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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial

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

Detailed Summary: 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)
Sponsor: Jaseng Hospital of Korean Medicine

Current Primary Outcome: Change from baseline in Neck discomfort on Visual Analogue Scale(VAS) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in Satisfaction levels on present status of him/her [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: At baseline, week 4 ]
    ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)


Original Secondary Outcome: Same as current

Information By: Jaseng Hospital of Korean Medicine

Dates:
Date Received: August 28, 2014
Date Started: June 2014
Date Completion:
Last Updated: September 24, 2014
Last Verified: September 2014