Neck PainNCT03314285
Evaluation of Sleep Quality in Patients With Chronic Neck Pain
A study testing Sleep Quality in people with Neck Pain and Sleep, run by Alper Mengi at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Sleep Quality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2017to 15 Nov 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient has chronic mechanical neck pain for at least 3 months and without radicular pain
- Patient's visual analogue scale score is 3 and over
Who cannot join
- History of neurological deficit
- History of cervical stenosis, cervical surgery, spondylolisthesis, scoliosis
- History of central or peripheral nervous system disorders
- History of inflammatory neck pain
- Pregnant or breast feeding
- History of fibromyalgia disease
Show all 10Show fewer
- History of severe osteoporosis or osteomalacia
- History of infectious, malignancy, and active psychiatric disease
- Noncooperative
- Patient has chronic pain in a region other than the neck region
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa Taksim Research and Education Hospital
Istanbul
About this study
Official title: Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain
This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance.
Read the detailed description
It is thought that chronic neck pain affects sleepiness negatively. However, there are no studies on chronic neck pain and sleep quality. In this study, we would like to determine whether there is a link between chronic neck pain and sleep quality and the factors that may be related.
- Being tested
- Sleep Quality
- Keywords
- Cervicalgia
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep QualityOther
Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.
| Study group | Role | What they receive |
|---|---|---|
| Neck Pain | Other | Patients with chronic mechanical neck pain will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale. Receives: Other: Sleep Quality |
| Healthy volunteers | Other | Healthy volunteers without any disease will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale. Receives: Other: Sleep Quality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburg Sleep Quality Scale
Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.The Pittsburgh Sleep Quality Scale is a 19-item self-rated questionnaire for evaluating subjective sleep quality the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
Measured: 30 day
Secondary outcomes (2)
Demographic Data
Gender, Age, Education Level, Job
Measured: 30 day
Pain Severity
The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain in activity , in rest , and during the night for the last one week were inquired.
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start12 Oct 2017
- Primary completion12 Nov 2017
- Study completion15 Nov 2017
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alper Mengi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Alper Mengi, Gaziosmanpasa Research and Education Hospital
- Investigators
- Alper Mengi, M.D., Principal investigator, Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Taksim Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314285
- Sponsor's protocol ID
- 04.10.2017/79
- Status last verified
- Mar 2019
- First submitted
- 12 Oct 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Trial of Evaluation of Sleep Quality in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT03314285
- Acronym / sponsor ID
- 04.10.2017/79
- Keywords
- Cervicalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Alper MengiOther government
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 12 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 19 Oct 2017 (actual)
- 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.
This study aimed to investigate the effect of chronic neck pain on sleep quality and to determine the factors that may be related to sleep disturbance.
Detailed description
It is thought that chronic neck pain affects sleepiness negatively. However, there are no studies on chronic neck pain and sleep quality. In this study, we would like to determine whether there is a link between chronic neck pain and sleep quality and the factors that may be related.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck Pain | Other | Other: Sleep QualityPatients with chronic mechanical neck pain will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale. |
| Healthy volunteers | Other | Other: Sleep QualityHealthy volunteers without any disease will be evaluated for sleep quality by the Pittsburgh Sleep Quality Scale. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has chronic mechanical neck pain for at least 3 months and without radicular pain
- Patient's visual analogue scale score is 3 and over
Key exclusion criteria (10 listed)
- History of neurological deficit
- History of cervical stenosis, cervical surgery, spondylolisthesis, scoliosis
- History of central or peripheral nervous system disorders
- History of inflammatory neck pain
- Pregnant or breast feeding
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 |
|---|---|---|
| Sleep QualitySleep quality to be measured by the Pittsburgh Sleep Quality Scale. | Other | Healthy volunteers, Neck Pain |
Primary outcome
Pittsburg Sleep Quality Scale
Time frame: 30 day
Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.The Pittsburgh Sleep Quality Scale is a 19-item self-rated questionnaire for evaluating subjective sleep quality the previous month. The 19 questions are combined into 7 clinically-derived component scores, each weighted equally from 0-3. The 7 component scores are added to obtain a global score ranging from 0-21, with higher scores indicating worse sleep quality.
2 secondary outcomes
Demographic Data
Time frame: 30 day
Pain Severity
Time frame: 7 day
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 25 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Alper Mengi, M.D. principal investigator
Department of Physical Medicine and Rehabilitation, Gaziosmanpasa Taksim Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Quality in people with Neck Pain and Sleep, run by Alper Mengi at 1 site in Turkey (Türkiye).
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 2 inclusion and 10 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 25 Mar 2019. 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 Turkey (Türkiye). 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. 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?
Pittsburg Sleep Quality Scale (time frame: 30 day). 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 25 Mar 2019.