The Influence of Body Mass Index and Smartphone Overuse on Cervical Myofascial Pain: A Cross-sectional Study

February 3, 2024 updated by: Wafaa Mahmoud Amin, University of Jazan

The Influence of Body Mass Index and Smartphone Overuse on Cervical Myofascial Pain in College-aged Female Students: A Cross-sectional Study

An observational cross-sectional study will be conducted on 90 female students (right dominant) aged 19-26 years at Jazan University, they will have 40 points or more on Smartphone Addiction Proneness Scale (SAPS) and will be divided into three groups (30 students for each): Group I (BMI<25kg/m2), Group II (BMI 25-30kg/m2), and Group III (BMI >30 kg/m2). Pain pressure thresholds were measured using a pressure gauge algometer (PGA) over trigger points in the neck muscles.

Study Overview

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

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Jazan
      • Riyadh, Jazan, Saudi Arabia, 45142
        • Recruiting
        • Jazan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

A study will be conducted on 90 female students from Jazan University

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • PPTs
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:
  • PPTs
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:
  • PPTs

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Mohamed M. Ahmed, PHD, Jazan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2024

Primary Completion (Estimated)

February 15, 2024

Study Completion (Estimated)

February 29, 2024

Study Registration Dates

First Submitted

January 13, 2024

First Submitted That Met QC Criteria

January 13, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available upon official request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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