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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893944
• Other study ID #: 07694812.7.0000.5501
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: February 14, 2014
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: February 2014
• Source: Universidade do Vale do Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• virtual reality
customized applications using virtual and augmented reality to be developed.

Locations

Country	Name	City	State
Brazil	Lersm, Ip&D	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain secondary to breast cancer	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.	one year	No