Skip to main content
Clinical Trials/NCT06503562
NCT06503562
Recruiting
Not Applicable

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

Acibadem University2 sites in 1 country30 target enrollmentJuly 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neck Pain
Sponsor
Acibadem University
Enrollment
30
Locations
2
Primary Endpoint
The Numerical Rating Scale (NPRS-11)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2024
End Date
July 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Acibadem University
Responsible Party
Principal Investigator
Principal Investigator

Nuray Alaca

Assoc, Prof. Nuray Alaca, Head of department Physiotherapy and Rehabilitation

Acibadem University

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,

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

Outcomes

Primary Outcomes

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

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)

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

Secondary Outcomes

  • Central Sensitization Scale(Change from baseline range of motion at 4th week)
  • Global Rating of Change scale (Patient Satisfaction)(Change from baseline range of motion at 4th week)
  • Pittsburgh Sleep Quality Index(Change from baseline range of motion at 4th week)
  • SF 12 Quality of life(Change from baseline range of motion at 4th week)
  • Hospital Anxiety and Depression Scale(Change from baseline range of motion at 4th week)

Study Sites (2)

Loading locations...

Similar Trials