Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06741605

Biomechanical Risk Factors of Cervical Pain in Pregnant Women

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Doaa Ahmed Fadel

Zagazig, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Pain intensity

    Time frame: 2 months

    The 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).

  2. Measurement of trigger points

    Time frame: 2 months

    Pressure 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 outcomes

  1. Measurement of craniovertebral angle (CVA)

    Time frame: 2 months

    Posture 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

  2. Measurement of cervical flexion range of motion (ROM)

    Time frame: 2 months

    Place 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

  3. Measurement of cervical extension range of motion (ROM)

    Time frame: 2 months

    Place 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°.

  4. Measurement of cervical lateral flexion range of motion (ROM)

    Time frame: 2 months

    The 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°

  5. Measurement of cervical rotation range of motion (ROM)

    Time frame: 2 months

    The 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°.

  6. Assessment of neck disability

    Time frame: 2 months

    The 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

  7. Measuring breast size

    Time frame: 2 months

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Nagy, PHD

CONTACT

[email protected]

+201021177871

Doaa Fadel, Master

CONTACT

[email protected]

+201013791440

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.