Evaluation of Sleep Quality in Patients With Chronic Neck Pain
Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2017
CompletedStudy Start
First participant enrolled
October 12, 2017
CompletedFirst Posted
Study publicly available on registry
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2017
CompletedMarch 25, 2019
March 1, 2019
1 month
October 12, 2017
March 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Demographic Data
30 day
Pain Severity
7 day
Study Arms (2)
Neck Pain
OTHERPatients with chronic mechanical neck pain will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.
Healthy volunteers
OTHERHealthy volunteers without any disease will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.
Interventions
Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alper Mengilead
Study Sites (1)
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alper Mengi, M.D.
Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Taksim Training and Research Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Physiatrist, Medical Doctor
Study Record Dates
First Submitted
October 12, 2017
First Posted
October 19, 2017
Study Start
October 12, 2017
Primary Completion
November 12, 2017
Study Completion
November 15, 2017
Last Updated
March 25, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share