Study of TENS in Reducing Symptoms of Peripheral Neuropathy Induced by Chemotherapy
NCT02107417 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2016-02-15
Summary
This study aims to investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) in reducing the symptoms of pain and numbness and improve the daily lives of cancer patients who have Chemotherapy-induced peripheral neuropathy (CIPN).
Conditions
- Peripheral Neuropathy
- Pain
- Paresthesia
- Neuritis
Interventions
- DEVICE
-
active TENS
Experimental Group (EG) who will receive the application of active TENS. The participants of these group will receive TENS within the following parameters: VF mode TENS with a variable frequency between 7 Hz and 65 Hz. It has a pulse width of 200 µs, this is the highest tolerable intensity while still remaining comfortable for the patient. It has an application time of 60 minutes with the highest tolerable intensity, while still remaining comfortable for the patient.
- DEVICE
-
placebo TENS
who will be administering the placebo TENS.The participants of these group will receive TENS within the following parameters: VF mode TENS with a variable frequency between 7 Hz and 65 Hz. It has a pulse width of 200 µs, this is the highest tolerable intensity while still remaining comfortable for the patient. It has an application time of 60 minutes The TENS-placebo will be applied where no current will be emitted. Patients in the placebo group will only feel the tingling for 45 seconds and after this period the device will not emit impulses, but it will work for 1 hour.
Sponsors & Collaborators
-
Instituto Nacional de Cancer, Brazil
collaborator OTHER_GOV -
Instituto do Cancer do Estado de São Paulo
collaborator OTHER -
Hospital de Câncer de Barretos
collaborator OTHER -
Centro de Estudos e Pesquisas Oncológicas (CEPO)
collaborator UNKNOWN -
Centro de Oncologia do Hospital Universitário São Francisco
collaborator UNKNOWN -
University of Sao Paulo General Hospital
lead OTHER
Principal Investigators
-
Tania Tonezzer, B.S · Post-Graduation Student of Rehabilitation Science Program from Department of Speech Therapy, Physical Therapy and Occupational Therapy, São Paulo University, São Paulo, Brazil.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2015-12-31
- Completion
- 2017-12-31
Countries
- Brazil
Study Locations
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