Cervical Myofascial Pain SyndromeNCT06221085
The Influence of Body Mass Index and Smartphone Overuse on Cervical Myofascial Pain: A Cross-sectional Study
An observational study of Cervical Myofascial Pain Syndrome and Smartphone Addiction, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 26 years, women only
- Conditions the study is for
- Cervical Myofascial Pain Syndrome, Smartphone Addiction, Body Weight
- What is being tested?
- Pain Pressure Threshold (PPT)
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 18 Jan 2024to 29 Apr 2024
- 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 19 to 26 years
- Women only
- Adult
Study population: A study will be conducted on 90 female students from Jazan University
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Pain Pressure Threshold (PPT)
- Medical subject headings
- Internet Addiction Disorder, Body Weight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Pressure Threshold (PPT)Diagnostic test
Also called PPTs
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.
| Study group | Role | What they receive |
|---|---|---|
| normal BMI | 30 female students who have normal BMI <25kg/m2. Receives: Diagnostic Test: Pain Pressure Threshold (PPT) | |
| overweight | 30 female students who are overweight and their BMI 25 - 30 kg/m2 Receives: Diagnostic Test: Pain Pressure Threshold (PPT) | |
| obese | 30 female students who are obese and their BMI > 30 kg/m2. Receives: Diagnostic Test: Pain Pressure Threshold (PPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two minutes
Secondary outcomes (3)
PPT of Upper Part of Sternocleidomastoid (SCM)
TrPs are in the upper part of the sternal division of the muscle near its insertion into the mastoid process.
Measured: two minutes
PPT of middle Part of Sternocleidomastoid (SCM)
TrPs are in the middle part of this division.
Measured: two minutes
PPT of lower Part of Sternocleidomastoid (SCM)
TrPs are at the lower end of this division, near its attachment to the sternum.
Measured: two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start18 Jan 2024
- Primary completion15 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Myofascial Pain SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wafaa Mahmoud Amin, University of Jazan
- Investigators
- Mohamed M. Ahmed, PHD, Study director, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221085
- Sponsor's protocol ID
- HAPO-10-Z-003
- Status last verified
- Jun 2024
- First submitted
- 13 Jan 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available upon official request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Body Mass Index and Smartphone Overuse on Cervical Myofascial Pain in College-aged Female Students: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06221085
- Acronym / sponsor ID
- HAPO-10-Z-003
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of JazanOther government
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal BMI | – | Diagnostic Test: Pain Pressure Threshold (PPT)30 female students who have normal BMI <25kg/m2. |
| overweight | – | Diagnostic Test: Pain Pressure Threshold (PPT)30 female students who are overweight and their BMI 25 - 30 kg/m2 |
| obese | – | Diagnostic Test: Pain Pressure Threshold (PPT)30 female students who are obese and their BMI > 30 kg/m2. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- A study will be conducted on 90 female students from Jazan University
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Pressure Threshold (PPT)Also: PPTsResearchers 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. | Diagnostic test | normal BMI, obese, overweight |
Primary outcome
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.
3 secondary outcomes
PPT of Upper Part of Sternocleidomastoid (SCM)
Time frame: two minutes
PPT of middle Part of Sternocleidomastoid (SCM)
Time frame: two minutes
PPT of lower Part of Sternocleidomastoid (SCM)
Time frame: two minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No. Data is available upon official request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed M. Ahmed, PHD study director
University of Jazan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Myofascial Pain Syndrome and Smartphone Addiction, run by University of Jazan at 1 site in Saudi Arabia.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PPT of upper fiber of trapezius muscle (time frame: two minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2024.