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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03072745
Other study ID # 2010/182
Secondary ID
Status Completed
Phase N/A
First received March 2, 2017
Last updated March 2, 2017
Start date January 1, 2011
Est. completion date June 1, 2012

Study information

Verified date March 2017
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.


Description:

Almost 20 % of the adult European population suffers from chronic pain of moderate to severe intensity, and clinical insomnia has been reported in 53-73% of chronic pain patients. Insomnia seems to be correlated with small to moderate impairments in several cognitive functions involved in working and episodic memory and in attention tasks, and chronic pain has been shown to be associated with objective deficits in memory and executive functioning. The aim of the present study is to examine cognitive function in a patient population with complex chronic pain to test the hypothesis that insomnia severity on its own predicts objective cognitive function, and that a correlation is not better explained by comorbid depression or anxiety, morphine equivalent daily dose, or the level of pain itself.

Inividuals with complex chronic pain are assessed with a neuropsychological test battery examining different aspects of memory and executive functioning:

The Digit Span subtest from Wechsler's Adult Intelligence Scale III (WAIS-III): Verbal working memory.

Claeson-Dahl Inventory of Learning and Memory (CD): Verbal retention. The Rey Complex Figure Test (RCFT): Visuospatial retention. The Wisconsin Card Sorting Test (WCST): Cognitive flexibility. The Trail-Making Test (TMT): Sustained attention.

The presence of insomnia is examined with the Bergen Insomnia Scale (BIS) , and insomnia severity with the Insomnia Severity Index (ISI). Present pain level at the time of the neuropsychological assessment is quantified using the Visual Analogue Scale (VAS). Pain medication is transformed to the morphine equivalent daily dose (MEDD). Anxiety and depression are assessed with the Hospital Anxiety and Depression Scale.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 1, 2012
Est. primary completion date May 1, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Attending tertiary chronic pain management

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Neuropsychological assessment
Assessment with a neuropsychological test battery examining different aspects of memory and executive functioning

Locations

Country Name City State
Sweden Uppsala University Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Memory impairment Composite score comprising verbal working memory, verbal retention, and visuospatial retention. 1 day
Secondary Executive functioning impairment Composite score comprising cognitive flexibility and sustained attention. 1 day
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