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OpenTrials
Completed

NCT Number: NCT02824588

Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Working memory training

Behavioral

Training mental flexibility

Internet use

Behavioral

Used as control for time spent on computer

Primary outcomes

  1. Objective neuropsychological tests

    Time frame: 36 weeks

    CANTAB test battery

Secondary outcomes

  1. Pain intensity

    Time frame: 36 weeks

    VAS scale

  2. Stress regulation

    Time frame: 36 weeks

    Hair cortisol

  3. Symptoms of depression

    Time frame: 36 weeks

    Hopkins symptom checklist

  4. Sleep duration, quality and awakening

    Time frame: 36 weeks

    Actigraphy

  5. Quality of life

    Time frame: 36 weeks

    EQ-5D

  6. Medication use

    Time frame: 36 weeks

    Registered analgetic usage

  7. Self-reported memory and concentration impairments

    Time frame: 36 weeks

    Everyday Memory Questionnaire

  8. Self-reported cognitive intrusion

    Time frame: 36 weeks

    Questionnaire

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia

Acronym: NEPA

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2016
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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