Chronic Neck PainNBENCT05788263
The Effects of Neuroscience-Based Exercise
A study testing neuroscience based aproach in people with Chronic Neck Pain and Persistent Neck Pain, run by Fatih Tekin at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Neck Pain, Persistent Neck Pain, Neuroscience Approach
- What is being tested?
- neuroscience based aproach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosing with chronic non-specific neck pain
- Volunteer to participate in the study
- beetwen 18-25 years old
Who cannot join
- have had any cervical area surgery
- having any disease that would affect the assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20100
About this study
Official title: The Effects of Neuroscience-Based Exercise Approaches on Pain, Disability and Gait Parameters in Individuals With Chronic Non-Specific Neck Pain
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.
Read the 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.
- Being tested
- neuroscience based aproach
- Keywords
- Neuroscience based exercises, Chronic neck pain, gait parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuroscience based aproachOther
exercise for pain
| Study group | Role | What they receive |
|---|---|---|
| Craniovertebral angle assesment | Experimental | 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. Receives: Other: neuroscience based aproach |
| Spatio-temporal gait analyz (LEGSystm) | Experimental | 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 Receives: Other: neuroscience based aproach |
| Neck Disabilty Index | Experimental | It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life. Receives: Other: neuroscience based aproach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 minute
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.
Measured: 1 minute
Neck Disability Index
It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Mar 2023
- Primary completion20 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- basic randomization via spss 24.00 program
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Tekin
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Sponsor-investigator, Fatih Tekin, Pamukkale University
- Investigators
- fatih tekin, assist prof, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788263
- Sponsor's protocol ID
- NEUROSCİENCE
- Acronym
- NBE
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2023
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuroscience-Based Exercise Approaches on Pain, Disability and Gait Parameters in Individuals With Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT05788263
- Acronym / sponsor ID
- NBE / NEUROSCİENCE
- Keywords
- Neuroscience based exercises, Chronic neck pain, gait parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fatih TekinUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- basic randomization via spss 24.00 program
| Arm | Type | Receives |
|---|---|---|
| Craniovertebral angle assesment | Experimental | Other: neuroscience based aproachCraniovertebral 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. |
| Spatio-temporal gait analyz (LEGSystm) | Experimental | Other: neuroscience based aproachThe 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 Disabilty Index | Experimental | Other: neuroscience based aproachIt is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosing with chronic non-specific neck pain
- Volunteer to participate in the study
- beetwen 18-25 years old
Key exclusion criteria (2 listed)
- have had any cervical area surgery
- having any disease that would affect the assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuroscience based aproachexercise for pain | Other | Craniovertebral angle assesment, Neck Disabilty Index, Spatio-temporal gait analyz (LEGSystm) |
Primary outcome
craniovertebral angle degree
Time frame: 1 minute
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
Time frame: 1 minute
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
Time frame: 3 minutes
It is a questionnaire created to determine the level of disability caused by chronic neck pain in daily life.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatih tekin, assist prof study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuroscience based aproach in people with Chronic Neck Pain and Persistent Neck Pain, run by Fatih Tekin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
craniovertebral angle degree (time frame: 1 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.