Pain Neuroscience Education in Patients With Fibromyalgia

Sponsor
Kutahya Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT04050839
Collaborator
(none)
40
1
2
22
1.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pain neuroscience education
  • Drug: Medical treatment
N/A

Study Design

Study Type:
Interventional
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 :
Sep 15, 2019
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jul 15, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Fibromyalgia Impact Questionnaire (FIQ) [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) [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 [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 [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

Criteria

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

Locations

Site City State Country Postal Code
1 KutahyaMSU Kütahya Kutahya Health Sciences University Turkey 43000

Sponsors and Collaborators

  • Kutahya Health Sciences University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ismail Saracoglu, Principal Investigator, Kutahya Health Sciences University
ClinicalTrials.gov Identifier:
NCT04050839
Other Study ID Numbers:
  • KutahyaMSUfibro
First Posted:
Aug 8, 2019
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ismail Saracoglu, Principal Investigator, Kutahya Health Sciences University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022