Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life (EPNS)
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|ClinicalTrials.gov Identifier: NCT02240849|
Recruitment Status : Completed
First Posted : September 16, 2014
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Posterior Cervical Pain Sleep Disorders||Device: Functional pillow Device: Placebo general pillow||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (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|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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
- Change from baseline in Neck discomfort on Visual Analogue Scale(VAS) [ Time Frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention ]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 ]5-point Likert scale
- Change from baseline in functional impairment on Neck Disability Index(NDI) [ Time Frame: At baseline, week 2, 4 following intervention ]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 ]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 ]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 ]ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|