NCT01142141

Brief Summary

To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable breast-cancer

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

August 1, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

Enrollment Period

3.1 years

First QC Date

June 9, 2010

Last Update Submit

June 9, 2010

Conditions

Breast CancerAxillary Lymph Node DissectionShoulder Joint Limitation

Study Arms (1)

Manual therapy, kinesiotherapy

OTHER
Other: manual therapy, kinesiotherapy

Interventions

manual therapy, kinesiotherapyOTHER
Manual therapy, kinesiotherapy

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • surgery of breast cancer at University of Campinas
  • axillary lymph node dissection
  • injury of shoulder range of motion

You may not qualify if:

  • bilateral surgery
  • previous radiotherapy
  • bone metastasis in homolateral upper limb
  • axillary web syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083881, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 11, 2010

Study Start

August 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 11, 2010

Record last verified: 2010-06

Locations

BR(1)