Therapeutic Neuroscience Education in Individuals With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435807
• Other study ID #: Neuroscience Education
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: June 2022
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 15, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli	Merkezefendi

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnare	Total score ranging from 0 to 100. Higher scores indicate worse functional status	10 min
Primary	Visual Analogue Scale	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.	5 min
Primary	Widespread Pain Index	The WPI evaluates the patient's pain in the last week in terms of 19 regions and is scored between 0-19.	10 min
Primary	Symptom Severity Scale	The SSS is scored between 0-12.	7 min
Primary	Brief Pain Inventory	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.	7 min
Primary	Pain Catastrophizing Scale	The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.	10 min
Primary	Tampa Scale for Kinesiophobia	The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.	10 min
Secondary	Biopsychosocial Questionnaire	It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.	10 min
Secondary	Dynamic Loewenstein Occupational Therapy Cognitive Assessment	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).	1 hour