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

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

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

Study Overview

• Status: Completed
• Conditions: Neck Pain; Sleep Disorders; Posterior Cervical Pain
• Intervention / Treatment: Device: Functional pillow; Device: Placebo general pillow

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)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline, 3 day, week 1, 2, 3, 4 following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Satisfaction levels on present status of him/her	5-point Likert scale	At baseline, 3 day, week 1, 2, 3, 4 following intervention
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.	At baseline, week 2, 4 following intervention
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.	At baseline, week 2, 4 following intervention
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	At baseline, week 4 following intervention
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)	At baseline, week 4

Collaborators and Investigators

• Sponsor: Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (Estimate): September 16, 2014

Study Record Updates

• Last Update Posted (Actual): November 7, 2018
• Last Update Submitted That Met QC Criteria: November 5, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: sleep; Neck pain; cervical lordosis; functional pillow
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Pain; Neurologic Manifestations; Sleep Wake Disorders; Neck Pain
• Other Study ID Numbers: JS-CT-2014-03