The Effect of Therapeutic Neuroscience Education on Chronic Low Back Pain

Sponsor
Pamukkale University (Other)
Overall Status
Completed
CT.gov ID
NCT04099576
Collaborator
(none)
31
1
2
10.2
3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: physiotherapy and education
  • Other: Physiotherapy alone
N/A

Study Design

Study Type:
Interventional
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 :
Nov 7, 2016
Actual Primary Completion Date :
Sep 2, 2017
Actual Study Completion Date :
Sep 13, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale [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 [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 [1 minute]

    partial curl-up is an endurance test evaluating endurance of trunk flexors.

  2. modified Sorensen tests [Five minutes]

    modified Sorensen tests is an endurance test evaluating isometric endurance of trunk extansors.

  3. Roland Morris Index [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pamukkale University Medical Ethics Committee Denizli Turkey

Sponsors and Collaborators

  • Pamukkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Suat EREL, Professor, Pamukkale University
ClinicalTrials.gov Identifier:
NCT04099576
Other Study ID Numbers:
  • 60116787-020/8825
First Posted:
Sep 23, 2019
Last Update Posted:
Sep 23, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suat EREL, Professor, Pamukkale University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2019