Clinical trial NCT02240849: Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life
Official title: Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Posterior Cervical Pain
Sleep Disorders
Keywords: Neck pain
functional pillow
sleep
cervical lordosis
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)
timeFrame: At baseline, 3 day, week 1, 2, 3, 4 following intervention
Secondary outcomes:
measure: Change from baseline in Satisfaction levels on present status of him/her
timeFrame: At baseline, 3 day, week 1, 2, 3, 4 following intervention
measure: Change from baseline in functional impairment on Neck Disability Index(NDI)
timeFrame: At baseline, week 2, 4 following intervention
measure: Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)
timeFrame: At baseline, week 2, 4 following intervention
measure: Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)
timeFrame: At baseline, week 4 following intervention
measure: Change from baseline in radiological angle on Range of motion(ROM)
timeFrame: At baseline, week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
state: Gangnam-Gu
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Joonshik Shin
role: PRINCIPAL_INVESTIGATOR
References: