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

NCT ID: NCT02240849

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-09-30

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)

Conditions

Neck Pain; Posterior Cervical Pain; Sleep Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Functional pillow

Intervention Type: DEVICE

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo general pillow

Intervention Type: DEVICE

Interventions

Functional pillow

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

Intervention Type: DEVICE

Placebo general pillow

Intervention Type: DEVICE

Other Intervention Names

Functional pillow (Jaseng-chuna pillow™)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Hospital of Korean Medicine

OTHER

Sponsor Role: lead

Responsible Party

In-Hyuk Ha

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joonshik Shin

Role: PRINCIPAL_INVESTIGATOR

Jaseng Hospital of Korean Medicine

Locations

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Countries

South Korea

Other Identifiers

JS-CT-2014-03

Identifier Type: -

Identifier Source: org_study_id