Chronic Nonspecific Neck Pain and Central Nervous System Focused Treatment Program

NCT06503562 | Recruiting

• 1 other identifier: ATADEK-2024-9/341
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Chronic Pain Syndrome; Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

• 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

Study Arms (2)

Traditional Physiotherapy Program

OTHER

Other: Classical Physiotherapy

Traditional Physiotherapy Program and central nervous system focused treatment program

EXPERIMENTAL

Other: central nervous system focused treatment program; Other: Classical Physiotherapy

Interventions

central nervous system focused treatment program OTHER

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

Traditional Physiotherapy Program and central nervous system focused treatment program

Classical Physiotherapy OTHER

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.

Traditional Physiotherapy Program; Traditional Physiotherapy Program and central nervous system focused treatment program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (2)

Acibadem University

Istanbul, +90, Turkey (Türkiye)

RECRUITING

Nuray ALACA

Istanbul, +90, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nuray ALACA

CONTACT

05324251290; nuray.alaca@acibadem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc, Prof. Nuray Alaca, Head of department Physiotherapy and Rehabilitation

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: July 10, 2024
• Primary Completion: November 10, 2024
• Study Completion: July 10, 2025
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

TU (2)