The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
physiotherapy and education
Physiotherapy alone
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring therapeutic neuroscience education, chronic low back pain, kinesiophobia, pain
Eligibility Criteria
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
Sites / Locations
- Pamukkale University Medical Ethics Committee
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physiotherapy plus Education
Control group
Arm Description
The experimental group received a three-week program consisting of 15 sessions of physiotherapy and six sessions of therapeutic neuroscience education.
The control group received a three-week program consisting of 15 sessions of physiotherapy alone. .
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
partial curl-up
partial curl-up is an endurance test evaluating endurance of trunk flexors.
modified Sorensen tests
modified Sorensen tests is an endurance test evaluating isometric endurance of trunk extansors.
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.
Full Information
NCT ID
NCT04099576
First Posted
September 18, 2019
Last Updated
September 19, 2019
Sponsor
Pamukkale University
1. Study Identification
Unique Protocol Identification Number
NCT04099576
Brief Title
The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain
Official Title
Physiotherapy Combined With Therapeutic Neuroscience Education Versus Physiotherapy Alone for Patients With Chronic Low Back Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
September 2, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
therapeutic neuroscience education, chronic low back pain, kinesiophobia, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physiotherapy plus Education
Arm Type
Experimental
Arm Description
The experimental group received a three-week program consisting of 15 sessions of physiotherapy and six sessions of therapeutic neuroscience education.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group received a three-week program consisting of 15 sessions of physiotherapy alone. .
Intervention Type
Other
Intervention Name(s)
physiotherapy and education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy alone
Intervention Description
Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program.
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
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.
Time Frame
1 minute
Title
Tampa Kinesiophobia Scale
Description
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.
Time Frame
Five minutes
Secondary Outcome Measure Information:
Title
partial curl-up
Description
partial curl-up is an endurance test evaluating endurance of trunk flexors.
Time Frame
1 minute
Title
modified Sorensen tests
Description
modified Sorensen tests is an endurance test evaluating isometric endurance of trunk extansors.
Time Frame
Five minutes
Title
Roland Morris Index
Description
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.
Time Frame
Five minutes
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18-60 years
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pamukkale University Medical Ethics Committee
City
Denizli
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data of patients will be given in SPSS program.
Citations:
PubMed Identifier
25887550
Citation
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.
Results Reference
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The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain
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