Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099576
Recruitment Status : Completed
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Suat EREL, Pamukkale University

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.


Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Other: physiotherapy and education Other: Physiotherapy alone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. partial curl-up [ Time Frame: 1 minute ]
    partial curl-up is an endurance test evaluating endurance of trunk flexors.

  2. modified Sorensen tests [ Time Frame: Five minutes ]
    modified Sorensen tests is an endurance test evaluating isometric endurance of trunk extansors.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-60 years
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099576


Locations
Layout table for location information
Turkey
Pamukkale University Medical Ethics Committee
Denizli, Turkey
Sponsors and Collaborators
Pamukkale University
Publications:
Layout table for additonal information
Responsible Party: Suat EREL, Professor, Pamukkale University
ClinicalTrials.gov Identifier: NCT04099576    
Other Study ID Numbers: 60116787-020/8825
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data of patients will be given in SPSS program.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suat EREL, Pamukkale University:
therapeutic neuroscience education
chronic low back pain
kinesiophobia
pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms