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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
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, Jaseng Hospital of Korean Medicine

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

Condition or disease Intervention/treatment Phase
Neck Pain Posterior Cervical Pain Sleep Disorders Device: Functional pillow Device: Placebo general pillow Not Applicable

Detailed 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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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)



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, Korea, Republic of, 135-896
Sponsors and Collaborators
Jaseng Hospital of Korean Medicine
Investigators
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Principal Investigator: Joonshik Shin Jaseng Hospital of Korean Medicine
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Responsible Party: In-Hyuk Ha, Dr, Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier: NCT02240849    
Other Study ID Numbers: JS-CT-2014-03
First Posted: September 16, 2014    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Keywords provided by In-Hyuk Ha, Jaseng Hospital of Korean Medicine:
Neck pain
functional pillow
sleep
cervical lordosis
Additional relevant MeSH terms:
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Sleep Wake Disorders
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Mental Disorders