Clinical trial NCT06503562: Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program
Official title: The Effect of Central Nervous System Focused Treatment Program in Chronic Nonspecific Neck Pain -Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neck Pain
Chronic Pain Syndrome
Rehabilitation
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Numerical Rating Scale (NPRS-11)
timeFrame: Change from baseline range of motion at 4th week
measure: Range of Motion
timeFrame: Change from baseline range of motion at 4th week
measure: Pressure Pain Threshold
timeFrame: Change from baseline range of motion at 4th week
measure: Neck disability index
timeFrame: Change from baseline range of motion at 4th week
measure: Pain Catastrophizing Scale
timeFrame: Change from baseline range of motion at 4th week
measure: Fear avoidance belief questionnaire
timeFrame: Change from baseline range of motion at 4th week
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline range of motion at 4th week
measure: SF 12 Quality of life
timeFrame: Change from baseline range of motion at 4th week
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from baseline range of motion at 4th week
measure: Central Sensitization Scale
timeFrame: Change from baseline range of motion at 4th week
measure: Global Rating of Change scale (Patient Satisfaction)
timeFrame: Change from baseline range of motion at 4th week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
city: Istanbul
country: Turkey
facility: Nuray ALACA
Study officials:
References: