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Mechanical Neck PainNCT05994066

Sleep Disturbance,Physical and Mental Fatigue on Mechanical Neck Pain

An observational study of Mechanical Neck Pain, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Mechanical neck pain is a prevalent problem in community and it can lead to disability. In current community, increasing of life stress on individual may lead to sleep disorders, mental and physical fatigue. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Mechanical Neck Pain
What is being tested?
Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).
How many people
230 participants
Where
No sites listed yet
Study dates
30 Aug 2023to 1 Oct 2023
Phase
Observational
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 60 years
  • All sexes
  • Adult

Study population: Our study considered as an observational cross - sectional study. 230 patients will participate in the stuudy The inclusion criteria will be age between 18 -60 years , who do have neck disability index score more than (4) points, they have being included in our study. The exclusion criteria were people who are having any cervical injury( fracture,whiplash injury) cervical disc , neurological disease, past surgery in neck region. Also we excluded who has been scored with 4 points or less in NDI . The study was on online survey we used what'sup app and telegram app

Who may be able to join

  • The inclusion criteria were age between 18 -60 years , who do have neck disability index score more than (4) points, they have being included in our study.

Who cannot join

  • The exclusion criteria were people who are having any cervical injury( fracture,whiplash injury) cervical disc , neurological disease, past surgery in neck region. Also we excluded who has been scored with 4 points or less in NDI

Trial locations and contacts

No sites are listed yet.

Zeinab Ali, PHD contact

+201061360551

zeinaboh4@gmail.com

About this study

Official title: Effect of Sleep Quality,Physical and Mental Fatigue on Mechanical Neck Pain

Mechanical neck pain is a prevalent problem in community and it can lead to disability.

In current community, increasing of life stress on individual may lead to sleep disorders, mental and physical fatigue.

Read more

Objectives of study is to investigate the effect of sleep quality, mental and physical fatigue on mechanical neck pain.

Methods and Materials Two hundred thirty individuals were having mechanical neck pain . Neck disability index, chalder fatigue scale and Pittsburg sleep quality index were applied on all individuals participating in the study , NDI was used to determine the pain and functional disability of the participants , PSQI was used to assess the sleep quality, lastly the CFS was used to determine

Read the detailed description

Our study considered as an observational cross - sectional study.

Sample size :

Individual's ;230 patient with mechanical neck pain will participate in the study The inclusion criteria were age between 18 -60 years , who do have neck disability index score more than (4) points, they have being included in our study. The exclusion criteria were people who are having any cervical injury( fracture,whiplash injury) cervical disc , neurological disease, past surgery in neck region. Also we excluded who has been scored with 4 points or less in NDI . The study will be in the out clinic of orthopedic in faculty of physical therapy , cairo university

Material tool :

We used three index , NECK DISABILITY INDEX [NDI] , CHALDER FATIGUE SCALE [CFS] , PITTSBURGH SLEEP QUALITY SCALE [PSQI]. -NDI : neck disability index is consists of 10 questions including = pain severity,ability of personal care ,lifting weight, job capability, headaches intense , concentration, quality of sleeping and driving and recreation activities. The total score ranges between 0- 50 points . Zero to 4 points mean( NO DISABILITY), 5 to 14 points means (LIGHT DISABILITY ) , 15 to 24 points means ( MODERATE DISABILITY ), 25 to 34 points means (SEVERE DISABILITY) 35 to 50 points means (COMPLETE DISABILITY).

  • CFS : The CFS is consisting of 11 questions including a seven item physical fatigue subdimension and a four item mental fatigue sub-dimension.The physical fatigue subdimension score ranges from 0 to 21, the mental fatigue sub-dimension score from 0 to12 The total fatigue score is from 0-33. High scores indicates a greater fatigue level.
  • PSQI : The scale is consisting of 24 items,19 items are filled by the individuals,while 5 are filled by the bedmate*if they have one*. 18 of 19 items that filled by the individual himself

\herself are scored and used to asses sleep quality,while the remaining 6 items are used to have clinical inflammation. It has 7 components:

  1. subjective sleep quality
  2. sleep latency
  3. sleep duration
  4. habitual sleep efficiency
  5. sleep disturbances
  6. use of sleeping pills
  7. day time dysfunction . The total PUKIN score is obtained by summing the score of the components. The total of each item is 0-3 while the total score of PUKI is ranging between 0-21 . High score indicates poor sleep quality. A total score of 5 or less is indicating good sleep quality, while scores above 5 indicates poor sleep quality.
Being tested
Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).Other

    Demographic data of the individuals were recorded. All participants completed NDI, Chalder Fatigue Scale (CFS) and Pittsburgh Sleep Quality Index (PSQI).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arabic version of NDIto determine the pain experience and functional disability of the participants.

    NDI consists of 10 questions concern of the pain severity, ability for personal care, lifting weight, job capability headache intensity, concentration, quality of sleeping and driving and recreation activities. Total score ranges between 0 to 50 points. Zero to four points mean "no disability", 5 to 14 points mean "light disability", 15 to 24 points mean "moderate disability", 25 to 34 points mean "severe disability", and 35 to 50 points mean "complete disability" (15).

    Measured: 1 month

  2. Pittsburgh Sleep Quality Index (PSQI)

    In this scale consisting of 24 items, 19 items are filled in by the individual, while five items are filled in by the person's bedmate. Eighteen of the 19 items that need to be answered by the individual are scored and used to assess sleep quality, while the remaining six items are used to have clinical information. It has seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills, and daytime dysfunction. The total PUKI score is obtained by summing the scores of the components. The total score of each component varies between zero to three and the total score of PUKI ranges from 0 to 21. High scores indicate poor sleep quality. A total score of five or less indicates good sleep quality, while scores above 5 indicate poor sleep quality (16).

    Measured: 1 month

  3. Chalder Fatigue Scale (CFS)

    CFS consists of 11 questions including a 7-item physical fatigue sub-dimension and a 4-item mental fatigue sub-dimension (19). 4-point Likert scale was used. The scoring of each item varies between zero to three points. The physical fatigue sub-dimension score ranges from 0 to 21, the mental fatigue sub-dimension score ranges from 0 to 12, and the total fatigue score ranges from 0 to 33. High scores indicate a greater fatigue level (18). The arabic version of the questionnaire was used in the study (19).

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2023
  2. Study start30 Aug 2023 (estimated)
  3. Primary completion30 Sep 2023 (estimated)
  4. Study completion1 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05994066
Sponsor's protocol ID
Sleep disturbance,physical and
Status last verified
Aug 2023
First submitted
8 Aug 2023
Last updated
16 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bonvanie IJ, Oldehinkel AJ, Rosmalen JGM, Janssens KAM. Sleep problems and pain: a longitudinal cohort study in emerging adults. Pain. 2016 Apr;157(4):957-963. doi: 10.1097/j.pain.0000000000000466.

    PubMed 26683236

  • Bjornsdottir SV, Jonsson SH, Valdimarsdottir UA. Mental health indicators and quality of life among individuals with musculoskeletal chronic pain: a nationwide study in Iceland. Scand J Rheumatol. 2014;43(5):419-23. doi: 10.3109/03009742.2014.881549. Epub 2014 May 12.

    PubMed 24814312

Questions about this trial

What is this clinical trial studying?

An observational study of Mechanical Neck Pain, run by Cairo University.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Zeinab Ali, PHD (+201061360551, zeinaboh4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arabic version of NDIto determine the pain experience and functional disability of the participants. (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05994066, which also lists 2 linked publications.

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 16 Aug 2023.

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