Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Working Memory Deficits, Neuropathic Pain, Fibromyalgia

Intervention / Treatment
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* Behavioral: Working Memory Training
* Behavioral: Internet use


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Working Memory Training | Behavioral: Working Memory Training<br>* Training mental flexibility<br>|
| Active Comparator: Control<br>Internet use | Behavioral: Internet use<br>* Used as control for time spent on computer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective neuropsychological tests | CANTAB test battery | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | VAS scale | 36 weeks | 
| Stress regulation | Hair cortisol | 36 weeks | 
| Symptoms of depression | Hopkins symptom checklist | 36 weeks | 
| Sleep duration, quality and awakening | Actigraphy | 36 weeks | 
| Quality of life | EQ-5D | 36 weeks | 
| Medication use | Registered analgetic usage | 36 weeks | 
| Self-reported memory and concentration impairments | Everyday Memory Questionnaire | 36 weeks | 
| Self-reported cognitive intrusion | Questionnaire | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Working memory