Clinical trial NCT06741605: Biomechanical Risk Factors of Cervical Pain in Pregnant Women
Official title: Biomechanical Risk Factors of Cervical Pain in Pregnant Women
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 116
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They will be selected from the departments of obstetrics and gynecology at Sinhout Hospital and Minya Elkamh Central Hospital, El-Sharqia Governorate, Egypt.

Brief summary: The purpose of the study is to assess the biomechanical risk factors for neck pain in pregnant women.

Detailed description: Neck pain during pregnancy has significant physical, psychological, and social impacts on women's lives. Moreover, the economic burden of neck pain is remarkable and includes treatment costs, reduced productivity, and job-related problems. Untreated neck pain during pregnancy can potentially lead to chronic musculoskeletal problems postpartum.

The significance of the study is based on the concept of "early prediction for early mitigation of the risk and prevention of the onset or progression".

Studies have investigated risk factors for neck pain. However, there is a notable gap in research regarding these factors in pregnant women, especially physical (biomechanical) risk factors, despite the significant biomechanical changes they undergo during pregnancy. This study aims to fill this gap by investigating the relationship between biomechanical risk factors and neck pain in pregnant women.

To our knowledge, this is the first study in which this relationship will be assessed to provide evidence about the biomechanical risk factors for neck pain in pregnant women.

Eligibility criteria: Inclusion Criteria:

* Pregnant women in their third trimester suffering from cervical pain.
* They have experienced cervical pain starting during pregnancy.
* They reported no neck pain or neck-related disorders during the previous year and were screened for the absence of cervical pathology during a physical examination.

Exclusion Criteria:

* Objective signs of structural pathology on physical examination, including but not limited to shoulder bursitis, impingement, tendonitis, fracture, cervical nerve or disc impairment, radiculopathy, or loss of upper extremity sensory or motor function.
* Acute injury of the neck or shoulders (\<12 weeks before the study).
* History of fibromyalgia or musculoskeletal pain present in more than 4 body regions concurrently.
* Self-reported systemic illness, including cancer, rheumatic, cardiovascular, or neurological disease
* Untreated psychiatric condition
* Previous surgery involving the cervical spine or shoulders
* Uncontrolled hypertension (resting systolic blood pressure \>150 mm Hg, or diastolic blood pressure \>90 mm Hg).

Primary outcomes:
measure: Pain intensity
timeFrame: 2 months
measure: Measurement of trigger points
timeFrame: 2 months
Secondary outcomes:
measure: Measurement of craniovertebral angle (CVA)
timeFrame: 2 months
measure: Measurement of cervical flexion range of motion (ROM)
timeFrame: 2 months
measure: Measurement of cervical extension range of motion (ROM)
timeFrame: 2 months
measure: Measurement of cervical lateral flexion range of motion (ROM)
timeFrame: 2 months
measure: Measurement of cervical rotation range of motion (ROM)
timeFrame: 2 months
measure: Assessment of neck disability
timeFrame: 2 months
measure: Measuring breast size
timeFrame: 2 months
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Doaa Ahmed Fadel
Study officials:
affiliation: Al-Azhar University
name: Hossam Hussien, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Doaa Osman, Professor
role: STUDY_CHAIR
References: