Neck Pain, Posterior Cervical Pain, Sleep Disorders
Conditions
Keywords
Neck pain, functional pillow, sleep, cervical lordosis
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)
Interventions
DEVICEPlacebo general pillow
DEVICEFunctional pillow
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Sponsors
Jaseng Hospital of Korean Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Countries
South Korea
Outcome results
None listed