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Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain (NEPA)

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ClinicalTrials.gov Identifier: NCT02824588
Recruitment Status : Completed
First Posted : July 6, 2016
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Henrik Børsting Jacobsen, Oslo University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Working Memory Deficits Neuropathic Pain Fibromyalgia Behavioral: Working Memory Training Behavioral: Internet use Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2, 2018
Actual Study Completion Date : September 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia Memory

Arm Intervention/treatment
Experimental: Intervention
Working Memory Training
Behavioral: Working Memory Training
Training mental flexibility

Active Comparator: Control
Internet use
Behavioral: Internet use
Used as control for time spent on computer




Primary Outcome Measures :
  1. Objective neuropsychological tests [ Time Frame: 36 weeks ]
    CANTAB test battery


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824588


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0450
Sponsors and Collaborators
Oslo University Hospital
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Responsible Party: Henrik Børsting Jacobsen, Post Doctoral Fellow, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02824588    
Other Study ID Numbers: 2016/8442
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Keywords provided by Henrik Børsting Jacobsen, Oslo University Hospital:
Pain
Working memory
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Neuralgia
Memory Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Pain
Neurologic Manifestations
Neurobehavioral Manifestations