Chronic Neck Pain: Mobility, Sleep, Function (observational)

Evaluation of Pain, Cervical Mobility, Sleep Quality and Functional Status in Individuals with Chronic Neck Pain

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?

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Turkey
  • Hamidiye
    • Istanbul, Hamidiye, Turkey
      • Istanbul Atlas Univercity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Chronic neck pain and healthy controls

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control; healthy controls	Other: 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'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.; Other: Visual analog scale (VAS); 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; Other: Pittsburgh Sleep Quality Index; Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire; Other: Cervical Range of Motion Assessment; 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; chronic neck pain (CNP) (persists longer than 3 months.	Other: 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'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.; Other: Visual analog scale (VAS); 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; Other: Pittsburgh Sleep Quality Index; Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire; Other: Cervical Range of Motion Assessment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gamze Demircioğlu

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Actual): September 4, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 26, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: pain; functional status; sleep quality; neck; range of motion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: neckpain

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No