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Chronic Neck Pain: Mobility, Sleep, Function

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06583850
Acronym
observational
Enrollment
130
Registered
2024-09-04
Start date
2024-06-05
Completion date
2024-09-26
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Neck

Keywords

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

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?

Interventions

OTHERThe 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.

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

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

OTHERCervical 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).

Sponsors

Gamze Demircioğlu
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The Neck Disability IndexBaselineThe 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 QualityBaselineFive 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 scaleBaselineA 10 cm VAS numbered from 0 to 10 was used for the assessment. 0 indicates no pain and 10 indicates unbearable pain.
Range of motionBaselineActive 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026