Neuromuscular Electrical Stimulation and Strength Trainin... | NCT01360281

Studies
Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis

NCT01360281

Sponsor

Universidade Gama Filho

Status

Unknown status

Last Update Posted

May 25, 2011Estimated

Enrollment

34Estimated

Phase

Not Applicable

Conditions

Knee Osteoarthritis

Interventions

Neuromuscular Electrical Stimulation
ECR

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

May 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2011

Primary Completion Date

Oct 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

May 19, 2011

First Submission Date that Met QC Criteria

May 23, 2011

First Posted Date

May 25, 2011Estimated

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

May 23, 2011

Last Update Posted Date

May 25, 2011Estimated

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

The purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.

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

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
ECR	Experimental	Other: ECR
Control	No Intervention
NMES	Experimental	Other: Neuromuscular Electrical Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuromuscular Electrical Stimulation	Other		NMES
ECR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Quadriceps strength		Before and after an 8 weeks intervention
Change in Pain		Before and after an 8 weeks intervention
Change in Moving function		Before and after an 8 weeks intervention

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

American College of rheumatology criterion for osteoarthritis diagnosis

Exclusion Criteria:

Patients that have done knee replacement or are about to do.
Patients with health conditions that are not compatible with the interventions
Patients that have done intraarticular corticoid

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

38 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thais Dadalto, Physical Therapist	Contact	55 21 81988001		tvdadalto@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinica Escola de Fisioterapia da Universidade Gama Filho	Recruiting	Rio de Janeiro	Rio de Janeiro		Brazil

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided