Chronic Neck Pain: Assessing Pain, Mobility, Sleep, and Function

Recruiting

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

• Registration Number: NCT06583850
• Lead Sponsor: Gamze Demircioğlu

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-05
• Status Verified: 2024-09
• Primary Completion: 2024-09-02
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-02
• Last Update Submitted: 2024-09-02
• Study First Posted: 2024-09-04
• Last Update Posted: 2024-09-04
• Study Completion: 2024-09-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic neck pain	The Neck Disability Index	chronic neck pain (CNP) (persists longer than 3 months.
chronic neck pain	Visual analog scale (VAS)	chronic neck pain (CNP) (persists longer than 3 months.
chronic neck pain	Pittsburgh Sleep Quality Index	chronic neck pain (CNP) (persists longer than 3 months.
chronic neck pain	Cervical Range of Motion Assessment	chronic neck pain (CNP) (persists longer than 3 months.
control	The Neck Disability Index	healthy controls
control	Visual analog scale (VAS)	healthy controls
control	Pittsburgh Sleep Quality Index	healthy controls
control	Cervical Range of Motion Assessment	healthy controls

Primary Outcome Measures

Name	Time	Method
The Neck Disability Index	Baseline	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.
Pittsburgh Sleep Quality	Baseline	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.
Visual analog scale	Baseline	A 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain.
Range of motion	Baseline	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.

Trial Locations

Locations (1)

Istanbul Atlas Univercity; 🇹🇷 Istanbul, Hamidiye, Turkey