- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02240849
Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life (EPNS)
November 5, 2018 updated by: In-Hyuk Ha, Jaseng Hospital of Korean Medicine
Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial
The purpose of this study is to investigate the effects of functional cervical pillow on inpatients with neck discomfort.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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)
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gangnam-Gu
-
Seoul, Gangnam-Gu, Korea, Republic of, 135-896
- Jaseng Hospital of Korean Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Other Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At baseline, 3 day, week 1, 2, 3, 4 following intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
At baseline, 3 day, week 1, 2, 3, 4 following intervention
|
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.
|
At baseline, week 2, 4 following intervention
|
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.
|
At baseline, week 2, 4 following intervention
|
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
|
At baseline, week 4 following intervention
|
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)
|
At baseline, week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
August 28, 2014
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimate)
September 16, 2014
Study Record Updates
Last Update Posted (Actual)
November 7, 2018
Last Update Submitted That Met QC Criteria
November 5, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JS-CT-2014-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Functional pillow
-
Centre Leon BerardHopital DebrousseCompleted
-
Taipei Medical UniversityCompletedPregnancy Related | Safety Issues | Breastfeeding | Newborn; FitTaiwan
-
Randers Regional HospitalCompletedPain | Fatigue | PonvDenmark
-
Ottawa Hospital Research InstituteUnknownArthroplasty, Replacement, Hip | Hip Replacement, TotalCanada
-
Ataturk UniversityCompletedCesarean Section; Dehiscence | First BirthTurkey
-
Taipei Veterans General Hospital, TaiwanUnknownOsteoporosis Fracture | Compression Fracture SpineTaiwan
-
Seoul National University HospitalCompletedDouble-lumen Tube DisplacementKorea, Republic of
-
Amasya UniversityAtaturk UniversityNot yet recruitingSleep | Pregnancy Related | Comfort
-
Brigham and Women's HospitalCompleted