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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00502333
Other study ID # FK-R-20
Secondary ID
Status Completed
Phase N/A
First received July 16, 2007
Last updated March 11, 2014
Start date November 2006
Est. completion date April 2012

Study information

Verified date March 2014
Source Kovacs Foundation
Contact n/a
Is FDA regulated No
Health authority Spain: Spanish Back Pain Research Network (REIDE)
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the influence of coping strategies and catastrophizing thoughts on disability and the prognosis of back and neck pain in patients treated within the Spanish National Health Service. Patients will be given a visual analog scale (VAS) to rate intensity of pain, the Roland Morris Questionnaire (RMQ) or the Neck Disability Index (NDI) to rate the degree of disability, and the Coping Strategies Questionnaire (CSQ) to rate coping strategies and catastrophizing. Questionnaires will be given at baseline and three months later.


Recruitment information / eligibility

Status Completed
Enrollment 1400
Est. completion date April 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Subjects treated for back or neck pain in the Spanish National Health Service.

- Able to read and write Spanish.

- Have signed the informed consent form.

Exclusion Criteria:

- Diagnosis or "red flags" for systemic diseases (e.g., cancer, infection).

- Pain due to fracture or direct trauma to the neck or back.

- Criteria for referral to surgery (e.g., neurogenic claudication due to spinal stenosis, cauda equina syndrome, serious nerve root compression for more than 6 weeks due to disc herniation).

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Kovacs Foundation Palma de Mallorca Balearic Islands

Sponsors (1)

Lead Sponsor Collaborator
Kovacs Foundation

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disability Baseline and 3 months No
Secondary Pain Baseline and 3 months No
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