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Applicability of Video Games and Vibrational Therapy in Reducing Pain Secondary to Breast Cancer

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ClinicalTrials.gov Identifier: NCT01893944
Recruitment Status : Completed
First Posted : July 9, 2013
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
Universidade do Vale do Paraíba

Brief Summary:
To evaluate the influence of virtual reality and vibrational therapy in reducing pain intensity secondary to breast cancer before and after application of treatment protocols, through biomedical instrumentation.

Condition or disease Intervention/treatment Phase
Pain Other: virtual reality Not Applicable

Detailed Description:
After physiotherapy assessment individuals will be randomly divided into three groups: Group Virtual Reality - Cinesioterapia (G1), Group Vibration Therapy - Cinesioterapia (G2) and Control Group (G3), which will be submitted to the respective treatment protocols. Group Virtual Reality Cinesioterapia (G1) participate in this group 20 women will be treated through the games Xbox 360 ®, attributed to this, customized applications using virtual and augmented reality to be developed. Vibration Therapy Group - Cinesioterapia (G2) - will participate in this group 20 women who will undergo 15 minutes of continuous vibration through the blanket vibrating members higher, with frequency 40 Hz, 3 function and intensity tolerable, keeping the limb supported and elevated to 120 º. At the end held muscle stretching exercises, dissociation of shoulder girdle and upper limb exercises assets. Control group (G3) - participate in this group 20 women who are treated with conventional cinesioterapia through muscle stretching exercises for flexors, extensors, adductors and abductors shoulder for 20 seconds each; dissociation girdle; financial assets and Active assisted for groups flexors, extensors, abductors and adductors of the upper limbs, which will be performed three sets of 10 repetitions for each exercise. Implementation of treatment protocols for the groups G1, G2 and G3 will run for two weeks, being Monday through Friday feira.totalizando 10 consecutive treatment sessions lasting 30 minutes each session. You will be prompted to patients groups G1, G2 and G3 to respond individually and without any aid the visual numeric scale of pain, 10 minutes pre-therapy, 15 minutes after the start and 10 minutes after the end of therapy. Patients will undergo the assessment of pain, electromyographic activity of muscles, muscle strength, range of motion analysis and perimetry in the first day of treatment, and after completing all the sessions patients were reassessed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Applicability of Video Games and Vibrational Therapy in Reducing Pain Secondary to Breast Cancer
Study Start Date : January 2013
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Virtual Reality
- Participate in this group 20 women to be treated by means of games Xbox 360 ®, attributed to this, custom applications using virtual and augmented reality to be developed.
Other: virtual reality
customized applications using virtual and augmented reality to be developed.

Experimental: Vibration therapy
- participate in this group 20 women who will undergo 15 minutes of continuous vibration by vibration of the upper mantle, with a frequency of 40 Hz, 3 function and intensity tolerable, keeping the limb supported and raised to 120 °.
Other: virtual reality
customized applications using virtual and augmented reality to be developed.

Active Comparator: control group
- participate in this group 20 women who are treated with conventional cinesioterapia through muscle stretching exercises, dissociation girdle, active and active-assisted exercises for groups flexors, extensors, abductors and adductors of the upper limbs, which will be three series 10 repetitions for each exercise.
Other: virtual reality
customized applications using virtual and augmented reality to be developed.




Primary Outcome Measures :
  1. Pain secondary to breast cancer [ Time Frame: one year ]
    Expect positive results of this research on the reduction of pain as well as physical and functional complications caused by surgery for breast cancer, enabling a better quality of life for patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who underwent surgery for unilateral mastectomy and axillary lymphadenectomy modified in a period exceeding one year;
  • Submit medical referral;
  • Which are not performing radiotherapy or chemotherapy;
  • Age 40-70 years;
  • Reporting pain, intermittent, prolonged duration and intensity that limits the ADL;
  • Lymphedema in the ipsilateral upper limb surgery;
  • To agree and sign the Statement of Consent

Exclusion Criteria:

  • Individuals who fail to provide medical referral;
  • Be a carrier of other types of cancer;
  • Have undergone other types of surgery removal of breast cancer; - be doing chemotherapy or radiotherapy;
  • Do not complain of pain symptoms and lymphedema;
  • Presenting severe joint lock.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893944


Locations
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Brazil
Lersm, Ip&D
São José dos Campos, São Paulo, Brazil
Sponsors and Collaborators
Universidade do Vale do Paraíba

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Responsible Party: Universidade do Vale do Paraíba
ClinicalTrials.gov Identifier: NCT01893944     History of Changes
Other Study ID Numbers: 07694812.7.0000.5501
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014
Keywords provided by Universidade do Vale do Paraíba:
Breast cancer
vibratory therapy
virtual reality
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases