Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

NCT02824588 | Completed DMC

• 1 other identifier: 2016/8442
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Working Memory Deficits; Neuropathic Pain; Fibromyalgia

Keywords

Pain; Working memory

Outcome Measures

Primary Outcomes (1)

• Objective neuropsychological tests

  CANTAB test battery

  36 weeks

Secondary Outcomes (8)

• Pain intensity

  36 weeks

• Stress regulation

  36 weeks

• Symptoms of depression

  36 weeks

• Sleep duration, quality and awakening

  36 weeks

• Quality of life

  36 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Working Memory Training

Behavioral: Working Memory Training

Control

ACTIVE COMPARATOR

Internet use

Behavioral: Internet use

Interventions

Working Memory Training BEHAVIORAL

Training mental flexibility

Intervention

Internet use BEHAVIORAL

Used as control for time spent on computer

Control

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of fibromyalgia or neuropathic pain
• Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control

You may not qualify if:

• Mania, suicidal ideation and/or active psychosis
• No objective cognitive impairments
• Personality disorders
• Pregnancy

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

MeSH Terms

Conditions

Neuralgia; Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Fellow

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 6, 2016
• Study Start: September 1, 2016
• Primary Completion: September 2, 2018
• Study Completion: September 2, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

NO (1)