Chronic Neck Pain: Mobility, Sleep, Function

NCT ID: NCT06583850

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-05

Study Completion Date

2024-09-26

Brief Summary

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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

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Conditions

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Pain Neck

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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chronic neck pain

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

The Neck Disability Index

Intervention Type 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.

Visual analog scale (VAS)

Intervention Type 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

Pittsburgh Sleep Quality Index

Intervention Type OTHER

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

Cervical Range of Motion Assessment

Intervention Type 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).

control

healthy controls

The Neck Disability Index

Intervention Type 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.

Visual analog scale (VAS)

Intervention Type 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

Pittsburgh Sleep Quality Index

Intervention Type OTHER

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

Cervical Range of Motion Assessment

Intervention Type 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).

Interventions

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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.

Intervention Type 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

Intervention Type OTHER

Pittsburgh Sleep Quality Index

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

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gamze Demircioğlu

OTHER

Sponsor Role lead

Responsible Party

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Gamze Demircioğlu

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Istanbul Atlas Univercity

Istanbul, Hamidiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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neckpain

Identifier Type: -

Identifier Source: org_study_id

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