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

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

Detailed Description
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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)

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

Conditions
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Neck Pain, Posterior Cervical Pain, Sleep Disorders

Intervention / Treatment
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* Device: Functional pillow
* Device: Placebo general pillow


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional pillow<br>cervical pillow, designed functionally to decrease neck pain and help to ensure the right support of the cervical curve, was applied to patients' posterior neck area. | Device: Functional pillow<br>* streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position<br>* Other names: Functional pillow (Jaseng-chuna pillow™);|
| Placebo Comparator: General pillow<br>Applicants Randomly allocated to this group were issued by placebo-general pillow. There is not any specific intervention for their neck discomfort except for that. | Device: Placebo general pillow<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neck pain, functional pillow, sleep, cervical lordosis