Neck PainNCT00349544
Validation of the Spanish Version of the Neck Disability Index
An observational study of Neck Pain and Cervicalgia, run by Kovacs Foundation at 1 site in Spain.
Trial summary
The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the correlation between intensity of cervical pain, degree of disability, and quality of life; to determine the correlation between the NDI, CCS6… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Cervicalgia
- How many people
- 221 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2005to Nov 2007
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit their physician for cervicalgia, with or without referred pain
Who may be able to join
- patients who visit physician for cervicalgia
- with or without referred pain
- must be able to read and write
Who cannot join
- disease of central nervous system, with or without treatment
- migraine
- indications for surgery
- suspicion of systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Transcultural Adaptation of the Neck Disability Index in the Spanish Population
The primary purpose of this study is to adapt the Neck Disability Index (NDI)and the Cervical Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the correlation between intensity of cervical pain, degree of disability, and quality of life; to determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain Questionnaire; and to determine factors that predict the chronification of disability.
- Conditions
- Neck Pain, Cervicalgia
- Keywords
- Neck pain, Cervicalgia, Quality of life, Disability
- Medical subject headings
- Neck Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startOct 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck 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
- Time perspective
- Cross-sectional
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Back Pain Research Network (REIDE)
- Investigators
- Francisco M. Kovacs, MD, PhD, Study chair, Kovacs Foundation, Palma de Mallorca 07012, SpainJuan Bago, MD, Study director, Hospital Vall d'Hebron 119-129, Barcelona 08035, SpainLuis Cuesta, MD, Study director, Mutua Asepeyo, Madrid 28820, SpainJosé Luis Martín, MD, Study director, Hospital Universitario Virgen de las Nieves, Granada 18014, SpainLuis Alvarez, MD, Study director, Fundación Jiménez Díaz, Madrid 28040, SpainMaría Angeles Usero, MD, Study director, Centro de Salud Perales del Rio, Madrid 28909, SpainCarmen Fernández, MD, Study director, Centro de Salut de Valldargent, Palma de Mallorca 07013, SpainMaría Dolores Castillo, MD, Study director, Delegación Pral. de Asuntos Sociales, Granada 18011, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349544
- Sponsor's protocol ID
- FK-R-10
- Status last verified
- May 2008
- First submitted
- 6 Jul 2006
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
PubMed 1834753Kovacs FM, Bago J, Royuela A, Seco J, Gimenez S, Muriel A, Abraira V, Martin JL, Pena JL, Gestoso M, Mufraggi N, Nunez M, Corcoll J, Gomez-Ochoa I, Ramirez MJ, Calvo E, Castillo MD, Marti D, Fuster S, Fernandez C, Gimeno N, Carballo A, Milan A, Vazquez D, Canellas M, Blanco R, Brieva P, Rueda MT, Alvarez L, Del Real MT, Ayerbe J, Gonzalez L, Ginel L, Ortega M, Bernal M, Bolado G, Vidal A, Ausin A, Ramon D, Mir MA, Tomas M, Zamora J, Cano A. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008 Apr 9;9:42. doi: 10.1186/1471-2474-9-42.
PubMed 18400084
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Transcultural Adaptation of the Neck Disability Index in the Spanish Population
- ClinicalTrials.gov ID
- NCT00349544
- Acronym / sponsor ID
- FK-R-10
- Conditions
- Neck Pain, Cervicalgia
- Keywords
- Neck pain, Cervicalgia, Quality of life, Disability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Collaborators
- Spanish Back Pain Research Network (REIDE)
- Study start
- Oct 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 7 Jul 2006 (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 adapt the Neck Disability Index (NDI)and the Cervical Core Set 6 (CCS6) to the Spanish population. Other objectives are to determine the correlation between intensity of cervical pain, degree of disability, and quality of life; to determine the correlation between the NDI, CCS6 and the Northwick Park Neck Pain Questionnaire; and to determine factors that predict the chronification of disability.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit their physician for cervicalgia, with or without referred pain
Key inclusion criteria (3 listed)
- patients who visit physician for cervicalgia
- with or without referred pain
- must be able to read and write
Key exclusion criteria (4 listed)
- disease of central nervous system, with or without treatment
- migraine
- indications for surgery
- suspicion of 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 9 May 2008.
- Background: PubMed 1834753Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
- Derived from this study: PubMed 18400084Kovacs FM, Bago J, Royuela A, Seco J, Gimenez S, Muriel A, Abraira V, Martin JL, Pena JL, Gestoso M, Mufraggi N, Nunez M, Corcoll J, Gomez-Ochoa I, Ramirez MJ, Calvo E, Castillo MD, Marti D, Fuster S, Fernandez C, Gimeno N, Carballo A, Milan A, Vazquez D, Canellas M, Blanco R, Brieva P, Rueda MT, Alvarez L, Del Real MT, Ayerbe J, Gonzalez L, Ginel L, Ortega M, Bernal M, Bolado G, Vidal A, Ausin A, Ramon D, Mir MA, Tomas M, Zamora J, Cano A. Psychometric characteristics of the Spanish version of instruments to measure neck pain disability. BMC Musculoskelet Disord. 2008 Apr 9;9:42. doi: 10.1186/1471-2474-9-42.
- Spanish Back Pain Research Network site that describes objectives and projects of its members.Link provided by the sponsor.
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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 chair
Kovacs Foundation, Palma de Mallorca 07012, Spain
Juan Bago, MD study director
Hospital Vall d'Hebron 119-129, Barcelona 08035, Spain
Luis Cuesta, MD study director
Mutua Asepeyo, Madrid 28820, Spain
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 Neck Pain and Cervicalgia, run by Kovacs Foundation at 1 site 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 4 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 9 May 2008. 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 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?
On the ClinicalTrials.gov record for NCT00349544, which also lists 2 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 9 May 2008.