The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain
|ClinicalTrials.gov Identifier: NCT04099576|
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Low-back Pain||Other: physiotherapy and education Other: Physiotherapy alone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Physiotherapy Combined With Therapeutic Neuroscience Education Versus Physiotherapy Alone for Patients With Chronic Low Back Pain: a Randomized Controlled Trial|
|Actual Study Start Date :||November 7, 2016|
|Actual Primary Completion Date :||September 2, 2017|
|Actual Study Completion Date :||September 13, 2017|
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.
- Visual Analogue Scale [ Time Frame: 1 minute ]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.
- Tampa Kinesiophobia Scale [ Time Frame: Five minutes ]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.
- partial curl-up [ Time Frame: 1 minute ]partial curl-up is an endurance test evaluating endurance of trunk flexors.
- modified Sorensen tests [ Time Frame: Five minutes ]modified Sorensen tests is an endurance test evaluating isometric endurance of trunk extansors.
- Roland Morris Index [ Time Frame: Five minutes ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099576
|Pamukkale University Medical Ethics Committee|