Electrical Stimulation and Chemotherapy Induced Peripheral Neuropathy
NCT02088996 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2015-08-26
Summary
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.
Conditions
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
Interventions
- DEVICE
-
longwave diathermy on high power and interferential therapy
- DEVICE
-
longwave diathermy on low power
Sponsors & Collaborators
-
Uppsala University
lead OTHER
Principal Investigators
-
Inger Andreasson, MD · Västmanlands sjukhus, Västerås
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-03-31
- Primary Completion
- 2015-12-31
- Completion
- 2015-12-31
Countries
- Sweden
Study Locations
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