Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAcibadem University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
central nervous system focused treatment program
Other interventionPain neuroscience education, breathing exercises and relaxation exercises with guided imagery
Classical Physiotherapy
Other interventionAll 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Traditional Physiotherapy ProgramOther 1 intervention
Group B: Traditional Physiotherapy Program and central nervous system focused treatment programExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline range of motion at 4th week2
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
Time frame
Change from baseline range of motion at 4th week3
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).
Time frame
Change from baseline range of motion at 4th week4
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
Time frame
Change from baseline range of motion at 4th weekSecondary outcomes
1
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.
Time frame
Change from baseline range of motion at 4th week2
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.
Time frame
Change from baseline range of motion at 4th week3
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.
Time frame
Change from baseline range of motion at 4th week4
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.
Time frame
Change from baseline range of motion at 4th weekSponsors and contacts
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Source ClinicalTrials.gov