscular and Nervous system. Aromatherapy is the use of essential oils that are extracted from plant parts which have a characteristic scent can be used to treat various diseases and improves general health. Aromatherapy massage denotes the technique of massage that is done by manipulating the soft tissues of the body by using an essential oil combined with a carrier oil.

Clove Essential Oil (Syzygium aromaticum L.Myrtaceae)  will be used for DPN patient in my study for Massaging the feet. Clove Essential Oil contains Eugenol about 50% and other compounds such as Eugenyl acetate, β Caryophyllene and α- humulene. Clove Essential Oil containing Eugenol being a potent inhibitor of Aldose reductase enzyme and an anti-oxidant will be diluted with carrier oil and used for DPN patients.

The most common area affected in DPN is the feet and hands, majorly feet which when serious maybe prone for amputation. Foot Massage improves micro-circulation, thus helping in proper functioning of nerve cells can be used to reduce the severity of DPN. In addition to that, foot massage also helps to relieve pain, gives relaxation and reduce  stress promoting a faster healing and improves sleep.

Diabetic Peripheral Neuropathy (DPN) poses a significant challenge in the management of diabetes, affecting millions of individuals worldwide. Despite advancements in medical treatments, conventional approaches often fall short in providing satisfactory relief from the debilitating symptoms associated with DPN, including pain, numbness, and impaired mobility. Consequently, there is an urgent need for innovative and effective interventions that can augment the existing treatment modalities. This study aims to bridge this critical gap in knowledge by conducting a comprehensive comparative investigation on the therapeutic effects of foot massages incorporating clove essential oil and carrier oil among individuals suffering from diabetic peripheral neuropathy. The study will contribute valuable insights into the potential benefits of this novel intervention, thereby offering a promising avenue for improved management and alleviation of DPN-associated symptoms.