Sleep Disturbance,Physical and Mental Fatigue on Mechanical Neck Pain

Mechanical Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994066
• Other study ID #: Sleep disturbance,physical and
• Status: Not yet recruiting
• Start date: August 30, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2023
• Source: Cairo University
• Contact: Zeinab Ali, PHD
• Phone: +201061360551
• Email: zeinaboh4[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: October 1, 2023
• Est. primary completion date: September 30, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Mechanical Neck Pain
• Mental Fatigue
• Neck Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 month
Primary	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).	1 month
Primary	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).	1 month