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Biomechanical Risk Factors of Cervical Pain in Pregnant Women

Biomechanical Risk Factors of Cervical Pain in Pregnant Women

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06741605
Enrollment
116
Registered
2024-12-19
Start date
2024-12-20
Completion date
2025-03-01
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Pain

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.

Interventions

None listed

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Pain intensity2 monthsThe VAS will be used to assess cervical pain for each pregnant woman. It is a pain rating scale, whose scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-no pain on the left end (0 cm) of the scale and worst pain on the right end of the scale (10 cm).
Measurement of trigger points2 monthsPressure algometer will be used to assess the trigger points of the neck muscles of each pregnant woman in the study. It will be placed perpendicularly to the fibers of the upper trapezius muscle, bilaterally, exactly over the myofascial trigger points. These points were pressed until the pain is reported, and the value displayed on the equipment's display will be recorded in kg/cm2.

Secondary

MeasureTime frameDescription
Measurement of cervical extension range of motion (ROM)2 monthsPlace the goniometer's axis over the external auditory meatus before using it. Place the stationary arm perpendicular to the floor or vertically. Place the movable arm in line with the nose's base. This should be noted as 0°.To assess cervical extension: ask the patient to look upwards as far as possible, until full extension of the neck is achieved. Normal cervical extension is usually 50°.
Measurement of cervical lateral flexion range of motion (ROM)2 monthsThe goniometer fulcrum will be aligned over the spinous process of the C7. The fixed arm of the goniometer will be aligned vertically along the imaginary line between the two acromion processes. The movable arm will be aligned over the external occipital protuberance. Ask the patient to tilt his/her head laterally to the left, without rotating the head, while her shoulders remain fix. Repeat the procedure for the opposite side and note the angle of flexion of the head. Normal flexion from starting point on either side is 45°
Measurement of craniovertebral angle (CVA)2 monthsPosture screen analysis mobile application will be used to measure the CVA for each pregnant woman The CVA is the best indicator of forward head posture. To determine this angle, two references are defined: One line runs from the swallow of the ear to the seventh cervical vertebra (C7) and another horizontal line parallel to the ground passes only through the spinous apophysis of C7. An angle of less than 50°-53° may indicate FHP. Thereby, the smaller the CVA, the greater the disability
Assessment of neck disability2 monthsThe neck disability index will be used to assess neck disability for each pregnant woman. It is a well-validated 10-item questionnaire, with each item rated on a 0 to 5-point scale. The sum of the 10 items gives a score between 0-50. The lower the score, the less self-rated the disability. 0-4 = no disability, 5-14 = mild disability, 15-24 = moderate disability, 25-34 = severe disability, and 35 or over = complete disability
Measuring breast size2 monthsThe breast size will be measured by using tape around torso on the level of the nipple to determine if breast size is a risk factor for cervical pain.
Measurement of cervical rotation range of motion (ROM)2 monthsThe goniometer fulcrum will be aligned over the center of the subject's head, the fixed arm of the goniometer will be aligned with an imaginary line between the subject's acromion processes and the movable arm will be aligned with the tip of the subject's nose. Ask the patient to rotate his/her head to the left as far as possible without tilting or tipping his/her head. Stabilize the shoulders by lightly pressing onto them. Repeat the process for the opposite direction. Normal rotation is approximately 80°.
Measurement of cervical flexion range of motion (ROM)2 monthsPlace the goniometer's axis over the external auditory meatus before using it. Place the stationary arm perpendicular to the floor or vertically. Place the movable arm in line with the nose's base. This should be noted as 0°. To assess cervical flexion: ask the patient to nod forward and bring their chin towards their chest. Normal cervical flexion is usually approximately 80º

Countries

Egypt

Contacts

Primary ContactDoaa Fadel, Master
doaaahmedfadel@gmail.com+201013791440
Backup ContactAmira Nagy, PHD
Amira.nagy@rochetmail.com+201021177871

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026