search
Back to results

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

Primary Purpose

Neck Pain, Posterior Cervical Pain, Sleep Disorders

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Functional pillow
Placebo general pillow
Sponsored by
Jaseng Hospital of Korean Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neck Pain focused on measuring Neck pain, functional pillow, sleep, cervical lordosis

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Functional pillow

General pillow

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Satisfaction levels on present status of him/her
5-point Likert scale
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.
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.
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
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)

Full Information

First Posted
August 28, 2014
Last Updated
November 5, 2018
Sponsor
Jaseng Hospital of Korean Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT02240849
Brief Title
Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life
Acronym
EPNS
Official Title
Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Hospital of Korean Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Posterior Cervical Pain, Sleep Disorders
Keywords
Neck pain, functional pillow, sleep, cervical lordosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional pillow
Arm Type
Experimental
Arm Description
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.
Arm Title
General pillow
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Functional pillow
Other Intervention Name(s)
Functional pillow (Jaseng-chuna pillow™)
Intervention Description
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Intervention Type
Device
Intervention Name(s)
Placebo general pillow
Primary Outcome Measure Information:
Title
Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)
Description
The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning
Time Frame
At baseline, 3 day, week 1, 2, 3, 4 following intervention
Secondary Outcome Measure Information:
Title
Change from baseline in Satisfaction levels on present status of him/her
Description
5-point Likert scale
Time Frame
At baseline, 3 day, week 1, 2, 3, 4 following intervention
Title
Change from baseline in functional impairment on Neck Disability Index(NDI)
Description
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.
Time Frame
At baseline, week 2, 4 following intervention
Title
Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)
Description
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.
Time Frame
At baseline, week 2, 4 following intervention
Title
Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)
Description
This is for checking the patients' changes on Quality of Life after using the cervical pillow
Time Frame
At baseline, week 4 following intervention
Title
Change from baseline in radiological angle on Range of motion(ROM)
Description
ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)
Time Frame
At baseline, week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joonshik Shin
Organizational Affiliation
Jaseng Hospital of Korean Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
State/Province
Gangnam-Gu
ZIP/Postal Code
135-896
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs