Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life (EPNS)
The purpose of this study is to investigate the effects of functional cervical pillow on inpatients with neck discomfort.
Posterior Cervical Pain
Device: Functional pillow
Device: Placebo general pillow
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial|
- Change from baseline in Neck discomfort on Visual Analogue Scale(VAS) [ Time Frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention ] [ Designated as safety issue: No ]The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning
- Change from baseline in Satisfaction levels on present status of him/her [ Time Frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention ] [ Designated as safety issue: No ]5-point Likert scale
- Change from baseline in functional impairment on Neck Disability Index(NDI) [ Time Frame: At baseline, week 2, 4 following intervention ] [ Designated as safety issue: No ]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.
- Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI) [ Time Frame: At baseline, week 2, 4 following intervention ] [ Designated as safety issue: No ]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.
- Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D) [ Time Frame: At baseline, week 4 following intervention ] [ Designated as safety issue: No ]This is for checking the patients' changes on Quality of Life after using the cervical pillow
- Change from baseline in radiological angle on Range of motion(ROM) [ Time Frame: At baseline, week 4 ] [ Designated as safety issue: No ]ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)
|Study Start Date:||June 2014|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Experimental: Functional pillow
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
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Other Name: Functional pillow (Jaseng-chuna pillow™)
Placebo Comparator: General pillow
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|
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)
Please refer to this study by its ClinicalTrials.gov identifier: NCT02240849
|Korea, Republic of|
|Jaseng Hospital of Korean Medicine|
|Seoul, Gangnam-Gu, Korea, Republic of, 135-896|
|Principal Investigator:||Joonshik Shin||Jaseng Hospital of Korean Medicine|