Low Back PainNCT01649011
Validation of a Translation Into Spanish of the Oswestry Disability Index
An observational study of Low Back Pain, run by American British Cowdray Medical Center at 1 site in Mexico.
Trial summary
The purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry Disability Index (ODI) version in patients with low back pain. Internal consistency, reproducibility and reliability will be addressed scoring the results of the translated version at two time frames. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Application of the initial evaluation and Final application of scales
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2012to Mar 2013
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with low back pain
Who may be able to join
- Patients with acute or chronic low back pain
- With or without previous back surgery
Who cannot join
- Visual or mentally impaired
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
American British Cowdray Medical Center
Mexico City, Mexico City, 05300
Ernesto Eduardo Galvan, MD, 52 5516647205, egalh@yahoo.com
Ernesto E Galvan Hernandez, MD, MSc
About this study
The purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry Disability Index (ODI) version in patients with low back pain.
Internal consistency, reproducibility and reliability will be addressed scoring the results of the translated version at two time frames. A previously spanish validated translation of the of the Roland Morris Disability Questionnaire (RMDQ) will be used to compare and evaluate both versions.
Read the detailed description
Low back pain (LBP) is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%, and is responsible for a major portion of work absenteeism. Measuring disability is important in LBP. First, as an outcome measure, it is an important indicator of the quality of life of the patient. The Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) have emerged as the most commonly recommended condition specific outcome measures for spinal disorders.
The development of the ODI was initiated by John O'Brien in 1976. The index was designed as a measure for both assessment and outcome on patients with low back pain. The questionnaire can be completed in less than 5 minutes and scored in less than 1 minute. Version 1.0 of the questionnaire was published in 1980 and widely disseminated after the 1981 meeting of the International Society for The Study of the Lumbar Spine (ISSLS) in Paris. A new ODI version was adapted in 1989 by the Chiropractic College in England. The American Academy of Orthopedic Surgeons and other spine associations adapted the ODI 1.0 version in 1996 omitting categories 1, 8 and 9. This version is included in the assessment protocol proposed by the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS), which brings together the main international spine associations. Version 2.0 was modified by the Medical Research Council Group in the UK in 1996 (16) and they omitted the word "painkillers" in the first category. Version 2.1a is the most recent and recommended by its author. In this version a section called previous treatment appears, which is not taken into account for scoring. The score can be obtained for its clinical use after permission at: http://www.mapi-trust.org/.
The RMDQ is a health status measure designed to be completed by patients to assess physical disability due to low back pain. It was designed for use in research (e.g., as an outcome measure for clinical trials) but has also been found useful for monitoring patients in clinical practice. Was derived from the Sickness Impact Profile (SIP), which is a 136 item health status measure covering all aspects of physical and mental function. Twenty four items were selected from the SIP by the original authors. It is simple, fast, and can be filled out by the patient. The patient must mark each item that applies to his or her current LBP. Scoring is also simple and fast; each checked item receives a score of 1, so scores range between 0 (no disability caused by LBP) and 24 (the maximum possible disability). To date only one version has been translated to Spanish and was published in 2002 by Kovacks FM, et al.
- Conditions
- Low Back Pain
- Being tested
- Application of the initial evaluation, Final application of scales
- Keywords
- Oswestry Disability Index, ODI, Roland Morris Disability Questionnaire, RMDQ
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the initial evaluationBehavioural
Initial evaluation involves the application of the previously spanish validated Rolland Morris Questionnaire and the new spanish Oswestry Disability Index
Final application of scalesBehavioural
Application of the previously spanish validated version of the RMQ and the new spanish translation of the ODI 2 weeks after initial evaluation
| Study group | Role | What they receive |
|---|---|---|
| Scores of the ODI and RMQ for low back pain | Not described Receives: Behavioral: Application of the initial evaluation; Behavioral: Final application of scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain scored by the translated and proposed version of the ODI
The objective of this outcome measure is to evaluate the ability of the translated ODI version to measure changes in time on patients with low back pain. The score will be registered 2 times with 3 weeks apart
Measured: Initial evaluation and 2 weeks after
Secondary outcomes (1)
Low back pain scored by the RMQ spanish version
The RMQ will be administered at the same time that the proposed translated ODI version, at the beginning of the study and 3 weeks later. The RMQ was previously translated and validated to spanish, and will work like a reference to evaluate the reproducibility of any change in the score obtained by the ODI spanish version.
Measured: Initial evaluation and 2 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American British Cowdray Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galvan Ernesto Eduardo, American British Cowdray Medical Center
- Investigators
- Ernesto E Galvan Hernandez, MD, MSc, Principal investigator, American British Cowdray Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649011
- Sponsor's protocol ID
- ABC-ODI-12-2012
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.
PubMed 11880841Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
PubMed 6450426Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
PubMed 11124727
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Translation Into Spanish of the Oswestry Disability Index
- ClinicalTrials.gov ID
- NCT01649011
- Acronym / sponsor ID
- ABC-ODI-12-2012
- Conditions
- Low Back Pain
- Keywords
- Oswestry Disability Index, ODI, Roland Morris Disability Questionnaire, RMDQ
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- American British Cowdray Medical CenterUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (estimated)
- First posted
- 25 Jul 2012 (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 purpose of the study is to validate in Mexico a spanish translation of the 2.1a Oswestry Disability Index (ODI) version in patients with low back pain.
Internal consistency, reproducibility and reliability will be addressed scoring the results of the translated version at two time frames. A previously spanish validated translation of the of the Roland Morris Disability Questionnaire (RMDQ) will be used to compare and evaluate both versions.
Detailed description
Low back pain (LBP) is one of the most frequent ailments in industrialized countries, with a lifetime prevalence of more than 70%, and is responsible for a major portion of work absenteeism. Measuring disability is important in LBP. First, as an outcome measure, it is an important indicator of the quality of life of the patient. The Oswestry Disability Index (ODI) and the Roland Morris Disability Questionnaire (RMDQ) have emerged as the most commonly recommended condition specific outcome measures for spinal disorders.
The development of the ODI was initiated by John O'Brien in 1976. The index was designed as a measure for both assessment and outcome on patients with low back pain. The questionnaire can be completed in less than 5 minutes and scored in less than 1 minute. Version 1.0 of the questionnaire was published in 1980 and widely disseminated after the 1981 meeting of the International Society for The Study of the Lumbar Spine (ISSLS) in Paris. A new ODI version was adapted in 1989 by the Chiropractic College in England. The American Academy of Orthopedic Surgeons and other spine associations adapted the ODI 1.0 version in 1996 omitting categories 1, 8 and 9. This version is included in the assessment protocol proposed by the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS), which brings together the main international spine associations. Version 2.0 was modified by the Medical Research Council Group in the UK in 1996 (16) and they omitted the word "painkillers" in the first category. Version 2.1a is the most recent and recommended by its author. In this version a section called previous treatment appears, which is not taken into account for scoring. The score can be obtained for its clinical use after permission at: http://www.mapi-trust.org/.
The RMDQ is a health status measure designed to be completed by patients to assess physical disability due to low back pain. It was designed for use in research (e.g., as an outcome measure for clinical trials) but has also been found useful for monitoring patients in clinical practice. Was derived from the Sickness Impact Profile (SIP), which is a 136 item health status measure covering all aspects of physical and mental function. Twenty four items were selected from the SIP by the original authors. It is simple, fast, and can be filled out by the patient. The patient must mark each item that applies to his or her current LBP. Scoring is also simple and fast; each checked item receives a score of 1, so scores range between 0 (no disability caused by LBP) and 24 (the maximum possible disability). To date only one version has been translated to Spanish and was published in 2002 by Kovacks FM, et al.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scores of the ODI and RMQ for low back pain | – | Behavioral: Application of the initial evaluation, Behavioral: Final application of scales |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back pain
Key inclusion criteria (2 listed)
- Patients with acute or chronic low back pain
- With or without previous back surgery
Key exclusion criteria (1 listed)
- Visual or mentally impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of the initial evaluationInitial evaluation involves the application of the previously spanish validated Rolland Morris Questionnaire and the new spanish Oswestry Disability Index | Behavioural | Scores of the ODI and RMQ for low back pain |
| Final application of scalesApplication of the previously spanish validated version of the RMQ and the new spanish translation of the ODI 2 weeks after initial evaluation | Behavioural | Scores of the ODI and RMQ for low back pain |
Primary outcome
Low back pain scored by the translated and proposed version of the ODI
Time frame: Initial evaluation and 2 weeks after
The objective of this outcome measure is to evaluate the ability of the translated ODI version to measure changes in time on patients with low back pain. The score will be registered 2 times with 3 weeks apart
1 secondary outcome
Low back pain scored by the RMQ spanish version
Time frame: Initial evaluation and 2 weeks after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
- Background: PubMed 11880841Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.
- Background: PubMed 6450426Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
- Background: PubMed 11124727Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.
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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.
Ernesto E Galvan Hernandez, MD, MSc principal investigator
American British Cowdray Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by American British Cowdray Medical Center at 1 site in Mexico.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ernesto E Galvan, MD (52 5516647205, egalh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back pain scored by the translated and proposed version of the ODI (time frame: Initial evaluation and 2 weeks after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01649011, which also lists 3 linked publications.
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 27 Jul 2012.