NCT00477568

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

7.6 years

First QC Date

May 22, 2007

Last Update Submit

August 22, 2019

Conditions

Back Pain

Keywords

Wheelchair usersBack painPrevalenceRisk factors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundación Kovacs

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

Instituto de Asuntos Sociales y Deportes de Mallorca

Palma de Mallorca, Balearic Island, 07014, Spain

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scientific Department, Kovacs Foundation

Study Record Dates

First Submitted

May 22, 2007

First Posted

May 23, 2007

Study Start

November 1, 2007

Primary Completion

June 1, 2015

Study Completion

December 1, 2017

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

ES(2)