Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life

Neck Pain Clinical Trial

— EPNS  

Official title:

Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240849
• Other study ID #: JS-CT-2014-03
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2018
• Source: Jaseng Hospital of Korean Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effects of functional cervical pillow on inpatients with neck discomfort.

Description:

50 inpatients with neck discomfort(NRS>4) will be randomly allocated to 2 groups. The experimental group was treated with functional cervical pillow and the control group was treated with general pillow. All applications of pillow were limited to 3-4 weeks. Primary outcomes were measured using the VAS scale. Post-treatment follow-up will be performed to measure primary outcomes at baseline, 3 day, per weeks until the duration of admission. Satisfaction levels of the patient's current status, Neck disability Index(NDI) PSQI, EQ-5D will also be collected. The applicants will also get thru the diagnosis of range of motion by X-ray(flexion, neutral, extension of their neck position)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Patients admitted to a Korean Medicine hospital

• Age between 18 and 69

• NRS score of >4 on the day of the intervention

• Voluntary participation with written consent given to study consent form, including cervical x-ray

Exclusion Criteria:

• Diagnosis of serious disease(s) which are possible causes of neck pain such as malignancy, vertebral fracture, spinal infection, inflammatory spondylitis, cauda-equina compression, etc.

• Prior diagnosis of other chronic disease(s) which could affect effectiveness or interpretation of treatment results such as cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, Alzheimer's disease, epilepsy, etc.

• Progressive neurologic deficit(s) or concurrent severe neurological symptoms

• Previously using any kind of functional pillow

Related Conditions & MeSH terms

• Neck Pain
• Parasomnias
• Posterior Cervical Pain
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Device:
• Functional pillow
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
• Placebo general pillow

Locations

Country	Name	City	State
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul	Gangnam-Gu

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Hospital of Korean Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)	The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning	At baseline, 3 day, week 1, 2, 3, 4 following intervention
Secondary	Change from baseline in Satisfaction levels on present status of him/her	5-point Likert scale	At baseline, 3 day, week 1, 2, 3, 4 following intervention
Secondary	Change from baseline in functional impairment on Neck Disability Index(NDI)	The NDI is a modification of the Oswestry Low Back Pain Disability Index . It is a patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation.	At baseline, week 2, 4 following intervention
Secondary	Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)	The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration,habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.	At baseline, week 2, 4 following intervention
Secondary	Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)	This is for checking the patients' changes on Quality of Life after using the cervical pillow	At baseline, week 4 following intervention
Secondary	Change from baseline in radiological angle on Range of motion(ROM)	ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)	At baseline, week 4