Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000749404
Ethics application status
Approved
Date submitted
3/01/2016
Date registered
7/06/2016
Date last updated
26/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The relation between head, neck and shoulders anthropometric measures and incidence of mechanical neck pain.
Scientific title
The relation between anthropometric measures of head, neck and shoulders and different cervical angles and activity of cervical muscles and mechanical neck pain
Secondary ID [1] 288231 0
nil
Universal Trial Number (UTN)
u1111-1178-0179
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanical neck pain. 297743 0
Condition category
Condition code
Musculoskeletal 297376 297376 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
One hundred subjects of both sexes will be selected and assigned into two groups. Each group will have fifty participants. fifty patient with chronic mechanical neck pain for at least three months and compare with fifty asymptomatic subjects. Cervical angles (C2-C7, Oc-C2, C1-C2,) and anterior head translation (AHT) will be measured by using lateral X rays. Anthropometric measures of head neck and shoulder will be measured for both groups ( head circumference by medical tape, head breadth by sliding caliper, head depth by sliding caliper, head length bysliding calipar, neck circumference by medical tape, neck length by sliding caliparr, neck girth by sliding calipar and biacromial breadth by sliding caliper) and by antroposterior and lateral X rays. Activity of upper trapezius, anterior scalenes, erector spinae and sternocleidomastoid during resting by using EMG for both groups. Time of testing will be one hour in single occasion.
Intervention code [1] 293522 0
Not applicable
Comparator / control treatment
Healthy control group act as the comparator for this study.
Control group
Active

Outcomes
Primary outcome [1] 296928 0
Anthropometric measures of head, neck and shoulders ( head breadth, depth, length and circumfereence, neck circumference,girth and length, biacromial width) in centimeters by tape measurments and caliper and Xrays. They are a composite.
Timepoint [1] 296928 0
At a single timepoint only.
Secondary outcome [1] 319722 0
activity of cervical muscle( upper trapezius, anterior scalenes, erector spinae and sternocleidomastoid)by sEMG
Timepoint [1] 319722 0
At a single timepoint only.
Secondary outcome [2] 319723 0
Different cervical angles (occipito-cervical angle (Oc-C2), C1-C2 and C2-C7) in degree and anterior head translation in mm by xrays. They are a composite outcome.
Timepoint [2] 319723 0
At a single timepoint only.

Eligibility
Key inclusion criteria
Control group:
1) 50 subjects of both sexes.
2) The age group were selected between 18-29 years,
3) Their BMI ranged from 18.5 to 25 kg/cm
Experimental group:
1) 50 subjects of both sexes age ranging from 18 to 29years old.
2) Their BMI ranged from 18.5 to 25 kg/cm,
3) Subjects Referred from orthopedist with mechanical neck pain for at least three monthes
Minimum age
18 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any history of cervical spine disk herniation
2) Any history of cervical trauma
3) Pregnant women.
4) Participants with congenital postural deformities
5) Participants with definitive visual disorder.
6) Osteoporotic and rheumatic arthritic patients.
7) Current participation in supervised physical therapy for neck pain.
8) Impingement syndrome
9) Shoulder fracture
10) Shoulder dislocation
11) Medications which affect muscle activity
12) Recent shoulder surgery

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
one hundersd participant will be selected. This number are recommended by my supervisors, as previous studies in this arae are not increase than ninty.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
30/05/2017
Actual
15/06/2017
Date of last data collection
Anticipated
Actual
30/07/2017
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 7492 0
Egypt
State/province [1] 7492 0
cairo

Funding & Sponsors
Funding source category [1] 292615 0
University
Name [1] 292615 0
cairo university,
Country [1] 292615 0
Egypt
Primary sponsor type
University
Name
cairo university
Address
Faculty of Physical Therapy-Cairo University
Address:7 Ahmed Elzaiat St.BenElsaryat EI Dokki-Giza-.
Postal Code:12612
Country
Egypt
Secondary sponsor category [1] 291335 0
None
Name [1] 291335 0
none
Address [1] 291335 0
none
Country [1] 291335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294096 0
research ethical committee Faulty yof physical therapy CAIRO university
Ethics committee address [1] 294096 0
Ethics committee country [1] 294096 0
Egypt
Date submitted for ethics approval [1] 294096 0
30/01/2016
Approval date [1] 294096 0
09/02/2016
Ethics approval number [1] 294096 0
P.T.REC/012/001185

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62442 0
Dr Mariam Omran Gras
Address 62442 0
Faculty of Physical Therapy-Cairo University
Address:7 Ahmed Elzaiat St.BenElsaryat EI Dokki-Giza-.
Postal Code:12612
Country 62442 0
Egypt
Phone 62442 0
+20 2-01281940603
Fax 62442 0
Email 62442 0
[email protected]
Contact person for public queries
Name 62443 0
Mariam Omran Gras
Address 62443 0
Faculty of Physical Therapy-Cairo University
Address:7 Ahmed Elzaiat St.BenElsaryat EI Dokki-Giza-.
Postal Code:12612
Country 62443 0
Egypt
Phone 62443 0
+20 2-01281940603
Fax 62443 0
Email 62443 0
[email protected]
Contact person for scientific queries
Name 62444 0
Mariam Omran Gras
Address 62444 0
Faculty of Physical Therapy-Cairo University
Address:7 Ahmed Elzaiat St.BenElsaryat EI Dokki-Giza-.
Postal Code:12612
Country 62444 0
Egypt
Phone 62444 0
+20 2-01281940603
Fax 62444 0
Email 62444 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInter-relationships between cervical angles, muscle activity levels and mechanical neck pain.2018https://dx.doi.org/10.3923/jms.2018.11.19
N.B. These documents automatically identified may not have been verified by the study sponsor.