Evaluation of Sleep Quality in Patients With Chronic Neck Pain

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03314285
• Other study ID #: 04.10.2017/79
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: March 2019
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: November 15, 2017
• Est. primary completion date: November 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Sleep

Intervention

Other:
• Sleep Quality
Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Taksim Research and Education Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Alper Mengi

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburg Sleep Quality Scale	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.	30 day
Secondary	Demographic Data	Gender, Age, Education Level, Job	30 day
Secondary	Pain Severity	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.	7 day