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

Not Applicable

Completed

• Conditions: Posterior Cervical Pain; Sleep Disorders; Neck Pain
• Interventions: Device: Functional pillow; Device: Placebo general pillow

• Registration Number: NCT02240849
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-28
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Functional pillow	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.
General pillow	Placebo 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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)	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

Name	Time	Method
Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)	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)	At baseline, week 4	ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)
Change from baseline in Satisfaction levels on present status of him/her	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)	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)	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.

Trial Locations

Locations (1)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of