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

Primary Purpose

Working Memory Deficits, Neuropathic Pain, Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Working Memory Training
Internet use
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Working Memory Deficits focused on measuring Pain, Working memory

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Working Memory Training

Internet use

Outcomes

Primary Outcome Measures

Objective neuropsychological tests
CANTAB test battery

Secondary Outcome Measures

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

Full Information

First Posted
June 27, 2016
Last Updated
September 2, 2018
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02824588
Brief Title
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain
Acronym
NEPA
Official Title
Executive Control, Processing Speed and Memory Function in Long- Term Peripheral Neuropathic Pain and Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2, 2018 (Actual)
Study Completion Date
September 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Working Memory Deficits, Neuropathic Pain, Fibromyalgia
Keywords
Pain, Working memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Working Memory Training
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Internet use
Intervention Type
Behavioral
Intervention Name(s)
Working Memory Training
Intervention Description
Training mental flexibility
Intervention Type
Behavioral
Intervention Name(s)
Internet use
Intervention Description
Used as control for time spent on computer
Primary Outcome Measure Information:
Title
Objective neuropsychological tests
Description
CANTAB test battery
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Pain intensity
Description
VAS scale
Time Frame
36 weeks
Title
Stress regulation
Description
Hair cortisol
Time Frame
36 weeks
Title
Symptoms of depression
Description
Hopkins symptom checklist
Time Frame
36 weeks
Title
Sleep duration, quality and awakening
Description
Actigraphy
Time Frame
36 weeks
Title
Quality of life
Description
EQ-5D
Time Frame
36 weeks
Title
Medication use
Description
Registered analgetic usage
Time Frame
36 weeks
Title
Self-reported memory and concentration impairments
Description
Everyday Memory Questionnaire
Time Frame
36 weeks
Title
Self-reported cognitive intrusion
Description
Questionnaire
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0450
Country
Norway

12. IPD Sharing Statement

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Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

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