- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06221085
The Influence of Body Mass Index and Smartphone Overuse on Cervical Myofascial Pain: A Cross-sectional Study
The Influence of Body Mass Index and Smartphone Overuse on Cervical Myofascial Pain in College-aged Female Students: A Cross-sectional Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Materials and Methods
Study design:
This is an observational cross-sectional design will be conducted on female subjects from Applied Medical College, Jazan University, Kingdome of Saudi Arabia.
Participants:
A study will be conducted on 90 female students from Jazan University based on the following:
The study will be conducted according to the tenets of the Declaration of Helsinki, and registered in the clinical registry after getting the ethical approval from the Standing Committee for Scientific Research at Jazan University. The sample size is determined using G-Power software (Universities, Düsseldorf, Germany) with a power of 80%, a p-value of 0.05, and an effect size of 0.5. A sample size of 75 (25 individuals in each group) individuals will be included in the study, and to compensate for the dropout rate, the sample size will be increased by 20% in each group to be 30 individuals in each group. The Participants will be divided according to the BMI into three groups: Group I: 30 female students who have normal BMI <25kg/m2. Group II: 30 female students who are overweight and their BMI 25 - 30 kg/m2. Group III: 30 female students who are obese and their BMI > 30 kg/m2.
Measurements:
Body mass index assessment and calculation:
Investigators will measure the height of the participants using a stadiometer with a calibrated analog scale and the weight using a Breuer electronic scale with an accuracy of 0.01 kg.
Pain Pressure Threshold (PPT):
The examiner identifies a trigger point by palpating and applying vertical pressure to the skin. Once identified, the clinician guides the tip of Pressure gauge algometer (PGA) between the finger and thumb to avoid slipping along rounded contours. The clinician applies it perpendicular to the long axis of the structure on which it is placed. The examiner increases the pressure at a rate of 1 kg/s until the subject feels pain or discomfort, and then the PPT values are measured three times for each muscle. Participants verbally report the first sensation of pain or discomfort, at which point the examiner stops the pressure.
PPT of upper fiber of trapezius muscle: The upper trapezius trigger point is located in the more horizontal fibers of the upper trapezius at the back of the shoulder, about halfway between the spine and the acromion.
Sternocleidomastoid (SCM) PPT:
TrPs are in the upper part of the sternal division of the muscle, near its insertion into the mastoid process. TrPs are in the middle part of this division. TrPs are at the lower end of this division, near its attachment to the sternum.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wafaa M Amin
- Phone Number: +966596211342
- Email: wafaa_770@yahoo.com
Study Locations
-
-
Jazan
-
Riyadh, Jazan, Saudi Arabia, 45142
- Recruiting
- Jazan University
-
Contact:
- Wafaa M Amin, Ph.D
- Phone Number: 00966596211342
- Email: wafaa_770@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age between 19 and 26 years.
- Participants who send at least 25 text messages or emails per day.
- Use their smartphone to browse the Internet, and/or play games for more than one hour per day.
- If participants score on the Smartphone Addiction Scale (SAPS) > 40 points.
- Right dominant hand.
Exclusion Criteria:
Any subject will be excluded from the study if they meet one or more of the following criteria:
- Neck musculoskeletal trauma.
- Congenital deformities.
- Surgical or neurological disease.
- History of neck injury, and pregnancy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
normal BMI
30 female students who have normal BMI <25kg/m2.
|
Researchers measure pain pressure thresholds (PPTs) by applying a Pressure gauge algometer (PGA) over the myofascial trigger points (TrPs) on the body. PPT is defined as the lowest stimulus intensity at which a subject perceives pain. The clinician applies it perpendicular to the long axis of the structure on which it is placed. The examiner increases the pressure at a rate of 1 kg/s until the subject feels pain or discomfort, and then the PPT values are measured three times for each muscle. Participants verbally report the first sensation of pain or discomfort, at which point the examiner stops the pressure.
Other Names:
|
overweight
30 female students who are overweight and their BMI 25 - 30 kg/m2
|
Researchers measure pain pressure thresholds (PPTs) by applying a Pressure gauge algometer (PGA) over the myofascial trigger points (TrPs) on the body. PPT is defined as the lowest stimulus intensity at which a subject perceives pain. The clinician applies it perpendicular to the long axis of the structure on which it is placed. The examiner increases the pressure at a rate of 1 kg/s until the subject feels pain or discomfort, and then the PPT values are measured three times for each muscle. Participants verbally report the first sensation of pain or discomfort, at which point the examiner stops the pressure.
Other Names:
|
obese
30 female students who are obese and their BMI > 30 kg/m2.
|
Researchers measure pain pressure thresholds (PPTs) by applying a Pressure gauge algometer (PGA) over the myofascial trigger points (TrPs) on the body. PPT is defined as the lowest stimulus intensity at which a subject perceives pain. The clinician applies it perpendicular to the long axis of the structure on which it is placed. The examiner increases the pressure at a rate of 1 kg/s until the subject feels pain or discomfort, and then the PPT values are measured three times for each muscle. Participants verbally report the first sensation of pain or discomfort, at which point the examiner stops the pressure.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PPT of upper fiber of trapezius muscle
Time Frame: two minutes
|
The upper trapezius trigger point is located in the more horizontal fibers of the upper trapezius at the back of the shoulder, about halfway between the spine and the acromion.
|
two minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PPT of Upper Part of Sternocleidomastoid (SCM)
Time Frame: two minutes
|
TrPs are in the upper part of the sternal division of the muscle near its insertion into the mastoid process.
|
two minutes
|
PPT of middle Part of Sternocleidomastoid (SCM)
Time Frame: two minutes
|
TrPs are in the middle part of this division.
|
two minutes
|
PPT of lower Part of Sternocleidomastoid (SCM)
Time Frame: two minutes
|
TrPs are at the lower end of this division, near its attachment to the sternum.
|
two minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed M. Ahmed, PHD, Jazan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAPO-10-Z-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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