Neck PainEPNSNCT02240849
Effectiveness of Functional Pillow on Neck Pain, Disability, Quality of Sleep and Life
A study testing Functional pillow in people with Neck Pain and Posterior Cervical Pain, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the effects of functional cervical pillow on inpatients with neck discomfort. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Neck Pain, Posterior Cervical Pain, Sleep Disorders
- What is being tested?
- Functional pillow
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: 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.
Read the 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)
- Conditions
- Neck Pain, Posterior Cervical Pain, Sleep Disorders
- Being tested
- Functional pillow, Placebo general pillow
- Keywords
- Neck pain, functional pillow, sleep, cervical lordosis
- Medical subject headings
- Neck Pain, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional pillowDevice
Also called Functional pillow (Jaseng-chuna pillow™)
streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
Placebo general pillowDevice
| Study group | Role | What they receive |
|---|---|---|
| Functional pillow | Experimental | 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. Receives: Device: Functional pillow |
| General pillow | Placebo comparator | 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. Receives: Device: Placebo general pillow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Neck discomfort on Visual Analogue Scale(VAS)
The patient is asked to mark on the visual analogue scale the intensity of the neck discomfort they are experiencing during night and morning
Measured: At baseline, 3 day, week 1, 2, 3, 4 following intervention
Secondary outcomes (5)
Change from baseline in Satisfaction levels on present status of him/her
5-point Likert scale
Measured: At baseline, 3 day, week 1, 2, 3, 4 following intervention
Change from baseline in functional impairment on Neck Disability Index(NDI)
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.
Measured: At baseline, week 2, 4 following intervention
Change from baseline in quality of sleep on Pittsburgh Sleep Quality Index(PSQI)
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.
Measured: At baseline, week 2, 4 following intervention
Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)
This is for checking the patients' changes on Quality of Life after using the cervical pillow
Measured: At baseline, week 4 following intervention
Change from baseline in radiological angle on Range of motion(ROM)
ROM of applicants will be assessed by X-ray diagnosis. (neutral, flexion, extension view)
Measured: At baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startJun 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Hospital of Korean Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, Jaseng Hospital of Korean Medicine
- Investigators
- Joonshik Shin, Principal investigator, Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240849
- Sponsor's protocol ID
- JS-CT-2014-03
- Acronym
- EPNS
- Status last verified
- Nov 2018
- First submitted
- 28 Aug 2014
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Functionally Customized Pillow on Neck Pain, Disability, Quality of Sleep and Life: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02240849
- Acronym / sponsor ID
- EPNS / JS-CT-2014-03
- Conditions
- Neck Pain, Posterior Cervical Pain, Sleep Disorders
- Keywords
- Neck pain, functional pillow, sleep, cervical lordosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jaseng Hospital of Korean MedicineUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional pillow | Experimental | Device: Functional pillowcervical 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. |
| General pillow | Placebo comparator | Device: Placebo general pillowApplicants Randomly allocated to this group were issued by placebo-general pillow. There is not any specific intervention for their neck discomfort except for that. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional pillowAlso: Functional pillow (Jaseng-chuna pillow™)streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position | Device | Functional pillow |
| Placebo general pillow | Device | General pillow |
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
5 secondary outcomes
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
Change from baseline in functional impairment on Neck Disability Index(NDI)
Time frame: 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
Change from baseline in quality of life on EuroQol Group-5 dimension(EQ-5D)
Time frame: At baseline, week 4 following intervention
Change from baseline in radiological angle on Range of motion(ROM)
Time frame: At baseline, week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joonshik Shin principal investigator
Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional pillow in people with Neck Pain and Posterior Cervical Pain, run by Jaseng Hospital of Korean Medicine at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Neck discomfort on Visual Analogue Scale(VAS) (time frame: At baseline, 3 day, week 1, 2, 3, 4 following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.