Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program
NCT Number: NCT06503562
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Neck Pain|Chronic Pain Syndrome|Rehabilitation
Interventions: OTHER: central nervous system focused treatment program|OTHER: Classical Physiotherapy
Sponsor: Acibadem University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-07-10
Locations: Acibadem University, Istanbul, +90, Turkey|Nuray ALACA, Istanbul, +90, Turkey

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.

Primary Outcome Measures: 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., 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, 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)., 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, 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, 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), Change from baseline range of motion at 4th week
Secondary Outcome Measures: 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., 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., 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., 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., 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., Change from baseline range of motion at 4th week