NCT01360281

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started May 2011

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

May 25, 2011

Status Verified

May 1, 2011

Enrollment Period

5 months

First QC Date

May 19, 2011

Last Update Submit

May 23, 2011

Conditions

Knee Osteoarthritis

Keywords

Quadriceps strengthosteoarthritis rehabilitationNMES

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

ECR

EXPERIMENTAL
Other: ECR

Control

NO INTERVENTION

NMES

EXPERIMENTAL
Other: Neuromuscular Electrical Stimulation

Interventions

Neuromuscular Electrical StimulationOTHER
NMES
ECROTHER

Resisted exercises

ECR

Eligibility Criteria

Age38 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American College of rheumatology criterion for osteoarthritis diagnosis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Escola de Fisioterapia da Universidade Gama Filho

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Thais Dadalto, Physical Therapist

CONTACT

55 21 81988001tvdadalto@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2011

First Posted

May 25, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

May 25, 2011

Record last verified: 2011-05

Locations

BR(1)