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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02824588
Other study ID # 2016/8442
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date September 2, 2018

Study information

Verified date September 2018
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this project is to investigate and improve executive control function in two distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized that there is a significant difference in the executive control function of patients with neuropathic pain and FM pain. It is also hypothesized that all participants with poor executive control functioning will report significant improvements in pain intensity, functioning and cognitive complaints following cognitive training. The study tests and influence the working memory concepts of inhibition, updating and flexibility through an experimental, cross-over treatment design.

To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80 with FM) from the Departments of pain management and research at St Olav's University Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine whether or not executive control, processing speed and memory function differs in two distinct populations of pain patients. Moreover, whether impairments are amended by computerized training.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date September 2, 2018
Est. primary completion date September 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria:

- Confirmed diagnosis of fibromyalgia or neuropathic pain

- Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control

Exclusion Criteria:

- Mania, suicidal ideation and/or active psychosis

- No objective cognitive impairments

- Personality disorders

- Pregnancy

Study Design


Intervention

Behavioral:
Working Memory Training
Training mental flexibility
Internet use
Used as control for time spent on computer

Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective neuropsychological tests CANTAB test battery 36 weeks
Secondary Pain intensity VAS scale 36 weeks
Secondary Stress regulation Hair cortisol 36 weeks
Secondary Symptoms of depression Hopkins symptom checklist 36 weeks
Secondary Sleep duration, quality and awakening Actigraphy 36 weeks
Secondary Quality of life EQ-5D 36 weeks
Secondary Medication use Registered analgetic usage 36 weeks
Secondary Self-reported memory and concentration impairments Everyday Memory Questionnaire 36 weeks
Secondary Self-reported cognitive intrusion Questionnaire 36 weeks
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