Back to resultsEvaluation of Sleep Quality in Patients With Chronic Neck Pain
Primary Purpose
Neck Pain, Sleep
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sleep Quality
Sponsored by
About this trial
This is an interventional diagnostic trial for Neck Pain focused on measuring Cervicalgia
Eligibility Criteria
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
Sites / Locations
- Gaziosmanpasa Taksim Research and Education Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Neck Pain
Healthy volunteers
Arm Description
Patients with chronic mechanical neck pain will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.
Healthy volunteers without any disease will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Demographic Data
Gender, Age, Education Level, Job
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03314285
Brief Title
Evaluation of Sleep Quality in Patients With Chronic Neck Pain
Official Title
Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
November 12, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alper Mengi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Sleep
Keywords
Cervicalgia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neck Pain
Arm Type
Other
Arm Description
Patients with chronic mechanical neck pain will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers without any disease will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.
Intervention Type
Other
Intervention Name(s)
Sleep Quality
Intervention Description
Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.
Primary Outcome Measure Information:
Title
Pittsburg Sleep Quality Scale
Description
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.
Time Frame
30 day
Secondary Outcome Measure Information:
Title
Demographic Data
Description
Gender, Age, Education Level, Job
Time Frame
30 day
Title
Pain Severity
Description
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.
Time Frame
7 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alper Mengi, M.D.
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Taksim Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa Taksim Research and Education Hospital
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Sleep Quality in Patients With Chronic Neck Pain
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