Neck PainNCT05249517
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain
A study testing Pain Neuroscience Education and Progressive submaximal exercise program in people with Neck Pain, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Pain Neuroscience Education and Progressive submaximal exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 8 Dec 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 18-55
- History of neck pain lasting at least three months
- Agreeing to participate in the study
- Being able to read and write Turkish
- Having a computer or tablet and an active internet connection at home
- To be able to use a computer, tablet and internet at a level to participate in video conference or to have a relative who can help in this regard.
Who cannot join
- History of spinal surgery
- Traumatic cervical injuries
- Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
- Tumor conditions
- Having vision and hearing problems
- Cognitive problems
- Receiving physiotherapy for neck and/or low back pain in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Izmir
About this study
Official title: Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain: A Double-Blinded Randomized Controlled Trial
In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated.
Read the detailed description
Neck pain is a general health problem that is very common in society and affects daily life activities by causing disability. Non-specific chronic neck pain is defined as "continuous neck pain that persists for 12 weeks or longer beyond the healing process without any known specific pathology. Chronic pain is considered to be a complex problem in which cognitive and emotional factors, as well as biological factors, significantly affect the perception of pain. In the last decade, a patient education model that educates people about the neurobiology and neurophysiology of pain has been recognized as an intriguing approach to the management of chronic pain. Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain. In the literature, there is evidence supporting the use of PNE in reducing pain and disability and overcoming the psychosocial factors of chronic pain.
While the Covid-19 pandemic has made telerehabilitation applications widespread, it has also shown us its necessity, but until now, no study in which Pain Neuroscience Education was carried out with the telerehabilitation method has been found in the literature.
This study aimed to perform Pain Neuroscience Education with the telerehabilitation method on patients with non-specific chronic neck pain and to examine the effects on pain-related factors, disability, and quality of life.
It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. In this study, in addition to telerehabilitation-based PNE, progressive submaximal exercise program will also be given to the participants through telerehabilitation.
- Conditions
- Neck Pain
- Being tested
- Pain Neuroscience Education, Progressive submaximal exercise program
- Keywords
- Neck pain, Telerehabilitation, Pain neuroscience education
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience EducationOther
Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain.
Progressive submaximal exercise programOther
It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood.
| Study group | Role | What they receive |
|---|---|---|
| Pain Neuroscience Education (PNE) | Experimental | Telerehabilitation based pain neuroscience education Receives: Other: Pain Neuroscience Education |
| Exercise + PNE | Active comparator | Telerehabilitation based progressive submaximal exercise program and PNE Receives: Other: Progressive submaximal exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numerical Pain Rating Scale will be used to evaluate the severity of pain. Participants will be asked to determine the number that best describes their pain, with 0 = no pain and 10 = unbearable pain, on a scale divided into numbers between 0 and 10 for the severity of pain they feel during rest and activity.
Measured: 6 weeks
Neurophysiology of Pain Questionnaire
The Neurophysiology of Pain Questionnaire will be used to assess pain information. The Pain Neurophysiology Questionnaire was developed as a method of assessing whether healthcare professionals and patients understand the pain and its underlying complex neurophysiological mechanisms. Scoring is in the range of 0-13 points according to the number of correct answers given. Higher scores mean better pain knowledge. It is widely used by clinicians to monitor information exchange in pain education interventions.
Measured: 6 weeks
Secondary outcomes (4)
Neck Disability Index
The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The ındex consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each item is scored between zero (no disability) and five (total disability). The maximum score is therefore 50. Higher scores indicate having more disabilities.
Measured: 6 weeks
Tampa Scale of Kinesiophobia
Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia, which is an anxiety state that develops against activity and physical movement due to pain and fear of re-injury. The scale has 17 pain statements, and the patient selected her agreement for each question using a 4-point scale. The maximum score is 68. Higher score indicates having more fear of movement.
Measured: 6 weeks
Pain Catastrophising Scale
Pain Catastrophising Scale will be used to determine the degree of pain catastrophising felt by individuals with pain. Pain Catastrophising Scale is a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.
Measured: 6 weeks
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
The Turkish version of the World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF) will be used to assess the quality of life. The scale consists of 4 quality of life domains: physical, psychological, social relations and environmental. It has 27 statements and the maximum score is 135. Higher score means higher quality of life.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Feb 2022
- Primary completion8 Sep 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Ozturk, Dokuz Eylul University
- Investigators
- Yesim SALIK SENGUL, Assoc. Prof., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249517
- Sponsor's protocol ID
- DokuzEU_AO
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05249517
- Acronym / sponsor ID
- DokuzEU_AO
- Conditions
- Neck Pain
- Keywords
- Neck pain, Telerehabilitation, Pain neuroscience education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 21 Feb 2022 (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.
In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated.
Detailed description
Neck pain is a general health problem that is very common in society and affects daily life activities by causing disability. Non-specific chronic neck pain is defined as "continuous neck pain that persists for 12 weeks or longer beyond the healing process without any known specific pathology. Chronic pain is considered to be a complex problem in which cognitive and emotional factors, as well as biological factors, significantly affect the perception of pain. In the last decade, a patient education model that educates people about the neurobiology and neurophysiology of pain has been recognized as an intriguing approach to the management of chronic pain. Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain. In the literature, there is evidence supporting the use of PNE in reducing pain and disability and overcoming the psychosocial factors of chronic pain.
While the Covid-19 pandemic has made telerehabilitation applications widespread, it has also shown us its necessity, but until now, no study in which Pain Neuroscience Education was carried out with the telerehabilitation method has been found in the literature.
This study aimed to perform Pain Neuroscience Education with the telerehabilitation method on patients with non-specific chronic neck pain and to examine the effects on pain-related factors, disability, and quality of life.
It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. In this study, in addition to telerehabilitation-based PNE, progressive submaximal exercise program will also be given to the participants through telerehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Pain Neuroscience Education (PNE) | Experimental | Other: Pain Neuroscience EducationTelerehabilitation based pain neuroscience education |
| Exercise + PNE | Active comparator | Other: Progressive submaximal exercise programTelerehabilitation based progressive submaximal exercise program and PNE |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between the ages of 18-55
- History of neck pain lasting at least three months
- Agreeing to participate in the study
- Being able to read and write Turkish
- Having a computer or tablet and an active internet connection at home
Key exclusion criteria (7 listed)
- History of spinal surgery
- Traumatic cervical injuries
- Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
- Tumor conditions
- Having vision and hearing problems
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 |
|---|---|---|
| Pain Neuroscience EducationPain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain. | Other | Pain Neuroscience Education (PNE) |
| Progressive submaximal exercise programIt has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. | Other | Exercise + PNE |
Primary outcome
Numeric Pain Rating Scale
Time frame: 6 weeks
Numerical Pain Rating Scale will be used to evaluate the severity of pain. Participants will be asked to determine the number that best describes their pain, with 0 = no pain and 10 = unbearable pain, on a scale divided into numbers between 0 and 10 for the severity of pain they feel during rest and activity.
Neurophysiology of Pain Questionnaire
Time frame: 6 weeks
The Neurophysiology of Pain Questionnaire will be used to assess pain information. The Pain Neurophysiology Questionnaire was developed as a method of assessing whether healthcare professionals and patients understand the pain and its underlying complex neurophysiological mechanisms. Scoring is in the range of 0-13 points according to the number of correct answers given. Higher scores mean better pain knowledge. It is widely used by clinicians to monitor information exchange in pain education interventions.
4 secondary outcomes
Neck Disability Index
Time frame: 6 weeks
Tampa Scale of Kinesiophobia
Time frame: 6 weeks
Pain Catastrophising Scale
Time frame: 6 weeks
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
Time frame: 6 weeks
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 15 Feb 2023.
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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.
Yesim SALIK SENGUL, Assoc. Prof. principal investigator
Dokuz Eylul 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 Pain Neuroscience Education and Progressive submaximal exercise program in people with Neck Pain, run by Dokuz Eylul University 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 6 inclusion and 7 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 15 Feb 2023. 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?
Numeric Pain Rating Scale (time frame: 6 weeks). The study lists 2 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 15 Feb 2023.