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

Jaseng Hospital of Korean Medicine

Status: Completed

Conditions: Sleep Disorders; Posterior Cervical Pain; Neck Pain

Treatments: Device: Placebo general pillow; Device: Functional pillow

Study type: Interventional

Funder types: Other

Identifiers

NCT02240849

JS-CT-2014-03

Details and patient eligibility

About

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

Full 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)

Enrollment: 50 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Functional pillow

Experimental group

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.

Treatment:

Device: Functional pillow

General pillow

Placebo Comparator group

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.

Treatment:

Device: Placebo general pillow