Back PainNCT00477568
Back Pain Prevalence in Wheelchair Users and Associated Risk Factors
An observational study of Back Pain, run by Kovacs Foundation at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Pain
- How many people
- 750 participants
- Where
- 2 sitesSpain
- Study dates
- Nov 2007to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Wheelchair users who do so on a constant basis (not occasional).
Who may be able to join
- Adults with established disability;
- Permanent wheelchair users;
- Having physical and intellectual ability to answer questionnaire.
Who cannot join
- Transitory wheelchair users;
- Diagnosis of inflammatory rheumatic disease, cancer, systemic infection;
- Red flags for systemic disease.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Fundación Kovacs
Palma de Mallorca, Balearic Islands, 07012
Instituto de Asuntos Sociales y Deportes de Mallorca
Palma de Mallorca, Balearic Island, 07014
About this study
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.
- Conditions
- Back Pain
- Keywords
- Wheelchair users, Back pain, Prevalence, Risk factors
- Medical subject headings
- Back Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Mallorca Institute of Social Affairs
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Unidad de la Espalda Kovacs, Hospital Universitario HLA-MoncloaJuan Noguera, MD, Principal investigator, Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477568
- Sponsor's protocol ID
- FK-R-14
- Status last verified
- Aug 2019
- First submitted
- 22 May 2007
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back Pain Prevalence in Wheelchair Users and Associated Risk Factors
- ClinicalTrials.gov ID
- NCT00477568
- Acronym / sponsor ID
- FK-R-14
- Conditions
- Back Pain
- Keywords
- Wheelchair users, Back pain, Prevalence, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Mallorca Institute of Social Affairs
- Study start
- Nov 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 23 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Wheelchair users who do so on a constant basis (not occasional).
Key inclusion criteria (3 listed)
- Adults with established disability;
- Permanent wheelchair users;
- Having physical and intellectual ability to answer questionnaire.
Key exclusion criteria (3 listed)
- Transitory wheelchair users;
- Diagnosis of inflammatory rheumatic disease, cancer, systemic infection;
- Red flags for systemic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco M Kovacs, MD, PhD study director
Unidad de la Espalda Kovacs, Hospital Universitario HLA-Moncloa
Juan Noguera, MD principal investigator
Instituto de Asuntos Sociales y Deportes de Mallorca, Palma de Mallorca, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by Kovacs Foundation at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.