- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00502333
The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain
March 11, 2014 updated by: Francisco M. Kovacs, Kovacs Foundation
The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain Treated Within the Spanish National Health Service
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
1400
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Balearic Islands
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Palma de Mallorca, Balearic Islands, Spain, 07012
- Kovacs Foundation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated within the Spanish National Health Service for subacute or chronic neck or back pain
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Disability
Time Frame: Baseline and 3 months
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Baseline and 3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain
Time Frame: Baseline and 3 months
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Baseline and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Francisco M Kovacs, MD, PhD, Kovacs Foundation, Palma de Mallorca, 07012, Spain
- Principal Investigator: Mario Gestoso, MD, Kovacs Foundation,Palma de Mallorca, Spain
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
July 16, 2007
First Submitted That Met QC Criteria
July 16, 2007
First Posted (Estimate)
July 17, 2007
Study Record Updates
Last Update Posted (Estimate)
March 13, 2014
Last Update Submitted That Met QC Criteria
March 11, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FK-R-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.