Chronic Neck Pain: Mobility, Sleep, Function

NCT06583850 | Completed

• 1 other identifier: neckpain
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to compare pain, cervical mobility, sleep quality, and functional status between individuals with chronic neck pain (CNP) and healthy individuals. The study focuses on understanding the complex relationships between these factors in individuals with CNP, with the aim of providing insights that could contribute to more effective rehabilitation strategies. The main questions it aims to answer are:

• How pain, cervical mobility, sleep quality, and functional status differs between individuals with and without chronic neck pain?
• What is the relationship between functional status and cervical mobility and sleep quality in individuals with chronic neck pain?

Conditions

Pain; Neck

Keywords

pain; neck; range of motion; sleep quality; functional status

Outcome Measures

Primary Outcomes (4)

• The Neck Disability Index

  The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability.

  Baseline

• Pittsburgh Sleep Quality

  Five questions on the scale are answered by the participant\'s partner or roommate and are used solely for clinical information..The PSQI has seven components: subjective sleep quality, sleep latency, total sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score is calculated by summing the scores of the seven components, ranging from 0 to 21 points.

  Baseline

• Visual analog scale

  A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain.

  Baseline

• Range of motion

  Active Cervical Range of Motion Assessment was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane). The same physiotherapist performed all goniometric measurements to eliminate any differences between the measurements that the measurer could cause. The American Association of Orthopaedic Surgeons (AAOS) values were taken as a reference for NEH in the cervical region. Care was taken to ensure that the participant wore comfortable clothes during the measurements. Before starting the measurement, the desired movement was shown to the participant by the physiotherapist.

  Baseline

Study Arms (2)

chronic neck pain

chronic neck pain (CNP) (persists longer than 3 months.

Other: The Neck Disability Index; Other: Visual analog scale (VAS); Other: Pittsburgh Sleep Quality Index; Other: Cervical Range of Motion Assessment

control

healthy controls

Other: The Neck Disability Index; Other: Visual analog scale (VAS); Other: Pittsburgh Sleep Quality Index; Other: Cervical Range of Motion Assessment

Interventions

The Neck Disability Index OTHER

The Neck Disability Index (NDI) is the most widely used self-report tool to assess neck pain status, and provides information not only about pain experiences but also about a person\'s functional status. The NDI consists of 10 questions related to pain, functional activities, self-care, and quality of life that are measured on a 6-point scale (0, no disability; 5, full disability). The numeric score for each item is summed for a score ranging from 0 to 50; 0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability and above 35 points as complete disability.

chronic neck pain; control

Visual analog scale (VAS) OTHER

A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain. Participants were asked to mark a point between 0-10 according to their pain status

chronic neck pain; control

Pittsburgh Sleep Quality Index OTHER

Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire

chronic neck pain; control

Cervical Range of Motion Assessment OTHER

Active Cervical Range Of Motion was measured with a universal goniometer in all three planes of motion in the cervical region: lateral flexion (frontal plane), axial rotation to both right and left sides (horizontal plane), and flexion-extension (sagittal plane).

chronic neck pain; control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Chronic neck pain and healthy controls

You may qualify if:

• Age between 18 and 55 years.
• Chronic neck pain (CNP) persisting for longer than 3 months (for the CNP group).
• Volunteering participation in the study.
• Healthy controls, including relatives of CNP participants.

You may not qualify if:

• History of neck trauma or other cervical spine conditions (e.g., radiculopathy).
• Prior surgical interventions involving the head, face, cervical spine, upper or lower extremities, or cervical disc herniation.
• Degenerative spinal conditions.
• Use of analgesics, anti-inflammatory medications, or muscle relaxants within the previous week.
• Presence of rheumatological or cardiovascular diseases, chronic neurological or psychiatric disorders, substance abuse, anemia, or diabetes.

Sponsors & Collaborators

• Gamze Demircioğlu: lead

Study Sites (1)

Istanbul Atlas Univercity

Istanbul, Hamidiye, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 4, 2024
• Study Start: June 5, 2024
• Primary Completion: September 4, 2024
• Study Completion: September 26, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

TU (1)