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NCT Number: NCT05435807

Therapeutic Neuroscience Education in Individuals With Fibromyalgia

The aim of this study was to investigate the effects of Therapeutic Neuroscience Education (TNE) in individuals with Fibromyalgia (FM). The study included 25 females with FM, randomly separated into two groups as the intervention group (Clinical Pilates Exercises+TNE, n=11) and the control group (Clinical Pilates Exercises, n=14).

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, Merkezefendi, 20070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age between 18-65 years,
  • female gender,
  • a VAS of at least 40mm to report the pain intensity of the last week,
  • having been diagnosed with FM for at least 1 year to present a range of somatic and cognitive symptoms in addition to widespread pain,
  • using a fixed dose of medication for at least the past 6 months (serotonin noradrenaline reuptake inhibitors [Ex, duloxetine, milnacipran]; alpha 2-delta receptor ligand [Ex, pregabalin]; gabapentinoids).

Exclusion criteria

  • the presence of another disease which may affect the physical condition,
  • cognitive impairment at a level preventing cooperation,
  • being pregnant,
  • inability to understand or speak Turkish,
  • concurrent autoimmune or inflammatory disease,
  • the presence of a central nervous system disease (eg multiple sclerosis, Parkinson's disease),
  • serious psychiatric conditions (eg, psychotic disorders) that would prevent participation,
  • participation in a rehabilitation program in the past year,
  • have been exercising regularly for 6 months,
  • not participating in at least 75% of treatments.

Treatment and study plan

Therapeutic Neuroscience Education

Behavioral

Therapeutic Neuroscience Education (TNE) is an intervention used by physiotherapists, which can be defined as a cognitive behavioral therapy method. By helping patients better understand the biological process that underlies their painful condition, it aims to achieve therapeutic effects such as reducing pain and the fear associated with musculoskeletal injuries and increasing movement and functionality.

Primary outcomes

  1. Fibromyalgia Impact Questionnare

    Time frame: 10 min

    Total score ranging from 0 to 100. Higher scores indicate worse functional status

  2. Visual Analogue Scale

    Time frame: 5 min

    VAS is used to convert values that cannot be measured numerically, such as pain, into numerical values. Two end definitions of the parameter to be evaluated are written at the two ends of a 10 cm line and the patient is asked to mark this line indicating the appropriate level of their condition. In this study, 0='no pain' and 10='worst possible pain' were defined.

  3. Widespread Pain Index

    Time frame: 10 min

    The WPI evaluates the patient's pain in the last week in terms of 19 regions and is scored between 0-19.

  4. Symptom Severity Scale

    Time frame: 7 min

    The SSS is scored between 0-12.

  5. Brief Pain Inventory

    Time frame: 7 min

    This is a short and easy-to-apply inventory that can be used to assess pain, which consists of the two sections of Pain Severity (4 items) and Pain Interference (7 items). The total score in both categories ranges from 0 to 10, with higher scores indicating more pain and more pain causes more disability.

  6. Pain Catastrophizing Scale

    Time frame: 10 min

    The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.

  7. Tampa Scale for Kinesiophobia

    Time frame: 10 min

    The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.

Secondary outcomes

  1. Biopsychosocial Questionnaire

    Time frame: 10 min

    It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.

  2. Dynamic Loewenstein Occupational Therapy Cognitive Assessment

    Time frame: 1 hour

    The DLOTCA battery has 28 subtests for 7 cognitive areas.Scoring consists of three components for each subtest:

    • Before meditation score (5 points indicate the best performance).
    • Mediation score (high score (4 or 5) indicates poor performance).
    • After mediation score (5 points show the best performance).

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 28, 2022
Registry last updated
Jun 28, 2022

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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