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

NCT02240849 | Completed

• 1 other identifier: JS-CT-2014-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neck Pain; Posterior Cervical Pain; Sleep Disorders

Keywords

Neck pain; functional pillow; sleep; cervical lordosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in Satisfaction levels on present status of him/her

  At baseline, 3 day, week 1, 2, 3, 4 following intervention

• Change from baseline in functional impairment on Neck Disability Index(NDI)

  At baseline, week 2, 4 following intervention

• Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)

  At baseline, week 2, 4 following intervention

• Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)

  At baseline, week 4 following intervention

• Change from baseline in radiological angle on Range of motion(ROM)

  At baseline, week 4

Study Arms (2)

Functional pillow

EXPERIMENTAL

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

General pillow

PLACEBO COMPARATOR

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

Interventions

Functional pillow DEVICE

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

Also known as: Functional pillow (Jaseng-chuna pillow™)

Functional pillow

Placebo general pillow DEVICE

General pillow

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

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

Location

MeSH Terms

Conditions

Neck Pain; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Mental Disorders

Study Officials

• Joonshik Shin

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 16, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 7, 2018

Record last verified: 2018-11

Locations

KR (1)