NCT01893944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

2 months

First QC Date

June 24, 2013

Last Update Submit

February 14, 2014

Conditions

Keywords

Breast cancervibratory therapyvirtual reality

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Virtual Reality

EXPERIMENTAL

\- 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

Vibration therapy

EXPERIMENTAL

\- 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

control group

ACTIVE COMPARATOR

\- 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

Interventions

customized applications using virtual and augmented reality to be developed.

Vibration therapyVirtual Realitycontrol group

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lersm, Ip&D

São José dos Campos, São Paulo, Brazil

Location

MeSH Terms

Conditions

PainBreast Neoplasms

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2013

First Posted

July 9, 2013

Study Start

January 1, 2013

Primary Completion

March 1, 2013

Study Completion

December 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations