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Pain Neuroscience Education in Patients With Fibromyalgia

Primary Purpose

Pain, Chronic, Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pain neuroscience education
Medical treatment
Sponsored by
Kutahya Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring pain neuroscience education, patient education

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KutahyaMSU

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Neuroscience pain education group

Control group

Arm Description

Pain neuroscience education in addition medical treatment

Medical treatment only

Outcomes

Primary Outcome Measures

Fibromyalgia Impact Questionnaire (FIQ)
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes
Pressure pain thresholds (PPT)
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).
Tinel's Sign
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

Tampa Scale of Kinesiophobia
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.

Full Information

First Posted
August 7, 2019
Last Updated
March 23, 2022
Sponsor
Kutahya Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT04050839
Brief Title
Pain Neuroscience Education in Patients With Fibromyalgia
Official Title
The Effectiveness of Pain Neuroscience Education in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kutahya Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Fibromyalgia
Keywords
pain neuroscience education, patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuroscience pain education group
Arm Type
Experimental
Arm Description
Pain neuroscience education in addition medical treatment
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Medical treatment only
Intervention Type
Other
Intervention Name(s)
Pain neuroscience education
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Medical treatment
Intervention Description
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 Outcome Measure Information:
Title
Fibromyalgia Impact Questionnaire (FIQ)
Description
The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes
Time Frame
Change from Baseline FIQ at 4th weeks
Title
Pressure pain thresholds (PPT)
Description
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).
Time Frame
Change from Baseline PPT at 4th weeks
Title
Tinel's Sign
Description
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.
Time Frame
Change from Baseline PPT at 4th weeks
Secondary Outcome Measure Information:
Title
Tampa Scale of Kinesiophobia
Description
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.
Time Frame
Change from Baseline PPT at 4th weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
KutahyaMSU
City
Kütahya
State/Province
Kutahya Health Sciences University
ZIP/Postal Code
43000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain Neuroscience Education in Patients With Fibromyalgia

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