Pain Neuroscience Education in Patients With Fibromyalgia

Overview

Many patients with fibromyalgia have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. Current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia syndrome. This study aimed to explore the effectiveness of pain neuroscience education in patients with fibromyalgia.

Full Title of Study: “The Effectiveness of Pain Neuroscience Education in Patients With Fibromyalgia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 15, 2020

Interventions

  • Other: Pain neuroscience education
    • A total of 4 NPE (Neuroscience paine education) sessions were held, once each week in addition medical treatment similar to control group. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, group sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
  • Drug: Medical treatment
    • The patients in control group continued taking their regular gabapentin and pregabalin-derivative drug therapy at the same dosage and duration specified by their physicians.

Arms, Groups and Cohorts

  • Experimental: Neuroscience pain education group
    • Pain neuroscience education in addition medical treatment
  • Active Comparator: Control group
    • Medical treatment only

Clinical Trial Outcome Measures

Primary Measures

  • Fibromyalgia Impact Questionnaire (FIQ)
    • Time Frame: Change from Baseline FIQ at 4th weeks
    • The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes
  • Pressure pain thresholds (PPT)
    • Time Frame: Change from Baseline PPT at 4th weeks
    • Pressure pain thresholds in following five points, 7th cervical vertebra, 3th lumbal vertebra, 5th lumbal vertebra, the belly of calf muscles, and 2nd distal interfalangeal joint were measured using a analog pressure algometer(Baseline, USA).

Secondary Measures

  • Tampa Scale of Kinesiophobia
    • Time Frame: Change from Baseline PPT at 4th weeks
    • The Tampa Scale for Kinesiophobia (TSK) was used for the assessment of kinesiophobia. The TSK is a 17-item questionnaire developed to measure the fear of movement/re-injury.

Participating in This Clinical Trial

Inclusion Criteria

  • have fibromyalgia as defined by the criteria of the 1990 ACR
  • have Turkish as their native language
  • between 18 and 65 years of age

Exclusion Criteria

  • Having cognitive impairment
  • Receiving psychotherapy
  • Illiterate people
  • Patients with significant hearing loss

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kutahya Medical Sciences University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ismail Saracoglu, Principal Investigator – Kutahya Medical Sciences University
  • Overall Contact(s)
    • Ismail Saracoglu, Phd, 00905058414662, ismail.saracoglu@ksbu.edu.tr

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