Clinical trial NCT00349544: Validation of the Spanish Version of the Neck Disability Index
Official title: Validation of the Transcultural Adaptation of the Neck Disability Index in the Spanish Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain
Cervicalgia
Keywords: Neck pain
Cervicalgia
Quality of life
Disability
Lead sponsor: Kovacs Foundation
Sponsor class: OTHER
Collaborators: name: Spanish Back Pain Research Network (REIDE)
First posted: 2006-07-07
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit their physician for cervicalgia, with or without referred pain

Brief 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 and the Northwick Park Neck Pain Questionnaire; and to determine factors that predict the chronification of disability.


Eligibility criteria: Inclusion Criteria:

* patients who visit physician for cervicalgia
* with or without referred pain
* must be able to read and write

Exclusion Criteria:

* disease of central nervous system, with or without treatment
* migraine
* indications for surgery
* suspicion of systemic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma de Mallorca
country: Spain
facility: Fundación Kovacs
state: Balearic Islands
Study officials:
affiliation: Kovacs Foundation, Palma de Mallorca 07012, Spain
name: Francisco M. Kovacs, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron 119-129, Barcelona 08035, Spain
name: Juan Bago, MD
role: STUDY_DIRECTOR
affiliation: Mutua Asepeyo, Madrid 28820, Spain
name: Luis Cuesta, MD
role: STUDY_DIRECTOR
affiliation: Hospital Universitario Virgen de las Nieves, Granada 18014, Spain
name: José Luis Martín, MD
role: STUDY_DIRECTOR
affiliation: Fundación Jiménez Díaz, Madrid 28040, Spain
name: Luis Alvarez, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud Perales del Rio, Madrid 28909, Spain
name: María Angeles Usero, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salut de Valldargent, Palma de Mallorca 07013, Spain
name: Carmen Fernández, MD
role: STUDY_DIRECTOR
affiliation: Delegación Pral. de Asuntos Sociales, Granada 18011, Spain
name: María Dolores Castillo, MD
role: STUDY_DIRECTOR
affiliation: Consorci Sanitari del Parc Taulí, Hospital Sabadell, Barcelona 08208, Spain
name: Montserrat Cañellas, MD
role: STUDY_DIRECTOR
affiliation: Hospital Clínic de Barcelona, Barcelona 08036, Spain
name: Montserrat Núñez, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud Ciudad Jardín, Málaga 29017, Spain
name: Sergio Giménez, MD
role: STUDY_DIRECTOR
affiliation: ZBS Órgiva, Granada 18640, Spain
name: Pablo Panero, MD
role: STUDY_DIRECTOR
affiliation: Centro de Salud Serrería II, Valencia 46022, Spain
name: Luis González, MD
role: STUDY_DIRECTOR
affiliation: Servicio de Rehabilitación del Hospital Clínico de Valladolid, Valladolid 47002, Spain
name: Myriam Bernal, MD
role: STUDY_DIRECTOR
affiliation: Unidad Básica de Salut Es Castell, Menorca 07720, Spain
name: Mateo Seguí, MD
role: STUDY_DIRECTOR
affiliation: Unidad de Bioestadística, Hospital Ramón y Cajal, Madrid 28034, Spain
name: Víctor Abraira, PhD
role: STUDY_DIRECTOR
References:
citation: Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. 1991 Sep;14(7):409-15.
citation: Kovacs 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.