Manual Therapy in Postoperative Breast Cancer | NCT01142141

Studies
Manual Therapy in Postoperative Breast Cancer

NCT01142141

Sponsor

University of Campinas, Brazil

Status

Completed

Last Update Posted

Jun 11, 2010Estimated

Enrollment

136Actual

Phase

Not Applicable

Conditions

Breast Cancer
Axillary Lymph Node Dissection
Shoulder Joint Limitation

Interventions

manual therapy, kinesiotherapy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Jun 9, 2010

First Submission Date that Met QC Criteria

Jun 9, 2010

First Posted Date

Jun 11, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2010

Last Update Posted Date

Jun 11, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Manual therapy, kinesiotherapy	Other		Other: manual therapy, kinesiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
manual therapy, kinesiotherapy	Other		Manual therapy, kinesiotherapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Campinas		Campinas	São Paulo	13083881	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026201	Musculoskeletal Manipulations

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided