NCT00502333

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

5.2 years

First QC Date

July 16, 2007

Last Update Submit

March 11, 2014

Conditions

Back PainNeck Pain

Keywords

back painneck painprognosiscatastrophizingcoping strategiesdisabilityPrognosis for back and neck pain

Outcome Measures

Primary Outcomes (1)

  • Disability

    Baseline and 3 months

Secondary Outcomes (1)

  • Pain

    Baseline and 3 months

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated within the Spanish National Health Service for subacute or chronic neck or back pain

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kovacs Foundation

Palma de Mallorca, Balearic Islands, 07012, Spain

Location

MeSH Terms

Conditions

Back PainNeck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Francisco M Kovacs, MD, PhD

    Kovacs Foundation, Palma de Mallorca, 07012, Spain

    STUDY DIRECTOR

  • Mario Gestoso, MD

    Kovacs Foundation,Palma de Mallorca, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scientific Department, Kovacs Foundation

Study Record Dates

First Submitted

July 16, 2007

First Posted

July 17, 2007

Study Start

November 1, 2006

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

ES(1)