Therapeutic Neuroscience Education in Individuals With Fibromyalgia

Sponsor
Pamukkale University (Other)
Overall Status
Completed
CT.gov ID
NCT05435807
Collaborator
(none)
25
1
2
24.5
1

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Therapeutic Neuroscience Education
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2019
Actual Primary Completion Date :
Dec 20, 2020
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention group

Clinical Pilates Exercises+TNE

Behavioral: Therapeutic Neuroscience Education
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.

Experimental: control group

Clinical Pilates Exercises

Behavioral: Therapeutic Neuroscience Education
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.

Outcome Measures

Primary Outcome Measures

  1. Fibromyalgia Impact Questionnare [10 min]

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

  2. Visual Analogue Scale [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 [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 [7 min]

    The SSS is scored between 0-12.

  5. Brief Pain Inventory [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 [10 min]

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

  7. Tampa Scale for Kinesiophobia [10 min]

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

Secondary Outcome Measures

  1. Biopsychosocial Questionnaire [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pamukkale University Denizli Merkezefendi Turkey 20070

Sponsors and Collaborators

  • Pamukkale University

Investigators

  • Principal Investigator: Bilge Basakcı Calık, Prof., Pamukkale University
  • Principal Investigator: Ummuhan Bas ASLAN, Prof., Pamukkale University
  • Principal Investigator: Uğur Karasu, MD, Pamukkale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Elif Gur Kabul, research assistant, Pamukkale University
ClinicalTrials.gov Identifier:
NCT05435807
Other Study ID Numbers:
  • Neuroscience Education
First Posted:
Jun 28, 2022
Last Update Posted:
Jun 28, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 28, 2022