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

September 2, 2018 updated by: Henrik Børsting Jacobsen, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0450
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

September 2, 2018

Study Completion (Actual)

September 2, 2018

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

September 5, 2018

Last Update Submitted That Met QC Criteria

September 2, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/8442

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Working Memory Training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe