The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain

Physiotherapy Combined With Therapeutic Neuroscience Education Versus Physiotherapy Alone for Patients With Chronic Low Back Pain: a Randomized Controlled Trial

Ongoing fear and catastrophization in people with chronic low back pain (CLBP) causes increased pain, disability and kinesiophobia, and decreased endurance of trunk muscles. Nowadays, recurrent low back pain complaints are increasing day by day. Besides the use of electrophysical agents and exercise in the treatment of chronic low back pain, education methods used to reduce the negative effects of psychosocial factors are important for healing.

Although there were studies about the combination of Therapeutic Neuroscience Education (TNE) with exercise in CLBP, there are no studies that combine electrophysical agents, exercise and TNE methods in the literature. Therefore, in this study, we aimed to investigate whether TNE combined with physiotherapy consisting of electrophysical modalities and home program exercise is superior to only physiotherapy in patients with CLBP.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Other: physiotherapy and education; Other: Physiotherapy alone

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University Medical Ethics Committee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

The inclusion criteria were:

• aged between 18-60 years
• to have CLBP ˃ 3 months duration
• to have independent walking ability
• to be literate in Turkish.

Exclusion Criteria:

• to have vertebral compression fractures
• to have transitional vertebrae
• to have an underlying tumoral, rheumatologic or inflammatory disease
• to have trauma, surgical history
• to be pregnant or less than six months postpartum period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Physiotherapy plus Education; The experimental group received a three-week program consisting of 15 sessions of physiotherapy and six sessions of therapeutic neuroscience education.	Other: physiotherapy and education; Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program. In addition to physiotherapy, therapeutic neuroscience education were applied to experimental group. One-to-one speech sessions focusing on pain neurophysiology were organized twice a week for three weeks. Each session lasted 40 minutes. The Therapeutic neuroscience education program included nociception, ion channel neurophysiology, central and peripheral sensitization, methods to help reduce sensitization, neuroplasticity, psychosocial factors involved in the transition from acute pain to chronic pain and behavioral, cognitive responses to pain.
ACTIVE_COMPARATOR: Control group; The control group received a three-week program consisting of 15 sessions of physiotherapy alone. .	Other: Physiotherapy alone; Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale	Visual Analogue Scale assessed pain severity. Visual Analog Scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of pain. hence the left end is usually labeled 'no pain', and the right end usually labeled 'extreme pain'. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark by using a ruler. The scale is provided a range of scores from 0-100. High score indicates a high level of pain.	1 minute
Tampa Kinesiophobia Scale	Tampa Kinesiophobia Scale (TKS) evaluated kinesiophobia. TKS is a questionnaire evaluating kinesiophobia due to low back pain. The TKS questionnaire contained 17 items that assessed fear-related concepts. Each item has a four-point Likert scale with scoring options tiered from "strongly agree" to "strongly disagree" and a total score ranging from 17 to 68. Higher scores represented stronger levels of fear avoidance behavior.	Five minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial curl-up	partial curl-up is an endurance test evaluating endurance of trunk flexors.	1 minute
modified Sorensen tests	modified Sorensen tests is an endurance test evaluating isometric endurance of trunk extansors.	Five minutes
Roland Morris Index	Roland Morris Index (RMI) consists of 24 items related to physical functions. The questionnaire is a list of 24 statements relating to activities and the impairments of pain, appetite, mood, and sleep. A total score of the questionnaire range from 0 to 24 and a higher score indicate more severe disability.	Five minutes

Collaborators and Investigators

• Sponsor: Pamukkale University

Publications and helpful links

General Publications

• Walti P, Kool J, Luomajoki H. Short-term effect on pain and function of neurophysiological education and sensorimotor retraining compared to usual physiotherapy in patients with chronic or recurrent non-specific low back pain, a pilot randomized controlled trial. BMC Musculoskelet Disord. 2015 Apr 10;16:83. doi: 10.1186/s12891-015-0533-2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2016
• Primary Completion (ACTUAL): September 2, 2017
• Study Completion (ACTUAL): September 13, 2017

Study Registration Dates

• First Submitted: September 18, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (ACTUAL): September 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: pain; chronic low back pain; kinesiophobia; therapeutic neuroscience education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 60116787-020/8825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data of patients will be given in SPSS program.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No