Back Pain Prevalence in Wheelchair Users and Associated R... | NCT00477568

Studies
Back Pain Prevalence in Wheelchair Users and Associated Risk Factors

NCT00477568

Sponsor

Kovacs Foundation

Status

Completed

Last Update Posted

Aug 28, 2019Actual

Enrollment

750Actual

Phase

Not provided

Conditions

Back Pain

Interventions

Not provided

Countries

Spain

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

Aug 2019

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

Nov 2007

Primary Completion Date

Jun 2015Actual

Completion Date

Dec 2017Actual

First Submitted Date

May 22, 2007

First Submission Date that Met QC Criteria

May 22, 2007

First Posted Date

May 23, 2007Estimated

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

Aug 22, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francisco M. Kovacs, Director of Scientific Department, Kovacs Foundation, Kovacs FoundationPrincipal Investigator

Lead Sponsor

Kovacs FoundationOTHER

Collaborators

Name	Class
Mallorca Institute of Social Affairs	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

The primary purpose of this study is to determine the prevalence of back pain in permanent wheelchair users (excludes transitory users) in different regions of Spain. Another study objective is the identification of risk factors for back pain in this population. Data collection will be by means of a structured questionnaire which will be validated in a previous pilot study.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

750Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults with established disability;
Permanent wheelchair users;
Having physical and intellectual ability to answer questionnaire.

Exclusion Criteria:

Transitory wheelchair users;
Diagnosis of inflammatory rheumatic disease, cancer, systemic infection;
Red flags for systemic disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Wheelchair users who do so on a constant basis (not occasional).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francisco M Kovacs, MD, PhD	Unidad de la Espalda Kovacs, Hospital Universitario HLA-Moncloa	Study Director
Juan Noguera, MD	Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fundación Kovacs		Palma de Mallorca	Balearic Islands	07012	Spain
Instituto de Asuntos Sociales y Deportes de Mallorca

Condition Browse Module

MeSH Terms

ID	Term
D001416	Back Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided