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Trial record 2 of 184881 for:    ALL

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
In-Hyuk Ha, Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier:
NCT02240849
First received: August 28, 2014
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Neck Pain
Posterior Cervical Pain
Sleep Disorders
Device: Functional pillow
Device: Placebo general pillow

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Jaseng Hospital of Korean Medicine:

Primary Outcome Measures:
  • Change from baseline in Neck discomfort on Visual Analogue Scale(VAS) [ Time Frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    5-point Likert scale

  • Change from baseline in functional impairment on Neck Disability Index(NDI) [ Time Frame: At baseline, week 2, 4 following intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)


Enrollment: 50
Study Start Date: June 2014
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Functional pillow
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Other Name: Functional pillow (Jaseng-chuna pillow™)
Placebo Comparator: 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.
Device: Placebo general pillow

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

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02240849

Locations
Korea, Republic of
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, Korea, Republic of, 135-896
Sponsors and Collaborators
Jaseng Hospital of Korean Medicine
Investigators
Principal Investigator: Joonshik Shin Jaseng Hospital of Korean Medicine
  More Information

No publications provided

Responsible Party: In-Hyuk Ha, Dr, Jaseng Hospital of Korean Medicine
ClinicalTrials.gov Identifier: NCT02240849     History of Changes
Other Study ID Numbers: JS-CT-2014-03
Study First Received: August 28, 2014
Last Updated: September 24, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Jaseng Hospital of Korean Medicine:
Neck pain
functional pillow
sleep
cervical lordosis

Additional relevant MeSH terms:
Neck Pain
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on February 25, 2015