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Pain Neuroscience Education in Patients With Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04050839
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : April 4, 2022
Sponsor:
Information provided by (Responsible Party):
Ismail Saracoglu, Kutahya Health Sciences University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Chronic Fibromyalgia Other: Pain neuroscience education Drug: Medical treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Pain Neuroscience Education in Patients With Fibromyalgia
Actual Study Start Date : September 15, 2019
Actual Primary Completion Date : June 15, 2021
Actual Study Completion Date : July 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neuroscience pain education group
Pain neuroscience education in addition medical treatment
 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.
Active Comparator: Control group
Medical treatment only
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050839


Locations
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Turkey
KutahyaMSU
Kütahya, Kutahya Health Sciences University, Turkey, 43000
Sponsors and Collaborators
Kutahya Health Sciences University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ismail Saracoglu, Principal Investigator, Kutahya Health Sciences University
ClinicalTrials.gov Identifier: NCT04050839    
Other Study ID Numbers: KutahyaMSUfibro
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ismail Saracoglu, Kutahya Health Sciences University:
pain neuroscience education
patient education
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations