Back PainNCT00502333
The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain
An observational study of Back Pain and Neck Pain, run by Kovacs Foundation at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- How many people
- 1,400 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2006to Apr 2012
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated within the Spanish National Health Service for subacute or chronic neck or back pain
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- back pain, neck pain, prognosis, catastrophizing, coping strategies, disability, Prognosis for back and neck pain
- Medical subject headings
- Back Pain, Neck Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability
Measured: Baseline and 3 months
Secondary outcomes (1)
Pain
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startNov 2006
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kovacs Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco M. Kovacs, Kovacs Foundation
- Investigators
- Francisco M Kovacs, MD, PhD, Study director, Kovacs Foundation, Palma de Mallorca, 07012, SpainMario Gestoso, MD, Principal investigator, Kovacs Foundation,Palma de Mallorca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502333
- Sponsor's protocol ID
- FK-R-20
- Status last verified
- Mar 2014
- First submitted
- 16 Jul 2007
- Last updated
- 13 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Coping Strategies and Catastrophizing on Patients With Back and Neck Pain Treated Within the Spanish National Health Service
- ClinicalTrials.gov ID
- NCT00502333
- Acronym / sponsor ID
- FK-R-20
- Keywords
- back pain, neck pain, prognosis, catastrophizing, coping strategies, disability, Prognosis for back and neck pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Kovacs FoundationUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Jul 2007 (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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated within the Spanish National Health Service for subacute or chronic neck or back pain
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
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
Disability
Time frame: Baseline and 3 months
1 secondary outcome
Pain
Time frame: Baseline and 3 months
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 13 Mar 2014.
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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 director
Kovacs Foundation, Palma de Mallorca, 07012, Spain
Mario Gestoso, MD principal investigator
Kovacs Foundation,Palma de Mallorca, 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 Back Pain and Neck Pain, 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 3 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 13 Mar 2014. 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.
What does the primary outcome measure?
Disability (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2014.