Pain Neuroscience Education in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

The Effectiveness of Pain Neuroscience Education in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050839
• Other study ID #: KutahyaMSUfibro
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: July 15, 2021

Study information

• Verified date: March 2022
• Source: Kutahya Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes
• Pain, Chronic

Intervention

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.

Locations

Country	Name	City	State
Turkey	KutahyaMSU	Kütahya	Kutahya Health Sciences University

Sponsors (1)

Lead Sponsor	Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibromyalgia Impact Questionnaire (FIQ)	The FIQ is an assessment and evaluation instrument developed to measure fibromyalgia (FM) patient status, progress and outcomes	Change from Baseline FIQ at 4th weeks
Primary	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).	Change from Baseline PPT at 4th weeks
Primary	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.	Change from Baseline PPT at 4th weeks
Secondary	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.	Change from Baseline PPT at 4th weeks