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Completed

NCT Number: NCT04050839

Pain Neuroscience Education in Patients with Fibromyalgia

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.

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Key information

Conditions

Pain, Chronic Chronic Pain Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KutahyaMSU

Kütahya, Kutahya Health Sciences University, 43000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain neuroscience education

Other

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.

medical treatment

Drug

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.

Primary outcomes

  1. 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

  2. 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).

  3. Tinel's Sign

    Time frame: Change from Baseline PPT at 4th weeks

    The Tinel sign is the result of a simple, noninvasive test that checks for nerve problems. The test is positive when a tingling or prickling sensation is felt in the distribution of the Tibial nerve.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

The Effectiveness of Pain Neuroscience Education in Patients with Fibromyalgia

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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