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Completed

NCT Number: NCT03314285

Evaluation of Sleep Quality in Patients With Chronic Neck Pain

This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance.

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Key information

Conditions

Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gaziosmanpasa Taksim Research and Education Hospital

Istanbul, Turkey (Türkiye)

About this study

It is thought that chronic neck pain affects sleepiness negatively. However, there are no studies on chronic neck pain and sleep quality. In this study, we would like to determine whether there is a link between chronic neck pain and sleep quality and the factors that may be related.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient has chronic mechanical neck pain for at least 3 months and without radicular pain
  • Patient's visual analogue scale score is 3 and over

Exclusion criteria

  • History of neurological deficit
  • History of cervical stenosis, cervical surgery, spondylolisthesis, scoliosis
  • History of central or peripheral nervous system disorders
  • History of inflammatory neck pain
  • Pregnant or breast feeding
  • History of fibromyalgia disease
  • History of severe osteoporosis or osteomalacia
  • History of infectious, malignancy, and active psychiatric disease
  • Noncooperative
  • Patient has chronic pain in a region other than the neck region

Treatment and study plan

Sleep quality

Other

Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.

Primary outcomes

  1. Pittsburg Sleep Quality Scale

    Time frame: 30 day

    Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.The Pittsburgh Sleep Quality Scale is a 19-item self-rated questionnaire for evaluating subjective sleep quality the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.

Secondary outcomes

  1. Demographic Data

    Time frame: 30 day

    Gender, Age, Education Level, Job

  2. Pain Severity

    Time frame: 7 day

    The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain in activity , in rest , and during the night for the last one week were inquired.

Sponsors and collaborators

Lead sponsor

Alper Mengi

Other Gov

Registry information

Official study title

Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 19, 2017
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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