Evaluation of Sleep Quality in Patients With Chronic Neck Pain

• Sponsor: Alper Mengi (Other)
• Overall Status: Completed
• CT.gov ID: NCT03314285
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 77

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neck Pain; Sleep	Other: Sleep Quality	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain
• Actual Study Start Date: Oct 12, 2017
• Actual Primary Completion Date: Nov 12, 2017
• Actual Study Completion Date: Nov 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Neck Pain Patients with chronic mechanical neck pain will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.	Other: Sleep Quality; Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.
Other: Healthy volunteers Healthy volunteers without any disease will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale.	Other: Sleep Quality; Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.

Outcome Measures

Primary Outcome Measures

1. Pittsburg Sleep Quality Scale [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 Outcome Measures

1. Demographic Data [30 day]

   Gender, Age, Education Level, Job

2. Pain Severity [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpasa Taksim Research and Education Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Alper Mengi

Investigators

• Principal Investigator: Alper Mengi, M.D., Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Taksim Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alper Mengi, Physiatrist, Medical Doctor, Gaziosmanpasa Research and Education Hospital
• ClinicalTrials.gov Identifier: NCT03314285
• Other Study ID Numbers: 04.10.2017/79
• First Posted: Oct 19, 2017
• Last Update Posted: Mar 25, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alper Mengi, Physiatrist, Medical Doctor, Gaziosmanpasa Research and Education Hospital: Cervicalgia
• Additional relevant MeSH terms: Neck Pain

Study Results

No Results Posted as of Mar 25, 2019