The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain

NCT04099576 | Completed

• 1 other identifier: 60116787-020/8825
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain

Keywords

therapeutic neuroscience education; chronic low back pain; kinesiophobia; pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• partial curl-up

  1 minute

• modified Sorensen tests

  Five minutes

• Roland Morris Index

  Five minutes

Study Arms (2)

Physiotherapy plus Education

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

The control group received a three-week program consisting of 15 sessions of physiotherapy alone. .

Other: Physiotherapy alone

Interventions

physiotherapy and education OTHER

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.

Physiotherapy plus Education

Physiotherapy alone OTHER

Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program.

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: 18-60 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University Medical Ethics Committee

Denizli, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 25887550 BACKGROUND

MeSH Terms

Conditions

Kinesiophobia; Pain

Interventions

Physical Therapy Modalities; Educational Status

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 23, 2019
• Study Start: November 7, 2016
• Primary Completion: September 2, 2017
• Study Completion: September 13, 2017
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)