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The Effects of Neuroscience-Based Exercise (NBE)

Primary Purpose

Chronic Neck Pain, Persistent Neck Pain, Neuroscience Approach

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
neuroscience based aproach
Sponsored by
Fatih Tekin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Neck Pain focused on measuring Neuroscience based exercises, Chronic neck pain, gait parameters

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosing with chronic non-specific neck pain Volunteer to participate in the study beetwen 18-25 years old Exclusion Criteria: have had any cervical area surgery having any disease that would affect the assessments

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Craniovertebral angle assesment

Spatio-temporal gait analyz (LEGSystm)

Neck Disabilty Index

Arm Description

Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.

The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm. The device consists of two sensors. The sensors are placed 3-5 cm above the ankle of the subject to be tested with the help of velcro. The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth. The software analyzes the raw data it receives from the device and turns it into results.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time

It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.

Outcomes

Primary Outcome Measures

craniovertebral angle degree
Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.
Legsystm
The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm. The device consists of two sensors. The sensors are placed 3-5 cm above the ankle of the subject to be tested with the help of velcro. The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth. The software analyzes the raw data it receives from the device and turns it into results.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.
Neck Disability Index
It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
April 4, 2023
Sponsor
Fatih Tekin
Collaborators
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT05788263
Brief Title
The Effects of Neuroscience-Based Exercise
Acronym
NBE
Official Title
The Effects of Neuroscience-Based Exercise Approaches on Pain, Disability and Gait Parameters in Individuals With Chronic Non-Specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatih Tekin
Collaborators
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to examine the effects of neuroscience-based exercise approaches on pain, disability and gait parameters in individuals with non-specific chronic neck pain. Material- Methods Demographic data, gait parameters, Dizabilty level and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Neck Disability Index and photometer, respectively. The evaluations were performed 2 times before and after the treatment.
Detailed Description
Neuroscience-based exercise approaches are a promising method that has been introduced in recent years in the treatment of non-specific musculoskeletal pain and related dysfunctions. The basis of this method is the exercises and trainings created by considering the neurobiological (changes in tissues) and neurophysiological basis (brain fog, somatosensory sensitization) of nociplastic pain in the musculoskeletal system. In the neuroscience-based exercise approach, it is aimed to reduce the increase in sensitivity in brain fog and somatosensory pathways. The main purpose is to teach the cortex that movement can be done painlessly and accurately and to alleviate the symptoms in the related tissues. It is aimed to perform the exercise painlessly and accurately by adding cognitive goals and changing the focus (14). In the literature, although there are very few studies showing that neuroscience education and therapeutic exercise combinations are effective on chronic nociplastic pain in patients with non-specific chronic neck pain, no studies examining the effects of neuroscience-based exercise approaches on gait parameters in individuals with non-specific chronic neck pain were found (15). ,16). Our study will contribute to the literature in this field and will reveal the effects of neuroscience-based exercise approaches more clearly. The aim of this study is to examine the effects of neuroscience-based exercise approaches on pain, disability and gait parameters in individuals with non-specific chronic neck pain. Material- Methods Demographic data, gait parameters, Dizabilty level and craniovertebral angle values of individuals were evaluated with clinical data evaluation form, Spatio-Temporal Gait Analysis (LEGSystm), Neck Disability Index and photometer, respectively. The evaluations were performed 2 times before and after the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain, Persistent Neck Pain, Neuroscience Approach
Keywords
Neuroscience based exercises, Chronic neck pain, gait parameters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
basic randomization via spss 24.00 program
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Craniovertebral angle assesment
Arm Type
Experimental
Arm Description
Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.
Arm Title
Spatio-temporal gait analyz (LEGSystm)
Arm Type
Experimental
Arm Description
The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm. The device consists of two sensors. The sensors are placed 3-5 cm above the ankle of the subject to be tested with the help of velcro. The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth. The software analyzes the raw data it receives from the device and turns it into results.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time
Arm Title
Neck Disabilty Index
Arm Type
Experimental
Arm Description
It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.
Intervention Type
Other
Intervention Name(s)
neuroscience based aproach
Intervention Description
exercise for pain
Primary Outcome Measure Information:
Title
craniovertebral angle degree
Description
Craniovertebral angle is the most widely used measurement to assess Forward head posture. Craniovertebral angle is described as the acute angle formed between a horizontal line passing through the spinous process of the seventh cervical vertebra (C7) and the line connecting the midpoint of the tragus to the spinous process of C7.
Time Frame
1 minute
Title
Legsystm
Description
The gait performance of the cases was evaluated with a spatio-temporal gait analysis device named LEGSystm developed by BioSensicstm. The device consists of two sensors. The sensors are placed 3-5 cm above the ankle of the subject to be tested with the help of velcro. The device is controlled from the computer with its own software and instantly sends the raw data it collects to the computer via Bluetooth. The software analyzes the raw data it receives from the device and turns it into results.The Modified Get Up and Go Test (MKYT), which is also supported by the legsyst, was used for assesment. The test was repeated 2 times and the average time was recorded. Legsystm provides information on double stride length, duration and speed of walking, as well as standing, turning, sitting times and total time.
Time Frame
1 minute
Title
Neck Disability Index
Description
It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosing with chronic non-specific neck pain Volunteer to participate in the study beetwen 18-25 years old Exclusion Criteria: have had any cervical area surgery having any disease that would affect the assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatih tekin, assist prof
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Pamukkale
ZIP/Postal Code
20100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Neuroscience-Based Exercise

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