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Completed

NCT Number: NCT02240849

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

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

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Key information

Conditions

Neck Pain Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Posterior Cervical Pain Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional pillow

Device

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

Other names: Functional pillow (Jaseng-chuna pillow™)

Placebo general pillow

Device

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Jaseng Hospital of Korean Medicine

Other

Registry information

Official study title

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

Acronym: EPNS

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 16, 2014
Registry last updated
Nov 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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