Effectiveness of Cane in Osteoarthritis (OA) Patients | NCT00698412

Studies
Effectiveness of Cane in Osteoarthritis (OA) Patients

NCT00698412

Sponsor

Federal University of São Paulo

Status

Completed

Last Update Posted

Jun 17, 2008Estimated

Enrollment

64Actual

Phase

Phase 4

Conditions

Knee Osteoarthritis

Interventions

Cane

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 2008

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

Jan 2005

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Jun 13, 2008

First Submission Date that Met QC Criteria

Jun 13, 2008

First Posted Date

Jun 17, 2008Estimated

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 13, 2008

Last Update Posted Date

Jun 17, 2008Estimated

Name	Class
Fundação de Amparo à Pesquisa do Estado de São Paulo	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Sixty four participants were enrolled in a randomized, controlled clinical trial to evaluate the effectiveness of daily cane use on pain, function, quality of life and energy consumption during the gait in patients with knee osteoarthritis.

Detailed Description

Treatment, Randomized, Single Blind, Parallel Assignment, Efficacy Study

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cane group	Device: Cane
2	No Intervention	Control Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cane	Device	This group use the cane every day since the baseline	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain - visual analogue scale		T0, T30 and T60

Secondary Outcomes

Measure	Description	Time Frame
Function - Lequesne index		T0, T30 and T60
Function - WOMAC questionnaire		T0,T30 and T60
Quality of life - SF-36

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primary Knee osteoarthritis (ACR criteria)
VAS for knee pain between 3 and 7
No changes the NSAID intake or physical activity in the previous 3 months

Exclusion Criteria:

Symptomatic heart or pulmonary disease
Severe systemic disease
Other symptomatic disease in the lower limb or in the upper limb that will carry the cane
Joint injection in the previous 3 months
PT in the previous 3 months
Previously cane use
Start regular physical activity in the last month

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anamaria Jones, PT	Federal University of São Paulo	Principal Investigator
Jamil Natour, MD	Federal University of São Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Federal University of Sao Paulo		São Paulo	São Paulo		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22128081	Derived	Jones A, Silva PG, Silva AC, Colucci M, Tuffanin A, Jardim JR, Natour J. Impact of cane use on pain, function, general health and energy expenditure during gait in patients with knee osteoarthritis: a randomised controlled trial. Ann Rheum Dis. 2012 Feb;71(2):172-9. doi: 10.1136/ard.2010.140178. Epub 2011 Nov 29.

ID	Term
D020370	Osteoarthritis, Knee
D010146	Pain

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

ID	Term
D009983	Orthopedic Equipment
D013523	Surgical Equipment
D004864	Equipment and Supplies