Pain Neuroscience Education in Patients with Fibromyalgia

NCT04050839 | Completed

• 1 other identifier: KutahyaMSUfibro
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Chronic; Fibromyalgia

Keywords

pain neuroscience education; patient education

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Tampa Scale of Kinesiophobia

  Change from Baseline PPT at 4th weeks

Study Arms (2)

Neuroscience pain education group

EXPERIMENTAL

Pain neuroscience education in addition medical treatment

Other: Pain neuroscience education; Drug: Medical treatment

Control group

ACTIVE COMPARATOR

Medical treatment only

Drug: Medical treatment

Interventions

Pain neuroscience education OTHER

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.

Neuroscience pain education group

Medical treatment DRUG

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.

Control group; Neuroscience pain education group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have fibromyalgia as defined by the criteria of the 1990 ACR
• have Turkish as their native language
• between 18 and 65 years of age

You may not qualify if:

• Having cognitive impairment
• Receiving psychotherapy
• Illiterate people
• Patients with significant hearing loss

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

KutahyaMSU

Kütahya, Kutahya Health Sciences University, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: September 15, 2019
• Primary Completion: June 15, 2021
• Study Completion: July 15, 2021
• Last Updated: October 15, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)