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

Jaseng Hospital of Korean Medicine50 enrolled

Overview

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

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Neck Pain Posterior Cervical Pain Sleep Disorders

Interventions

Functional pillowDEVICE

streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position

Placebo general pillowDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Outcomes

Primary Outcomes

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

Time frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention

Secondary Outcomes

Change from baseline in Satisfaction levels on present status of him/her

5-point Likert scale

Time frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention

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.

Time frame: At baseline, week 2, 4 following intervention

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.

Time frame: At baseline, week 2, 4 following intervention

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

Time frame: At baseline, week 4 following intervention

Change from baseline in radiological angle on Range of motion(ROM)

Data from ClinicalTrials.gov

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