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Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program

The Effect of Central Nervous System Focused Treatment Program in Chronic Nonspecific Neck Pain -Randomised Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06503562
Enrollment
30
Registered
2024-07-16
Start date
2024-07-10
Completion date
2025-07-10
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain Syndrome, Neck Pain, Rehabilitation

Brief 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. 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.

Interventions

OTHERcentral nervous system focused treatment program

Pain neuroscience education, breathing exercises and relaxation exercises with guided imagery

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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 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, * 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,

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The Numerical Rating Scale (NPRS-11)Change from baseline range of motion at 4th weekThe 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 MotionChange from baseline range of motion at 4th weekCROM 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 ThresholdChange from baseline range of motion at 4th weekA 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 indexChange from baseline range of motion at 4th weekSince 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 ScaleChange from baseline range of motion at 4th weekCatastrophobia 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 questionnaireChange from baseline range of motion at 4th weekFear 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)

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality IndexChange from baseline range of motion at 4th weekIt 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.
SF 12 Quality of lifeChange from baseline range of motion at 4th weekA 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.
Hospital Anxiety and Depression ScaleChange from baseline range of motion at 4th weekHospital 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.
Central Sensitization ScaleChange from baseline range of motion at 4th weekCentral 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.
Global Rating of Change scale (Patient Satisfaction)Change from baseline range of motion at 4th weekPatient 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026