Neck PainNCT06503562
Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program
A study testing central nervous system focused treatment program and Classical Physiotherapy in people with Neck Pain and Chronic Pain Syndrome, run by Acibadem University at 2 sites in Turkey (Türkiye).
Trial summary
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Chronic Pain Syndrome, Rehabilitation
- What is being tested?
- central nervous system focused treatment program and Classical Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Jul 2024to 10 Jul 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with nonspecific neck pain by a doctor,
- To be between the ages of 18-65,
- Having neck pain for more than 3 months
- No previous neck or shoulder surgery,
- No shoulder pain due to any cause,
- A tumour or inflammatory disease underlying the neck pain not to be found,
Show all 12Show fewer
- A clinically underlying stenosis or discogenic problem not to be present.
- Negative results from the following clinical examination tests;
- Spurling test,
- Lhermitte test,
- Cervical distraction test,
- Adson test,
Who cannot join
- Not meeting the inclusion criteria,
- Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
- Systemic rheumatological or metabolic diseases or cancer
- Refusal to participate in the study,
- Failure to complete treatment,
- Having any neurological problem
- Severe psychological illnesses
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Acibadem University
Istanbul, Turkey, +90
Nuray ALACA
Istanbul, Turkey, +90
About this study
Official title: The Effect of Central Nervous System Focused Treatment Program in Chronic Nonspecific Neck Pain -Randomised Controlled Trial
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. Patients with chronic nonspecific neck pain (CNSP) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. However, it is also reported that chronic pain occurs as a result of neuroplasticity, that is, the brain learning pain through the central synthesis mechanism in the central nervous system. For this reason, although the importance of central nervous system-oriented therapies is increasing day by day, this system-oriented therapies are still ignored in clinics. Therefore, in this master's thesis study, it is aimed to investigate the effects of central nervous system-focused therapies (pain neuroscience education, breathing exercises and relaxation exercises with guided imagery) on pain, range of motion, functional status, pain-related fear, anxiety, depression and quality of life in addition to traditional physiotherapy applied to patients with CNSP.
- Conditions
- Neck Pain, Chronic Pain Syndrome, Rehabilitation
- Being tested
- central nervous system focused treatment program, Classical Physiotherapy
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central nervous system focused treatment programOther
Pain neuroscience education, breathing exercises and relaxation exercises with guided imagery
Classical PhysiotherapyOther
All participants will receive conventional physiotherapy five days a week for one month. Transcutaneous electrical nerve stimulation, 15 min hotpack will be applied to the neck and back. Afterwards, mobilisations to the cervical and thoracic spine joints and myofascial release to the upper trapezius muscle will be applied. The patient will be given 3X10 neck active range of motion exercises to do at home every day and self stretches to the muscles in the neck region (SCM, upper trapezius, scalene and pectoral) according to the patient's condition. After the first week, strengthening exercises with isometric and resistive isotonic exercises will be given to the neck and upper back muscles gradually increasing. Patients will not be given any medication and will be asked not to use any medication.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Physiotherapy Program | Other | Not described Receives: Other: Classical Physiotherapy |
| Traditional Physiotherapy Program and central nervous system focused treatment program | Experimental | Not described Receives: Other: central nervous system focused treatment program; Other: Classical Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale (NPRS-11)
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Measured: Change from baseline range of motion at 4th week
Range of Motion
CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures
Measured: Change from baseline range of motion at 4th week
Pressure Pain Threshold
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Measured: Change from baseline range of motion at 4th week
Neck disability index
Since some parts of the 10-item questionnaire could not be answered by the patients (driving, working life), the average neck disability index score will be calculated by dividing the total score by the number of questions answered. The scoring is between 0 and 50. 0 points means the best result, 50 points means the worst result. 0 - 4 points; no disability, 5 - 14 points; mild disability, 15 - 24 points; moderate disability, 25 - 34 points; severe disability, > 35 points; complete disability
Measured: Change from baseline range of motion at 4th week
Pain Catastrophizing Scale
Catastrophobia one of the cognitive and emotional outcomes of chronic pain, is an important concept related to the perception of pain. Catastrophobic people tend to feel pain more severe than it actually is. The Pain Catastrophobia Scale consists of 13 items and assesses the frequency of concerns about the perception and persistence of existing pain. It has 3 subheadings: helplessness, magnification and rumination. It is scored as never (0) and always (4). The person can score a total of 52 points
Measured: Change from baseline range of motion at 4th week
Fear avoidance belief questionnaire
Fear avoidance belief questionnaire is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
Measured: Change from baseline range of motion at 4th week
Secondary outcomes (5)
Pittsburgh Sleep Quality Index
It containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over.
Measured: Change from baseline range of motion at 4th week
SF 12 Quality of life
A health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health.Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less on the physical-quality of life 12 has been recommended as a cut-off to determine a physical condition; while a score of 42 or less on the mental quality of life may be indicative of 'clinical depression.
Measured: Change from baseline range of motion at 4th week
Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Measured: Change from baseline range of motion at 4th week
Central Sensitization Scale
Central Sensitization Scale, which can be applied in the presence of chronic pain, is used in central sensitization syndromes. It consists of two parts. Part A of the scale includes a Likert scale (0-4 points) that questions health-related symptoms. This section is scored from 0 to 100, with higher numbers being associated with a higher degree of central sensitization. Scores of 40 and above indicate the presence of central sensitization. In section B, it questions whether any of the central sensitization syndromes have been diagnosed before.
Measured: Change from baseline range of motion at 4th week
Global Rating of Change scale (Patient Satisfaction)
Patient satisfaction regarding improvement in shoulder function will be evaluated by the Global Rating of Change scale. All participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly between -3 to +3, with a higher value indicating better condition in this study.
Measured: Change from baseline range of motion at 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start10 Jul 2024
- Primary completion10 Nov 2024
- Study completion10 Jul 2025
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.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Alaca, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06503562
- Sponsor's protocol ID
- ATADEK-2024-9/341
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Central Nervous System Focused Treatment Program in Chronic Nonspecific Neck Pain -Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06503562
- Acronym / sponsor ID
- ATADEK-2024-9/341
- Conditions
- Neck Pain, Chronic Pain Syndrome, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 16 Jul 2024 (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.
Neck pain is one of the most common musculoskeletal pain disorders secondary to low back pain. Pharmacological and non-medical treatments such as physiotherapy are applied in its treatment. Patients with chronic nonspecific neck pain (CNSP) can be treated with various interventions such as drug therapy, manual therapy, heat and exercise. However, it is also reported that chronic pain occurs as a result of neuroplasticity, that is, the brain learning pain through the central synthesis mechanism in the central nervous system. For this reason, although the importance of central nervous system-oriented therapies is increasing day by day, this system-oriented therapies are still ignored in clinics. Therefore, in this master's thesis study, it is aimed to investigate the effects of central nervous system-focused therapies (pain neuroscience education, breathing exercises and relaxation exercises with guided imagery) on pain, range of motion, functional status, pain-related fear, anxiety, depression and quality of life in addition to traditional physiotherapy applied to patients with CNSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Physiotherapy Program | Other | Other: Classical Physiotherapy |
| Traditional Physiotherapy Program and central nervous system focused treatment program | Experimental | Other: central nervous system focused treatment program, Other: Classical Physiotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Being diagnosed with nonspecific neck pain by a doctor,
- To be between the ages of 18-65,
- Having neck pain for more than 3 months
- No previous neck or shoulder surgery,
- No shoulder pain due to any cause,
Key exclusion criteria (7 listed)
- Not meeting the inclusion criteria,
- Positive neurological examination (positive motor presence, reflex or sensory abnormalities indicating spinal root compression) or abnormal neurological findings related to nerve compression in the upper limb
- Systemic rheumatological or metabolic diseases or cancer
- Refusal to participate in the study,
- Failure to complete treatment,
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 |
|---|---|---|
| central nervous system focused treatment programPain neuroscience education, breathing exercises and relaxation exercises with guided imagery | Other | Traditional Physiotherapy Program and central nervous system focused treatment program |
| Classical PhysiotherapyAll participants will receive conventional physiotherapy five days a week for one month. Transcutaneous electrical nerve stimulation, 15 min hotpack will be applied to the neck and back. Afterwards, mobilisations to the cervical and thoracic spine joints and myofascial release to the upper trapezius muscle will be applied. The patient will be given 3X10 neck active range of motion exercises to do at home every day and self stretches to the muscles in the neck region (SCM, upper trapezius, scalene and pectoral) according to the patient's condition. After the first week, strengthening exercises with isometric and resistive isotonic exercises will be given to the neck and upper back muscles gradually increasing. Patients will not be given any medication and will be asked not to use any medication. | Other | Traditional Physiotherapy Program, Traditional Physiotherapy Program and central nervous system focused treatment program |
Primary outcome
The Numerical Rating Scale (NPRS-11)
Time frame: Change from baseline range of motion at 4th week
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Range of Motion
Time frame: Change from baseline range of motion at 4th week
CROM device will be used. The active range of motion of each individual will be measured and measured in accordance with the manufacturer's procedures
Pressure Pain Threshold
Time frame: Change from baseline range of motion at 4th week
A digital pressure algometer will be applied to the web space of the foot opposite the trigger point. Participants are instructed to say "stop" or "pain" so the stimulus can be terminated "when the sensation first transitions from pressure to pain" (pain threshold).
Neck disability index
Time frame: Change from baseline range of motion at 4th week
Since some parts of the 10-item questionnaire could not be answered by the patients (driving, working life), the average neck disability index score will be calculated by dividing the total score by the number of questions answered. The scoring is between 0 and 50. 0 points means the best result, 50 points means the worst result. 0 - 4 points; no disability, 5 - 14 points; mild disability, 15 - 24 points; moderate disability, 25 - 34 points; severe disability, > 35 points; complete disability
Pain Catastrophizing Scale
Time frame: Change from baseline range of motion at 4th week
Catastrophobia one of the cognitive and emotional outcomes of chronic pain, is an important concept related to the perception of pain. Catastrophobic people tend to feel pain more severe than it actually is. The Pain Catastrophobia Scale consists of 13 items and assesses the frequency of concerns about the perception and persistence of existing pain. It has 3 subheadings: helplessness, magnification and rumination. It is scored as never (0) and always (4). The person can score a total of 52 points
Fear avoidance belief questionnaire
Time frame: Change from baseline range of motion at 4th week
Fear avoidance belief questionnaire is a questionnaire based on the fear-avoidance model of exaggerated pain perception. The FABQ measures patient's fear of pain and consequent avoidance of physical activity (PA) because of their fear.There is a maximum score of 96. A higher score indicates more strongly held fear avoidance beliefs. There are two subscales within the FABQ; the work subscale (FABQw) with 7 questions (maximum score of 42) and the physical activity subscale (FABQpa) with 4 questions (maximum score of 24)
5 secondary outcomes
Pittsburgh Sleep Quality Index
Time frame: Change from baseline range of motion at 4th week
SF 12 Quality of life
Time frame: Change from baseline range of motion at 4th week
Hospital Anxiety and Depression Scale
Time frame: Change from baseline range of motion at 4th week
Central Sensitization Scale
Time frame: Change from baseline range of motion at 4th week
Global Rating of Change scale (Patient Satisfaction)
Time frame: Change from baseline range of motion at 4th week
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 24 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing central nervous system focused treatment program and Classical Physiotherapy in people with Neck Pain and Chronic Pain Syndrome, run by Acibadem University at 2 sites 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 12 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 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The Numerical Rating Scale (NPRS-11) (time frame: Change from baseline range of motion at 4th week). The study lists 6 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 24 Jul 2026.