Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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Chemotherapy-induced peripheral neuropathy (CIPN) implies sensory or deficits pain, loss of motor functions and impaired proprioception which in turn may affect balance and fine motor skills. It is mainly subjected to the peripheral parts of the extremities, may be transient or permanent.CIPN is a common, potentially severe and often dose-limiting side effect after patient exposure of numerous classes of antineoplastic agents including platins, taxanes, vinca alkaloids, bortezomib and thalidomide. At present, no evidence based treatment of CIPN is available. A variety of different drugs or drug combinations have been clinically tested but the value of these treatments is uncertain. Many patients with CIPN are referred to physiotherapy but still this treatment is more based on clinical experience and tradition than scientific evidence. In a nonrandomized study, sensory electrical stimulation(MC5-A Calmare ®) was tested on 16 persons.The electrodes were placed on the hand and foot and intensity was gradually increased and given daily for 10 days. Pain was reduced 20% in numeric pain score for 15 of the 16 participating patients. Our clinical experience indicates that treatment with long wave diathermy (LWD) may decrease CIPN symptoms. This treatment produces electromagnetic radiation according the capacitor method with heightened circulation and heat which is assumed to reduce pain. Interferential Therapy (IT) is an electro-physical method which is based on an electric field in the painful area through four electrodes or vacuum cups placed on the skin. Increased blood circulation and pain relief is supposed to be achieved. IT use two different intermediate frequencies (1001-10000 Hz) alternating currents in the painful area. The treatment effect correspond to the gate control-theory; inhibition of pain signals in small diameter fibers by activity in large-diameter Aβ-fibers by spinal neurons. Some studies have shown effect in treating pain with interferential currents when pain is experimentally induced or induced by cold in otherwise pain-free volunteers, when compared to a control or placebo. The hypothesis of this study is that the combination therapy longwave diathermy on high power and interferential currents gives better results than longwave diathermy on low power.

Detailed Description
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A randomized controlled trial to investigate the effects of combination therapy longwave diathermy on high power and interferential currents, as compared to longwave diathermy at low power (control group) for sensory and motor symptoms in patients with CIPN in the feet and lower legs. Sensory and motor symptoms are defined as numbness, pain, discomfort and balance impairment. Interferential currents is administered by Electrostimulation unit ES-520 & Vacuum Unit. The longwave diathermy at low and high power is given thru capacitive energy transfer system and is administered by Skanlab 25 Bodywave. The drugs that have been clinically tested in other studies were magnesium, calcium, vitamin E and B6, glutamine, glutathione, n-acetyl cysteine omega-3 fatty acids, acetyl-L-carnitine and alpha lipoic acid.

Official Title
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Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy.

Conditions
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Chemotherapy Induced Peripheral Neuropathy (CIPN)

Intervention / Treatment
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* Device: longwave diathermy on high power and interferential therapy
* Device: longwave diathermy on low power


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - patients over 18 years who received chemotherapy and had documented side effects such as numbness, tingling, pain or swelling sensation in the feet/lower legs. Exclusion Criteria: pregnancy, thrombosis thrombophlebitis in the feet or lower legs, muscle cramps, acute bleeding disorders, dementia, type 1 diabetes mellitus, open sores on the feet or lower legs, peripheral sensory neuropathies due to causes other than chemotherapy, ongoing chemotherapy with drugs known to cause CIPN.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IT and LWD on high power<br>IT and LWD on high power | Device: longwave diathermy on high power and interferential therapy<br> <br> |
| Placebo Comparator: LWD on low power<br>LWD on low power | Device: longwave diathermy on low power<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in numbness from baseline | The definition of spreading of numbness was pins and needles, tingling and parasthesias. Patients were asked to draw the distribution of their numbness in their legs and feet on a sketch, -which was constructed based on pain drawing sketch. | baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity and discomfort from baseline . | Numerical rating scale (NRS) were used for measuring the intensity of pain. This is a reliable instrument and has been validated for patients with cancer. Patients rate their pain from zero to 100, with zero reflecting no pain and 100 reflecting the worst possible pain. Discomfort is defined as uncomfortable not knowing where your feet are in relation to the room and met with NRS. | baseline and 12 weeks | 
| Change in numbness from baseline | The definition of spreading of numbness was pins and needles, tingling and parasthesias. Patients were asked to draw the distribution of their numbness in their legs and feet on a sketch, -which was constructed based on pain drawing sketch. | baseline and 6 months | 
| Change in pain intensity and discomfort from baseline | Numerical rating scale (NRS) were used for measuring the intensity of pain. This is a reliable instrument and has been validated for patients with cancer. Patients rate their pain from zero to 100, with zero reflecting no pain and 100 reflecting the worst possible pain. Discomfort is defined as uncomfortable not knowing where your feet are in relation to the room and met with NRS. | baseline and 6 months |