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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02778555
Other study ID # R01AT008561-01A1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date March 2016

Study information

Verified date June 2019
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study sought to develop and validate a brief, daily version of the Pain Catastrophizing Scale.


Description:

The Pain Catastrophizing Scale (PCS; 13 items; factors: rumination, helplessness, magnification) (Sullivan 1995) measures trait catastrophizing in the context of actual or anticipated pain. Currently, there is no validated tool for measuring pain catastrophizing at the daily level. Lack of a validated daily measure stands as a barrier for studies that aim to characterize mechanisms of pain treatment and how PC adaptation / change occurs.


Recruitment information / eligibility

Status Completed
Enrollment 713
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Age 18 or above

2. Chronic pain of any etiology

3. Online access

4. Ability to participate in daily measurements over 14 days

Exclusion Criteria:

1. Lack of ability to answer questionnaires and daily catastrophizing captures, at the discretion of study staff.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaires


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

References & Publications (1)

Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Factor Analysis & PROMIS Correlation for Samples 2 & 3 The validation process involves identifying, of the original 14 PCS items, which items show the largest factor loadings to the underlying factor structure that fits the data best, using model fit indices that will determine appropriate fit of the statistical model to the data, as well as convergent validity with other relevant measures (pain intensity, depression, anxiety, anger), which is tested through the use of Pearson correlations.
Metrics used to test the hypothesis: Intraclass correlations were used to establish variability. RMSEA, CFI, TLI, and WRMR as our goodness of fit indices for arriving at 3- and 5-item measures, and to compare the measures. Reliability was tested using a. Correlations between daily pain, mood, activity, sleep, and energy were tested using pearson coefficients.
Intent was to measure correlations between the brief PCS and the PROMIS for validation sample 2, and correlations between the brief PCS and the PROMIS for validation sample 3.
14 days
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